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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

Sponsor
R-Pharm (Industry)
Overall Status
Completed
CT.gov ID
NCT00207129
Collaborator
(none)
25
Enrollment
1
Location
2
Arms
14
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Oct 1, 2004
Actual Primary Completion Date :
Dec 1, 2005
Actual Study Completion Date :
Dec 1, 2005

Arms and Interventions

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 Names:
  • 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).

    Outcome Measures

    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 []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Local Institution San Antonio Texas United States

    Sponsors and Collaborators

    • R-Pharm

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00207129
    Other Study ID Numbers:
    • CA163-038
    First Posted:
    Sep 21, 2005
    Last Update Posted:
    Jan 30, 2017
    Last Verified:
    Jan 1, 2017
    Additional relevant MeSH terms:
    Neoplasms
    Capecitabine

    Study Results

    No Results Posted as of Jan 30, 2017