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Sponsored by: |
Abraxis BioScience Inc. |
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Information provided by: | Abraxis BioScience Inc. |
ClinicalTrials.gov Identifier: | NCT00274456 |
This is an open-label study conducted at study sites in Russia and the Ukraine comparing the toxicity and antitumor activity of ABI-007 to Taxotere.
Condition | Intervention | Phase |
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Metastatic Breast Cancer |
Drug: ABI-007 and Taxotere |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A RANDOMIZED PHASE II STUDY OF WEEKLY OR EVERY 3 WEEKS ABI-007 VERSUS EVERY 3 WEEKS TAXOTERE AS FIRST LINE THERAPY OF STAGE IV (METASTATIC) BREAST CANCER |
Estimated Enrollment: | 300 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | June 2007 |
This is an open-label, randomized study to compare the following regimens with respect to toxicity and antitumor activity: the MTD of ABI 007 for a q3w schedule (300 mg/m2 every 3 weeks); ABI-007 100 mg/m2 administered weekly for 3 weeks with a 1 week rest; ABI-007 150 mg/m2 administered weekly for 3 weeks with a 1 week rest; and the standard dose and schedule of Taxotere (100 mg/m2 every 3 weeks).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CA024 |
Study First Received: | January 10, 2006 |
Last Updated: | September 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00274456 History of Changes |
Health Authority: | United States: Food and Drug Administration; Ukraine: Ministry of Health |
Docetaxel Skin Diseases Paclitaxel Breast Neoplasms Breast Diseases |
Docetaxel Neoplasms Neoplasms by Site Skin Diseases Antineoplastic Agents |
Therapeutic Uses Breast Neoplasms Pharmacologic Actions Breast Diseases |