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

November 17, 2017 updated by: AbbVie

A Phase I Study to Assess the Effect of a CYP3A Inducer (Rifampin) on the Pharmacokinetics of ABT-263 (Navitoclax)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • ABT-263, navitoclax
Drug: Rifampin
Subjects will be dosed with Navitoclax, then, dosed with Navitoclax in combination with Rifampin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the effect of rifampin on the pharmacokinetics of navitoclax.
Time Frame: Weekly
Weekly

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the safety of navitoclax when administered alone and in combination with rifampin in these patients.
Time Frame: Daily
Daily

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

May 10, 2010

First Submitted That Met QC Criteria

May 10, 2010

First Posted (Estimate)

May 12, 2010

Study Record Updates

Last Update Posted (Actual)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-955

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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