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

Phase 1

Completed

• Conditions: Advanced Solid Tumors; Neoplasms
• Interventions: Drug: Capecitabine; Drug: Ixabepilone

• Registration Number: NCT00207129
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-21
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
B	Capecitabine	-
A	Ixabepilone	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Safety/Tumor response

Trial Locations

Locations (1)

Local Institution; 🇺🇸 San Antonio, Texas, United States