Phase II Study of Novel Epothilone (BMS-247550) in Patients With MBC Who Are Refractory to an Anthracycline, a Taxane, and Capecitabine
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Metastases
Female
Breast Cancer, Metastases
Trial Information
Phase II Study of Novel Epothilone (BMS-247550) in Patients With MBC Who Are Refractory to an Anthracycline, a Taxane, and Capecitabine
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate as determined by the IRRC
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA163-081
NCT ID:
NCT00080262
Start Date:
February 2004
Completion Date:
December 2006
Related Keywords:
- Breast Cancer
- Metastases
- Metastatic Breast Cancer
- Breast Neoplasms
- Neoplasm Metastasis
Name | Location |
|---|---|
| Local Institution | Baltimore, Maryland |
| Local Institution | Bronx, New York |
| Local Institution | Corona, California |
| Local Institution | Hamden, Connecticut |
| Local Institution | Fort Lauderdale, Florida |
| Local Institution | Springfield, Massachusetts |
| Local Institution | Wilmington, North Carolina |
| Local Institution | Duncansville, Pennsylvania |
| Local Institution | Austin, Texas |
| Local Institution | Providence, Rhode Island |
| Local Institution | Chattanooga, Tennessee |
| Local Institution | Salt Lake City, Utah |
