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Sponsored by: |
Abraxis BioScience Inc. |
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Information provided by: | Abraxis BioScience Inc. |
ClinicalTrials.gov Identifier: | NCT00140140 |
The purpose of this study is to: 1) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the absence of planned growth factor support with GCSF (Patients with HER-2/neu positive disease may receive Herceptin, and 2) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the presence of planned growth factor support with GCSF.
Condition | Intervention | Phase |
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Stage IV (Metastatic) Breast Cancer |
Drug: ABI-007; Vinorelbine; G-CSF (Granulocyte- Colony Stimulating Factor) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | An Open-Label Phase I Study of Weekly ABI-007 and Vinorelbine With or Without G-CSF in Patients With Stage IV (Metastatic) Breast Cancer |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | August 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Prior irradiation is permitted, provided:
Exclusion Criteria:
United States, North Carolina | |
Abraxis BioScience Inc. | |
Durham, North Carolina, United States, 27703 |
Study Director: | M Hawkins, M.D. | Abraxis BioScience Inc. |
Study ID Numbers: | CA025 |
Study First Received: | August 30, 2005 |
Last Updated: | September 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00140140 |
Health Authority: | United States: Food and Drug Administration |
Vinorelbine Skin Diseases Paclitaxel Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Antineoplastic Agents, Phytogenic Pharmacologic Actions |