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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00080262
• Other study ID #: CA163-081
• Status: Completed
• Phase: Phase 2
• First received: March 25, 2004
• Last updated: January 27, 2017
• Start date: February 2004
• Est. completion date: December 2006

Study information

• Verified date: January 2017
• Source: R-Pharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastases

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
R-Pharm

Countries where clinical trial is conducted

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

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate as determined by the IRRC
Secondary	Time to progression, duration of response, overall survival

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm