A Study to Assess the Effect of Rifampin on the Metabolism of Navitoclax

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01121133
Recruitment Status : Completed
First Posted : May 12, 2010
Last Update Posted : November 21, 2017
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Brief Summary:
This is an open-label, single or multiple center study to determine the interaction of rifampin with navitoclax (ABT-263) in approximately 12 subjects with cancer.

Condition or disease Intervention/treatment Phase
Lymphoma, Including Chronic Lymphocytic Leukemia Solid Tumors Drug: navitoclax Drug: Rifampin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study to Assess the Effect of a CYP3A Inducer (Rifampin) on the Pharmacokinetics of ABT-263 (Navitoclax)
Study Start Date : May 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Arm Intervention/treatment
Experimental: Arm A (navitoclax and rifampin) Drug: navitoclax
Subjects will be dosed with Navitoclax, then dosed with Navitoclax in combination with Rifampin.
Other Name: ABT-263, navitoclax
Drug: Rifampin
Subjects will be dosed with Navitoclax, then, dosed with Navitoclax in combination with Rifampin.

Primary Outcome Measures :
  1. To determine the effect of rifampin on the pharmacokinetics of navitoclax. [ Time Frame: Weekly ]

Secondary Outcome Measures :
  1. To determine the safety of navitoclax when administered alone and in combination with rifampin in these patients. [ Time Frame: Daily ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • 18 years of age or older.
  • Has a non-hematologic malignancy (radiographic, histologic, or cytologic confirmation), or hematologic malignancy (histologic or cytologic confirmation) that is either: relapsed or refractory to standard therapy, failed at least one prior therapy or no known effective therapy exists.
  • In the investigator's opinion, the subject's life expectancy is at least 90 days.
  • If clinically indicated, (e.g., subjects over the age of 70) subjects must have documented brain imaging (MRI or CT) negative for subdural or epidural hematoma within 28 days prior to the first dose of study drug.

Exclusion Criteria

  • Subjects with brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the first dose of study drug.
  • History of or is clinically suspicious for cancer-related central nervous system (CNS) disease.
  • Has undergone an allogeneic stem cell transplant.
  • Has an underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
  • Has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
  • Has active immune thrombocytopenic purpura or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug).
  • Significant history of cardiovascular disease (e.g., MI, thrombotic or thromboembolic event in the last 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease. Female subject is pregnant or breast-feeding.
  • History of or an active medical condition(s) that affects absorption or motility (e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, etc).
  • Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:

    • tuberculosis
    • diagnosis of fever and neutropenia within 1 week prior to study drug administration
  • Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal (with the exception of hormones for hypothyroidism or estrogen replacement therapy [ERT], or agonists required to suppress serum testosterone levels [e.g., LHRH, GnRH, etc.] for subjects with prostate cancer Subject is currently receiving or requires anticoagulation therapy (e.g., warfarin at any dose) or any drugs or herbal supplements that affect platelet function, with the exception of low-dose heparin used to maintain the patency of a catheter.
  • Subject has used known inhibitors (e.g., ketoconazole) or inducers (e.g., rifampin and carbamazepine) of cytochrome P450 3A (CYP3A) within 1 week prior to first dose of study.
  • Subject has a history of hypersensitivity to any of the rifamycins.
  • In the opinion of the Investigator, the subject is an unsuitable candidate to receive ABT-263.
  • History of or is clinically suspicious for cancer-related central nervous system (CNS) disease.

Publications of Results:
Responsible Party: Kyle Holen, M.D./Medical Director, Abbott Identifier: NCT01121133     History of Changes
Other Study ID Numbers: M10-955
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: May 2011

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Antineoplastic Agents