A Phase 1/2a Study of ABT-263 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 10/6/2018 |
| Start Date: | July 25, 2007 |
| End Date: | September 4, 2020 |
A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia
The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of
ABT-263 under two different dosing schedules with the objective of defining the dose limiting
toxicity and maximum tolerated dose. The Phase 2a portion of the study will evaluate ABT-263
at the defined recommended Phase 2 dose to obtain additional safety information and a
preliminary assessment of efficacy. The Extension Study portion will allow active subjects to
continue to receive ABT-263 for up to 9 years after the last subject transitions with less
frequent study evaluations.
ABT-263 under two different dosing schedules with the objective of defining the dose limiting
toxicity and maximum tolerated dose. The Phase 2a portion of the study will evaluate ABT-263
at the defined recommended Phase 2 dose to obtain additional safety information and a
preliminary assessment of efficacy. The Extension Study portion will allow active subjects to
continue to receive ABT-263 for up to 9 years after the last subject transitions with less
frequent study evaluations.
Inclusion Criteria:
- Relapsed or refractory Chronic Lymphocytic Leukemia and require treatment in opinion
of investigator
- Eastern Cooperative Oncology Group (ECOG) <= 1
- Adequate bone marrow independent of growth factor support, renal and hepatic function
per defined laboratory criteria
Exclusion Criteria:
- History or clinically suspicious for cancer-related Central Nervous System disease
- Receipt of allogenic or autologous stem cell transplant
- Recent history (within 1 year of first dose) of underlying, predisposing condition of
bleeding or currently exhibits signs of bleeding
- Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis
- Active immune thrombocytopenic purpura or history of being refractory to platelet
transfusions (within 1 year of first dose)
We found this trial at
7
sites
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