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Effect of Capecitabine on the Pharmacokinetics of BMS-247550 and BMS-247550 on the Pharmacokinetics of Capecitabine and Its Metabolites in Patients With Advanced Malignancies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00207129
First Posted: September 21, 2005
Last Update Posted: January 30, 2017
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:
R-Pharm
  Purpose
The purpose of this study is to test how BMS-247550 (ixabepilone) affects the removal of capecitabine from the body and how capecitabine affects the removal of BMS-247550 from the body.

Condition Intervention Phase
Advanced Solid Tumors Neoplasms Drug: Ixabepilone Drug: Capecitabine Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Capecitabine on the Pharmacokinetics of BMS-247550 on the Pharmacokinetics of Capecitabine and Its Metabolites in Patients With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by R-Pharm:

Primary Outcome Measures:
  • Effect of capecitabine on the pharmacokinetics of BMS-247550 and to assess the effect of BMS-247550 on the pharmacokinetics of capecitabine

Secondary Outcome Measures:
  • Safety/Tumor response

Estimated Enrollment: 25
Study Start Date: October 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Ixabepilone
Solution, I.V. infusion, 40 mg/m2, Cycles 1-18: once per cycle (Day 1) cycles 2-18 (6-54 weeks) depending on response.
Other Name: Ixempra
Experimental: B Drug: Capecitabine
Tablets, Oral, 1000 mg/m2, Cycle 1: Once (Day 1) Cycle 2: Twice daily (Days 1-5) Cycles 3-18: None, 2 cycles (6 weeks).

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Recovery from surgery or radiation therapy
  • Measurable or non-measurable disease
  • Available for follow-up

Exclusion Criteria:

  • Neuropathy
  • Uncontrolled pulmonary or cardiovascular disease
  • Known history of HIV infection
  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): NCT00207129


Locations
United States, Texas
Local Institution
San Antonio, Texas, United States
Sponsors and Collaborators
R-Pharm
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00207129     History of Changes
Other Study ID Numbers: CA163-038
First Submitted: September 12, 2005
First Posted: September 21, 2005
Last Update Posted: January 30, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents