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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01121133
First received: May 10, 2010
Last updated: June 4, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Lymphoma, Including Chronic Lymphocytic Leukemia
Solid Tumors
Drug: navitoclax
Drug: Rifampin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • To determine the effect of rifampin on the pharmacokinetics of navitoclax. [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]

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

Enrollment: 12
Study Start Date: May 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: rifampin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121133

Locations
United States, California
Site Reference ID/Investigator# 35742
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Kyle Holen, M.D./Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT01121133     History of Changes
Other Study ID Numbers: M10-955
Study First Received: May 10, 2010
Last Updated: June 4, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Navitoclax
Rifampin
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antineoplastic Agents
Antitubercular Agents
Enzyme Inhibitors
Leprostatic Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014