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

This study has been withdrawn prior to enrollment.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: September 25, 2007
Last updated: August 31, 2015
Last verified: October 2007
The purpose of this study is to test how vinflunine interacts with rifampin in the human body

Condition Intervention Phase
Cancer Drug: Vinflunine Drug: Rifampin Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Rifampin on the Pharmacokinetics of Intravenous (IV) Vinflunine in Subjects With Advanced Cancer

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 0
Study Start Date: September 2007
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00534807

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

Additional Information: Identifier: NCT00534807     History of Changes
Other Study ID Numbers: CA183-033
Study First Received: September 25, 2007
Last Updated: August 31, 2015

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 processed this record on August 16, 2017