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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This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00534807
First received: September 25, 2007
Last updated: June 10, 2008
Last verified: October 2007
History of Changes
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
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:

MedlinePlus related topics: Cancer
Drug Information available for: Rifampin
U.S. FDA Resources

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 ]

Estimated Enrollment: 35
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)
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534807

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

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00534807     History of Changes
Other Study ID Numbers: CA183-033
Study First Received: September 25, 2007
Last Updated: June 10, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013