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

NCT ID: NCT00207129

Last Updated: 2017-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-12-31

Brief Summary

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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

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Conditions

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Advanced Solid Tumors Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Ixabepilone

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Capecitabine

Intervention Type DRUG

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).

Interventions

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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.

Intervention Type 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).

Intervention Type DRUG

Other Intervention Names

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Ixempra

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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R-Pharm

INDUSTRY

Sponsor Role lead

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CA163-038

Identifier Type: -

Identifier Source: org_study_id

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