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

2014-08-27 03:19:10 | BioPortfolio

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.

Description

Subjects who complete Part 1 of the study will be provided an opportunity to receive Formulation A under a continuous once daily dosing schedule during Part 2 of the study. Subjects enrolled in the second part of the study may continue to receive Formulation A under the continuous once daily dosing schedule for up to one year following the date of the last subject enrolled on study provided they continue to tolerate the drug, have no evidence of disease progression, and do not meet any of the protocol specific criteria for subject discontinuation.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Lymphoma

Intervention

ABT-263, ABT-263, ABT-263, ABT-263

Location

Indiana University-Purdue University at Indianapolis (IUPUI)
Indianapolis
Indiana
United States
46202

Status

Recruiting

Source

Abbott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:10-0400

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