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

AbbVie

Status and phase

Withdrawn

Phase 1

Conditions

Relapsed/Refractory Non-Hodgkin's Lymphoma

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

M13-363

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject must have relapsed or refractory disease.
Subject must have histologically documented diagnosis of non-hodgkin's lymphoma as defined by a B-cell neo-plasm in the World Health Organization (WHO) classification scheme except as noted in exclusion criteria.
Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
Subject has adequate bone marrow (independent of growth factor support per local laboratory reference range).
Subject has adequate coagulation, renal and hepatic function.

Exclusion criteria

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).
Subject has undergone an allogeneic stem cell transplant.
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).
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.
Subject has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.