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

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00080262

First received: March 25, 2004

Last updated: April 7, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 25, 2004

Last Updated Date

April 7, 2011

Start Date ^ICMJE

February 2004

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Response rate as determined by the IRRC

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00080262 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to progression, duration of response, overall survival

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer
Metastases

Intervention ^ICMJE

Drug: Ixabepilone

Solution, IV, 40 mg/m2, every 21 days, extended, until PD or discontinued for other reasons.

Other Name: BMS-247550

Study Arm (s)

Experimental: 1

Intervention: Drug: Ixabepilone

Publications *

Perez EA, Lerzo G, Pivot X, Thomas E, Vahdat L, Bosserman L, Viens P, Cai C, Mullaney B, Peck R, Hortobagyi GN. Efficacy and safety of ixabepilone (BMS-247550) in a phase II study of patients with advanced breast cancer resistant to an anthracycline, a taxane, and capecitabine. J Clin Oncol. 2007 Aug 10;25(23):3407-14. Epub 2007 Jul 2.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

125

Completion Date

December 2006

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Canada, France, Germany, Mexico, Netherlands, Norway, South Africa, Sweden

Administrative Information

NCT Number ^ICMJE

NCT00080262

Other Study ID Numbers ^ICMJE

CA163-081

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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