Trial Outcomes & Findings for Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers (NCT NCT00074308)
NCT ID: NCT00074308
Last Updated: 2018-06-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2018-06-20
Participant Flow
Participant milestones
| Measure |
Phase 1 - Dose 1
Bevacizumab (5 mg/kg) Imatinib (400 mg/day)
|
Phase 1 Dose 2
Bevacizumab (10 mg/kg) Imatinib (400 mg/day)
|
Phase 1 Dose 3
Bevacizumab (10 mg/kg) Imatinib (600 mg/day)
|
Phase 1 Dose 4
Bevacizumab (10 mg/kg) Imatinib (800 mg/day)
|
Phase 2
Bevacizumab (10 mg/kg) Imatinib (400 mg/day)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
8
|
23
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
8
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers
Baseline characteristics by cohort
| Measure |
Phase 1
n=17 Participants
Patients receive oral imatinib mesylate once or twice daily (400-800 mg/day) on days 1-28 and bevacizumab IV (5-10mg/kg) over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase 2
n=23 Participants
Patients receive oral imatinib mesylate once or twice daily (400 mg/day) on days 1-28 and bevacizumab IV (10mg/kg) over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptance toxicity.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Arm 1 · <=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Arm 1 · Between 18 and 65 years
|
17 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Age, Categorical
Arm 1 · >=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Arm 1 · Female
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Arm 1 · Male
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysOutcome measures
| Measure |
Phase 1 = Dose Escalation
n=17 Participants
Patients receive oral imatinib mesylate once or twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
bevacizumab: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
MTD, Defined as One Dose Level Below the Dose That Induced DLT in at Least One Third of Patients at a Dose Level, Graded According to NCI CTCAE Version 3.0 (Phase I)
|
2 dose level
|
PRIMARY outcome
Timeframe: 16 weeksProgression Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Phase 1 = Dose Escalation
n=23 Participants
Patients receive oral imatinib mesylate once or twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
bevacizumab: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Progression-free Survival at 16 Weeks (Phase II)
|
8 Participants
|
SECONDARY outcome
Timeframe: 8 weeksResponse and progression was evaluated in this study using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
Phase 1 = Dose Escalation
n=23 Participants
Patients receive oral imatinib mesylate once or twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
bevacizumab: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Response Rate at 8 Weeks, Evaluated Using RECIST (Phase II)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Data not collected
Kaplan-Meier estimates of overall survival and 95% confidence intervals will be calculated.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1 - Dose 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 Dose 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 Dose 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 Dose 4
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Phase 1 - Dose 1
n=3 participants at risk
Bevacizumab (5 mg/kg) Imatinib (400 mg/day)
|
Phase 1 Dose 2
n=3 participants at risk
Bevacizumab (10 mg/kg) Imatinib (400 mg/day)
|
Phase 1 Dose 3
n=3 participants at risk
Bevacizumab (10 mg/kg) Imatinib (600 mg/day)
|
Phase 1 Dose 4
n=8 participants at risk
Bevacizumab (10 mg/kg) Imatinib (800 mg/day)
|
Phase 2
n=23 participants at risk
Bevacizumab (10 mg/kg) Imatinib (400 mg/day)
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood and lympathic system disorders
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Cardiac disorders
Hypertension
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/8 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/23 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/8 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/23 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Gastrointestinal disorders
Nausea/vomiting
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/23 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Renal and urinary disorders
Renal insufficiency
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/23 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/8 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/8 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
Other adverse events
| Measure |
Phase 1 - Dose 1
n=3 participants at risk
Bevacizumab (5 mg/kg) Imatinib (400 mg/day)
|
Phase 1 Dose 2
n=3 participants at risk
Bevacizumab (10 mg/kg) Imatinib (400 mg/day)
|
Phase 1 Dose 3
n=3 participants at risk
Bevacizumab (10 mg/kg) Imatinib (600 mg/day)
|
Phase 1 Dose 4
n=8 participants at risk
Bevacizumab (10 mg/kg) Imatinib (800 mg/day)
|
Phase 2
n=23 participants at risk
Bevacizumab (10 mg/kg) Imatinib (400 mg/day)
|
|---|---|---|---|---|---|
|
General disorders
Weight gain
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Psychiatric disorders
Anorexia
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
General disorders
Weight loss
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/23 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/23 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Cardiac disorders
Hypertension
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/23 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/23 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
General disorders
Cough
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
General disorders
Edema
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
General disorders
Fatigue
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
General disorders
Fever
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
General disorders
Flushing
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
General disorders
Nausea/vomiting
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Renal and urinary disorders
Renal insufficiency
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
0.00%
0/3 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
12.5%
1/8 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
4.3%
1/23 • Number of events 1 • Grades 1 and 2 events are included as non-serious. Grade 3 and 4 events are included as serious
|
Additional Information
Jane Daly
Abramson Cancer Center of the University of Pennsylvania
Phone: 215-662-2812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60