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

Cancer Clinical Trial

Official title:

Effect of Rifampin on the Pharmacokinetics of Intravenous (IV) Vinflunine in Subjects With Advanced Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00534807
• Other study ID #: CA183-033
• Status: Withdrawn
• Phase: Phase 1
• First received: September 25, 2007
• Last updated: August 31, 2015
• Start date: September 2007
• Est. completion date: November 2008

Study information

• Verified date: October 2007
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Vinflunine

• Rifampin

Locations

Country	Name	City	State
United States	Local Institution	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Outcome Measure of the effect of rifampin on the pharmacokinetics (PK) of intravenous (IV) vinflunine will be determined from the PK measurements		taken during Cycle 2 of study treatment, at approximately 4 weeks after the start of study treatment
Secondary	The Secondary Outcome Measures of the safety and tolerability of vinflunine when administered alone and with rifampin		determined after 2 complete 21-day Cycles of study treatment, at approximately 6 weeks after the start of study treatment

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm