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

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Metastases	Drug: Ixabepilone	Phase II

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

ChemIDplus related topics:

Ixabepilone Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Response rate as determined by the IRRC

Secondary Outcome Measures:

Time to progression, duration of response, overall survival

Estimated Enrollment:	125
Study Start Date:	February 2004

Arms	Assigned Interventions
1: Experimental	Drug: Ixabepilone Solution, IV, 40 mg/m2, every 21 days, extended, until PD or discontinued for other reasons.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080262

Show 46 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	CA163-081
First Received:	March 25, 2004
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00080262
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Metastatic Breast Cancer

Study placed in the following topic categories:

Capecitabine

Skin Diseases

Epothilones

Neoplasm Metastasis

Breast Neoplasms

Taxane

Breast Diseases

Additional relevant MeSH terms:

Neoplastic Processes

Neoplasms

Pathologic Processes

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Mitosis Modulators

Tubulin Modulators

Antimitotic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00080262