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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00101400 |
The purpose of this study is to evaluate the anti-cancer activity and safety of BAY 43-9006 (sorafenib) in patients, who suffer from an advanced breast tumour, which has spread to other organs of body despite treatment that the patient has received so far.
Condition | Intervention | Phase |
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Cancer Breast Cancer |
Drug: Nexavar (Sorafenib, BAY43-9006) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Multicenter Uncontrolled Trial of BAY 43-9006 in Subjects With Metastatic Breast Cancer. |
Enrollment: | 54 |
Study Start Date: | February 2004 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Nexavar (Sorafenib, BAY43-9006)
BAY 43-9006 400 mg b.i.d. daily
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Excluded therapies include:
Germany, Baden-Württemberg | |
Stuttgart, Baden-Württemberg, Germany, 70199 | |
Germany, Bayern | |
München, Bayern, Germany, 80637 | |
Germany, Hessen | |
Frankfurt, Hessen, Germany, 60596 | |
Italy | |
Parma, Italy, 43100 | |
Milano, Italy, 20162 | |
Bologna, Italy, 40138 | |
Milano, Italy, 20133 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Spa ( Therapeutic Area Head ) |
Study ID Numbers: | 100555 |
Study First Received: | January 10, 2005 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00101400 |
Health Authority: | United States: Food and Drug Administration |
Skin Diseases Breast Neoplasms Sorafenib Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |