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

January 27, 2017 updated by: R-Pharm

Effect of Capecitabine on the Pharmacokinetics of BMS-247550 on the Pharmacokinetics of Capecitabine and Its Metabolites in Patients With Advanced Malignancies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Safety/Tumor response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R-Pharm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

January 30, 2017

Last Update Submitted That Met QC Criteria

January 27, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA163-038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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