We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of the Alternative Administration of Ixabepilone and Vinflunine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00362830
First Posted: August 10, 2006
Last Update Posted: September 19, 2016
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.
Information provided by:
Bristol-Myers Squibb
  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
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

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 ]

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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00362830     History of Changes
Other Study ID Numbers: CA183-008
First Submitted: August 7, 2006
First Posted: August 10, 2006
Last Update Posted: September 19, 2016
Last Verified: September 2016

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