Trial Outcomes & Findings for Veliparib, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed or Refractory Lymphoma, Multiple Myeloma, or Solid Tumors (NCT NCT01326702)
NCT ID: NCT01326702
Last Updated: 2019-12-16
Results Overview
Maximum Tolerated Dose (MTD) reflects the highest dose of Veliparib when combined with Bendamustine Hydrochloride that did not cause a DLT. The maximum tolerated dose (MTD) was defined as the highest dose level at which 33% of patients experienced DLT.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
43 participants
Primary outcome timeframe
28 days
Results posted on
2019-12-16
Participant Flow
Participant milestones
| Measure |
Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg
Bendamustine 70 mg/m2, ABT-888 50 mg
|
Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
Bendamustine 90 mg/m2, ABT-888 50 mg
|
Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
Bendamustine 90 mg/m2, ABT-888 100 mg BID
|
Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
Bendamustine 90 mg/m2, ABT-888 150 mg BID
|
Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
Bendamustine 90 mg/m2, ABT-888 200 mg BID
|
Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
Bendamustine 90 mg/m2, ABT-888 300 mg BID
|
Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
Bendamustine 90 mg/m2, ABT-888 400 mg BID
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
4
|
5
|
15
|
7
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
7
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
5
|
3
|
4
|
8
|
7
|
Reasons for withdrawal
| Measure |
Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg
Bendamustine 70 mg/m2, ABT-888 50 mg
|
Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
Bendamustine 90 mg/m2, ABT-888 50 mg
|
Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
Bendamustine 90 mg/m2, ABT-888 100 mg BID
|
Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
Bendamustine 90 mg/m2, ABT-888 150 mg BID
|
Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
Bendamustine 90 mg/m2, ABT-888 200 mg BID
|
Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
Bendamustine 90 mg/m2, ABT-888 300 mg BID
|
Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
Bendamustine 90 mg/m2, ABT-888 400 mg BID
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Other
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
progressive disease
|
1
|
1
|
3
|
1
|
3
|
2
|
3
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
1
|
1
|
3
|
|
Overall Study
Not Treated
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Veliparib, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed or Refractory Lymphoma, Multiple Myeloma, or Solid Tumors
Baseline characteristics by cohort
| Measure |
Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg
n=3 Participants
Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg
|
Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
n=3 Participants
Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
|
Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
n=6 Participants
Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
|
Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
n=4 Participants
Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
|
Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
n=5 Participants
Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
|
Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
n=15 Participants
Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
|
Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
n=7 Participants
Bendamustine 90 mg/m2, ABT-888 400 mg BID
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
22 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
21 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
26 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
17 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
4 participants
n=4 Participants
|
5 participants
n=21 Participants
|
15 participants
n=10 Participants
|
7 participants
n=115 Participants
|
43 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: The MTD was established at Dose Level 6 Veliparib 300mg PO BID plus Bendamustine 90 mg/m2
Maximum Tolerated Dose (MTD) reflects the highest dose of Veliparib when combined with Bendamustine Hydrochloride that did not cause a DLT. The maximum tolerated dose (MTD) was defined as the highest dose level at which 33% of patients experienced DLT.
Outcome measures
| Measure |
All Study Participants
n=43 Participants
All Study Participants
|
Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
Bendamustine 90 mg/m2, ABT-888 50 mg
|
Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
Bendamustine 90 mg/m2, ABT-888 100 mg BID
|
Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
Bendamustine 90 mg/m2, ABT-888 150 mg BID
|
Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
Bendamustine 90 mg/m2, ABT-888 200 mg BID
|
Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
Bendamustine 90 mg/m2, ABT-888 300 mg BID
|
Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
Bendamustine 90 mg/m2, ABT-888 400 mg BID
|
|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose of Veliparib When Combined With Bendamustine Hydrochloride
|
300 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.
Outcome measures
| Measure |
All Study Participants
n=3 Participants
All Study Participants
|
Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
n=3 Participants
Bendamustine 90 mg/m2, ABT-888 50 mg
|
Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
n=5 Participants
Bendamustine 90 mg/m2, ABT-888 100 mg BID
|
Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
n=2 Participants
Bendamustine 90 mg/m2, ABT-888 150 mg BID
|
Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
n=3 Participants
Bendamustine 90 mg/m2, ABT-888 200 mg BID
|
Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
n=14 Participants
Bendamustine 90 mg/m2, ABT-888 300 mg BID
|
Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
n=2 Participants
Bendamustine 90 mg/m2, ABT-888 400 mg BID
|
|---|---|---|---|---|---|---|---|
|
Response Rate
Complete Response
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Response Rate
Partial Response
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Response Rate
Stable Disease
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Response Rate
Progression of Disease
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 2 yearsAdverse events assessed by NCI CTCAE version 4.0 (Phase Ib) See adverse events section.
Outcome measures
| Measure |
All Study Participants
n=3 Participants
All Study Participants
|
Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
n=3 Participants
Bendamustine 90 mg/m2, ABT-888 50 mg
|
Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
n=6 Participants
Bendamustine 90 mg/m2, ABT-888 100 mg BID
|
Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
n=4 Participants
Bendamustine 90 mg/m2, ABT-888 150 mg BID
|
Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
n=5 Participants
Bendamustine 90 mg/m2, ABT-888 200 mg BID
|
Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
n=15 Participants
Bendamustine 90 mg/m2, ABT-888 300 mg BID
|
Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
n=7 Participants
Bendamustine 90 mg/m2, ABT-888 400 mg BID
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
3 participants
|
3 participants
|
4 participants
|
2 participants
|
2 participants
|
5 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Dose Level 7; Bendamustine 90mg/m2, ABT-888 400mg BID Participants treated on Dose Level 7 make up the cohort expansion of VBR in participants with CD20+ B-cell lymphoma.
Summary statistics will be used for CR. Responses will be evaluated by the International Uniform Response Criteria for Multiple Myeloma.
Outcome measures
| Measure |
All Study Participants
n=7 Participants
All Study Participants
|
Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
Bendamustine 90 mg/m2, ABT-888 50 mg
|
Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
Bendamustine 90 mg/m2, ABT-888 100 mg BID
|
Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
Bendamustine 90 mg/m2, ABT-888 150 mg BID
|
Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
Bendamustine 90 mg/m2, ABT-888 200 mg BID
|
Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
Bendamustine 90 mg/m2, ABT-888 300 mg BID
|
Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
Bendamustine 90 mg/m2, ABT-888 400 mg BID
|
|---|---|---|---|---|---|---|---|
|
Complete Response (CR) to Study Treatment (Phase IIa)
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first documented response to the first documented progression or death, assessed up to 30 days post-treatmentPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days post-treatmentPopulation: Data were not collected
Kaplan-Meier estimates will be calculated and log-rank tests will be employed when certain comparisons are needed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From time zero to 12 hours on day 2 of course 1Area Under the Curve from time zero to 12 hours following Veliparib administration
Outcome measures
| Measure |
All Study Participants
n=3 Participants
All Study Participants
|
Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
n=2 Participants
Bendamustine 90 mg/m2, ABT-888 50 mg
|
Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
n=6 Participants
Bendamustine 90 mg/m2, ABT-888 100 mg BID
|
Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
n=3 Participants
Bendamustine 90 mg/m2, ABT-888 150 mg BID
|
Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
n=5 Participants
Bendamustine 90 mg/m2, ABT-888 200 mg BID
|
Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
n=6 Participants
Bendamustine 90 mg/m2, ABT-888 300 mg BID
|
Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
n=7 Participants
Bendamustine 90 mg/m2, ABT-888 400 mg BID
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameters of Veliparib (Phase Ib)
|
1.79 μg*h/mL
Standard Deviation 0.41
|
3.58 μg*h/mL
Standard Deviation 0.93
|
7.93 μg*h/mL
Standard Deviation 1.90
|
12.6 μg*h/mL
Standard Deviation 3.8
|
16.9 μg*h/mL
Standard Deviation 11.1
|
19.0 μg*h/mL
Standard Deviation 10.5
|
25.0 μg*h/mL
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants treated on Dose Level 7 make up the cohort expansion of VBR in participants with CD20+ B-cell lymphoma.
Kaplan-Meier estimates will be calculated and log-rank tests will be employed when certain comparisons are needed. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.
Outcome measures
| Measure |
All Study Participants
n=7 Participants
All Study Participants
|
Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
Bendamustine 90 mg/m2, ABT-888 50 mg
|
Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
Bendamustine 90 mg/m2, ABT-888 100 mg BID
|
Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
Bendamustine 90 mg/m2, ABT-888 150 mg BID
|
Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
Bendamustine 90 mg/m2, ABT-888 200 mg BID
|
Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
Bendamustine 90 mg/m2, ABT-888 300 mg BID
|
Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
Bendamustine 90 mg/m2, ABT-888 400 mg BID
|
|---|---|---|---|---|---|---|---|
|
Progression-free Survival Using RECIST Version 1.1 (Phase IIa)
|
14.2 Months
Interval 2.0 to 20.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 daysOutcome measures
| Measure |
All Study Participants
n=3 Participants
All Study Participants
|
Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
n=3 Participants
Bendamustine 90 mg/m2, ABT-888 50 mg
|
Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
n=6 Participants
Bendamustine 90 mg/m2, ABT-888 100 mg BID
|
Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
n=4 Participants
Bendamustine 90 mg/m2, ABT-888 150 mg BID
|
Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
n=5 Participants
Bendamustine 90 mg/m2, ABT-888 200 mg BID
|
Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
n=15 Participants
Bendamustine 90 mg/m2, ABT-888 300 mg BID
|
Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
n=7 Participants
Bendamustine 90 mg/m2, ABT-888 400 mg BID
|
|---|---|---|---|---|---|---|---|
|
Participants With Dose Limiting Toxicities
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
Adverse Events
Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
Serious events: 3 serious events
Other events: 1 other events
Deaths: 1 deaths
Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg
n=3 participants at risk
Bendamustine 70 mg/m2, ABT-888 50 mg
|
Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
n=3 participants at risk
Bendamustine 90 mg/m2, ABT-888 50 mg
|
Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
n=6 participants at risk
Bendamustine 90 mg/m2, ABT-888 100 mg BID
|
Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
n=4 participants at risk
Bendamustine 90 mg/m2, ABT-888 150 mg BID
|
Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
n=5 participants at risk
Bendamustine 90 mg/m2, ABT-888 200 mg BID
|
Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
n=15 participants at risk
Bendamustine 90 mg/m2, ABT-888 300 mg BID
|
Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
n=7 participants at risk
Bendamustine 90 mg/m2, ABT-888 400 mg BID
|
|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Hematuria
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
|
Vascular disorders
Hypertension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
0.00%
0/7
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
|
Infections and infestations
Sepsis
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Abdominal pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
|
Infections and infestations
Lung Infection
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
|
General disorders
Fatigue
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
0.00%
0/7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms ben/mal/unk (in cyst/polyp) Other, Specify
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
0.00%
0/7
|
|
Vascular disorders
Hemolysis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Syncope
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hyperhidrosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
14.3%
1/7 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Fever
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
Other adverse events
| Measure |
Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg
n=3 participants at risk
Bendamustine 70 mg/m2, ABT-888 50 mg
|
Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
n=3 participants at risk
Bendamustine 90 mg/m2, ABT-888 50 mg
|
Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
n=6 participants at risk
Bendamustine 90 mg/m2, ABT-888 100 mg BID
|
Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
n=4 participants at risk
Bendamustine 90 mg/m2, ABT-888 150 mg BID
|
Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
n=5 participants at risk
Bendamustine 90 mg/m2, ABT-888 200 mg BID
|
Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
n=15 participants at risk
Bendamustine 90 mg/m2, ABT-888 300 mg BID
|
Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
n=7 participants at risk
Bendamustine 90 mg/m2, ABT-888 400 mg BID
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 8
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
|
Renal and urinary disorders
Hematuria
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Number of events 4
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • Number of events 5
|
33.3%
1/3 • Number of events 4
|
16.7%
1/6 • Number of events 3
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
|
Investigations
White blood cell decreased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
0.00%
0/7
|
Additional Information
Dr. John Gerecitano
Memorial Sloan Kettering Cancer Center
Phone: 212-639-3748
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60