A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia

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 11 years after the last subject transitions with less frequent study evaluations.

Inclusion Criteria:

• Relapsed or refractory CLL 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 is 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).