A Study of the Alternative Administration of Ixabepilone and Vinflunine - Full Text View

Purpose

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

Condition	Intervention	Phase
Cancer	Drug: vinflunine + ixabepilone	Phase I

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Ixabepilone Vinflunine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	60
Study Start Date:	August 2006
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: vinflunine + ixabepilone solution for injection, IV, vinflunine: 250 to 320 mg/m2 + ixabepilone: 30 to 40 mg/m2, every 3 wks, variable duration

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362830

Locations


United States, Florida
	University Of Miami Miller School Of Medicine
	Miami, Florida, United States, 33136

United States, Ohio
	The Cleveland Clinic Foundation
	Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA183-008
First Received:	August 7, 2006
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00362830
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Epothilones

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Mitosis Modulators

Tubulin Modulators

Antimitotic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00362830