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
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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

Additional Information:
No publications provided

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

ClinicalTrials.gov processed this record on April 17, 2014