Trial Outcomes & Findings for ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer (NCT NCT01489865)
NCT ID: NCT01489865
Last Updated: 2025-11-06
Results Overview
Protocol defined events that are definitely, possibly or probably related to one or both agents and have occurred in the first cycle of therapy. Applies only to patients in the Phase I portion of the study.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
64 participants
Primary outcome timeframe
28 days
Results posted on
2025-11-06
Participant Flow
Participant milestones
| Measure |
Phase 1: ABT-888 40mg (Cohort 1)
ABT-888 orally at 40mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6 with 5-FU bolus:
Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IVon Day 1; 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hoursDays 1-3
|
Phase 1: ABT-888 60 mg (Cohort 2)
ABT-888 orally at 60mg twice a day for Days 1-7 of each 14-day cycle. mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3
|
Phase 1: ABT-888 80 mg (Cohort 3)
ABT-888 orally at 80 mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3
|
Phase 1: ABT-888 100 mg (Cohort 4)
ABT-888 orally at 100mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3
|
Phase 1: ABT-888 150 mg (Cohort 5)
ABT-888 orally at 150mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3
|
Phase 1: ABT-888 200 mg (Cohort 6)
ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3
|
Phase 1: ABT-888 250 mg (Cohort 7)
ABT-888 orally at 250mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3
|
Phase 1: ABT-888 300 mg (Cohort 8)
ABT-888 orally at 300mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3
|
Phase 2: ABT-888 at Recommended Phase 2 Dose (200mg)
ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
3
|
3
|
3
|
7
|
6
|
0
|
33
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
3
|
3
|
3
|
7
|
6
|
0
|
32
|
Reasons for withdrawal
| Measure |
Phase 1: ABT-888 40mg (Cohort 1)
ABT-888 orally at 40mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6 with 5-FU bolus:
Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IVon Day 1; 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hoursDays 1-3
|
Phase 1: ABT-888 60 mg (Cohort 2)
ABT-888 orally at 60mg twice a day for Days 1-7 of each 14-day cycle. mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3
|
Phase 1: ABT-888 80 mg (Cohort 3)
ABT-888 orally at 80 mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3
|
Phase 1: ABT-888 100 mg (Cohort 4)
ABT-888 orally at 100mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3
|
Phase 1: ABT-888 150 mg (Cohort 5)
ABT-888 orally at 150mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3
|
Phase 1: ABT-888 200 mg (Cohort 6)
ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3
|
Phase 1: ABT-888 250 mg (Cohort 7)
ABT-888 orally at 250mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3
|
Phase 1: ABT-888 300 mg (Cohort 8)
ABT-888 orally at 300mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3
|
Phase 2: ABT-888 at Recommended Phase 2 Dose (200mg)
ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Progression of Disease
|
4
|
2
|
2
|
3
|
1
|
6
|
3
|
0
|
23
|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
5
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
2
|
|
Overall Study
Shifted
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Phase 1: ABT-888 60 mg (Cohort 2)
n=3 Participants
ABT-888 orally at 60mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 80 mg (Cohort 3)
n=3 Participants
ABT-888 orally at 80mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 100 mg (Cohort 4)
n=3 Participants
ABT-888 orally at 100mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 150 mg (Cohort 5)
n=3 Participants
ABT-888 orally at 150mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 200 mg (Cohort 6)
n=7 Participants
ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 250 mg (Cohort 7)
n=6 Participants
ABT-888 orally at 250mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 40mg (Cohort 1)
n=6 Participants
ABT-888 orally at 40mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6 with 5-FU bolus mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 2: ABT-888 atRecommended Phase 2 Dose (200mg)
n=33 Participants
ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
>=65 years
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
3 Participants
n=12 Participants
|
2 Participants
n=51 Participants
|
2 Participants
n=51 Participants
|
3 Participants
n=49 Participants
|
13 Participants
n=51 Participants
|
25 Participants
n=75 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=75 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=50 Participants
|
3 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
0 Participants
n=12 Participants
|
5 Participants
n=51 Participants
|
4 Participants
n=51 Participants
|
3 Participants
n=49 Participants
|
20 Participants
n=51 Participants
|
39 Participants
n=75 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=51 Participants
|
1 Participants
n=51 Participants
|
2 Participants
n=49 Participants
|
17 Participants
n=51 Participants
|
27 Participants
n=75 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=12 Participants
|
5 Participants
n=51 Participants
|
5 Participants
n=51 Participants
|
4 Participants
n=49 Participants
|
16 Participants
n=51 Participants
|
37 Participants
n=75 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=51 Participants
|
2 Participants
n=75 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=50 Participants
|
3 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=12 Participants
|
7 Participants
n=51 Participants
|
6 Participants
n=51 Participants
|
6 Participants
n=49 Participants
|
30 Participants
n=51 Participants
|
60 Participants
n=75 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=49 Participants
|
2 Participants
n=51 Participants
|
2 Participants
n=75 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=75 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=49 Participants
|
2 Participants
n=51 Participants
|
2 Participants
n=75 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=75 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=51 Participants
|
1 Participants
n=51 Participants
|
0 Participants
n=49 Participants
|
7 Participants
n=51 Participants
|
11 Participants
n=75 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=50 Participants
|
3 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=12 Participants
|
5 Participants
n=51 Participants
|
5 Participants
n=51 Participants
|
6 Participants
n=49 Participants
|
23 Participants
n=51 Participants
|
49 Participants
n=75 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=75 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=51 Participants
|
2 Participants
n=75 Participants
|
PRIMARY outcome
Timeframe: 28 daysProtocol defined events that are definitely, possibly or probably related to one or both agents and have occurred in the first cycle of therapy. Applies only to patients in the Phase I portion of the study.
Outcome measures
| Measure |
Phase 1: ABT-888 60 mg (Cohort 2)
n=3 Participants
ABT-888 orally at 60mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 80 mg (Cohort 3)
n=3 Participants
ABT-888 orally at 80mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 100 mg (Cohort 4)
n=3 Participants
ABT-888 orally at 100mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 150 mg (Cohort 5)
n=3 Participants
ABT-888 orally at 150mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 200 mg (Cohort 6)
n=7 Participants
ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 250 mg (Cohort 7)
n=6 Participants
ABT-888 orally at 250mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 40mg (Cohort 1)
n=6 Participants
ABT-888 orally at 40mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6 with 5-FU bolus mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 2: ABT-888 at Recommended Phase 2 Dose (200mg)
ABT-888 orally at 200mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Dose Limiting Toxicities
|
0 Dose Limiting Toxicities
|
0 Dose Limiting Toxicities
|
0 Dose Limiting Toxicities
|
0 Dose Limiting Toxicities
|
0 Dose Limiting Toxicities
|
4 Dose Limiting Toxicities
|
3 Dose Limiting Toxicities
|
—
|
PRIMARY outcome
Timeframe: 6 monthsNumber of Participants in Phase II with a Complete response and Partial response as determined by RECIST 1.1.
Outcome measures
| Measure |
Phase 1: ABT-888 60 mg (Cohort 2)
ABT-888 orally at 60mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 80 mg (Cohort 3)
ABT-888 orally at 80mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 100 mg (Cohort 4)
ABT-888 orally at 100mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 150 mg (Cohort 5)
ABT-888 orally at 150mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 200 mg (Cohort 6)
ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 250 mg (Cohort 7)
ABT-888 orally at 250mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 40mg (Cohort 1)
n=33 Participants
ABT-888 orally at 40mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6 with 5-FU bolus mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 2: ABT-888 at Recommended Phase 2 Dose (200mg)
ABT-888 orally at 200mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
|---|---|---|---|---|---|---|---|---|
|
Phase II: Objective Response Rate (ORR)
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: response-evaluable patients
DCR is defined as the number of patients with a complete response, partial response, or stable disease at 6 months per Recist 1.1.
Outcome measures
| Measure |
Phase 1: ABT-888 60 mg (Cohort 2)
n=3 Participants
ABT-888 orally at 60mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 80 mg (Cohort 3)
n=3 Participants
ABT-888 orally at 80mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 100 mg (Cohort 4)
n=3 Participants
ABT-888 orally at 100mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 150 mg (Cohort 5)
n=3 Participants
ABT-888 orally at 150mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 200 mg (Cohort 6)
n=7 Participants
ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 250 mg (Cohort 7)
n=6 Participants
ABT-888 orally at 250mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 40mg (Cohort 1)
n=6 Participants
ABT-888 orally at 40mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6 with 5-FU bolus mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 2: ABT-888 at Recommended Phase 2 Dose (200mg)
n=33 Participants
ABT-888 orally at 200mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: up to 114 monthsPFS is defined as the number of days from enrollment to progression or death, whichever occurred first.
Outcome measures
| Measure |
Phase 1: ABT-888 60 mg (Cohort 2)
n=3 Participants
ABT-888 orally at 60mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 80 mg (Cohort 3)
n=3 Participants
ABT-888 orally at 80mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 100 mg (Cohort 4)
n=3 Participants
ABT-888 orally at 100mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 150 mg (Cohort 5)
n=3 Participants
ABT-888 orally at 150mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 200 mg (Cohort 6)
n=7 Participants
ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 250 mg (Cohort 7)
n=6 Participants
ABT-888 orally at 250mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 40mg (Cohort 1)
n=6 Participants
ABT-888 orally at 40mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6 with 5-FU bolus mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 2: ABT-888 at Recommended Phase 2 Dose (200mg)
n=33 Participants
ABT-888 orally at 200mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
49 days
Interval 42.0 to 58.0
|
159 days
Interval 91.0 to 948.0
|
77 days
Interval 56.0 to 106.0
|
132 days
Interval 37.0 to 671.0
|
148 days
Interval 33.0 to 209.0
|
60.5 days
Interval 49.0 to 122.0
|
126.5 days
Interval 65.0 to 509.0
|
102 days
Interval 15.0 to 3431.0
|
SECONDARY outcome
Timeframe: up to 114 monthsThe number of days from enrollment until death or last contact. Patients who were alive at the time of analysis were censored at their last contact.
Outcome measures
| Measure |
Phase 1: ABT-888 60 mg (Cohort 2)
n=3 Participants
ABT-888 orally at 60mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 80 mg (Cohort 3)
n=3 Participants
ABT-888 orally at 80mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 100 mg (Cohort 4)
n=3 Participants
ABT-888 orally at 100mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 150 mg (Cohort 5)
n=3 Participants
ABT-888 orally at 150mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 200 mg (Cohort 6)
n=7 Participants
ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 250 mg (Cohort 7)
n=6 Participants
ABT-888 orally at 250mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 40mg (Cohort 1)
n=6 Participants
ABT-888 orally at 40mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6 with 5-FU bolus mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 2: ABT-888 at Recommended Phase 2 Dose (200mg)
n=33 Participants
ABT-888 orally at 200mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6:
Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival
|
89 days
Interval 58.0 to 169.0
|
325 days
Interval 159.0 to 948.0
|
294 days
Interval 146.0 to 320.0
|
211 days
Interval 37.0 to 671.0
|
176 days
Interval 104.0 to 319.0
|
145.5 days
Interval 49.0 to 336.0
|
153 days
Interval 89.0 to 750.0
|
260 days
Interval 15.0 to 3431.0
|
Adverse Events
Phase 1: ABT-888 40mg (Cohort 1)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 6 deaths
Phase 1: ABT-888 60 mg (Cohort 2)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1: ABT-888 80 mg (Cohort 3)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1: ABT-888 100 mg (Cohort 4)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1: ABT-888 150 mg (Cohort 5)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1: ABT-888 200 mg (Cohort 6)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 7 deaths
Phase 1: ABT-888 250 mg (Cohort 7)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 6 deaths
Phase 2: ABT-888 at Recommended Phase 2 Dose (200mg)
Serious events: 12 serious events
Other events: 32 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Phase 1: ABT-888 40mg (Cohort 1)
n=6 participants at risk
ABT-888 orally at 40mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6 with 5-FU bolus mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 60 mg (Cohort 2)
n=3 participants at risk
ABT-888 orally at 60mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 80 mg (Cohort 3)
n=3 participants at risk
ABT-888 orally at 80mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 100 mg (Cohort 4)
n=3 participants at risk
ABT-888 orally at 100mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 150 mg (Cohort 5)
n=3 participants at risk
ABT-888 orally at 150mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 200 mg (Cohort 6)
n=6 participants at risk；n=7 participants at risk
ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 250 mg (Cohort 7)
n=7 participants at risk；n=6 participants at risk
ABT-888 orally at 250mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 2: ABT-888 at Recommended Phase 2 Dose (200mg)
n=33 participants at risk
ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
9.1%
3/33 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/33 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/33 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
6.1%
2/33 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
6.1%
2/33 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
2/6 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/33 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
6.1%
2/33 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/33 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Investigations
Sepsis
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/33 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
Other adverse events
| Measure |
Phase 1: ABT-888 40mg (Cohort 1)
n=6 participants at risk
ABT-888 orally at 40mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6 with 5-FU bolus mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 60 mg (Cohort 2)
n=3 participants at risk
ABT-888 orally at 60mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 80 mg (Cohort 3)
n=3 participants at risk
ABT-888 orally at 80mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 100 mg (Cohort 4)
n=3 participants at risk
ABT-888 orally at 100mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 150 mg (Cohort 5)
n=3 participants at risk
ABT-888 orally at 150mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 200 mg (Cohort 6)
n=6 participants at risk；n=7 participants at risk
ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 1: ABT-888 250 mg (Cohort 7)
n=7 participants at risk；n=6 participants at risk
ABT-888 orally at 250mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
Phase 2: ABT-888 at Recommended Phase 2 Dose (200mg)
n=33 participants at risk
ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
66.7%
2/3 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/33 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
66.7%
2/3 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
66.7%
2/3 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
66.7%
4/6 • Number of events 6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
28.6%
2/7 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
27.3%
9/33 • Number of events 9 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
66.7%
2/3 • Number of events 4 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
2/6 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
28.6%
2/7 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
27.3%
9/33 • Number of events 10 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
2/6 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
1/6 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
12.1%
4/33 • Number of events 4 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Gastrointestinal disorders
Gastroparesis
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/33 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
15.2%
5/33 • Number of events 5 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Number of events 4 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
66.7%
2/3 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
100.0%
3/3 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
100.0%
3/3 • Number of events 4 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
66.7%
2/3 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
66.7%
4/6 • Number of events 4 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
57.1%
4/7 • Number of events 6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
75.8%
25/33 • Number of events 38 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
66.7%
2/3 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
100.0%
3/3 • Number of events 5 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
50.0%
3/6 • Number of events 4 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
28.6%
2/7 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
42.4%
14/33 • Number of events 18 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
General disorders
Edema limbs
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
66.7%
2/3 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
14.3%
1/7 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
6.1%
2/33 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 5 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
100.0%
3/3 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
66.7%
2/3 • Number of events 4 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
100.0%
3/3 • Number of events 4 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
66.7%
2/3 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
66.7%
4/6 • Number of events 5 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
42.9%
3/7 • Number of events 4 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
69.7%
23/33 • Number of events 29 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
14.3%
1/7 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
9.1%
3/33 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
General disorders
Pain
|
33.3%
2/6 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
66.7%
2/3 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
66.7%
4/6 • Number of events 5 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
14.3%
1/7 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
6.1%
2/33 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
12.1%
4/33 • Number of events 4 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
15.2%
5/33 • Number of events 10 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
2/6 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
15.2%
5/33 • Number of events 10 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Investigations
Lymphocyte count decreased
|
66.7%
4/6 • Number of events 5 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
6.1%
2/33 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Investigations
Neutrophil count decreased
|
66.7%
4/6 • Number of events 7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 4 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
50.0%
3/6 • Number of events 9 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
42.9%
3/7 • Number of events 5 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
21.2%
7/33 • Number of events 16 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Investigations
Platelet count decreased
|
50.0%
3/6 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 11 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
66.7%
2/3 • Number of events 6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
50.0%
3/6 • Number of events 4 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
42.9%
3/7 • Number of events 7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
6.1%
2/33 • Number of events 5 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Investigations
Weight loss
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
9.1%
3/33 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Investigations
White blood cell decreased
|
50.0%
3/6 • Number of events 4 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
50.0%
3/6 • Number of events 9 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
42.9%
3/7 • Number of events 5 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
6.1%
2/33 • Number of events 7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
66.7%
2/3 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
2/6 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
36.4%
12/33 • Number of events 14 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
6.1%
2/33 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
6.1%
2/33 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
14.3%
1/7 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
9.1%
3/33 • Number of events 4 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Nervous system disorders
Dysesthesia
|
33.3%
2/6 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
100.0%
3/3 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
50.0%
3/6 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
18.2%
6/33 • Number of events 6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
15.2%
5/33 • Number of events 5 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
14.3%
1/7 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
15.2%
5/33 • Number of events 5 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Nervous system disorders
Paresthesia
|
33.3%
2/6 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
14.3%
1/7 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
27.3%
9/33 • Number of events 10 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
6.1%
2/33 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
6.1%
2/33 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
14.3%
1/7 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
6.1%
2/33 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
16.7%
1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
9.1%
3/33 • Number of events 4 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Vascular disorders
Hypertension
|
33.3%
2/6 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
3.0%
1/33 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
18.2%
6/33 • Number of events 6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
2/6 • Number of events 6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
14.3%
1/7 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
9.1%
3/33 • Number of events 4 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
|
Eye disorders
Blurred vision
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
33.3%
1/3 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/3 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/6 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
0.00%
0/7 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
6.1%
2/33 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
|
Additional Information
Benjamin Weinberg, MD
Lombardi Comprehensive Cancer Center
Phone: 202-444-2223
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place