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Assess the Oral Bioavailability of a New ABT-263 Formulation in Subjects With Cancer

NCT00982566 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2017-11-21

No results posted yet for this study

Summary

This is a randomized, single dose, open-label, multicenter crossover study to determine the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately 48 evaluable subjects with lymphoid malignancies, including chronic lymphocytic leukemia, and solid tumors will be enrolled in this study.

Conditions

Interventions

DRUG

ABT-263

Part 1: Single (oral) dose of 250 mg of Formulation B1 vs. single (oral) dose of 250 mg of Formulation A

DRUG

ABT-263

Part 1 continued. Single (oral) dose of 250 mg of Formulation B2 vs. single (oral) dose of 250 mg of Formulation A

DRUG

ABT-263

Part 1: Single (oral) dose of 200 mg of Formulation C vs. single (oral) dose of 200 mg of Formulation A

DRUG

ABT-263

Part 1: Single (oral) dose of 200 mg of Formulation C vs. single (oral) dose of 200 mg of Formulation A

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • AbbVie

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-10-31
Completion
2010-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00982566 on ClinicalTrials.gov