Novel Epothilone (BMS-247550) in Patients With Metastatic Breast Cancer (MBC)

January 27, 2017 updated by: R-Pharm

Phase II Study of Novel Epothilone (BMS-247550) in Patients With MBC Who Are Refractory to an Anthracycline, a Taxane, and Capecitabine

The purpose of this research study is to assess the response rate of the investigational drug BMS-247550 (Ixabepilone) in women with metastatic breast cancer who are refractory to an anthracycline, a taxane, and capecitabine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

125

Phase

  • Phase 2

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

  • Argentina
      • Buenos Aires, Argentina
        • Local Institution
      • Santa Fe, Argentina
        • Local Institution
  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • Local Institution
  • France
      • Besancon Cedex, France
        • Local Institution
      • Bobigny, France
        • Local Institution
      • Clermont-Ferrand, France
        • Local Institution
      • Dijon Cedex, France
        • Local Institution
      • Lyon, France
        • Local Institution
      • Marseille Cedex 9, France
        • Local Institution
      • Vandoeuvre Les Nancy, France
        • Local Institution
  • Germany
      • Frankfurt, Germany
        • Local Institution
      • Frankfurt Hoechst, Germany
        • Local Institution
  • Mexico
      • Chihuahua, Mexico
        • Local Institution
      • Distrito Federal, Mexico
        • Local Institution
    • Yucatan
      • Merida, Yucatan, Mexico
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands
        • Local Institution
      • Leiden, Netherlands
        • Local Institution
  • Norway
      • Oslo, Norway
        • Local Institution
      • Trondheim, Norway
        • Local Institution
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa
        • Local Institution
    • Free State
      • Fichardtpark, Free State, South Africa
        • Local Institution
    • Gauteng
      • Pretoria, Gauteng, South Africa
        • Local Institution
    • Kwa Zulu Natal
      • Overport, Kwa Zulu Natal, South Africa
        • Local Institution
    • Western Cape
      • Panorama, Western Cape, South Africa
        • Local Institution
  • Sweden
      • Helsingborg, Sweden
        • Local Institution
      • Lund, Sweden
        • Local Institution
      • Malmo, Sweden
        • Local Institution
      • Stockholm, Sweden
        • Local Institution
  • United States
    • California
      • La Verne, California, United States
        • Local Institution
    • Connecticut
      • Meriden, Connecticut, United States
        • Local Institution
    • Florida
      • Jacksonville, Florida, United States
        • Local Institution
    • Maryland
      • Baltimore, Maryland, United States
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States
        • Local Institution
    • New York
      • New York, New York, United States
        • Local Institution
    • North Carolina
      • Asheville, North Carolina, United States
        • Local Institution
      • Charlotte, North Carolina, United States
        • Local Institution
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Local Institution
    • Rhode Island
      • Providence, Rhode Island, United States
        • Local Institution
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Local Institution
      • Jackson, Tennessee, United States
        • Local Institution
      • Knoxville, Tennessee, United States
        • Local Institution
      • Nashville, Tennessee, United States
        • Local Institution
    • Texas
      • Houston, Texas, United States
        • Local Institution
      • San Antonio, Texas, United States
        • Local Institution
    • Utah
      • Salt Lake City, Utah, 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

Female

Description

Inclusion Criteria:

  • Patients must have received all 3 drugs- an anthracycline, taxane, and capecitabine (alone or in combination) and be resistant
  • No more than 3 prior chemotherapy regimens in the metastatic setting
  • Must have at least one target lesion that is radiographically measurable
  • Good performance status
  • No history of or current brain or leptomeningeal disease

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: 1
Drug: Ixabepilone
Solution, IV, 40 mg/m2, every 21 days, extended, until PD or discontinued for other reasons.
Other Names:
  • BMS-247550

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate as determined by the IRRC

Secondary Outcome Measures

Outcome Measure
Time to progression, duration of response, overall survival

Collaborators and Investigators

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

Sponsor

R-Pharm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2004

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

March 25, 2004

First Submitted That Met QC Criteria

March 25, 2004

First Posted (Estimate)

March 26, 2004

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA163-081

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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