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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
Not Enrolling
Female
Breast Cancer, Metastases

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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 InstitutionBaltimore, Maryland  
Local InstitutionBronx, New York  
Local InstitutionCorona, California  
Local InstitutionHamden, Connecticut  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionWilmington, North Carolina  
Local InstitutionDuncansville, Pennsylvania  
Local InstitutionAustin, Texas  
Local InstitutionProvidence, Rhode Island  
Local InstitutionChattanooga, Tennessee  
Local InstitutionSalt Lake City, Utah