A Study of ABT-263 in Subjects With Relapsed or Refractory Lymphoid Malignancies
Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
The Phase 1 portion of the study evaluated the pharmacokinetic profile and safety of ABT-263
with the objective of defining the dose limiting toxicity and maximum tolerated dose in
subjects with lymphoid malignancies. The Phase 2a portion of the study is evaluating ABT-263
using a step-up dosing regimen and may be increased to the defined recommended Phase 2 dose
to obtain additional safety information and a preliminary assessment of efficacy in subject
with lymphoid malignancies. The Extension portion of the study is to allow Phase 2a subjects
who remain active 1 year after the last subject enrolls or who have been on study
approximately 1 year to continue receiving ABT-263 with less frequent study evaluations.
Subjects in the Extension Study will continue receiving study drug for up to 7 years after
the last subject transitions to the Extension Study, or until disease progression or toxicity
that necessitates discontinuation (whichever comes first).