A Study to Assess the Effect of Rifampin on the Metabolism of ABT-199

NCT ID: NCT01969682

Last Updated: 2014-05-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-05-31

Brief Summary

This is an open-label multicenter, study to assess the pharmacokinetic interaction of rifampin with ABT-199 in up to 12 subjects with relapsed or refractory non-Hodgkin's lymphoma.

Detailed Description

This is a Phase 1 study designed to assess how the body processes the study drug ABT-199 when taken alone and in combination with rifampin and to assess the safety of ABT-199 in combination with rifampin. Subjects may enroll in a separate extension study to continue receiving ABT-199 after completion of this study.

Conditions

Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Arm A (ABT-199 and rifampin)

Group Type: EXPERIMENTAL

ABT-199

Intervention Type: DRUG

Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with rifampin

Rifampin

Intervention Type: DRUG

Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with rifampin

Interventions

ABT-199

Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with rifampin

Intervention Type: DRUG

Rifampin

Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with rifampin

Intervention Type: DRUG

Other Intervention Names

GDC-0199

Eligibility Criteria

Inclusion Criteria

• Subject must have relapsed or refractory non-Hodgkin's lymphoma.

Exclusion Criteria

• Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
• Subject must have adequate bone marrow (independent of growth factor support per local laboratory reference range), coagulation, renal and hepatic function:

• Absolute Neutrophil Count (ANC) greater than or equal to 1000/µL (without growth factor support unless neutropenia is clearly due to underlying disease);
• Platelets greater than or equal to 75,000/mm3 (unless thrombocytopenia is clearly due to disease-related immune thrombocytopenia or to underlying disease; entry platelet count must be independent of transfusion within 14 days of Screening);
• Hemoglobin greater than or equal to 9.0 g/dL (unless anemia is clearly due to underlying disease; entry hemoglobin must be independent of transfusion within 14 days of Screening);
• If cytopenias are present, no evidence of myelodysplastic syndrome or hypoplastic bone marrow;
• Subject must have activated partial thromboplastin time (aPTT) and prothrombin time (PT) not to exceed 1.5 × the upper normal limit (ULN);
• Calculated creatinine clearance greater than or equal to 50 mL/min using a 24-hour urine collection for creatinine clearance or per the Cockcroft-Gault equation;
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3.0 × ULN of institution's normal range;
• Bilirubin less than or equal to 1.5 × ULN. Subjects with Gilbert's Syndrome may have a bilirubin greater than 1.5 × ULN per discussion with the AbbVie medical monitor.

• Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or mantle cell lymphoma (MCL).
• Subject is receiving combination anti-retroviral therapy for HIV (due to potential drug-drug interactions between anti-retroviral medications and ABT-199, as well as anticipated ABT-199 mechanism based lymphopenia that may potentially increase the risk of opportunistic infections).
• Subject has hypersensitivity to any of the rifamycins.
• Subject has a cardiovascular disability status of New York Heart Association Class greater than or equal to 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea or anginal pain.
• Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease within the past 6 months that in the opinion of the investigator would adversely affect his/her participating in this study.
• Subject has malabsorption syndrome or other condition which precludes enteral route of administration (e.g., prior surgical resection).
• Subject has undergone an allogeneic stem cell transplant.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Chien, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

Site Reference ID/Investigator# 101416

Hackensack, New Jersey, United States

Countries

United States

Other Identifiers

M13-366

Identifier Type: -

Identifier Source: org_study_id