A Pharmacokinetic Study to Access How the Body Absorbs and Removes ABT-199 in Adults With Non-Hodgkin's Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-01-31

Brief Summary

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A pharmacokinetic study to access how the body absorbs and removes ABT-199 in adults with Non-Hodgkin's Lymphoma.

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Detailed Description

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Conditions

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Relapsed/Refractory Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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[14C]ABT-199

Subjects with relapsed or refractory Non-Hodgkin's Lymphoma

Group Type EXPERIMENTAL

[14C]ABT-199 (GDC-0199)

Intervention Type DRUG

\[14C\]ABT-199 will be administered as a single oral administration

Interventions

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[14C]ABT-199 (GDC-0199)

\[14C\]ABT-199 will be administered as a single oral administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subject must have relapsed or refractory disease.

Exclusion Criteria

3. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
4. Subject has adequate bone marrow (independent of growth factor support per local laboratory reference range).
5. Subject has adequate coagulation, renal and hepatic function.

1. Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (CLL), mantle cell leukemia (MCL), or small lymphocytic lymphoma (SLL).
2. Subject has undergone an allogeneic stem cell transplant.
3. Subject is receiving combination anti-retroviral therapy for human immunodeficiency virus (HIV) (due to potential drug-drug interactions, as well as the potential for increased risk of opportunistic infections).
4. Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease within 6 months that in the opinion of the Investigator would adversely affect his/her participation in this study.
5. Subject has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No