Overview

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

Status:
Withdrawn
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie
Collaborator:
Genentech, Inc.
Treatments:
Rifampin
Venetoclax
Criteria
Inclusion Criteria:

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

- Subject must have histologically documented diagnosis of non-Hodgkin's lymphoma as
defined by a B-cell neoplasm in the World Health Organization (WHO) classification
scheme except as noted in the 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.

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), 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.