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

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
Status
LocationsStatus
Locations

Royal Prince Alfred Hospital

Camperdown, Australia, 2050

Status
Completed
 
Locations

UZ Brussel

BRUXELLES - BRUSSEL, Belgium, 1090

Status
Completed
 
Locations

Hospital Sao Lucas da Pontificia Universidade Catolica do RS

Porto Alegre, Brazil, 90619900

Status
Completed
 
Locations

Cross Cancer Institute

Edmonton, Canada, T6G 1Z2

Status
Completed
 
Locations

Universitätsklinikum Ulm

Ulm, Germany, 89075

Status
Completed
 
Locations

Instituto Valenciano de Oncología

Valencia, Spain, 46009

Status
Completed
 
Locations

Velindre Hospital

Cardiff, United Kingdom, CF14 2TL

Status
Completed
 
Locations

Universitair Medisch Centrum St. Radboud

NIJMEGEN, Netherlands, 6525 GA

Status
Completed
 
Locations

Hertzen Institute of Oncology

Moscow, Russia, 125284

Status
Completed
 
Locations

Regional Cancer Dispensary

Poltava, Ukraine, 36024

Status
Completed
 
Locations

Centro Oncológico de Rosario

Rosario, Argentina, S2000DSK

Status
Completed
 
Locations

Austin Health

Heidelberg, Australia, 3084

Status
Completed
 
Locations

Institut Jules Bordet/Jules Bordet Instituut

BRUXELLES - BRUSSEL, Belgium, 1000

Status
Completed
 
Locations

Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner

Curitiba, Brazil, 81520-060

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Centro Especializado ISIS

Santa Fé, Argentina, S3000FFV

Status
Completed
 
Locations

Hospital Clínico Universidad de Chile

Santiago de Chile, Chile

Status
Completed
 
Locations

Institut Gustave Roussy - Villejuif

VILLEJUIF, France, 94805

Status
Completed
 
Locations

Zala Megyei Korhaz

Zalaegerszeg, Hungary, 8900

Status
Completed
 
Locations

Rambam Medical Center

Haifa, Israel, 3109601

Status
Completed
 
Locations

IRCCS Istituti Fisioterapici Ospitalieri

Roma, Italy, 00144

Status
Completed
 
Locations

Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie

Warszawa, Poland, 02-781

Status
Completed
 
Locations

Mary Potter Oncology Centre

Pretoria, South Africa

Status
Completed
 
Locations

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Canada, H3T 1E2

Status
Completed
 
Locations

Royal Marsden NHS Trust (Surrey)

Sutton, United Kingdom, SM2 5PT

Status
Completed
 
Locations

A.O. di Reggio Emilia

Reggio Emilia, Italy, 42100

Status
Completed
 
Locations

Donetsk Regional Oncological Center Regional Antitumor Cente

Donetsk, Ukraine, 83092

Status
Completed
 
Locations

Westmead Hospital

Westmead, Australia, 2145

Status
Completed
 
Locations

Hospital de Cruces

Cruces/Barakaldo, Spain, 48903

Status
Completed
 
Locations

Hopital Européen Georges Pompidou - Paris

PARIS CEDEX 15, France, 75908

Status
Completed
 
Locations

Centre François Baclesse - CLCC - Caen

CAEN CEDEX 5, France, 14076

Status
Completed
 
Locations

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Status
Completed
 
Locations

Akademia Medyczna we Wroclawiu

Wroclaw, Poland, 50-043

Status
Completed
 
Locations

City Clinical Oncology Center

St. Petersburg, Russia, 198255

Status
Completed
 
Locations

Louisiana Oncology Associates, PMC

Lafayette, United States, 70506

Status
Completed
 
Locations

Instituto Medico Especializado Alexander Fleming

Capital Federal-Buenos Aires, Argentina, C1426ANZ

Status
Completed
 
Locations

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil, 90020-060

Status
Completed
 
Locations

Princess Margaret Hospital-University Health Network

Toronto, Canada, M5G 2M9

Status
Completed
 
Locations

National Institute of Oncology

Budapest, Hungary, 1121

Status
Completed
 
Locations

Addington Hospital Durban

Durban, South Africa, 4001

Status
Completed
 
Locations

Liverpool Hospital

Liverpool, Australia, 2170

Status
Completed
 
Locations

Juravinski Cancer Centre

Hamilton, Canada, L8V 5C2

Status
Completed
 
Locations

Universitätsklinikum Regensburg

Regensburg, Germany, 93042

Status
Completed
 
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Completed
 
Locations

Christie Hospital

Manchester, United Kingdom, M20 4BX

Status
Completed
 
Locations

Newcastle General Hospital

Newcastle Upon Tyne, United Kingdom, NE4 6BE

Status
Completed
 
Locations

Samodzielny Publiczn Szpital Kliniczny nr 2 PUM w Szczecinie

Szczecin, Poland, 70-111

Status
Completed
 
Locations

Clinical Oncology Dispensary

Kazan, Russia, 420029

Status
Completed
 
Locations

City Oncology Hospital

Kiev, Ukraine, 115

Status
Completed
 
Locations

University of Utah Medical Center

Salt Lake City, United States, 84132

Status
Completed
 
Locations

Fundación Centro Oncológico de Integración Regional

Mendoza, Argentina, 5500

Status
Completed
 
Locations

Hôpital Saint André - Bordeaux

BORDEAUX, France, 33000

Status
Completed
 
Locations

Szent Margit Hospital

Budapest, Hungary, 1032

Status
Completed
 
Locations

Wojewodzkie Centrum Onkologii

Gdansk, Poland, 80-210

Status
Completed
 
Locations

The Canberra Hospital

Garran, Australia, 2605

Status
Completed
 
Locations

Institut Claudius Regaud - Toulouse

TOULOUSE, France, 31052

Status
Completed
 
Locations

University of Debrecen Medical&Health Science Center

Debrecen, Hungary, 4004

Status
Completed
 
Locations

Akademia Medyczna

Poznan, Poland, 61-878

Status
Completed
 
Locations

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

Moscow, Russia, 115478

Status
Completed
 
Locations

Grigoriev Institute for medical radiology

Kharkiv, Ukraine, 61024

Status
Completed
 
Locations

Klinikum Darmstadt

Darmstadt, Germany, 64276

Status
Completed
 
Locations

Altay Oncological Dispensary

Barnaul, Russia, 656049

Status
Completed
 
Locations

Lvov Cancer Center

Lviv, Ukraine, 79031

Status
Completed
 
Locations

Palmetto Hematology Oncology, PC

Spartanburg, United States, 29303

Status
Completed
 
Locations

London Regional Cancer Program

London, Canada, N6A 4L6

Status
Completed
 
Locations

Mount Vernon Hospital

Northwood, United Kingdom, HA6 2RN

Status
Completed
 
Locations

IRCCS Istituto Nazionale Tumori

Milano, Italy, 20133

Status
Completed
 
Locations

Murray Valley Private Hospital

Wodonga, Australia, 0390

Status
Completed
 
Locations

Centre Oscar Lambret - Lille

LILLE CEDEX, France, 59020

Status
Completed
 
Locations

Virginia Physicians, Inc.

Richmond, United States, 23229

Status
Completed
 
Locations

Centre Léon Bérard

LYON CEDEX, France, 69008

Status
Completed
 
Locations

University of Birmingham

Birmingham, United Kingdom, B15 2TT

Status
Completed
 
Locations

Kirov Regional Clinical Oncology Dispensary

Kirov, Russia, 610021

Status
Completed
 
Locations

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

Status
Completed
 
Locations

Institut Paoli-Calmettes - Marseille

MARSEILLE, France, 13273

Status
Completed
 
Locations

Virginia Mason Medical Center

Seattle, United States, 98101

Status
Completed
 
Locations

Kentuckiana Cancer Institute, PLLC

Louisville, United States, 40202

Status
Completed
 
Locations

Western Infirmary

Glasgow, United Kingdom, G11 6NT

Status
Completed
 
Locations

A.O.U. di Modena Policlinico

Modena, Italy, 41124

Status
Completed
 
Locations

Petrov Research Instutute of Oncology

St. Petersburg, Russia, 198255

Status
Completed
 
Locations

University of Stellenbosch

Cape Town, South Africa, 7500

Status
Completed
 
Locations

Vivantes Klinikum Am Urban

Berlin, Germany, 10967

Status
Completed
 
Locations

A.O. di Perugia

Perugia, Italy, 06122

Status
Completed
 
Locations

Centrum Onkologii Ziemi Lubelskiej

Lublin, Poland, 20-090

Status
Completed
 
Locations

Medical Radiol. Research Centre of Minzdravsocrazvitie, FGBU

Obninsk, Russia, 249036

Status
Completed
 
Locations

Universitas Hospital

Bloemfontein, South Africa, 9300

Status
Completed
 
Locations

Centre René Gauducheau - Nantes

NANTES, France, 44805

Status
Completed
 
Locations

IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Status
Completed
 
Locations

Regionalny Osrodek Onkologiczny - Wojew. Szpital Onkolgiczny

Lodz, Poland, 93-509

Status
Completed
 
Locations

University of Missouri HealthCare

Columbia, United States, 65203-3244

Status
Completed
 
Locations

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

Krakow, Poland, 31-115

Status
Completed
 
Locations

Hôpital Civil - Strasbourg

STRASBOURG, France, 67091

Status
Completed
 
Locations

Wojskowy Instytut Medyczny

Warszawa, Poland, 04-141

Status
Completed
 
Locations

Klinikum Mannheim gGmbH

Mannheim, Germany, 68167

Status
Completed
 
Locations

Arizona Clinical Research Center

Tucson, United States, 85712

Status
Completed
 
Locations

Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20246

Status
Completed
 
Locations

Washington University School of Medicine

St. Louis, United States, 63110-1093

Status
Completed
 
Locations

Krankenhaus Nordwest

Frankfurt, Germany, 60488

Status
Completed
 
Locations

Optima Research, Ltd

Laredo, United States, 78041

Status
Completed
 
Locations

The Cleveland Clinic

Cleveland, United States, 44195

Status
Completed
 
Locations

Hematology & Oncology of Dayton, Inc.

Dayton, United States, 45429

Status
Completed
 
Locations

Maimonides Medical Center

Brooklyn, United States, 11220

Status
Completed
 
Locations

University of Chicago

Chicago, United States, 60637

Status
Completed
 
Locations

Frederick Memorial Hospital

Frederick, United States, 21701

Status
Completed
 
Locations

Beth Israel Deaconess Medical Center

Boston, United States, 02215

Status
Completed
 
Locations

Our Lady of Mercy Medical Center

Bronx, United States, 10466-2604

Status
Completed
 
Locations

Baylor Sammons Cancer Center at Dallas

Dallas, United States, 75246

Status
Completed
 
Locations

Peachtree Hematology & Oncology Consultants, PC

Atlanta, United States, 30309

Status
Completed
 
Locations

Oregon Health and Science University

Portland, United States, 97239

Status
Completed
 
Locations

New York-Presbyterian Hospital

New York, United States, 10032

Status
Completed
 
Locations

University of Colorado Health Sciences Center

Aurora, United States, 80045

Status
Completed
 
Locations

LMU Klinikum der Universität München - Großhadern

München, Germany, 81377

Status
Completed
 
Locations

Kenmar Research Institute

Los Angeles, United States, 90057

Status
Completed
 
Locations

Medizinische Einrichtungen der Heinrich-Heine-Universität

Düsseldorf, Germany, 40225

Status
Completed
 
Locations

University of Southern California

Los Angeles, United States, 90033

Status
Completed
 
Locations

University of Minnesota Medical Center-Fairview

Minneapolis, United States, 55455

Status
Completed
 
Locations

Thomas Jefferson University Hospitals

Philadelphia, United States, 19107-5096

Status
Completed
 
Locations

Gabrail Cancer Center

Canton, United States, 44718

Status
Completed
 
Locations

Cancer Care Centers of South Texas

San Antonio, United States, 78212

Status
Completed
 
Locations

Froedtert Memorial Lutheran Hospital

Milwaukee, United States, 53226-3596

Status
Completed
 
Locations

University of California - Davis

Sacramento, United States, 95817

Status
Completed
 
Locations

Medical Oncology & Hematology, PC

Hamden, United States, 06518

Status
Completed
 

Trial Design