A Study of the Alternative Administration of Ixabepilone and Vinflunine

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00362830

First received: August 7, 2006

Last updated: July 28, 2008

Last verified: July 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

August 7, 2006

Last Updated Date

July 28, 2008

Start Date ^ICMJE

August 2006

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determine the maximum tolerated dose and describe any dose limiting toxicities of ixabepilone and vinflunine in an alternating regimen. [ Time Frame: upon occurrence ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Determine the maximum tolerated dose and describe any dose limiting toxicities of ixabepilone and vinflunine in an alternating regimen.

Change History

Complete list of historical versions of study NCT00362830 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. [ Time Frame: upon occurrence ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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.

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Study of the Alternative Administration of Ixabepilone and Vinflunine

Official Title ^ICMJE

A Study of the Alternating Administration of Ixabepilone and Vinflunine Every Three Weeks in Patients With Advanced Cancer

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cancer

Intervention ^ICMJE

Drug: vinflunine + ixabepilone

solution for injection, IV, vinflunine: 250 to 320 mg/m2 + ixabepilone: 30 to 40 mg/m2, every 3 wks, variable duration

Study Arm (s)

Experimental: 1

Intervention: Drug: vinflunine + ixabepilone

Publications *

* 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

Completed

Estimated Enrollment ^ICMJE

Completion Date

September 2007

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00362830

Other Study ID Numbers ^ICMJE

CA183-008

Has Data Monitoring Committee

Responsible Party

Study Director, Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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