Spots Global Cancer Trial Database for A Study of ABT-263 in Subjects With Relapsed or Refractory Lymphoid Malignancies

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Trial Identification

Brief Title: A Study of ABT-263 in Subjects With Relapsed or Refractory Lymphoid Malignancies

Official Title: A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics and Efficacy of ABT-263 in Subjects With Relapsed or Refractory Lymphoid Malignancies

Study ID: NCT00406809

Conditions

Chronic Lymphoid Leukemia

Lymphoid Malignancies

Non-Hodgkin's Lymphoma

Follicular Lymphoma

Mantle Cell Lymphoma

Peripheral T-cell Lymphoma

Interventions

ABT-263

Study Description

Brief 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).

Detailed Description: Enrollment breakdown: Entered Study: Phase 1a: 39; Phase 1b: 19; Phase 2a: 33; Total: 91 Entered Treatment: Phase 1a: 38; Phase 1b: 17; Phase 2a: 26; Total: 81