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

This study has been completed.

First Received: March 25, 2004 Last Updated: June 27, 2008 History of Changes

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

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Ixabepilone

U.S. FDA Resources

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

More Information

Additional 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

No publications provided

Study ID Numbers:	CA163-081
Study First Received:	March 25, 2004
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00080262 History of Changes
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
Tubulin Modulators
Neoplasm Metastasis

Breast Neoplasms
Antimitotic Agents
Taxane
Breast Diseases

Additional relevant MeSH terms:

Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Epothilones
Mitosis Modulators
Breast Neoplasms
Antimitotic Agents
Pharmacologic Actions

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Tubulin Modulators
Neoplasm Metastasis
Breast Diseases

ClinicalTrials.gov processed this record on July 02, 2009