Trial Outcomes & Findings for Testing Trametinib and Dabrafenib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol H) (NCT NCT04439292)
NCT ID: NCT04439292
Last Updated: 2026-05-19
Results Overview
ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
Results posted on
2026-05-19
Participant Flow
Subprotocol H was activated on August 12, 2015, and the expansion cohort was activated on October 2, 2020. Forty-four patients were enrolled on EAY131-H between January 4, 2016, and November 22, 2022. Twenty-four patients were enrolled on the basis of the results from the NCI-MATCH assay, and 20 on the basis of the outside assay results.
For subprotocol H, patients with BRAFV600-mutated malignancies were eligible. The mutation status was determined by an NCI-MATCH approved laboratory for 20 patients in this arm. These cases had to be centrally confirmed by the MATCH assay to be usable in the primary analysis.
Participant milestones
| Measure |
Treatment (Dabrafenib, Trametinib)
Patients receive dabrafenib mesylate 150 mg PO BID and trametinib dimethyl sulfoxide 2 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
Eligible, Treated and Mutation Status Confirmed
|
36
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
44
|
Reasons for withdrawal
| Measure |
Treatment (Dabrafenib, Trametinib)
Patients receive dabrafenib mesylate 150 mg PO BID and trametinib dimethyl sulfoxide 2 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Never Start Protocol Therapy
|
1
|
|
Overall Study
Ineligible
|
3
|
|
Overall Study
Still on Therapy
|
3
|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Death
|
1
|
|
Overall Study
Disease Progression
|
19
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Patient Non Compliance
|
1
|
Baseline Characteristics
Testing Trametinib and Dabrafenib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol H)
Baseline characteristics by cohort
| Measure |
Treatment (Dabrafenib, Trametinib)
n=36 Participants
Patients receive dabrafenib mesylate 150 mg PO BID and trametinib dimethyl sulfoxide 2 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
59.5 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registrationPopulation: Eligible, treated and mutation status confirmed
ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR.
Outcome measures
| Measure |
Treatment (Dabrafenib, Trametinib)
n=36 Participants
Patients receive dabrafenib mesylate 150 mg PO BID and trametinib dimethyl sulfoxide 2 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Objective Response Rate (ORR)
|
36.1 percentage of participants
Interval 22.9 to 51.2
|
SECONDARY outcome
Timeframe: Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration, from which 6-month PFS rate is determinedPopulation: Eligible, treated and mutation status confirmed
Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point.
Outcome measures
| Measure |
Treatment (Dabrafenib, Trametinib)
n=36 Participants
Patients receive dabrafenib mesylate 150 mg PO BID and trametinib dimethyl sulfoxide 2 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
6-month Progression-free Survival (PFS) Rate
|
67.6 percentage of participants
Interval 54.5 to 80.8
|
SECONDARY outcome
Timeframe: Assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registrationPopulation: Eligible, treated and mutation status confirmed
PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression.
Outcome measures
| Measure |
Treatment (Dabrafenib, Trametinib)
n=36 Participants
Patients receive dabrafenib mesylate 150 mg PO BID and trametinib dimethyl sulfoxide 2 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-Free Survival
|
11.4 months
Interval 6.6 to 15.6
|
Adverse Events
Treatment (Dabrafenib, Trametinib)
Serious events: 23 serious events
Other events: 43 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Treatment (Dabrafenib, Trametinib)
n=43 participants at risk
Patients receive dabrafenib mesylate 150 mg PO BID and trametinib dimethyl sulfoxide 2 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
General disorders
Fatigue
|
7.0%
3/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
4.7%
2/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Gastrointestinal disorders
Diarrhea
|
4.7%
2/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Gastrointestinal disorders
Small intestine ulcer
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Infections and infestations
Lung infection
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Infections and infestations
Sepsis
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Infections and infestations
Wound infection
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
Alanine aminotransferase increased
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
Alkaline phosphatase increased
|
4.7%
2/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
Aspartate aminotransferase increased
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
Ejection fraction decreased
|
4.7%
2/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
INR increased
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
Lymphocyte count decreased
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
Neutrophil count decreased
|
9.3%
4/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
Platelet count decreased
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
White blood cell decreased
|
9.3%
4/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.0%
3/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.7%
2/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Nervous system disorders
Dizziness
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Nervous system disorders
Syncope
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Vascular disorders
Hypertension
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Vascular disorders
Hypotension
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Vascular disorders
Thromboembolic event
|
2.3%
1/43 • Number of events 23 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
Other adverse events
| Measure |
Treatment (Dabrafenib, Trametinib)
n=43 participants at risk
Patients receive dabrafenib mesylate 150 mg PO BID and trametinib dimethyl sulfoxide 2 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
25.6%
11/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
9.3%
4/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
General disorders
Chills
|
48.8%
21/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
General disorders
Edema limbs
|
16.3%
7/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
General disorders
Fatigue
|
69.8%
30/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
General disorders
Fever
|
46.5%
20/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
General disorders
Flu like symptoms
|
7.0%
3/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
General disorders
Malaise
|
7.0%
3/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.3%
4/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.0%
6/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
14.0%
6/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
27.9%
12/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
27.9%
12/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Gastrointestinal disorders
Constipation
|
7.0%
3/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Gastrointestinal disorders
Diarrhea
|
16.3%
7/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Gastrointestinal disorders
Dry mouth
|
11.6%
5/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Gastrointestinal disorders
Nausea
|
53.5%
23/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Gastrointestinal disorders
Vomiting
|
27.9%
12/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
7.0%
3/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
Alanine aminotransferase increased
|
18.6%
8/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
Alkaline phosphatase increased
|
37.2%
16/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
Aspartate aminotransferase increased
|
34.9%
15/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
Creatinine increased
|
11.6%
5/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
Ejection fraction decreased
|
16.3%
7/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
Lymphocyte count decreased
|
14.0%
6/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
Neutrophil count decreased
|
18.6%
8/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
Platelet count decreased
|
20.9%
9/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
Weight loss
|
7.0%
3/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Investigations
White blood cell decreased
|
20.9%
9/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Metabolism and nutrition disorders
Anorexia
|
11.6%
5/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Metabolism and nutrition disorders
Dehydration
|
9.3%
4/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.0%
6/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
18.6%
8/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.0%
3/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.3%
4/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.3%
7/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.3%
4/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.0%
6/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.0%
6/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.6%
5/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Nervous system disorders
Dizziness
|
18.6%
8/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Nervous system disorders
Headache
|
27.9%
12/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Nervous system disorders
Paresthesia
|
7.0%
3/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Eye disorders
Blurred vision
|
11.6%
5/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Eye disorders
Eye disorders - Other, specify
|
7.0%
3/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.6%
8/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.6%
8/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
|
Vascular disorders
Hypertension
|
16.3%
7/43 • Number of events 43 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60