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.

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00207129

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 I

MedlinePlus related topics: Cancer

Drug Information available for: Ixabepilone Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	Effect of Capecitabine on the Pharmacokinetics of BMS-247550 on the Pharmacokinetics of Capecitabine and Its Metabolites in Patients With Advanced Malignancies

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 2005

Arms	Assigned Interventions
A: Experimental	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.
B: Experimental	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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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

Locations

United States, Texas
Local Institution
San Antonio, Texas, United States

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	CA163-038
Study First Received:	September 12, 2005
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00207129
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Capecitabine
Epothilones

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009