NCT00406809

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Lymphoid Leukemia
• Lymphoid Malignancies
• Non-Hodgkin's Lymphoma
• Follicular Lymphoma
• Mantle Cell Lymphoma
• Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	ABT-263	Oral solution Phase 1 dosing was under two different schedules: 14 days on drug, 7 days off or 21 days continuous dosing. Oral solution and tablets Phase 2a dosing under 21 day continuous dosing. \- 150 mg lead-in dose for 7-14 days followed by a 325 mg continuous once daily dose.

Timeline

• Start date: 2006-11-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2006-12-04
• Last updated: 2021-08-02

Locations

12 sites across 2 countries: United States, Canada