Trial Outcomes & Findings for BGJ398 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST) (NCT NCT02257541)
NCT ID: NCT02257541
Last Updated: 2020-03-30
Results Overview
The phase Ib will be pursued in standard 3+3 format, based on toxicities encountered during the first cycle of therapy.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
1 year
Results posted on
2020-03-30
Participant Flow
Participant milestones
| Measure |
Phase 1b, Dose Level -1
Phase 1b, Dose Level -1: BGJ398 50 mg
|
Phase 1b, Dose Level 1
Phase 1b, Dose Level 1: BGJ398 75 mg
|
Phase 1b, Dose Level 2
Phase 1b, Dose Level 2: BGJ398 100 mg
|
Phase 1b, Dose Level -2
Phase 1b, Dose Level -2: BGJ398 25 mg
|
Phase II
Phase II: BGJ398 75mg
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
8
|
1
|
3
|
1
|
|
Overall Study
COMPLETED
|
3
|
8
|
1
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BGJ398 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)
Baseline characteristics by cohort
| Measure |
Phase 1b, Dose Level -1
n=3 Participants
Phase 1b, Dose Level -1: BGJ398 50 mg
|
Phase 1b, Dose Level 1
n=8 Participants
Phase 1b, Dose Level 1: BGJ398 75 mg
|
Phase 1b, Dose Level 2
n=1 Participants
Phase 1b, Dose Level 2: BGJ398 100 mg
|
Phase 1b, Dose Level -2
n=3 Participants
Phase 1b, Dose Level -2: BGJ398 25 mg
|
Phase II
n=1 Participants
Phase II: BGJ398 75mg
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
58.88 years
n=7 Participants
|
44 years
n=5 Participants
|
53 years
n=4 Participants
|
53 years
n=21 Participants
|
54 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe phase Ib will be pursued in standard 3+3 format, based on toxicities encountered during the first cycle of therapy.
Outcome measures
| Measure |
Phase 1b, Dose Level -1
n=3 Participants
Phase 1b, Dose Level -1: BGJ398 50 mg
|
Phase 1b, Dose Level 1
n=8 Participants
Phase 1b, Dose Level 1: BGJ398 75 mg
|
Phase 1b, Dose Level 2
n=1 Participants
Phase 1b, Dose Level 2: BGJ398 100 mg
|
Phase 1b, Dose Level -2
n=3 Participants
Phase 1b, Dose Level -2: BGJ398 25 mg
|
|---|---|---|---|---|
|
Phase Ib Study: Number of Participants With Dose-Limiting Toxicities
|
3 Participants
|
8 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 32 weeks(CR+PR, RECIST 1.1) and by CHOI criteria PHASE 1b PARTICIPANTS ONLY Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Phase 1b, Dose Level -1
n=3 Participants
Phase 1b, Dose Level -1: BGJ398 50 mg
|
Phase 1b, Dose Level 1
n=8 Participants
Phase 1b, Dose Level 1: BGJ398 75 mg
|
Phase 1b, Dose Level 2
n=1 Participants
Phase 1b, Dose Level 2: BGJ398 100 mg
|
Phase 1b, Dose Level -2
n=3 Participants
Phase 1b, Dose Level -2: BGJ398 25 mg
|
|---|---|---|---|---|
|
Phase Ib Portion: Response Rate (RR)
Partial Response/PR
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase Ib Portion: Response Rate (RR)
Stable Disease/SD
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Phase Ib Portion: Response Rate (RR)
Progressive Disease/PD
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Phase Ib Portion: Response Rate (RR)
Not reported due to withdrawn from study
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 32 weeksdefined by RECIST 1.1 criteria and by CHOI criteria,and by EORTC criteria PHASE 1b PARTICIPANTS ONLY Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Phase 1b, Dose Level -1
n=3 Participants
Phase 1b, Dose Level -1: BGJ398 50 mg
|
Phase 1b, Dose Level 1
n=8 Participants
Phase 1b, Dose Level 1: BGJ398 75 mg
|
Phase 1b, Dose Level 2
n=1 Participants
Phase 1b, Dose Level 2: BGJ398 100 mg
|
Phase 1b, Dose Level -2
n=3 Participants
Phase 1b, Dose Level -2: BGJ398 25 mg
|
|---|---|---|---|---|
|
Phase Ib Study: Response Rate (RR)
Progressive Disease/PD
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Phase Ib Study: Response Rate (RR)
Stable Disease/SD
|
2 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Phase Ib Study: Response Rate (RR)
Not reported due to withdrawn from study
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Phase 1b, Dose Level -1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1b, Dose Level 1
Serious events: 7 serious events
Other events: 8 other events
Deaths: 3 deaths
Phase 1b, Dose Level 2:
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1b, Dose Level -2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase II
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1b, Dose Level -1
n=3 participants at risk
Phase 1b, Dose Level -1: BGJ398 50 mg
|
Phase 1b, Dose Level 1
n=8 participants at risk
Phase 1b, Dose Level 1: BGJ398 75 mg
|
Phase 1b, Dose Level 2:
n=1 participants at risk
Phase 1b, Dose Level 2: BGJ398 100 mg
|
Phase 1b, Dose Level -2
n=3 participants at risk
Phase 1b, Dose Level -2: BGJ398 25 mg
|
Phase II
n=1 participants at risk
Phase II: BGJ398 75mg
|
|---|---|---|---|---|---|
|
Investigations
CPK increased
|
33.3%
1/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
General disorders
Fatigue
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Intra-Abdominal Bleeding
|
0.00%
0/3 • 1 year
|
0.00%
0/8 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Ejection Fraction decreased
|
0.00%
0/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Lipase Increased
|
0.00%
0/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
Other adverse events
| Measure |
Phase 1b, Dose Level -1
n=3 participants at risk
Phase 1b, Dose Level -1: BGJ398 50 mg
|
Phase 1b, Dose Level 1
n=8 participants at risk
Phase 1b, Dose Level 1: BGJ398 75 mg
|
Phase 1b, Dose Level 2:
n=1 participants at risk
Phase 1b, Dose Level 2: BGJ398 100 mg
|
Phase 1b, Dose Level -2
n=3 participants at risk
Phase 1b, Dose Level -2: BGJ398 25 mg
|
Phase II
n=1 participants at risk
Phase II: BGJ398 75mg
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
3/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • 1 year
|
37.5%
3/8 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
AST Elevated
|
33.3%
1/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
66.7%
2/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
33.3%
1/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Cardiac disorders
Chest Pain - Cardiac
|
33.3%
1/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • 1 year
|
37.5%
3/8 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
CPK Increased
|
100.0%
3/3 • 1 year
|
50.0%
4/8 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Investigations
Creatinine Increased
|
33.3%
1/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Decreased TSH
|
33.3%
1/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • 1 year
|
37.5%
3/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Dry Mouth
|
33.3%
1/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
General disorders
Edema Limbs
|
33.3%
1/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
33.3%
1/3 • 1 year
|
0.00%
0/8 • 1 year
|
100.0%
1/1 • 1 year
|
33.3%
1/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
General disorders
Fatigue
|
66.7%
2/3 • 1 year
|
62.5%
5/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Eye disorders
Flashing Lights
|
33.3%
1/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
66.7%
2/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • 1 year
|
25.0%
2/8 • 1 year
|
100.0%
1/1 • 1 year
|
33.3%
1/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
1/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Lipase Increased
|
66.7%
2/3 • 1 year
|
37.5%
3/8 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
General disorders
Pain
|
33.3%
1/3 • 1 year
|
0.00%
0/8 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnea
|
33.3%
1/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • 1 year
|
0.00%
0/8 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/3 • 1 year
|
25.0%
2/8 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Eye disorders
Blurred Vision
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Eye disorders
Dry Eye
|
0.00%
0/3 • 1 year
|
25.0%
2/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • 1 year
|
25.0%
2/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 1 year
|
37.5%
3/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/3 • 1 year
|
25.0%
2/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 1 year
|
25.0%
2/8 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Serum amylase increased
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Weight gain
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Weight loss
|
0.00%
0/3 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • 1 year
|
0.00%
0/8 • 1 year
|
100.0%
1/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
General disorders
Fever
|
0.00%
0/3 • 1 year
|
0.00%
0/8 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
|
Eye disorders
Periorbital edema
|
0.00%
0/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
|
Eye disorders
Watering eyes
|
0.00%
0/3 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
Additional Information
Dr. William Tap, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4163
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place