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| Sponsor: | Bayer |
|---|---|
| Collaborator: |
Onyx Pharmaceuticals |
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00079612 |
Purpose
The purpose of the study is to:
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Renal Cell |
Drug: Sorafenib (Nexavar, BAY43-9006) Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Discontinuation Study of BAY 43-9006 in Patients With Advanced Refractory Cancer. |
| Enrollment: | 350 |
| Study Start Date: | September 2002 |
| Study Completion Date: | January 2007 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Sorafenib (Nexavar, BAY43-9006)
800mg daily (2x 400mg tabs)
|
| Placebo Comparator: Arm 2 |
Drug: Placebo
2x 400mg tabs daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| Chicago, Illinois, United States, 60637 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| San Antonio, Texas, United States, 78229 | |
| United Kingdom | |
| London, Greater London, United Kingdom, SW3 6JJ | |
| Glasgow, Strathclyde, United Kingdom, G11 6NT | |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00079612 History of Changes |
| Obsolete Identifiers: | NCT00044499 |
| Other Study ID Numbers: | 100391 |
| Study First Received: | March 9, 2004 |
| Last Updated: | June 4, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Renal Cell Cancer RCC Cancer |
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Kidney Diseases Urologic Diseases Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |