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

Tracking Information

First Received Date ^ICMJE

March 25, 2004

Last Updated Date

June 27, 2008

Start Date ^ICMJE

February 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Response rate as determined by the IRRC

Original Primary Outcome Measures ^ICMJE

Same as current

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

Same as current

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Breast Cancer
Metastases

Intervention ^ICMJE

Drug: Ixabepilone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

125

Completion Date

Primary Completion Date

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 ID ^ICMJE

NCT00080262

Responsible Party

Study ID Numbers ^ICMJE

CA163-081

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

June 2008

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