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This study has been withdrawn prior to enrollment.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: August 31, 2015
Last verified: October 2007
  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:


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)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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: NCT00534807

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

Additional Information:
ClinicalTrials.gov Identifier: NCT00534807     History of Changes
Other Study ID Numbers: CA183-033 
Study First Received: September 25, 2007
Last Updated: August 31, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rifampin
Vinblastine
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

ClinicalTrials.gov processed this record on August 25, 2016