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This study has been withdrawn prior to enrollment.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

Tracking Information
First Received Date ^ICMJE	September 25, 2007
Last Updated Date	June 10, 2008
Start Date ^ICMJE	September 2007
Estimated Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 25, 2007)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00534807 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 25, 2007)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of the Interaction of Rifampin and Vinflunine in Subjects With Advanced Cancer
Official Title ^ICMJE	Effect of Rifampin on the Pharmacokinetics of Intravenous (IV) Vinflunine in Subjects With Advanced Cancer
Brief Summary	The purpose of this study is to test how vinflunine interacts with rifampin in the human body
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cancer
Intervention ^ICMJE	Drug: Vinflunine Drug: Rifampin
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Estimated Enrollment ^ICMJE	35
Estimated Completion Date	November 2008
Estimated Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00534807
Other Study ID Numbers ^ICMJE	CA183-033
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Bristol-Myers Squibb
Verification Date	October 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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