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.
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
First received: September 12, 2005
Last updated: April 11, 2011
Last verified: April 2011

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
Drug: Ixabepilone
Drug: Capecitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 Bristol-Myers Squibb:

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).


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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00207129

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00207129     History of Changes
Other Study ID Numbers: CA163-038
Study First Received: September 12, 2005
Last Updated: April 11, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014