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A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer Clinical research trials and A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer. A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer clinical trial. Test subjects typically obtain the finest healthcare available for their A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.

Home > "A" Clinical Trials Conditions > A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer

A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer



A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer

For Condition: Carcinoma, Renal Cell
Status: Recruiting
Sponsor(s): Bayer Corporation , ONYX Pharmaceuticals
Synopsis: To evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY 43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regiment for advanced disease.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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 malignacies curatively treated > 2 years prior to entry. - Cardiac arrhythmias requiring anti-arrhythmics, symptomtic 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 metastatic brain or meningeal tumors. - Patients with seizure disorder requiring medication (such as anti-epileptics). - History of organ alograft 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: 1. ECOG performance status greater than or equal to 2 2. Abnormally high lactate dehydrogenase 3. Abnormally high serum hemoglobin 4. Abnormally high corrected serum calcium 5. Absence of prior nephrectomy Excluded therapies and medications, previous and concomitant: - Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphanats - 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.
Total Enrollment: 800

Location and Contact Information:

Overall Study Official:
RonaldBukowski,  Principal Investigator,  Cleveland Clinic Cancer Center, Cleveland, Ohio, USA

Palmetto Hematology Oncology, P.A., Gibbs cancer Center *Recruiting*
Spartanburg,  South Carolina,  29303
United States
Recruiting James  Bradof 864-560-1841

Vivantes Klinikum Am Urban *Recruiting*
Berlin,  ,  10967
Germany
Recruiting Michael  Siegsmund 49-30-697-0

Frederick Memorial Hospital *Recruiting*
Frederick,  Maryland,  21701
United States
Recruiting Paul  Rausch 301-662-8477

Centre Rene Gauducheau *Recruiting*
Saint-Herblain,  ,  44805
France
Recruiting Frederic  Rolland 33-2-40-67-99-76

Policlinico Universitario S. Matteo *Recruiting*
Pavia,  ,  27100
Italy
Recruiting Camillo  Porta 39-0382-502161

Universitats-Krankenhaus Eppendorf *Recruiting*
Hamburg,  ,  20251
Germany
Recruiting Hans  Heinzer 49-40-42803-3442

Instituto Valendiano de Oncologia *Recruiting*
Valencia,  ,  46009
Spain
Recruiting Miguel  Climent 34-96-111-40-52

The Cleveland Clinic Foundation *Recruiting*
Cleveland,  Ohio,  44195
United States
Recruiting Ronald  Bukowski 216-444-6825

City Oncology Hospital *Recruiting*
Kiev,  ,  115
Ukraine
Recruiting Ivan  Klimenko 38-044-450-74-80

Krankenhaus Nordwest *Recruiting*
Frankfurt,  Hessen,  60488
Germany
Recruiting Elke  Jager 49-69-7601-3380

Klinikm der Universitat Regensburg *Recruiting*
Regensburg,  Bayern,  93053
Germany
Recruiting Stefan  Krause 49-941-944-5538 5

Lvov Cancer Center *Recruiting*
Lvov,  ,  79031
Ukraine
Recruiting Yaroslav  Shparik 380-0322-23-09-72

Pretoria Urology Hospital *Recruiting*
Pretoria,  Gauteng, 
South Africa
Recruiting Lance  Coetzee 27-12-342-9432

Altay Oncological Dispensary *Recruiting*
Kazan,  ,  420029
Russian Federation
Recruiting Vladimir  Lubennikov 7-3852-23-26-20

Grigoriev Institute *Recruiting*
Kharkiv,  ,  61024
Ukraine
Recruiting Pilipenko  Nikolay 38-057-431-542

Wojewodzka Przychodnia Onkolog *Recruiting*
Gdansk,  ,  80-210
Poland
Recruiting Ewa  Solska 48-58-341-70-45

Institut Gustave Roussy (IGR), 39 rue Camille Desmoulins *Recruiting*
Villejuif,  ,  94805
France
Recruiting Bernard  Escudier (33) 1 42 11 54 10

Canberra Hospital *Recruiting*
Woden,  ,  ACT 2606
Australia
Recruiting David  Leong 61-2-6244-3856

Oddzial Chorob Rozorstowych *Recruiting*
Lodz,  ,  93-509
Poland
Recruiting Maria  Blasinska-Morawiec 48-42-689-54-71

Hospital Europeen Georges Pompidou *Recruiting*
Paris,  ,  75908
France
Recruiting Stephane  Oudard 33-1-56-09-34-76

Medical Department, Christie Hospital *Recruiting*
Manchester,  ,  M20 4B
United Kingdom
Recruiting Robert  Hawkins 44-161-446-8338

Jewish General Hospital *Recruiting*
Quebec City,  Quebec,  H3T 1E2
Canada
Recruiting Wilson  Miller 514-340-8222

Klinika Urologi, Pomorksa Akademia Medyczna *Recruiting*
Szczecin,  ,  70-111
Poland
Recruiting Andrzej  Sikorski 48-91-466-11-00

Klinika Chemioterapii *Recruiting*
Krakow,  ,  31-115
Poland
Recruiting Marek  Pawlicki 48-12-423-10-34

Klinika Onkologie, Centralny Szpital Kliniczny *Recruiting*
Warszawa,  ,  00-909
Poland
Recruiting Cezary  Szczylik 48-22-610-30-98

Mary Potter Oncology Resarch *Recruiting*
Pretoria,  Gauteng,  0001
South Africa
Recruiting Graham  Cohen 27-12-346-6701

Instituto Regina Elena *Recruiting*
Roma,  ,  00144
Italy
Recruiting Francesco  Cognetti 39-06-5-266-6228

Klinikum Grosshadern der Ludwig-Maximilians-Universitat *Recruiting*
Munchen,  ,  81377
Germany
Recruiting Michael  Siebels 49-89-7095-0

Klinikum der Justus-Liebig-Universitat *Recruiting*
Giessen,  ,  35392
Germany
Recruiting W  Weidner

Dept. of Oncology *Recruiting*
Budapest,  ,  1032
Hungary
Recruiting Marta  Baki 36-1-250-2420/292

Dept of Urology, Tygerberg Hospital *Recruiting*
Cape Town,  ,  7500
South Africa
Recruiting C  Heyns 27-21-938-9282

Ichilov Hospital *Recruiting*
Tel Aviv,  ,  64239
Israel
Recruiting R  Ben-Yoself 972-2-697-4444

Louisiana Oncology Associates *Recruiting*
Lafayette,  Louisiana,  70506
United States
Recruiting David  Rinaldi 337-235-7898

Azienda Ospedali Riuniti *Recruiting*
Bergamo,  ,  24128
Italy
Recruiting Roberto  Labianca 39-035-269-724

Institut Paoli-Calmettes *Recruiting*
Marseille,  ,  13273
France
Recruiting Gwenaelle  Gravis 33-4-91-22-33-33

Northern Centre for Cancer Treatment *Recruiting*
Newcastle upon Tyne,  ,  NE4 5BE
United Kingdom
Recruiting Rhona  McMenemin 01-91-2194299

Hematology/Oncology of Dayton *Recruiting*
Dayton,  Ohio,  45429
United States
Recruiting Howard  Gross 937-832-1093

Optima Research *Recruiting*
Laredo,  Texas,  78041
United States
Recruiting Yadvindera  Bains 956-753-2229

Cross Cancer Institute *Recruiting*
Edmonton,  Alberta,  T6G 1Z2
Canada
Recruiting Scott  North 780-432-8762

Centre Oscar Lambret *Recruiting*
Lille Cedex,  ,  59020
France
Recruiting Armelle  Caty 33-3-20-29-59-42

University of Chicago Medical Center *Recruiting*
Chicago,  Illinois,  60637
United States
Recruiting Apurva  Desai 773-702-6149

Katedra Onkologi *Recruiting*
Lublin,  ,  20-090
Poland
Recruiting Maria  Mazurkiewicz 48-81-747-75-11

Ludwiz Institute Oncology Unit *Recruiting*
Heidelberg,  ,  VIC 3084
Australia
Recruiting Ian  Davis 61-3-9496-5000

Rambam Oncology Institute *Recruiting*
Haifa,  ,  31096
Israel
Recruiting Elli  Gez 972-3-854-3812

Columbia Presbyterian Medical Center *Recruiting*
New York City,  New York,  10032
United States
Recruiting Daniel  Petrylak 212-305-1731

Katedra i Klinka Urologi AM *Recruiting*
Wroclaw,  ,  50-043
Poland
Recruiting Jerzy  Lorenz 48-71-343-47-59

Universidad de Chile Hospital *Recruiting*
Santiago de Chile,  , 
Chile
Recruiting Miguel  Fodor 56 2 6788974

Dept of Radiotherapy & Oncology, Addington Hospital *Recruiting*
Durban,  Kwazulu Natal,  4001
South Africa
Recruiting J  Jordaan 27-31-327-2182

Jefferson Oncology Group *Recruiting*
Philadelphia,  Pennsylvania,  19107
United States
Recruiting Gaetano  Cardi 215-955-8875

East Valley Heamtology Oncology Medical Group *Recruiting*
Burbank,  California,  91505
United States
Recruiting Raul  Mena 213-989-1888

Virginia Physicians Inc. *Recruiting*
Richmond,  Virginia,  23294
United States
Recruiting Gregory  Formanek 804-346-1702

Pacific Shores Medical Group *Recruiting*
Long Beach,  California,  90813
United States
Recruiting Nerses  Tchekmedyian 562-590-0345

Siteman Cancer Center *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Joel  Picus 314-747-1367

Institut Claudius Regaud *Recruiting*
Toulouse,  ,  31052
France
Recruiting Christine  Chevreau 33-5-61-42-41-74

Dept. of Chemotherapy C and Clinical Pharmacology *Recruiting*
Budapest,  ,  1121
Hungary
Recruiting Istvan  Bodrogi 36-1-224-8600

Border Medical Oncology *Recruiting*
Wodonga,  ,  3690
Australia
Recruiting Christopher  Steer 02-6055-3200

Dienst Oncologie *Recruiting*
Brussels,  ,  1090
Belgium
Recruiting Jacques  Greve 32-2-477-60-40

Kentuckiana Cancer Institute, PLLC *Recruiting*
Louisville,  Kentucky,  40202
United States
Recruiting Alfonso  Cervera 502-561-8200

Ellis Fischel Cancer Center *Recruiting*
Columbia,  Missouri,  65203
United States
Recruiting Clay  Anderson 573-882-6964

Hospital Vall d'Hebron *Recruiting*
Barcelona,  ,  08035
Spain
Recruiting Joaquim  Bellmunt 34-93-2746000

Velindre Hospital *Recruiting*
Cardiff,  South Glamorgan, 
United Kingdom
Recruiting Philip  Savage 44-29-206145888

Johannesburg Academic Hospital, Oncology Dept *Recruiting*
Johannesburg,  ,  2193
South Africa
Recruiting Paul  Ruff 27-11-488-4452

Hemoncare, PC *Recruiting*
Brooklyn,  New York,  11235
United States
Recruiting Fakhiuddin  Ahmed 718-616-0801

Klinika Onkologie, Oddzial Chemioterapii *Recruiting*
Poznan,  ,  61-878
Poland
Recruiting Piotr  Tomczak 48-61-854-90-38

Liverpool Hospital *Recruiting*
Liverpool,  ,  NSW1871
Australia
Recruiting Elizabeth  Hovey 02--9828-5180

Centrum Onkologii *Recruiting*
Warszawa,  ,  02-781
Poland
Recruiting Tomasz  Demkow 48-22-546-27-22

Dept Medical Oncology, Westmead Hospital *Recruiting*
Westmead,  ,  NSW 2145
Australia
Recruiting Howard  Gurney 02-9845-8988

Urology Clinic *Recruiting*
Debrecen,  ,  4004
Hungary
Recruiting Csaba  Toth 36-52-413-279

Centre Leon Berard *Recruiting*
Lyon,  ,  69008
France
Recruiting Sylvie  Negrier 33-4-78-78-2751

Klinikum Mannheim *Recruiting*
Mannheim,  Wurttemberg,  68167
Germany
Recruiting Maurice-Stefan  Michel 49-621-383-3584

Texas Oncology,P.A. *Recruiting*
Dallas,  Texas,  75246
United States
Recruiting Thomas  Hutson 214-370-1780

Ospedale Civile S.Maria Nuova *Recruiting*
Reggio Emilia,  ,  42100
Italy
Recruiting Corrado  Boni 39-0522-296858

Donetsk Regional Oncological C *Recruiting*
Donetsk,  ,  83092
Ukraine
Recruiting Yury  Dumansky 38-0622-22-58-09

Servicio de Oncologia, Hospital Clinico San Carlos *Recruiting*
Madrid,  ,  28040
Spain
Recruiting Jose  Gonzalez 34-913303000

University of Colorado Urologic Oncology Clinic *Recruiting*
Aurora,  Colorado,  80010
United States
Recruiting Harry  Drabkin 720-848-0170

ACRC/Arizona Clinical Research Center *Recruiting*
Tucson,  Arizona,  85712
United States
Recruiting Donald  Brooks 520-290-2510

New Grootte Schuur Hospital *Recruiting*
Cape Town,  Western Cape, 
South Africa
Recruiting R  Abratt 27-21-404-4266

Regional Cancer Dispensary *Recruiting*
Poltava,  ,  36024
Ukraine
Recruiting Vladimir  Bashtan 38-0532-50-28-22

Beth Israel Deaconess Medical Center *Recruiting*
Boston,  Massachusetts,  02215
United States
Recruiting David  McDermott 617-667-1931

Instituto dei Tumori *Recruiting*
Milano,  ,  20133
Italy
Recruiting Emilio  Bajetta 39-02-23902500

Hamilton Regional Cancer Center *Recruiting*
Hamilton,  Ontario,  L8V 5C2
Canada
Recruiting Sebastien  Hotte 905-387-9495

OCI/Princess Margaret Hospital *Recruiting*
Toronto,  Ontario,  M5G 2M9
Canada
Recruiting Malcolm  Moore 416-946-4501

City Clinical Oncology Dispens *Recruiting*
St Petersburg,  ,  197758
Russian Federation
Recruiting Pyotr  Karlov 7-812-376-89-20

RPAH Level 6,Gloucester House *Recruiting*
Camperdown,  ,  NSW 2050
Australia
Recruiting Michael  Boyer 02-0915-7695

Centre Francois Baclesse *Recruiting*
Caen,  ,  14076
France
Recruiting Emmanuel  Sevin

Dept of Urology, University of the Free State *Recruiting*
Bloemfontein,  Free State,  9300
South Africa
Recruiting S  Wentzel 27-51-405-3792

Groupe Hospitalier Saint Andre-Jean Abadie *Recruiting*
Bordeaux,  ,  33075
France
Recruiting Alain  Ravaud 33-05-56-79-58-08

Dept. of Oncology *Recruiting*
Szekesfehervar,  ,  8000
Hungary
Recruiting Jozsef  Cseh 36-22-535-662

Our Lady of Mercy Medical Center *Recruiting*
Bronx,  New York,  10466
United States
Recruiting Janice  Dutcher 718-920-9057

University of Utah Health Sciences Center *Recruiting*
Salt Lake City,  Utah,  84132
United States
Recruiting Richard  Middleton 801-581-3739


Additional Information:
Study ID Numbers:
  11213.IND 60,453/SN 317. CDER; 
Study Start Date: October 2003
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073307

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