A Study of the Alternative Administration of Ixabepilone and Vinflunine

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: vinflunine + ixabepilone

• Registration Number: NCT00362830
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of the study is to test how vinflunine interacts with ixabepilone in the human body.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-07
• Study First Submitted QC: 2006-08-09
• Study First Posted: 2006-08-10
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-16
• Last Update Posted: 2016-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ECOG status of 0-1

Exclusion Criteria

• Inability to tolerate venous access
• Brain mets
• Severe nerve damage
• ANC <2,000/mm3
• Platelets <100K
• Bilirubin >= 1.5 times the IULN
• ALT/AST >= 2.5 times the IULN
• Creatinine <50 mL/min
• Prior treatment with vinflunine and/or ixabepilone
• Strong use of CYPP450 drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	vinflunine + ixabepilone	-

Primary Outcome Measures

Name	Time	Method
Determine the maximum tolerated dose and describe any dose limiting toxicities of ixabepilone and vinflunine in an alternating regimen.	upon occurrence

Secondary Outcome Measures

Name	Time	Method
Determine the overall safety profile, efficacy and rate and extent to which ixabepilone and vinflunine are absorbed or otherwise available to the treatment site in the body.	upon occurrence

Trial Locations

Locations (2)

University Of Miami Miller School Of Medicine; 🇺🇸 Miami, Florida, United States

The Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States