A Study of the Interaction of Rifampin and Vinflunine in Subjects With Advanced Cancer

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: NCT00534807
Recruitment Status : Withdrawn
First Posted : September 26, 2007
Last Update Posted : September 1, 2015
Information provided by:
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to test how vinflunine interacts with rifampin in the human body

Condition or disease Intervention/treatment Phase
Cancer Drug: Vinflunine Drug: Rifampin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Rifampin on the Pharmacokinetics of Intravenous (IV) Vinflunine in Subjects With Advanced Cancer
Study Start Date : September 2007
Estimated Primary Completion Date : November 2008
Estimated Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Rifampin

Primary Outcome Measures :
  1. The Primary Outcome Measure of the effect of rifampin on the pharmacokinetics (PK) of intravenous (IV) vinflunine will be determined from the PK measurements [ Time Frame: taken during Cycle 2 of study treatment, at approximately 4 weeks after the start of study treatment ]

Secondary Outcome Measures :
  1. The Secondary Outcome Measures of the safety and tolerability of vinflunine when administered alone and with rifampin [ Time Frame: determined after 2 complete 21-day Cycles of study treatment, at approximately 6 weeks after the start of study treatment ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Cancer unresponsive to previous treatment
  • Consent for genetic samples

Exclusion Criteria:

  • Cancer of the blood
  • Spread of cancer to the brain
  • Moderate or severe nerve damage
  • Low white blood cell counts and platelet counts
  • Inadequate liver or kidney function
  • Prior treatment with vinflunine
  • Use of certain medications that might interfere with the metabolism of vinflunine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00534807

United States, Michigan
Local Institution
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information: Identifier: NCT00534807     History of Changes
Other Study ID Numbers: CA183-033
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: October 2007

Additional relevant MeSH terms:
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, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators