Treatment Use Study With Sunitinib (SU011248) For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
A SU011248 Expanded Access Protocol For Systemic Therapy Of Patients With Metastatic Renal Cell Carcinoma Who Are Ineligible For Participation In Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248
1 other identifier
expanded_access
N/A
47 countries
260
Brief Summary
The primary objective of this protocol is to provide access to SU011248 treatment for patients with metastatic RCC who are ineligible for participation in ongoing SU011248 clinical studies and have the potential to derive clinical benefit from treatment with SU011248 based on the judgment of the investigator.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2005
Longer than P75 for all trials
260 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 14, 2005
CompletedFirst Posted
Study publicly available on registry
August 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedMarch 9, 2012
March 1, 2012
6.3 years
August 14, 2005
March 8, 2012
Conditions
Interventions
Sutent, 25, 37.5. or 50 mg daily
Eligibility Criteria
You may qualify if:
- renal cell carcinoma that is not amendable to standard therapy with curative intent
You may not qualify if:
- current treatment in another therapeutic clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (271)
Pfizer Investigational Site
Scottsdale, Arizona, 85260, United States
Pfizer Investigational Site
San Francisco, California, 94115-2378, United States
Pfizer Investigational Site
San Francisco, California, 94115, United States
Pfizer Investigational Site
Aurora, Colorado, 80040-0510, United States
Pfizer Investigational Site
Norwalk, Connecticut, 06856, United States
Pfizer Investigational Site
Miami, Florida, 33176, United States
Pfizer Investigational Site
Ocala, Florida, 34474, United States
Pfizer Investigational Site
Tampa, Florida, 33612, United States
Pfizer Investigational Site
Atlanta, Georgia, 30309, United States
Pfizer Investigational Site
Maywood, Illinois, 60153, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46260-2082, United States
Pfizer Investigational Site
Council Bluffs, Iowa, 51503, United States
Pfizer Investigational Site
Covington, Louisiana, 70433, United States
Pfizer Investigational Site
Gretna, Louisiana, 70056, United States
Pfizer Investigational Site
Marrero, Louisiana, 70072, United States
Pfizer Investigational Site
Metairie, Louisiana, 70002, United States
Pfizer Investigational Site
Metairie, Louisiana, 70006, United States
Pfizer Investigational Site
New Orleans, Louisiana, 70115, United States
Pfizer Investigational Site
Baltimore, Maryland, 21287, United States
Pfizer Investigational Site
Boston, Massachusetts, 02114, United States
Pfizer Investigational Site
Boston, Massachusetts, 02115, United States
Pfizer Investigational Site
Boston, Massachusetts, 02215, United States
Pfizer Investigational Site
Detroit, Michigan, 48201, United States
Pfizer Investigational Site
Minneapolis, Minnesota, 55455, United States
Pfizer Investigational Site
Southaven, Mississippi, 38671, United States
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Tupelo, Mississippi, 38801, United States
Pfizer Investigational Site
Columbia, Missouri, 65201, United States
Pfizer Investigational Site
Columbia, Missouri, 65203, United States
Pfizer Investigational Site
Omaha, Nebraska, 68198-7680, United States
Pfizer Investigational Site
New York, New York, 10021, United States
Pfizer Investigational Site
New York, New York, 10022, United States
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The Bronx, New York, 10466, United States
Pfizer Investigational Site
Durham, North Carolina, 27710, United States
Pfizer Investigational Site
Cleveland, Ohio, 44195, United States
Pfizer Investigational Site
Norman, Oklahoma, 73071, United States
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Oklahoma City, Oklahoma, 73102, United States
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Oklahoma City, Oklahoma, 73109, United States
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Oklahoma City, Oklahoma, 73112, United States
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Oklahoma City, Oklahoma, 73120, United States
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Tulsa, Oklahoma, 74104, United States
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Tulsa, Oklahoma, 74136-1902, United States
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Portland, Oregon, 97210, United States
Pfizer Investigational Site
Portland, Oregon, 97227, United States
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Hershey, Pennsylvania, 17033-0850, United States
Pfizer Investigational Site
Memphis, Tennessee, 38104, United States
Pfizer Investigational Site
Memphis, Tennessee, 38120, United States
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Dallas, Texas, 75246, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84112, United States
Pfizer Investigational Site
Seattle, Washington, 98104, United States
Pfizer Investigational Site
Seattle, Washington, 98109, United States
Pfizer Investigational Site
Seattle, Washington, 98122, United States
Pfizer Investigational Site
Seattle, Washington, 98124, United States
Pfizer Investigational Site
Madison, Wisconsin, 53792, United States
Pfizer Investigational Site
Buenos Aires, C1034ACO, Argentina
Pfizer Investigational Site
Buenos Aires, C1426ANZ, Argentina
Pfizer Investigational Site
Buenos Aires, C1431FWO, Argentina
Pfizer Investigational Site
Randwick, New South Wales, 2031, Australia
Pfizer Investigational Site
St Leonards, New South Wales, 2065, Australia
Pfizer Investigational Site
Westmead, New South Wales, 2145, Australia
Pfizer Investigational Site
South Brisbane, Queensland, 4101, Australia
Pfizer Investigational Site
Elizabeth Vale, South Australia, 5112, Australia
Pfizer Investigational Site
Woodville South, South Australia, 5011, Australia
Pfizer Investigational Site
East Melbourne, Victoria, 3002, Australia
Pfizer Investigational Site
Heidelburg, Victoria, 3084, Australia
Pfizer Investigational Site
Perth, Western Australia, 6000, Australia
Pfizer Investigational Site
Innsbruck, 6020, Austria
Pfizer Investigational Site
Vienna, 1090, Austria
Pfizer Investigational Site
Brussels, 1000, Belgium
Pfizer Investigational Site
Brussels, 1200, Belgium
Pfizer Investigational Site
Ghent, 9000, Belgium
Pfizer Investigational Site
Leuven, 3000, Belgium
Pfizer Investigational Site
Liège, 4000, Belgium
Pfizer Investigational Site
Wilrijk, 2610, Belgium
Pfizer Investigational Site
Sarajevo, 71000, Bosnia and Herzegovina
Pfizer Investigational Site
Salvador, Estado de Bahia, 41950-640, Brazil
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, 30380-490, Brazil
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 20231-050, Brazil
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Pfizer Investigational Site
Jaú, São Paulo, 17210-080, Brazil
Pfizer Investigational Site
Jaú, São Paulo, 17210-120, Brazil
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São Paulo, São Paulo, 01308-050, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, 01509-900, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, 05651-000, Brazil
Pfizer Investigational Site
Sofia, Bulgaria, 1504, Bulgaria
Pfizer Investigational Site
Sofia, 1756, Bulgaria
Pfizer Investigational Site
Calgary, Alberta, T2N 4N2, Canada
Pfizer Investigational Site
Edmonton, Alberta, T6G 1Z2, Canada
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 5L3, Canada
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 4E6, Canada
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Victoria, British Columbia, V8R 6V5, Canada
Pfizer Investigational Site
Winnipeg, Manitoba, R3E 0V9, Canada
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Winnnipeg, Manitoba, R2H 2A6, Canada
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St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 1V7, Canada
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 2Y9, Canada
Pfizer Investigational Site
London, Ontario, N6A 4L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
Pfizer Investigational Site
Montreal, Quebec, H2L 4M1, Canada
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Montreal, Quebec, H3T 1E2, Canada
Pfizer Investigational Site
Québec, Quebec, G1R 2J6, Canada
Pfizer Investigational Site
Santiago, RM, Chile
Pfizer Investigational Site
Bogotá, Cundinamarca, 0000, Colombia
Pfizer Investigational Site
Cali, Colombia
Pfizer Investigational Site
Rijeka, 51000, Croatia
Pfizer Investigational Site
Split, 21000, Croatia
Pfizer Investigational Site
Brno, 656 53, Czechia
Pfizer Investigational Site
Hradec Králové, 500 05, Czechia
Pfizer Investigational Site
Prague, 150 06, Czechia
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Prague, 180 00, Czechia
Pfizer Investigational Site
Guayaquil, Guayas, Ecuador
Pfizer Investigational Site
Quito, Pichincha, Ecuador
Pfizer Investigational Site
Cairo, Egypt
Pfizer Investigational Site
Giza, Egypt
Pfizer Investigational Site
Turku, 20521, Finland
Pfizer Investigational Site
Lyon, Cedex 08, 69008, France
Pfizer Investigational Site
Saint-Herblain, Cedex, 44805, France
Pfizer Investigational Site
Strasbourg, Cedex, 67091, France
Pfizer Investigational Site
Bordeaux, 33000, France
Pfizer Investigational Site
Clermont Ferand, 63011, France
Pfizer Investigational Site
Marseille, 13273, France
Pfizer Investigational Site
Marseille, 13385, France
Pfizer Investigational Site
Montpellier, 34298 cedex 05, France
Pfizer Investigational Site
Paris, 75651, France
Pfizer Investigational Site
Paris, 75908, France
Pfizer Investigational Site
Reims, 51100, France
Pfizer Investigational Site
Rennes, 35042, France
Pfizer Investigational Site
Tours, 37044, France
Pfizer Investigational Site
Vandœuvre-lès-Nancy, 54511, France
Pfizer Investigational Site
Aachen, 52074, Germany
Pfizer Investigational Site
Berlin, 10117, Germany
Pfizer Investigational Site
Dresden, 01307, Germany
Pfizer Investigational Site
Essen, 45122, Germany
Pfizer Investigational Site
Frankfurt, 60590, Germany
Pfizer Investigational Site
Freiburg im Breisgau, 79106, Germany
Pfizer Investigational Site
Hamburg, 20246, Germany
Pfizer Investigational Site
Hanover, 30625, Germany
Pfizer Investigational Site
Homburg/Saar, 66421, Germany
Pfizer Investigational Site
Jena, 07740, Germany
Pfizer Investigational Site
Kassel, 34125, Germany
Pfizer Investigational Site
München, 81664, Germany
Pfizer Investigational Site
Nuremberg, 90419, Germany
Pfizer Investigational Site
Rostock, 18057, Germany
Pfizer Investigational Site
Ulm, 89081, Germany
Pfizer Investigational Site
Athens, Attica, 115 22, Greece
Pfizer Investigational Site
Athens, 11528, Greece
Pfizer Investigational Site
Pátrai, 26500, Greece
Pfizer Investigational Site
Thessaloniki, 540 07, Greece
Pfizer Investigational Site
Hong Hong, Hong Kong, Hong Kong
Pfizer Investigational Site
Budapest, 1122, Hungary
Pfizer Investigational Site
Pune, Maharashtra, 411 004, India
Pfizer Investigational Site
Pārel, Mumbai, 400 012, India
Pfizer Investigational Site
New Delhi, National Capital Territory of Delhi, 110 029, India
Pfizer Investigational Site
Jaipur, Rajasthan, 302 004, India
Pfizer Investigational Site
New Delhi, 110 085, India
Pfizer Investigational Site
Dublin, Ireland
Pfizer Investigational Site
Jerusalem, Israel
Pfizer Investigational Site
Tel Litwinsky, 52621, Israel
Pfizer Investigational Site
Bergamo, 24128, Italy
Pfizer Investigational Site
Brescia, 25123, Italy
Pfizer Investigational Site
Cattolica (RN), 47841, Italy
Pfizer Investigational Site
Cuneo, 12100, Italy
Pfizer Investigational Site
Legnago, VR, 37045, Italy
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Modena, 41100, Italy
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Napoli, 80131, Italy
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Padua, 35128, Italy
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Parma, 43100, Italy
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Pavia, 27100, Italy
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Perugia, 06132, Italy
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Pordenone, 33170, Italy
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Rimini, 47900, Italy
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Roma, 00135, Italy
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Roma, 00144, Italy
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Roma, 00152, Italy
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Torino, 10126, Italy
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Beirut, Lebanon
Pfizer Investigational Site
Petaling Jaya, Selangor, 46050, Malaysia
Pfizer Investigational Site
Kuala Lumpur, 59100, Malaysia
Pfizer Investigational Site
Chihuahua City, Chihuahua, 31000, Mexico
Pfizer Investigational Site
Guadalajara, Jalisco, 44240, Mexico
Pfizer Investigational Site
Mexico City, Mexico City, 06720, Mexico
Pfizer Investigational Site
Mexico City, Mexico City, 14000, Mexico
Pfizer Investigational Site
Puebla City, Puebla, 72530, Mexico
Pfizer Investigational Site
Toluca, State of Mexico, 50180, Mexico
Pfizer Investigational Site
Mérida, Yucatán, 97000, Mexico
Pfizer Investigational Site
Amsterdam, North Holland, 1066 CX, Netherlands
Pfizer Investigational Site
Groningen, Provincie Groningen, 9713 GZ, Netherlands
Pfizer Investigational Site
Amsterdam, 1081 HV, Netherlands
Pfizer Investigational Site
Rotterdam, 3075 EA, Netherlands
Pfizer Investigational Site
Oslo, 0310, Norway
Pfizer Investigational Site
Panama City, Provincia de Panamá, Panama
Pfizer Investigational Site
Lima, Lima Province, 11, Peru
Pfizer Investigational Site
Lima, Lima Province, L13, Peru
Pfizer Investigational Site
Quezon City, 1102, Philippines
Pfizer Investigational Site
Quezon City, Philippines
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Gdansk, 80-210, Poland
Pfizer Investigational Site
Lodz, 93-509, Poland
Pfizer Investigational Site
Poznan, 60-569, Poland
Pfizer Investigational Site
Warsaw, 00-909, Poland
Pfizer Investigational Site
Wroclaw, 50-556, Poland
Pfizer Investigational Site
Lisbon, 1070-213, Portugal
Pfizer Investigational Site
Porto, 4200-319, Portugal
Pfizer Investigational Site
Bucharest, 022328, Romania
Pfizer Investigational Site
Cluj-Napoca, 400015, Romania
Pfizer Investigational Site
Obninsk, Kaluga Oblast, 249036, Russia
Pfizer Investigational Site
Chelyabinsk, 454087, Russia
Pfizer Investigational Site
Moscow, 115478, Russia
Pfizer Investigational Site
Belgrade, 11000, Serbia
Pfizer Investigational Site
Singapore, 169610, Singapore
Pfizer Investigational Site
Bratislava, 83301, Slovakia
Pfizer Investigational Site
Žilina, 012 07, Slovakia
Pfizer Investigational Site
Ljubljana, Ljubljana, 1000 Ljubljana, Slovenia
Pfizer Investigational Site
Seoul, 110-744, South Korea
Pfizer Investigational Site
Seoul, 120-753, South Korea
Pfizer Investigational Site
Barcelona, Barcelona, 08025, Spain
Pfizer Investigational Site
Barcelona, Barcelona, 08035, Spain
Pfizer Investigational Site
L'hospitalet Del Llobregat, Barcelona, 08907, Spain
Pfizer Investigational Site
A Coruña, La Coruña, 15006, Spain
Pfizer Investigational Site
Madrid, Madrid, 28007, Spain
Pfizer Investigational Site
Madrid, Madrid, 28040, Spain
Pfizer Investigational Site
Madrid, Madrid, 28041, Spain
Pfizer Investigational Site
Pamplona, Navarre, 31008, Spain
Pfizer Investigational Site
Oviedo, Principality of Asturias, 33006, Spain
Pfizer Investigational Site
Salamanca, Salamanca, 37007, Spain
Pfizer Investigational Site
Seville, Sevilla, 41013, Spain
Pfizer Investigational Site
Valencia, Valencia, 46009, Spain
Pfizer Investigational Site
Barakaldo, Vizcaya, 48903, Spain
Pfizer Investigational Site
Gothenburg, 413 45, Sweden
Pfizer Investigational Site
Lund, 221 85, Sweden
Pfizer Investigational Site
Stockholm, 171 76, Sweden
Pfizer Investigational Site
Umeå, 901 85, Sweden
Pfizer Investigational Site
Basel, CH-4056, Switzerland
Pfizer Investigational Site
Bellinzona, CH-6500, Switzerland
Pfizer Investigational Site
Bern, 3010, Switzerland
Pfizer Investigational Site
Biel, 2500, Switzerland
Pfizer Investigational Site
Ch-4058 Basel, Switzerland
Pfizer Investigational Site
Ch-4101 Bruderholz, Switzerland
Pfizer Investigational Site
Ch-4410 Liesthal, Switzerland
Pfizer Investigational Site
Chur, CH-7000, Switzerland
Pfizer Investigational Site
Geneva, CH-1211, Switzerland
Pfizer Investigational Site
Taipei, 100, Taiwan
Pfizer Investigational Site
Taipei, 112, Taiwan
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Taoyun, 333, Taiwan
Pfizer Investigational Site
Bangkok, 10330, Thailand
Pfizer Investigational Site
Bangkok, 10700, Thailand
Pfizer Investigational Site
Istanbul, Capa, 34390, Turkey (Türkiye)
Pfizer Investigational Site
Istanbul, Cerrahpasa, 34303, Turkey (Türkiye)
Pfizer Investigational Site
Whitchurch, Cardiff, CF14 2TL, United Kingdom
Pfizer Investigational Site
London, Se1 9rt, United Kingdom
Pfizer Investigational Site
Sutton, Surrey, SM2 5PT, United Kingdom
Pfizer Investigational Site
Leeds, West Yorkshire, LS9 7TF, United Kingdom
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Belfast, BT9 7AB, United Kingdom
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Birmingham, B15 2TH, United Kingdom
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Birmingham, B15 2TT, United Kingdom
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Bristol, BS2 8ED, United Kingdom
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Cottingham, HU16 5JQ, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Guildford, GU2 5XX, United Kingdom
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London, EC1A 7BE, United Kingdom
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London, NW3 2Qg, United Kingdom
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London, SW3 6JJ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Sheffield, S10 2SJ, United Kingdom
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Southampton, SO16 6YD, United Kingdom
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Swansea, SA2 8QA, United Kingdom
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Caracas, Distrito Federal, 1040, Venezuela
Pfizer Investigational Site
Caracas, Miranda, 1060, Venezuela
Related Publications (4)
Barrios CH, Herchenhorn D, Chacon M, Cabrera-Galeana P, Sajben P, Zhang K. Safety and efficacy of sunitinib in patients from Latin America: subanalysis of an expanded access trial in metastatic renal cell carcinoma. Onco Targets Ther. 2016 Sep 23;9:5839-5845. doi: 10.2147/OTT.S109445. eCollection 2016.
PMID: 27713637DERIVEDLee SH, Bang YJ, Mainwaring P, Ng C, Chang JW, Kwong P, Li RK, Sriuranpong V, Toh CK, Yuan J, Pitman Lowenthal S, Chung HC. Sunitinib in metastatic renal cell carcinoma: an ethnic Asian subpopulation analysis for safety and efficacy. Asia Pac J Clin Oncol. 2014 Sep;10(3):237-45. doi: 10.1111/ajco.12163. Epub 2014 Feb 27.
PMID: 24576311DERIVEDGore ME, Hariharan S, Porta C, Bracarda S, Hawkins R, Bjarnason GA, Oudard S, Lee SH, Carteni G, Nieto A, Yuan J, Szczylik C. Sunitinib in metastatic renal cell carcinoma patients with brain metastases. Cancer. 2011 Feb 1;117(3):501-9. doi: 10.1002/cncr.25452. Epub 2010 Sep 22.
PMID: 20862748DERIVEDGore ME, Szczylik C, Porta C, Bracarda S, Bjarnason GA, Oudard S, Hariharan S, Lee SH, Haanen J, Castellano D, Vrdoljak E, Schoffski P, Mainwaring P, Nieto A, Yuan J, Bukowski R. Safety and efficacy of sunitinib for metastatic renal-cell carcinoma: an expanded-access trial. Lancet Oncol. 2009 Aug;10(8):757-63. doi: 10.1016/S1470-2045(09)70162-7. Epub 2009 Jul 15.
PMID: 19615940DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2005
First Posted
August 16, 2005
Study Start
July 1, 2005
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
March 9, 2012
Record last verified: 2012-03