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