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| Sponsor: | Bayer |
|---|---|
| Collaborator: |
ONYX Pharmaceuticals |
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00073307 |
Purpose
The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 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 |
|---|---|---|
|
Carcinoma, Renal Cell |
Drug: Sorafenib (Nexavar, 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 BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer. |
| Enrollment: | 905 |
| Study Start Date: | November 2003 |
| Estimated Study Completion Date: | October 2009 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Arm 2: Placebo Comparator |
Drug: Placebo
Placebo
|
| Arm 1: Experimental |
Drug: Sorafenib (Nexavar, BAY 43-9006)
Multi Kinase Inhibitor
|
Eligibility| 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:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Los Angeles, California, United States, 90057 | |
| Los Angeles, California, United States, 90089 | |
| Davis, California, United States, 95616 | |
| United States, Colorado | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60637 | |
| United States, Kentucky | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Lafayette, Louisiana, United States, 70506 | |
| United States, Maryland | |
| Frederick, Maryland, United States, 21701 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Columbia, Missouri, United States, 65212-0001 | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| New York, New York, United States, 10032 | |
| Brooklyn, New York, United States, 11219 | |
| Bronx, New York, United States, 10466-2604 | |
| United States, Ohio | |
| Cleveland, Ohio, United States, 44195 | |
| Dayton, Ohio, United States, 45429 | |
| Canton, Ohio, United States, 44718 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19107-5096 | |
| United States, South Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Texas | |
| Laredo, Texas, United States, 78041 | |
| Dallas, Texas, United States, 75246 | |
| San Antonio, Texas, United States, 78212 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| Richmond, Virginia, United States, 23294 | |
| United States, Washington | |
| Seattle, Washington, United States, 98101 | |
| United States, Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226-3596 | |
| Argentina | |
| Mendoza, Argentina, 5500 | |
| Santa Fé, Argentina, S3000FFV | |
| Argentina, Capital Federal | |
| Buenos Aires, Capital Federal, Argentina, C1426ANZ | |
| Argentina, Santa Fe | |
| Rosario, Santa Fe, Argentina, S2000DSK | |
| Australia, Australian Capital Territory | |
| Garran, Australian Capital Territory, Australia, 2605 | |
| Australia, New South Wales | |
| Camperdown, New South Wales, Australia, 2050 | |
| Sydney, New South Wales, Australia, 2145 | |
| Liverpool, New South Wales, Australia, 2170 | |
| Australia, Victoria | |
| Heidelberg, Victoria, Australia, 3084 | |
| Wodonga, Victoria, Australia, 0390 | |
| Belgium | |
| BRUXELLES, Belgium, 1090 | |
| BRUXELLES, Belgium, 1000 | |
| Brazil, PR | |
| Curitiba, PR, Brazil, 81520-060 | |
| Brazil, Rio Grande do Sul | |
| Porto Alegre, Rio Grande do Sul, Brazil, 90619900 | |
| Brazil, RS | |
| Porto Alegre, RS, Brazil, 90470 340 | |
| Canada, Alberta | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Ontario | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| London, Ontario, Canada, N6A 4L6 | |
| Canada, Quebec | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Chile | |
| Santiago, Chile, 838-0456 | |
| France | |
| SAINT HERBLAIN, France, 44805 | |
| CAEN CEDEX 5, France, 14076 | |
| PARIS CEDEX 15, France, 75908 | |
| BORDEAUX, France, 33000 | |
| TOULOUSE, France, 31052 | |
| LILLE CEDEX, France, 59020 | |
| LYON CEDEX, France, 69008 | |
| VILLEJUIF CEDEX, France, 94305 | |
| MARSEILLE, France, 13273 | |
| STRASBOURG, France, 67091 | |
| Germany | |
| Berlin, Germany, 10967 | |
| Hamburg, Germany, 20251 | |
| Germany, Baden-Württemberg | |
| Ulm, Baden-Württemberg, Germany, 89075 | |
| Mannheim, Baden-Württemberg, Germany, 68167 | |
| Germany, Bayern | |
| Regensburg, Bayern, Germany, 93053 | |
| München, Bayern, Germany, 81377 | |
| Germany, Hessen | |
| Darmstadt, Hessen, Germany, 64276 | |
| Frankfurt, Hessen, Germany, 60488 | |
| Germany, Nordrhein-Westfalen | |
| Düsseldorf, Nordrhein-Westfalen, Germany, 40225 | |
| Germany, Sachsen | |
| Dresden, Sachsen, Germany, 01307 | |
| Hungary | |
| Debrecen, Hungary, 4032 | |
| Budapest, Hungary, 1121 | |
| Budapest, Hungary, 1032 | |
| Zalaegerszeg, Hungary, 8900 | |
| Israel | |
| Haifa, Israel, 31096 | |
| Tel Aviv, Israel, 64239 | |
| Italy | |
| Roma, Italy, 00128 | |
| Reggio Emilia, Italy, 42100 | |
| Pavia, Italy, 27100 | |
| Modena, Italy, 41124 | |
| Perugia, Italy, 06122 | |
| Milano, Italy, 20133 | |
| Netherlands | |
| NIJMEGEN, Netherlands, 6525 GA | |
| Poland | |
| Warszawa, Poland, 02-781 | |
| Wroclaw, Poland, 50-367 | |
| Szczecin, Poland, 70-111 | |
| Lublin, Poland, 20-090 | |
| Poznan, Poland, 61-701 | |
| Gdansk, Poland, 80-210 | |
| Lodz, Poland, 93-509 | |
| Krakow, Poland, 31-115 | |
| Warszawa, Poland, 00-909 | |
| Russian Federation | |
| Moscow, Russian Federation, 125284 | |
| Moscow, Russian Federation, 115478 | |
| Kazan, Russian Federation, 420029 | |
| Barnaul, Russian Federation, 656049 | |
| St. Petersburg, Russian Federation, 198255 | |
| Kirov, Russian Federation, 610021 | |
| Russian Federation, Kaluga region | |
| Obninsk, Kaluga region, Russian Federation, 249036 | |
| South Africa, Free State | |
| Bloemfontein, Free State, South Africa, 9300 | |
| South Africa, GAUTENG | |
| Pretoria, GAUTENG, South Africa | |
| South Africa, Kwazulu Natal | |
| Durban, Kwazulu Natal, South Africa, 4001 | |
| South Africa, Western Cape | |
| Cape Town, Western Cape, South Africa, 7505 | |
| Spain | |
| Barcelona, Spain, 08035 | |
| Madrid, Spain, 28040 | |
| Valencia, Spain, 46009 | |
| Spain, Bizkaia | |
| Barakaldo, Bizkaia, Spain, 48903 | |
| Ukraine | |
| Poltava, Ukraine, 36024 | |
| Kharkiv, Ukraine, 61024 | |
| Kiev, Ukraine, 115 | |
| Lviv, Ukraine, 79031 | |
| Donetsk, Ukraine, 83092 | |
| United Kingdom, Greater Manchester | |
| Manchester, Greater Manchester, United Kingdom, M20 4BX | |
| United Kingdom, Middlesex | |
| Northwood, Middlesex, United Kingdom, HA6 2RN | |
| United Kingdom, South Glamorgan | |
| Cardiff, South Glamorgan, United Kingdom, CF14 2TL | |
| United Kingdom, Strathclyde | |
| Glasgow, Strathclyde, United Kingdom, G11 6NT | |
| United Kingdom, Surrey | |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
| United Kingdom, Tyne and Wear | |
| Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE4 5BE | |
| United Kingdom, West Midlands | |
| Birmingham, West Midlands, United Kingdom, B15 2TT | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
| Study ID Numbers: | 11213 |
| Study First Received: | November 19, 2003 |
| Last Updated: | October 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00073307 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Renal Cell Cancer (RCC) Cancer |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Urogenital Neoplasms Urologic Neoplasms Protein Kinase Inhibitors Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial |