Trial Outcomes & Findings for Testing the Addition of the Anti-cancer Drug, Tazemetostat, to (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment (NCT NCT04557956)
NCT ID: NCT04557956
Last Updated: 2026-09-01
Results Overview
In the phase I portion of the study, eligible patients with dual BRAF/MEK inhibitor-resistant BRAFV600-mutated metastatic melanoma will be treated with escalating doses of tazemetostat plus dabrafenib and trametinib. The maximum tolerated dose (MTD) is defined as the highest dose level at which ≤1 out of 6 subjects experience a Dose Limiting Toxicity (DLT). The MTD will be the recommended phase 2 dose (RP2D) for the expansion cohort. The RP2D will be determined using the standard 3+3 algorithm. Toxicities by grade, number of cycles administered, and response to treatment will be listed for each dose level.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
The DLT observation window is 30 days
Results posted on
2026-09-01
Participant Flow
Participant milestones
| Measure |
Phase I; Dose Level 1 (Tazemetostat, Dabrafenib, Trametinib)
Patients receive tazemetostat 400mg PO BID, dabrafenib 150 mg PO BID, and trametinib 2 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase I; Dose Level 2 (Tazemetostat, Dabrafenib, Trametinib)
Patients receive tazemetostat 600mg PO BID, dabrafenib 150 mg PO BID, and trametinib 2 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase I; Dose Level 3 (Tazemetostat, Dabrafenib, Trametinib)
Patients receive tazemetostat 800mg PO BID, dabrafenib 150 mg PO BID, and trametinib 2 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase II, Arm 1 (Tazemetostat)
Patients receive tazemetostat PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI throughout the study. At the time of progression, patients may crossover to Arm 2 after completion of radiation therapy.
|
Phase II, Arm 2 (Tazemetostat, Dabrafenib, Trametinib)
Patients receive tazemetostat PO BID, dabrafenib PO BID, and trametinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
6
|
0
|
0
|
|
Overall Study
COMPLETED
|
3
|
5
|
5
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I; Dose Level 1 (Tazemetostat, Dabrafenib, Trametinib)
Patients receive tazemetostat 400mg PO BID, dabrafenib 150 mg PO BID, and trametinib 2 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase I; Dose Level 2 (Tazemetostat, Dabrafenib, Trametinib)
Patients receive tazemetostat 600mg PO BID, dabrafenib 150 mg PO BID, and trametinib 2 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase I; Dose Level 3 (Tazemetostat, Dabrafenib, Trametinib)
Patients receive tazemetostat 800mg PO BID, dabrafenib 150 mg PO BID, and trametinib 2 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase II, Arm 1 (Tazemetostat)
Patients receive tazemetostat PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI throughout the study. At the time of progression, patients may crossover to Arm 2 after completion of radiation therapy.
|
Phase II, Arm 2 (Tazemetostat, Dabrafenib, Trametinib)
Patients receive tazemetostat PO BID, dabrafenib PO BID, and trametinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Still in follow up
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Testing the Addition of the Anti-cancer Drug, Tazemetostat, to (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment
Baseline characteristics by cohort
| Measure |
Phase I; Dose Level 1 (Tazemetostat, Dabrafenib, Trametinib)
n=4 Participants
Patients receive tazemetostat 400mg PO BID, dabrafenib 150mg PO BID, and trametinib 2mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase I; Dose Level 2 (Tazemetostat, Dabrafenib, Trametinib)
n=6 Participants
Patients receive tazemetostat 600mg PO BID, dabrafenib 150mg PO BID, and trametinib 2mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase I; Dose Level 3 (Tazemetostat, Dabrafenib, Trametinib)
n=6 Participants
Patients receive tazemetostat 800mg PO BID, dabrafenib 150mg PO BID, and trametinib 2mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase II, Arm 1 (Tazemetostat)
Patients receive tazemetostat PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI throughout the study. At the time of progression, patients may crossover to Arm 2 after completion of radiation therapy.
|
Phase II, Arm 2 (Tazemetostat, Dabrafenib, Trametinib)
Patients receive tazemetostat PO BID, dabrafenib PO BID, and trametinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
—
|
—
|
0 Participants
n=1601978 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=14 Participants
|
6 Participants
n=36 Participants
|
4 Participants
n=324 Participants
|
—
|
—
|
14 Participants
n=1601978 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=324 Participants
|
—
|
—
|
2 Participants
n=1601978 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=14 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=324 Participants
|
—
|
—
|
8 Participants
n=1601978 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=14 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=324 Participants
|
—
|
—
|
8 Participants
n=1601978 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=324 Participants
|
—
|
—
|
1 Participants
n=1601978 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=14 Participants
|
6 Participants
n=36 Participants
|
5 Participants
n=324 Participants
|
—
|
—
|
15 Participants
n=1601978 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
—
|
—
|
0 Participants
n=1601978 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
—
|
—
|
0 Participants
n=1601978 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
—
|
—
|
0 Participants
n=1601978 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
—
|
—
|
0 Participants
n=1601978 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
—
|
—
|
0 Participants
n=1601978 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=14 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=324 Participants
|
—
|
—
|
16 Participants
n=1601978 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
—
|
—
|
0 Participants
n=1601978 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
—
|
—
|
0 Participants
n=1601978 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=14 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
—
|
16 Participants
n=1601978 Participants
|
PRIMARY outcome
Timeframe: The DLT observation window is 30 daysPopulation: All patients in each dose level were treated and observed for DLTs. No patients were enrolled in the Phase II portion of this study. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. The frequency of patients with the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
In the phase I portion of the study, eligible patients with dual BRAF/MEK inhibitor-resistant BRAFV600-mutated metastatic melanoma will be treated with escalating doses of tazemetostat plus dabrafenib and trametinib. The maximum tolerated dose (MTD) is defined as the highest dose level at which ≤1 out of 6 subjects experience a Dose Limiting Toxicity (DLT). The MTD will be the recommended phase 2 dose (RP2D) for the expansion cohort. The RP2D will be determined using the standard 3+3 algorithm. Toxicities by grade, number of cycles administered, and response to treatment will be listed for each dose level.
Outcome measures
| Measure |
Phase I; Dose Level 1 (Tazemetostat, Dabrafenib, Trametinib)
n=4 Participants
Patients receive tazemetostat 400mg PO BID, dabrafenib 150mg PO BID, and trametinib 2mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase I; Dose Level 2 (Tazemetostat, Dabrafenib, Trametinib)
n=6 Participants
Patients receive tazemetostat 600mg PO BID, dabrafenib 150mg PO BID, and trametinib 2mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase I; Dose Level 3 (Tazemetostat, Dabrafenib, Trametinib)
n=6 Participants
Patients receive tazemetostat 800mg PO BID, dabrafenib 150mg PO BID, and trametinib 2mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase II, Arm 1 (Tazemetostat)
Patients receive tazemetostat PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI throughout the study. At the time of progression, patients may crossover to Arm 2 after completion of radiation therapy.
|
Phase II, Arm 2 (Tazemetostat, Dabrafenib, Trametinib)
Patients receive tazemetostat PO BID, dabrafenib PO BID, and trametinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
|---|---|---|---|---|---|
|
Recommended Phase 2 Dose (Phase I)
Tazemetostat (BID)
|
800 milligrams
|
800 milligrams
|
800 milligrams
|
—
|
—
|
|
Recommended Phase 2 Dose (Phase I)
Dabrafenib (BID)
|
300 milligrams
|
300 milligrams
|
300 milligrams
|
—
|
—
|
|
Recommended Phase 2 Dose (Phase I)
Trametinib (QD)
|
2 milligrams
|
2 milligrams
|
2 milligrams
|
—
|
—
|
PRIMARY outcome
Timeframe: At 6 and 12 monthsPopulation: No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed. Therefore, PFS can not be determined.
Median PFS in each arm will be assessed using Kaplan-Meier product limit methods and the randomized arms will be compared using log-rank test (at 0.15 one-sided significance level) when 36 PFS events are observed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: In DL 1, 1 patient went off study prior to being dosed. In DL2 and DL3 1 patient went off study during Cycle 1 (DL2 and DL3). In each of these cases, no imaging was obtained to assess for response. No patients were enrolled in the Phase II portion of this study.
Assessed by Response Evaluation Criteria in Solid Tumors 1.1, and 95% confidence intervals will be calculated. Response assessments were performed every 3 months. Responses were categorized as follows: Complete Response (CR); disappearance of all target lesions, Partial Response (PR); at least a 30% decrease in the sum of target lesions, Progressive Disease (PD); at least a 20% increase in the sum of target lesions, Stable Disease (SD); to enough increase to be PR, nor enough decrease to be PD.
Outcome measures
| Measure |
Phase I; Dose Level 1 (Tazemetostat, Dabrafenib, Trametinib)
n=4 Participants
Patients receive tazemetostat 400mg PO BID, dabrafenib 150mg PO BID, and trametinib 2mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase I; Dose Level 2 (Tazemetostat, Dabrafenib, Trametinib)
n=6 Participants
Patients receive tazemetostat 600mg PO BID, dabrafenib 150mg PO BID, and trametinib 2mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase I; Dose Level 3 (Tazemetostat, Dabrafenib, Trametinib)
n=6 Participants
Patients receive tazemetostat 800mg PO BID, dabrafenib 150mg PO BID, and trametinib 2mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase II, Arm 1 (Tazemetostat)
Patients receive tazemetostat PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI throughout the study. At the time of progression, patients may crossover to Arm 2 after completion of radiation therapy.
|
Phase II, Arm 2 (Tazemetostat, Dabrafenib, Trametinib)
Patients receive tazemetostat PO BID, dabrafenib PO BID, and trametinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
|---|---|---|---|---|---|
|
Overall Response Rates (Complete Response, Partial Response)
Complete Response (CR)
|
0 percentage of participants
Interval 0.0 to 62.0
|
0 percentage of participants
Interval 0.0 to 48.0
|
0 percentage of participants
Interval 0.0 to 48.0
|
—
|
—
|
|
Overall Response Rates (Complete Response, Partial Response)
Partial Response (PR)
|
0 percentage of participants
Interval 0.0 to 62.0
|
16.67 percentage of participants
Interval 0.3 to 66.0
|
0 percentage of participants
Interval 0.0 to 48.0
|
—
|
—
|
|
Overall Response Rates (Complete Response, Partial Response)
Stable Disease (SD)
|
0 percentage of participants
Interval 0.0 to 62.0
|
50 percentage of participants
Interval 11.0 to 89.0
|
16.67 percentage of participants
Interval 0.3 to 66.0
|
—
|
—
|
|
Overall Response Rates (Complete Response, Partial Response)
Progressive Disease (PD)
|
75 percentage of participants
Interval 18.0 to 99.0
|
16.67 percentage of participants
Interval 0.3 to 66.0
|
66.67 percentage of participants
Interval 21.0 to 96.0
|
—
|
—
|
|
Overall Response Rates (Complete Response, Partial Response)
Missing
|
25 percentage of participants
Interval 1.0 to 82.0
|
16.67 percentage of participants
Interval 0.3 to 66.0
|
16.67 percentage of participants
Interval 0.3 to 66.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
Will be estimated in each arm using Kaplan-Meier product limit methods, and its 95% confidence interval will be calculated.
Outcome measures
| Measure |
Phase I; Dose Level 1 (Tazemetostat, Dabrafenib, Trametinib)
n=4 Participants
Patients receive tazemetostat 400mg PO BID, dabrafenib 150mg PO BID, and trametinib 2mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase I; Dose Level 2 (Tazemetostat, Dabrafenib, Trametinib)
n=6 Participants
Patients receive tazemetostat 600mg PO BID, dabrafenib 150mg PO BID, and trametinib 2mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase I; Dose Level 3 (Tazemetostat, Dabrafenib, Trametinib)
n=6 Participants
Patients receive tazemetostat 800mg PO BID, dabrafenib 150mg PO BID, and trametinib 2mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase II, Arm 1 (Tazemetostat)
Patients receive tazemetostat PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI throughout the study. At the time of progression, patients may crossover to Arm 2 after completion of radiation therapy.
|
Phase II, Arm 2 (Tazemetostat, Dabrafenib, Trametinib)
Patients receive tazemetostat PO BID, dabrafenib PO BID, and trametinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
|---|---|---|---|---|---|
|
Overall Survival
|
3.5 months
Interval 0.8 to
The upper boundary of 95% CI cannot be estimated due to small sample size.
|
27.2 months
Interval 2.4 to
The upper boundary of 95% CI cannot be estimated due to small sample size.
|
7.2 months
Interval 3.0 to
The upper boundary of 95% CI cannot be estimated due to small sample size.
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsToxicity evaluation will be descriptive, and standard toxicity definitions and criteria will be used as outlined in the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The number and percentage of subjects experiencing each type of adverse event will be tabulated by severity. If appropriate, confidence intervals will be used to characterize the precision of the estimate. A complete listing of adverse events will also be tabulated, and will provide details including severity, relationship to treatment, onset, duration, and outcome. Laboratory data measured on a continuous scale will be characterized by summary statistics (mean and standard deviation).
Outcome measures
Outcome data not reported
Adverse Events
Phase I; Dose Level 1 (Tazemetostat, Dabrafenib, Trametinib)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 4 deaths
Phase I; Dose Level 2 (Tazemetostat, Dabrafenib, Trametinib)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 4 deaths
Phase I; Dose Level 3 (Tazemetostat, Dabrafenib, Trametinib)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 4 deaths
Phase II, Arm 1 (Tazemetostat)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase II, Arm 2 (Tazemetostat, Dabrafenib, Trametinib)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I; Dose Level 1 (Tazemetostat, Dabrafenib, Trametinib)
n=4 participants at risk
Patients receive tazemetostat 400mg PO BID, dabrafenib 150mg PO BID, and trametinib 2mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase I; Dose Level 2 (Tazemetostat, Dabrafenib, Trametinib)
n=6 participants at risk
Patients receive tazemetostat 600mg PO BID, dabrafenib 150mg PO BID, and trametinib 2mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase I; Dose Level 3 (Tazemetostat, Dabrafenib, Trametinib)
n=6 participants at risk
Patients receive tazemetostat 800mg PO BID, dabrafenib 150mg PO BID, and trametinib 2mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase II, Arm 1 (Tazemetostat)
Patients receive tazemetostat PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI throughout the study. At the time of progression, patients may crossover to Arm 2 after completion of radiation therapy.
|
Phase II, Arm 2 (Tazemetostat, Dabrafenib, Trametinib)
Patients receive tazemetostat PO BID, dabrafenib PO BID, and trametinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Gastric Obstruction
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Injury, poisoning and procedural complications
Tumor Hemorrhage
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Nervous system disorders
Delirium
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Renal and urinary disorders
Dehydration
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
Other adverse events
| Measure |
Phase I; Dose Level 1 (Tazemetostat, Dabrafenib, Trametinib)
n=4 participants at risk
Patients receive tazemetostat 400mg PO BID, dabrafenib 150mg PO BID, and trametinib 2mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase I; Dose Level 2 (Tazemetostat, Dabrafenib, Trametinib)
n=6 participants at risk
Patients receive tazemetostat 600mg PO BID, dabrafenib 150mg PO BID, and trametinib 2mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase I; Dose Level 3 (Tazemetostat, Dabrafenib, Trametinib)
n=6 participants at risk
Patients receive tazemetostat 800mg PO BID, dabrafenib 150mg PO BID, and trametinib 2mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
Phase II, Arm 1 (Tazemetostat)
Patients receive tazemetostat PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI throughout the study. At the time of progression, patients may crossover to Arm 2 after completion of radiation therapy.
|
Phase II, Arm 2 (Tazemetostat, Dabrafenib, Trametinib)
Patients receive tazemetostat PO BID, dabrafenib PO BID, and trametinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
2/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Blood and lymphatic system disorders
Eosiniphilia
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Cardiac disorders
Sinus Tachycardia
|
50.0%
2/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Eye disorders
Blurred vision
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Eye disorders
Diplopia
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
66.7%
4/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Dry Mouth
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Dry heaves
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Esphogeal spasm
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Gastric obstruction
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Gastroesphageal reflux disease
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
66.7%
4/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
66.7%
4/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Gastrointestinal disorders
Vomiting
|
75.0%
3/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
66.7%
4/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
General disorders
Chills
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
66.7%
4/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
General disorders
Edema limbs
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
100.0%
6/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
83.3%
5/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
General disorders
Fever
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
83.3%
5/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
50.0%
3/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
General disorders
Flu-like symptoms
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
General disorders
Pain
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Infections and infestations
Inferior lip sore
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Infections and infestations
Thrush
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Investigations
Alkaline Phosphatase increased
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
50.0%
3/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Investigations
Creatine Phosphokinase increased
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Investigations
Gamma-Glutamyl Transferase increased
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Investigations
Increased appetite
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Investigations
Lymphocyte count decreased
|
75.0%
3/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
50.0%
3/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Investigations
Teeth sensitivity
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Investigations
Thyroid stimulating hormone increased
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Investigations
Weight gain
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Investigations
Weight loss
|
50.0%
2/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Investigations
White blood cell decreased
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
100.0%
6/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
66.7%
4/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
2/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
33.3%
2/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limp
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
66.7%
4/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Nervous system disorders
Parasthesia
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Nervous system disorders
Right arm apraxia
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Nervous system disorders
Right arm coldness
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Nervous system disorders
Slow cognition
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Nervous system disorders
Sommnolence
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Psychiatric disorders
Dementia
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Renal and urinary disorders
Urinary frequncy
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Renal and urinary disorders
Urinary retention
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Renal and urinary disorders
Urinary urgency
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Reproductive system and breast disorders
Labial dysfunction
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Reproductive system and breast disorders
Urinary hesitancy
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
50.0%
3/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Skin and subcutaneous tissue disorders
Skin discoloration
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Vascular disorders
Hot flashes
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
16.7%
1/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
|
Vascular disorders
Thromboembolic event
|
25.0%
1/4 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
0.00%
0/6 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
—
0/0 • Adverse events are collected from the first dose of study medication (cycle 1 day 1) through 30 days after study completion for up to 3 years. Any patients who are removed from study for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event.
No patients were enrolled in the Phase II portion of this study due to several factors. 1. There was a change in clinical practice that made the population of BRAF mutated patients who progress on BRAF therapy more rare. 2. The frequency of patients that have the biomarker for enrollment is even more rare. It was determined that it would take too long to enroll the necessary patients and the Phase II portion of the trial was deemed unfeasible as designed.
|
Additional Information
Dr. Tanner M Johanns
Washington University School of Medicine
Phone: 3142732723
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60