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Study 7 of 63 for search of: | Australia, Australian Capital Territory |
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Sponsors and Collaborators: |
Bayer ONYX Pharmaceuticals |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00073307 |
The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY 43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.
Condition | Intervention | Phase |
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Cancer Carcinoma, Renal Cell |
Drug: Nexavar (Sorafenib, BAY 43-9006) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Randomized Study of BAY 43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer. |
Enrollment: | 905 |
Study Start Date: | November 2003 |
Estimated Study Completion Date: | May 2009 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 2: Placebo Comparator |
Drug: Placebo
Placebo
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Arm 1: Experimental |
Drug: Nexavar (Sorafenib, BAY 43-9006)
Multi Kinase Inhibitor
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients who have three or more of the following:
Excluded therapies and medications, previous and concomitant:
Study Chair: | Study Chair, M.D. | Cleveland Clinic Cancer Center, Cleveland, Ohio, USA |
Study Chair: | Study Chair, M.D. | Institut Gustave Roussy (IGR), Villejuif, France |
Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
Study ID Numbers: | 11213 |
Study First Received: | November 19, 2003 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00073307 |
Health Authority: | United States: Food and Drug Administration |
Renal Cell Cancer (RCC) |
Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Carcinoma Urologic Diseases Kidney Neoplasms |
Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Sorafenib Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |