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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

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ClinicalTrials.gov Identifier: NCT00207129
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : January 30, 2017
Sponsor:
Information provided by:
R-Pharm

Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Solid Tumors Neoplasms Drug: Ixabepilone Drug: Capecitabine Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
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
Study Start Date : October 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. 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 :
  1. Safety/Tumor response


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Additional Information:
ClinicalTrials.gov Identifier: NCT00207129     History of Changes
Other Study ID Numbers: CA163-038
First Posted: September 21, 2005    Key Record Dates
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