check_circleStudy Completed
Carcinoma, Renal Cell
Bayer Identifier:
11213
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study of BAY43-9006 in Patients with Unresectable and/or Metastatic Renal Cell Cancer
Trial 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.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
903Trial Dates
November 2003 - April 2010Phase
Phase 3Could I Receive a placebo
YesProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Royal Prince Alfred Hospital | Camperdown, 2050, Australia |
Completed | UZ Brussel | BRUXELLES - BRUSSEL, 1090, Belgium |
Completed | Hospital Sao Lucas da Pontificia Universidade Catolica do RS | Porto Alegre, 90619900, Brazil |
Completed | Cross Cancer Institute | Edmonton, T6G 1Z2, Canada |
Completed | Universitätsklinikum Ulm | Ulm, 89075, Germany |
Completed | Instituto Valenciano de Oncología | Valencia, 46009, Spain |
Completed | Velindre Hospital | Cardiff, CF14 2TL, United Kingdom |
Completed | Universitair Medisch Centrum St. Radboud | NIJMEGEN, 6525 GA, Netherlands |
Completed | Hertzen Institute of Oncology | Moscow, 125284, Russia |
Completed | Regional Cancer Dispensary | Poltava, 36024, Ukraine |
Completed | Centro Oncológico de Rosario | Rosario, S2000DSK, Argentina |
Completed | Austin Health | Heidelberg, 3084, Australia |
Completed | Institut Jules Bordet/Jules Bordet Instituut | BRUXELLES - BRUSSEL, 1000, Belgium |
Completed | Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner | Curitiba, 81520-060, Brazil |
Completed | Ciutat Sanitària i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Completed | Centro Especializado ISIS | Santa Fé, S3000FFV, Argentina |
Completed | Hospital Clínico Universidad de Chile | Santiago de Chile, Chile |
Completed | Institut Gustave Roussy - Villejuif | VILLEJUIF, 94805, France |
Completed | Zala Megyei Korhaz | Zalaegerszeg, 8900, Hungary |
Completed | Rambam Medical Center | Haifa, 3109601, Israel |
Completed | IRCCS Istituti Fisioterapici Ospitalieri | Roma, 00144, Italy |
Completed | Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie | Warszawa, 02-781, Poland |
Completed | Mary Potter Oncology Centre | Pretoria, South Africa |
Completed | Sir Mortimer B. Davis Jewish General Hospital | Montreal, H3T 1E2, Canada |
Completed | Royal Marsden NHS Trust (Surrey) | Sutton, SM2 5PT, United Kingdom |
Completed | A.O. di Reggio Emilia | Reggio Emilia, 42100, Italy |
Completed | Donetsk Regional Oncological Center Regional Antitumor Cente | Donetsk, 83092, Ukraine |
Completed | Westmead Hospital | Westmead, 2145, Australia |
Completed | Hospital de Cruces | Cruces/Barakaldo, 48903, Spain |
Completed | Hopital Européen Georges Pompidou - Paris | PARIS CEDEX 15, 75908, France |
Completed | Centre François Baclesse - CLCC - Caen | CAEN CEDEX 5, 14076, France |
Completed | Tel Aviv Sourasky Medical Center | Tel Aviv, 64239, Israel |
Completed | Akademia Medyczna we Wroclawiu | Wroclaw, 50-043, Poland |
Completed | City Clinical Oncology Center | St. Petersburg, 198255, Russia |
Completed | Louisiana Oncology Associates, PMC | Lafayette, 70506, United States |
Completed | Instituto Medico Especializado Alexander Fleming | Capital Federal-Buenos Aires, C1426ANZ, Argentina |
Completed | Irmandade Santa Casa de Misericordia de Porto Alegre | Porto Alegre, 90020-060, Brazil |
Completed | Princess Margaret Hospital-University Health Network | Toronto, M5G 2M9, Canada |
Completed | National Institute of Oncology | Budapest, 1121, Hungary |
Completed | Addington Hospital Durban | Durban, 4001, South Africa |
Completed | Liverpool Hospital | Liverpool, 2170, Australia |
Completed | Juravinski Cancer Centre | Hamilton, L8V 5C2, Canada |
Completed | Universitätsklinikum Regensburg | Regensburg, 93042, Germany |
Completed | Hospital Clínico Universitario San Carlos | Madrid, 28040, Spain |
Completed | Christie Hospital | Manchester, M20 4BX, United Kingdom |
Completed | Newcastle General Hospital | Newcastle Upon Tyne, NE4 6BE, United Kingdom |
Completed | Samodzielny Publiczn Szpital Kliniczny nr 2 PUM w Szczecinie | Szczecin, 70-111, Poland |
Completed | Clinical Oncology Dispensary | Kazan, 420029, Russia |
Completed | City Oncology Hospital | Kiev, 115, Ukraine |
Completed | University of Utah Medical Center | Salt Lake City, 84132, United States |
Completed | Fundación Centro Oncológico de Integración Regional | Mendoza, 5500, Argentina |
Completed | Hôpital Saint André - Bordeaux | BORDEAUX, 33000, France |
Completed | Szent Margit Hospital | Budapest, 1032, Hungary |
Completed | Wojewodzkie Centrum Onkologii | Gdansk, 80-210, Poland |
Completed | The Canberra Hospital | Garran, 2605, Australia |
Completed | Institut Claudius Regaud - Toulouse | TOULOUSE, 31052, France |
Completed | University of Debrecen Medical&Health Science Center | Debrecen, 4004, Hungary |
Completed | Akademia Medyczna | Poznan, 61-878, Poland |
Completed | Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS | Moscow, 115478, Russia |
Completed | Grigoriev Institute for medical radiology | Kharkiv, 61024, Ukraine |
Completed | Klinikum Darmstadt | Darmstadt, 64276, Germany |
Completed | Altay Oncological Dispensary | Barnaul, 656049, Russia |
Completed | Lvov Cancer Center | Lviv, 79031, Ukraine |
Completed | Palmetto Hematology Oncology, PC | Spartanburg, 29303, United States |
Completed | London Regional Cancer Program | London, N6A 4L6, Canada |
Completed | Mount Vernon Hospital | Northwood, HA6 2RN, United Kingdom |
Completed | IRCCS Istituto Nazionale Tumori | Milano, 20133, Italy |
Completed | Murray Valley Private Hospital | Wodonga, 0390, Australia |
Completed | Centre Oscar Lambret - Lille | LILLE CEDEX, 59020, France |
Completed | Virginia Physicians, Inc. | Richmond, 23229, United States |
Completed | Centre Léon Bérard | LYON CEDEX, 69008, France |
Completed | University of Birmingham | Birmingham, B15 2TT, United Kingdom |
Completed | Kirov Regional Clinical Oncology Dispensary | Kirov, 610021, Russia |
Completed | Medizinische Fakultät Carl Gustav Carus | Dresden, 01307, Germany |
Completed | Institut Paoli-Calmettes - Marseille | MARSEILLE, 13273, France |
Completed | Virginia Mason Medical Center | Seattle, 98101, United States |
Completed | Kentuckiana Cancer Institute, PLLC | Louisville, 40202, United States |
Completed | Western Infirmary | Glasgow, G11 6NT, United Kingdom |
Completed | A.O.U. di Modena Policlinico | Modena, 41124, Italy |
Completed | Petrov Research Instutute of Oncology | St. Petersburg, 198255, Russia |
Completed | University of Stellenbosch | Cape Town, 7500, South Africa |
Completed | Vivantes Klinikum Am Urban | Berlin, 10967, Germany |
Completed | A.O. di Perugia | Perugia, 06122, Italy |
Completed | Centrum Onkologii Ziemi Lubelskiej | Lublin, 20-090, Poland |
Completed | Medical Radiol. Research Centre of Minzdravsocrazvitie, FGBU | Obninsk, 249036, Russia |
Completed | Universitas Hospital | Bloemfontein, 9300, South Africa |
Completed | Centre René Gauducheau - Nantes | NANTES, 44805, France |
Completed | IRCCS Policlinico San Matteo | Pavia, 27100, Italy |
Completed | Regionalny Osrodek Onkologiczny - Wojew. Szpital Onkolgiczny | Lodz, 93-509, Poland |
Completed | University of Missouri HealthCare | Columbia, 65203-3244, United States |
Completed | Centrum Onkologii Instytut im. M. Sklodowskiej-Curie | Krakow, 31-115, Poland |
Completed | Hôpital Civil - Strasbourg | STRASBOURG, 67091, France |
Completed | Wojskowy Instytut Medyczny | Warszawa, 04-141, Poland |
Completed | Klinikum Mannheim gGmbH | Mannheim, 68167, Germany |
Completed | Arizona Clinical Research Center | Tucson, 85712, United States |
Completed | Universitätsklinikum Hamburg Eppendorf (UKE) | Hamburg, 20246, Germany |
Completed | Washington University School of Medicine | St. Louis, 63110-1093, United States |
Completed | Krankenhaus Nordwest | Frankfurt, 60488, Germany |
Completed | Optima Research, Ltd | Laredo, 78041, United States |
Completed | The Cleveland Clinic | Cleveland, 44195, United States |
Completed | Hematology & Oncology of Dayton, Inc. | Dayton, 45429, United States |
Completed | Maimonides Medical Center | Brooklyn, 11220, United States |
Completed | University of Chicago | Chicago, 60637, United States |
Completed | Frederick Memorial Hospital | Frederick, 21701, United States |
Completed | Beth Israel Deaconess Medical Center | Boston, 02215, United States |
Completed | Our Lady of Mercy Medical Center | Bronx, 10466-2604, United States |
Completed | Baylor Sammons Cancer Center at Dallas | Dallas, 75246, United States |
Completed | Peachtree Hematology & Oncology Consultants, PC | Atlanta, 30309, United States |
Completed | Oregon Health and Science University | Portland, 97239, United States |
Completed | New York-Presbyterian Hospital | New York, 10032, United States |
Completed | University of Colorado Health Sciences Center | Aurora, 80045, United States |
Completed | LMU Klinikum der Universität München - Großhadern | München, 81377, Germany |
Completed | Kenmar Research Institute | Los Angeles, 90057, United States |
Completed | Medizinische Einrichtungen der Heinrich-Heine-Universität | Düsseldorf, 40225, Germany |
Completed | University of Southern California | Los Angeles, 90033, United States |
Completed | University of Minnesota Medical Center-Fairview | Minneapolis, 55455, United States |
Completed | Thomas Jefferson University Hospitals | Philadelphia, 19107-5096, United States |
Completed | Gabrail Cancer Center | Canton, 44718, United States |
Completed | Cancer Care Centers of South Texas | San Antonio, 78212, United States |
Completed | Froedtert Memorial Lutheran Hospital | Milwaukee, 53226-3596, United States |
Completed | University of California - Davis | Sacramento, 95817, United States |
Completed | Medical Oncology & Hematology, PC | Hamden, 06518, United States |
Primary Outcome
- Final Overall Survival - Primary Analysis in the ITT (Intent To Treat) populationdate_rangeTime Frame:From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months laterenhanced_encryptionNoSafety Issue:
- Final Overall Survival - Secondary Analysis (Placebo data censored at 30June2005) in the ITT populationdate_rangeTime Frame:From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months laterenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Final Progression-Free Survival (PFS) - Independent radiological reviewdate_rangeTime Frame:From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeksenhanced_encryptionNoSafety Issue:
- Best Overall Response - Independent radiological reviewdate_rangeTime Frame:From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.enhanced_encryptionNoSafety Issue:
- Health-related quality of life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) assessmentdate_rangeTime Frame:From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.enhanced_encryptionNoSafety Issue:
- Health-related quality of life (HRQOL) by Physical Well-Being (PWB) score of the FACT-G (Functional Assessment of Cancer Therapy-General version) assessmentdate_rangeTime Frame:From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2