Trial Outcomes & Findings for Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer (NCT NCT02393690)
NCT ID: NCT02393690
Last Updated: 2024-07-26
Results Overview
A patient will be classified as a responder if they have a partial or complete response at the 6-month time point when compared to the baseline, pre-study radiologic scan(s). A Complete Response (CR) is defined as the disappearance of all target lesions and thyroglobulin measured to be less than 0.2 ng/ml. A Partial Response (PR) is defined as at least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the long or short axis of all the target lymph nodes (depending on which axis is being used for assessments) at current evaluation) taking as reference the baseline sum of dimensions (BSD). \> \> A patient will be classified as a responder if they have a partial or complete response at the 6-month time point. The proportion of patients with a response will be calculated and compared between the 2 Arms using a Fisher's Exact test.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
At 6 months
Results posted on
2024-07-26
Participant Flow
Participant milestones
| Measure |
Arm I (Selumetinib, Iodine I-131)
Patients receive 75 mg selumetinib PO BID starting on week 1, day 1 and continuing through 2 days after iodine I 131 therapy has been administered. Approximately 3 weeks after beginning treatment with selumetinib, patients receive iodine I-131 PO.
|
Arm II (Placebo, Iodine I-131)
Patients receive placebo PO BID starting on week 1, day 1 and continuing through 2 days after iodine I-131 therapy has been administered. Approximately 3 weeks after beginning treatment with placebo, patients receive iodine I-131 PO.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
30
|
|
Overall Study
COMPLETED
|
28
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Arm I (Selumetinib, Iodine I-131)
Patients receive 75 mg selumetinib PO BID starting on week 1, day 1 and continuing through 2 days after iodine I 131 therapy has been administered. Approximately 3 weeks after beginning treatment with selumetinib, patients receive iodine I-131 PO.
|
Arm II (Placebo, Iodine I-131)
Patients receive placebo PO BID starting on week 1, day 1 and continuing through 2 days after iodine I-131 therapy has been administered. Approximately 3 weeks after beginning treatment with placebo, patients receive iodine I-131 PO.
|
|---|---|---|
|
Overall Study
Ineligible
|
0
|
1
|
Baseline Characteristics
Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Selumetinib, Iodine I-131)
n=28 Participants
Patients receive 75 mg selumetinib PO BID starting on week 1, day 1 and continuing through 2 days after iodine I 131 therapy has been administered. Approximately 3 weeks after beginning treatment with selumetinib, patients receive iodine I-131 PO.
|
Arm II (Placebo, Iodine I-131)
n=29 Participants
Patients receive placebo PO BID starting on week 1, day 1 and continuing through 2 days after iodine I-131 therapy has been administered. Approximately 3 weeks after beginning treatment with placebo, patients receive iodine I-131 PO.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=99 Participants
|
61 years
n=107 Participants
|
62 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
29 participants
n=107 Participants
|
57 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: All patients that began protocol treatment and were evaluable for this endpoint are included.
A patient will be classified as a responder if they have a partial or complete response at the 6-month time point when compared to the baseline, pre-study radiologic scan(s). A Complete Response (CR) is defined as the disappearance of all target lesions and thyroglobulin measured to be less than 0.2 ng/ml. A Partial Response (PR) is defined as at least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the long or short axis of all the target lymph nodes (depending on which axis is being used for assessments) at current evaluation) taking as reference the baseline sum of dimensions (BSD). \> \> A patient will be classified as a responder if they have a partial or complete response at the 6-month time point. The proportion of patients with a response will be calculated and compared between the 2 Arms using a Fisher's Exact test.
Outcome measures
| Measure |
Arm I (Selumetinib, Iodine I-131)
n=28 Participants
Patients receive 75 mg selumetinib PO BID starting on week 1, day 1 and continuing through 2 days after iodine I 131 therapy has been administered. Approximately 3 weeks after beginning treatment with selumetinib, patients receive iodine I-131 PO.
|
Arm II (Placebo, Iodine I-131)
n=29 Participants
Patients receive placebo PO BID starting on week 1, day 1 and continuing through 2 days after iodine I-131 therapy has been administered. Approximately 3 weeks after beginning treatment with placebo, patients receive iodine I-131 PO.
|
|---|---|---|
|
Response at 6 Months
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All patients that began protocol treatment and were evaluable for this endpoint are included.
The best overall response rate will be compared between the two arms. This comparison will be done using a Fisher exact test. For a patient to be classified as a response, they need a partial or complete response that is confirmed at least 4 weeks later anytime during the study.
Outcome measures
| Measure |
Arm I (Selumetinib, Iodine I-131)
n=28 Participants
Patients receive 75 mg selumetinib PO BID starting on week 1, day 1 and continuing through 2 days after iodine I 131 therapy has been administered. Approximately 3 weeks after beginning treatment with selumetinib, patients receive iodine I-131 PO.
|
Arm II (Placebo, Iodine I-131)
n=29 Participants
Patients receive placebo PO BID starting on week 1, day 1 and continuing through 2 days after iodine I-131 therapy has been administered. Approximately 3 weeks after beginning treatment with placebo, patients receive iodine I-131 PO.
|
|---|---|---|
|
Overall Response Rate
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All patients that began protocol treatment and were evaluable for this endpoint are included.
PFS will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms.
Outcome measures
| Measure |
Arm I (Selumetinib, Iodine I-131)
n=28 Participants
Patients receive 75 mg selumetinib PO BID starting on week 1, day 1 and continuing through 2 days after iodine I 131 therapy has been administered. Approximately 3 weeks after beginning treatment with selumetinib, patients receive iodine I-131 PO.
|
Arm II (Placebo, Iodine I-131)
n=29 Participants
Patients receive placebo PO BID starting on week 1, day 1 and continuing through 2 days after iodine I-131 therapy has been administered. Approximately 3 weeks after beginning treatment with placebo, patients receive iodine I-131 PO.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
19 months
Interval 12.4 to
The upper limit of the confidence interval is not able to be estimated due to a low number of events.
|
10.2 months
Interval 6.8 to
The upper limit of the confidence interval is not able to be estimated due to a low number of events.
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All patients that began protocol treatment and were evaluable for this endpoint are included.
Changes in serum thyroglobulin levels will be compared between the 2 treatment arms by 6 month response using the Wilcoxon Rank-Sum test.
Outcome measures
| Measure |
Arm I (Selumetinib, Iodine I-131)
n=28 Participants
Patients receive 75 mg selumetinib PO BID starting on week 1, day 1 and continuing through 2 days after iodine I 131 therapy has been administered. Approximately 3 weeks after beginning treatment with selumetinib, patients receive iodine I-131 PO.
|
Arm II (Placebo, Iodine I-131)
n=29 Participants
Patients receive placebo PO BID starting on week 1, day 1 and continuing through 2 days after iodine I-131 therapy has been administered. Approximately 3 weeks after beginning treatment with placebo, patients receive iodine I-131 PO.
|
|---|---|---|
|
Changes in Serum Thyroglobulin Levels
|
-29.1 percent change from baseline
Standard Deviation 50.36
|
4.3 percent change from baseline
Standard Deviation 61.28
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All patients that began protocol treatment and were evaluable for this endpoint are included.
The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The number and percentage of patients experiencing grade 3+ adverse events will be compared between the 2 treatment arms.
Outcome measures
| Measure |
Arm I (Selumetinib, Iodine I-131)
n=28 Participants
Patients receive 75 mg selumetinib PO BID starting on week 1, day 1 and continuing through 2 days after iodine I 131 therapy has been administered. Approximately 3 weeks after beginning treatment with selumetinib, patients receive iodine I-131 PO.
|
Arm II (Placebo, Iodine I-131)
n=29 Participants
Patients receive placebo PO BID starting on week 1, day 1 and continuing through 2 days after iodine I-131 therapy has been administered. Approximately 3 weeks after beginning treatment with placebo, patients receive iodine I-131 PO.
|
|---|---|---|
|
Incidence of Adverse Events
|
6 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineWill explore the genomic and transcriptomic landscape of RAIA tumors for signatures that correlate to therapeutic benefit achieved in patients with RAI-avid recurrent and/or metastatic thyroid cancer treated with 131I in combination with placebo or selumetinib. Exploratory analysis will include correlating response to tumor genotypes. Descriptive statistics and graphical techniques will be used to summarize this data by treatment arm.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Selumetinib, Iodine I-131)
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Arm II (Placebo, Iodine I-131)
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Selumetinib, Iodine I-131)
n=28 participants at risk
Patients receive 75 mg selumetinib PO BID starting on week 1, day 1 and continuing through 2 days after iodine I 131 therapy has been administered. Approximately 3 weeks after beginning treatment with selumetinib, patients receive iodine I-131 PO.
|
Arm II (Placebo, Iodine I-131)
n=30 participants at risk
Patients receive placebo PO BID starting on week 1, day 1 and continuing through 2 days after iodine I-131 therapy has been administered. Approximately 3 weeks after beginning treatment with placebo, patients receive iodine I-131 PO.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/28 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/28 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
General disorders
Fatigue
|
0.00%
0/28 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
General disorders
Localized edema
|
0.00%
0/28 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Investigations
White blood cell decreased
|
3.6%
1/28 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
0.00%
0/30 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
0.00%
0/30 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/28 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
Other adverse events
| Measure |
Arm I (Selumetinib, Iodine I-131)
n=28 participants at risk
Patients receive 75 mg selumetinib PO BID starting on week 1, day 1 and continuing through 2 days after iodine I 131 therapy has been administered. Approximately 3 weeks after beginning treatment with selumetinib, patients receive iodine I-131 PO.
|
Arm II (Placebo, Iodine I-131)
n=30 participants at risk
Patients receive placebo PO BID starting on week 1, day 1 and continuing through 2 days after iodine I-131 therapy has been administered. Approximately 3 weeks after beginning treatment with placebo, patients receive iodine I-131 PO.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Eye disorders
Blurred vision
|
25.0%
7/28 • Number of events 11 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
10.0%
3/30 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Eye disorders
Retinopathy
|
3.6%
1/28 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
0.00%
0/30 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.6%
1/28 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Gastrointestinal disorders
Bloating
|
3.6%
1/28 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
0.00%
0/30 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/28 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Gastrointestinal disorders
Diarrhea
|
46.4%
13/28 • Number of events 19 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
33.3%
10/30 • Number of events 16 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/28 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
7.1%
2/28 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
0.00%
0/30 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/28 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Gastrointestinal disorders
Nausea
|
42.9%
12/28 • Number of events 16 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
30.0%
9/30 • Number of events 12 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
4/28 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
0.00%
0/30 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
General disorders
Fatigue
|
71.4%
20/28 • Number of events 50 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
63.3%
19/30 • Number of events 41 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
0.00%
0/28 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
General disorders
Localized edema
|
42.9%
12/28 • Number of events 22 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
10.0%
3/30 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
7/28 • Number of events 12 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
0.00%
0/30 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Investigations
Aspartate aminotransferase increased
|
35.7%
10/28 • Number of events 16 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/28 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
3.3%
1/30 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Investigations
Lymphocyte count decreased
|
3.6%
1/28 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Investigations
Neutrophil count decreased
|
17.9%
5/28 • Number of events 15 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Investigations
Platelet count decreased
|
32.1%
9/28 • Number of events 20 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
16.7%
5/30 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Investigations
Weight loss
|
3.6%
1/28 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
10.0%
3/30 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Investigations
White blood cell decreased
|
32.1%
9/28 • Number of events 26 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
13.3%
4/30 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
0.00%
0/30 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.6%
1/28 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
0.00%
0/30 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
0.00%
0/30 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/28 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Nervous system disorders
Headache
|
3.6%
1/28 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
0.00%
0/30 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
3.6%
1/28 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
0.00%
0/30 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
7/28 • Number of events 15 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
16.7%
5/30 • Number of events 16 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.6%
1/28 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
50.0%
14/28 • Number of events 24 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
10.0%
3/30 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
46.4%
13/28 • Number of events 21 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
0.00%
0/30 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
3.6%
1/28 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
0.00%
0/30 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
|
Vascular disorders
Hypertension
|
57.1%
16/28 • Number of events 44 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
50.0%
15/30 • Number of events 34 • Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
|
Additional Information
Alan Ho, M.D.
Academic and Community Cancer Research United (ACCRU)
Phone: 212-639-7202
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60