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.
Relapsed or refractory leukemia-cll/" >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).
