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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00080262 |
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 |
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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 |
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Study ID Numbers: | CA163-081 |
Study First Received: | March 25, 2004 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00080262 |
Health Authority: | United States: Food and Drug Administration |
Metastatic Breast Cancer |
Capecitabine Skin Diseases Epothilones Neoplasm Metastasis |
Breast Neoplasms Taxane Breast Diseases |
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 |