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.

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

sites

Dana Farber Cancer Institute /ID# 5547

50 Binney Street
Boston, Massachusetts 02115

from

Boston, MA