A Study of the Alternative Administration of Ixabepilone and Vinflunine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00362830
Recruitment Status : Completed
First Posted : August 10, 2006
Last Update Posted : September 19, 2016
Information provided by:
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Cancer Drug: vinflunine + ixabepilone Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of the Alternating Administration of Ixabepilone and Vinflunine Every Three Weeks in Patients With Advanced Cancer
Study Start Date : August 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ixabepilone

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

Primary Outcome Measures :
  1. Determine the maximum tolerated dose and describe any dose limiting toxicities of ixabepilone and vinflunine in an alternating regimen. [ Time Frame: upon occurrence ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00362830

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
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00362830     History of Changes
Other Study ID Numbers: CA183-008
First Posted: August 10, 2006    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic