Trial Condition(s):

Carcinoma, Renal Cell

Study of BAY43-9006 in Patients with Unresectable and/or Metastatic Renal Cell Cancer

Bayer Identifier:

11213

ClinicalTrials.gov Identifier:

NCT00073307

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

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.

Inclusion Criteria
- Patients with unresectable and/or metastatic, measurable renal cell carcinoma histologically or cytologically documented
 - Patients must have had one prior systemic therapy for advanced disease, which was completed at least 30 days but no longer than 8 months prior to randomization
 - Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST)
 - Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
 - Patients who have adequate coagulation, liver and kidney functions
Exclusion Criteria
- Patients with rare subtypes of renal cell carcinoma (RCC) such as pure papillary cell tumors, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors
 - Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma,or superficial bladder tumors, or other malignancies curatively treated > 2 years prior to entry
 - Cardiac arrhythmias requiring anti-arrhythmics, symptomatic coronary artery disease or ischemia or congestive heart failure
 - Patients with a history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
 - Patients with a history or presence of metastatic brain or meningeal tumors
 - Patients with seizure disorder requiring medication (such as anti-epileptics)
 - History of organ allograft or bone marrow transplant of stem cell rescue
 - Patients who are pregnant or breast-feeding Women of childbearing potential must have a negative pregnancy test prior to drug administration. Both men and women enrolled in this trial must use adequate birth control
 - Patients who have three or more of the following:
 -- ECOG performance status greater than or equal to 2,
 -- Abnormally high lactate dehydrogenase,
 -- Abnormally high serum hemoglobin,
 -- Abnormally high corrected serum calcium,
 -- Absence of prior nephrectomy
 - Excluded therapies and medications, previous and concomitant:
 -- Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphonates
 -- Significant surgery with 4 weeks of start of study
 -- Investigational drug therapy during or within 30 days
 -- Concomitant treatment with rifampin or St. John's Wort
 -- Prior use of Raf-kinase inhibitors (RKI), MEK or Farnesyl transferase inhibitors
 -- Prior use of Bevacizumab, and all other drugs (investigational or licensed) that target VEGF/VEGF receptors

Trial Summary

Enrollment Goal
903
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Royal Prince Alfred Hospital

Camperdown, Australia, 2050

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UZ Brussel

BRUXELLES - BRUSSEL, Belgium, 1090

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Hospital Sao Lucas da Pontificia Universidade Catolica do RS

Porto Alegre, Brazil, 90619900

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Cross Cancer Institute

Edmonton, Canada, T6G 1Z2

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Universitätsklinikum Ulm

Ulm, Germany, 89075

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Instituto Valenciano de Oncología

Valencia, Spain, 46009

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Velindre Hospital

Cardiff, United Kingdom, CF14 2TL

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Universitair Medisch Centrum St. Radboud

NIJMEGEN, Netherlands, 6525 GA

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Hertzen Institute of Oncology

Moscow, Russia, 125284

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Regional Cancer Dispensary

Poltava, Ukraine, 36024

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Centro Oncológico de Rosario

Rosario, Argentina, S2000DSK

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Austin Health

Heidelberg, Australia, 3084

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Institut Jules Bordet/Jules Bordet Instituut

BRUXELLES - BRUSSEL, Belgium, 1000

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Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner

Curitiba, Brazil, 81520-060

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Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

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Centro Especializado ISIS

Santa Fé, Argentina, S3000FFV

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Hospital Clínico Universidad de Chile

Santiago de Chile, Chile

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Institut Gustave Roussy - Villejuif

VILLEJUIF, France, 94805

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Zala Megyei Korhaz

Zalaegerszeg, Hungary, 8900

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Rambam Medical Center

Haifa, Israel, 3109601

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IRCCS Istituti Fisioterapici Ospitalieri

Roma, Italy, 00144

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Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie

Warszawa, Poland, 02-781

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Mary Potter Oncology Centre

Pretoria, South Africa

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Sir Mortimer B. Davis Jewish General Hospital

Montreal, Canada, H3T 1E2

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Royal Marsden NHS Trust (Surrey)

Sutton, United Kingdom, SM2 5PT

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A.O. di Reggio Emilia

Reggio Emilia, Italy, 42100

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Donetsk Regional Oncological Center Regional Antitumor Cente

Donetsk, Ukraine, 83092

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Westmead Hospital

Westmead, Australia, 2145

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Hospital de Cruces

Cruces/Barakaldo, Spain, 48903

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Hopital Européen Georges Pompidou - Paris

PARIS CEDEX 15, France, 75908

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Centre François Baclesse - CLCC - Caen

CAEN CEDEX 5, France, 14076

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Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

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Akademia Medyczna we Wroclawiu

Wroclaw, Poland, 50-043

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City Clinical Oncology Center

St. Petersburg, Russia, 198255

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Louisiana Oncology Associates, PMC

Lafayette, United States, 70506

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Instituto Medico Especializado Alexander Fleming

Capital Federal-Buenos Aires, Argentina, C1426ANZ

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Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil, 90020-060

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Princess Margaret Hospital-University Health Network

Toronto, Canada, M5G 2M9

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National Institute of Oncology

Budapest, Hungary, 1121

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Addington Hospital Durban

Durban, South Africa, 4001

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Liverpool Hospital

Liverpool, Australia, 2170

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Juravinski Cancer Centre

Hamilton, Canada, L8V 5C2

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Universitätsklinikum Regensburg

Regensburg, Germany, 93042

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Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

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Christie Hospital

Manchester, United Kingdom, M20 4BX

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Newcastle General Hospital

Newcastle Upon Tyne, United Kingdom, NE4 6BE

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Samodzielny Publiczn Szpital Kliniczny nr 2 PUM w Szczecinie

Szczecin, Poland, 70-111

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Clinical Oncology Dispensary

Kazan, Russia, 420029

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City Oncology Hospital

Kiev, Ukraine, 115

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University of Utah Medical Center

Salt Lake City, United States, 84132

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Fundación Centro Oncológico de Integración Regional

Mendoza, Argentina, 5500

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Hôpital Saint André - Bordeaux

BORDEAUX, France, 33000

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Szent Margit Hospital

Budapest, Hungary, 1032

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Wojewodzkie Centrum Onkologii

Gdansk, Poland, 80-210

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The Canberra Hospital

Garran, Australia, 2605

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Institut Claudius Regaud - Toulouse

TOULOUSE, France, 31052

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University of Debrecen Medical&Health Science Center

Debrecen, Hungary, 4004

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Akademia Medyczna

Poznan, Poland, 61-878

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Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS

Moscow, Russia, 115478

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Grigoriev Institute for medical radiology

Kharkiv, Ukraine, 61024

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Klinikum Darmstadt

Darmstadt, Germany, 64276

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Altay Oncological Dispensary

Barnaul, Russia, 656049

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Lvov Cancer Center

Lviv, Ukraine, 79031

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Palmetto Hematology Oncology, PC

Spartanburg, United States, 29303

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London Regional Cancer Program

London, Canada, N6A 4L6

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Mount Vernon Hospital

Northwood, United Kingdom, HA6 2RN

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IRCCS Istituto Nazionale Tumori

Milano, Italy, 20133

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Murray Valley Private Hospital

Wodonga, Australia, 0390

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Centre Oscar Lambret - Lille

LILLE CEDEX, France, 59020

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Virginia Physicians, Inc.

Richmond, United States, 23229

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Centre Léon Bérard

LYON CEDEX, France, 69008

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University of Birmingham

Birmingham, United Kingdom, B15 2TT

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Kirov Regional Clinical Oncology Dispensary

Kirov, Russia, 610021

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Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

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Institut Paoli-Calmettes - Marseille

MARSEILLE, France, 13273

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Virginia Mason Medical Center

Seattle, United States, 98101

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Kentuckiana Cancer Institute, PLLC

Louisville, United States, 40202

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Western Infirmary

Glasgow, United Kingdom, G11 6NT

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A.O.U. di Modena Policlinico

Modena, Italy, 41124

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Petrov Research Instutute of Oncology

St. Petersburg, Russia, 198255

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University of Stellenbosch

Cape Town, South Africa, 7500

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Vivantes Klinikum Am Urban

Berlin, Germany, 10967

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A.O. di Perugia

Perugia, Italy, 06122

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Centrum Onkologii Ziemi Lubelskiej

Lublin, Poland, 20-090

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Medical Radiol. Research Centre of Minzdravsocrazvitie, FGBU

Obninsk, Russia, 249036

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Universitas Hospital

Bloemfontein, South Africa, 9300

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Centre René Gauducheau - Nantes

NANTES, France, 44805

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IRCCS Policlinico San Matteo

Pavia, Italy, 27100

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Regionalny Osrodek Onkologiczny - Wojew. Szpital Onkolgiczny

Lodz, Poland, 93-509

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University of Missouri HealthCare

Columbia, United States, 65203-3244

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Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

Krakow, Poland, 31-115

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Hôpital Civil - Strasbourg

STRASBOURG, France, 67091

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Wojskowy Instytut Medyczny

Warszawa, Poland, 04-141

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Klinikum Mannheim gGmbH

Mannheim, Germany, 68167

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Arizona Clinical Research Center

Tucson, United States, 85712

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Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20246

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Washington University School of Medicine

St. Louis, United States, 63110-1093

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Krankenhaus Nordwest

Frankfurt, Germany, 60488

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Optima Research, Ltd

Laredo, United States, 78041

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The Cleveland Clinic

Cleveland, United States, 44195

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Hematology & Oncology of Dayton, Inc.

Dayton, United States, 45429

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Maimonides Medical Center

Brooklyn, United States, 11220

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University of Chicago

Chicago, United States, 60637

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Frederick Memorial Hospital

Frederick, United States, 21701

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Beth Israel Deaconess Medical Center

Boston, United States, 02215

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Our Lady of Mercy Medical Center

Bronx, United States, 10466-2604

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Baylor Sammons Cancer Center at Dallas

Dallas, United States, 75246

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Peachtree Hematology & Oncology Consultants, PC

Atlanta, United States, 30309

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Oregon Health and Science University

Portland, United States, 97239

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New York-Presbyterian Hospital

New York, United States, 10032

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University of Colorado Health Sciences Center

Aurora, United States, 80045

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LMU Klinikum der Universität München - Großhadern

München, Germany, 81377

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Kenmar Research Institute

Los Angeles, United States, 90057

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Medizinische Einrichtungen der Heinrich-Heine-Universität

Düsseldorf, Germany, 40225

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University of Southern California

Los Angeles, United States, 90033

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University of Minnesota Medical Center-Fairview

Minneapolis, United States, 55455

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Thomas Jefferson University Hospitals

Philadelphia, United States, 19107-5096

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Gabrail Cancer Center

Canton, United States, 44718

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Cancer Care Centers of South Texas

San Antonio, United States, 78212

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Froedtert Memorial Lutheran Hospital

Milwaukee, United States, 53226-3596

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University of California - Davis

Sacramento, United States, 95817

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Medical Oncology & Hematology, PC

Hamden, United States, 06518

Trial Design