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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT00534807
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Duration (Months): 14
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: Vinflunine; Drug: Rifampin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Rifampin on the Pharmacokinetics of Intravenous (IV) Vinflunine in Subjects With Advanced Cancer
• Study Start Date: Sep 1, 2007
• Anticipated Primary Completion Date: Nov 1, 2008
• Anticipated Study Completion Date: Nov 1, 2008

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Detroit	Michigan	United States	48201

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00534807
• Other Study ID Numbers: CA183-033
• First Posted: Sep 26, 2007
• Last Update Posted: Sep 1, 2015
• Last Verified: Oct 1, 2007

• Additional relevant MeSH terms: Rifampin

Study Results

No Results Posted as of Sep 1, 2015