Official Title
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
Brief Summary

The primary objective of this protocol is to provide access to SU011248 treatment forpatients with metastatic RCC who are ineligible for participation in ongoing SU011248clinical studies and have the potential to derive clinical benefit from treatment withSU011248 based on the judgment of the investigator.

Detailed Description

Given that an Expanded Access study does not meet the definition of a controlled clinical
investigation, and as such, is not considered an applicable drug clinical trial per NIH,
Basic Results for such studies are not required to be reported. Protocol A6181037 has
been identified as an Expanded Access trial, and has been registered to
ClinicalTrials.gov, however Basic Results will not be posted.

Approved for marketing
Carcinoma, Renal Cell

Drug: Sutent

Sutent, 25, 37.5. or 50 mg daily

Eligibility Criteria

Inclusion Criteria:

- renal cell carcinoma that is not amendable to standard therapy with curative intent

Exclusion Criteria:

- current treatment in another therapeutic clinical trial

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Argentina
Australia
Austria
Belgium
Bosnia and Herzegovina
Brazil
Bulgaria
Canada
Chile
Colombia
Croatia
Czech Republic
Ecuador
Egypt
Finland
France
Germany
Greece
Hong Kong
Hungary
India
Ireland
Israel
Italy
Korea, Republic of
Lebanon
Malaysia
Mexico
Netherlands
Norway
Panama
Peru
Philippines
Poland
Portugal
Romania
Russian Federation
Serbia
Singapore
Slovakia
Slovenia
Spain
Sweden
Switzerland
Taiwan
Thailand
Turkey
United Kingdom
United States
Venezuela
Locations

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Scottsdale, Arizona, United States

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San Francisco, California, United States

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San Francisco, California, United States

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Aurora, Colorado, United States

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Norwalk, Connecticut, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Maywood, Illinois, United States

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Indianapolis, Indiana, United States

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Council Bluffs, Iowa, United States

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Covington, Louisiana, United States

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Gretna, Louisiana, United States

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Marrero, Louisiana, United States

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Metairie, Louisiana, United States

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Metairie, Louisiana, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Minneapolis, Minnesota, United States

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Southaven, Mississippi, United States

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Tupelo, Mississippi, United States

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Columbia, Missouri, United States

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Columbia, Missouri, United States

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Omaha, Nebraska, United States

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Bronx, New York, United States

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New York, New York, United States

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New York, New York, United States

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Durham, North Carolina, United States

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Cleveland, Ohio, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Hershey, Pennsylvania, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Dallas, Texas, United States

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Salt Lake City, Utah, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Madison, Wisconsin, United States

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Buenos Aires, Argentina

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Buenos Aires, Argentina

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Buenos Aires, Argentina

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Randwick, New South Wales, Australia

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St Leonards, New South Wales, Australia

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Westmead, New South Wales, Australia

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South Brisbane, Queensland, Australia

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Elizabeth Vale, South Australia, Australia

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Woodville South, South Australia, Australia

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East Melbourne, Victoria, Australia

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Heidelburg, Victoria, Australia

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Perth, Western Australia, Australia

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Innsbruck, Austria

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Wien, Austria

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Bruxelles, Belgium

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Bruxelles, Belgium

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Gent, Belgium

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Leuven, Belgium

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Liege, Belgium

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Wilrijk, Belgium

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Sarajevo, Bosnia and Herzegovina

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Salvador, BA, Brazil

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Belo Horizonte, MG, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Rio de Janeiro, RJ, Brazil

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Rio de Janeiro, RJ, Brazil

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Porto Alegre, RS, Brazil

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Jau, SP, Brazil

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Jaú, SP, Brazil

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Jaú, SP, Brazil

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São Paulo, SP, Brazil

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São Paulo, SP, Brazil

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São Paulo, SP, Brazil

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Sofia, Bulgaria

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Sofia, Bulgaria

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Kelowna, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Winnnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Halifax, Nova Scotia, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Quebec, Canada

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Santiago, RM, Chile

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Bogotá, Cundinamarca, Colombia

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Cali, Colombia

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Rijeka, Croatia

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Split, Croatia

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Brno, Czech Republic

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Hradec Kralove, Czech Republic

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Praha 5, Czech Republic

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Praha 8, Czech Republic

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Guayaquil, Guayas, Ecuador

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Quito, Pichincha, Ecuador

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Cairo, Egypt

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Giza, Egypt

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Turku, Finland

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Lyon, Cedex 08, France

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Saint Herblain, Cedex, France

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Strasbourg, Cedex, France

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Bordeaux, France

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Clermont Ferand, France

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Marseille Cedex 9, France

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Marseille, France

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Montpellier, France

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Paris Cedex 13, France

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Paris, France

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Reims, France

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Rennes, France

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Tours, France

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Vandoeuvre les Nancy, France

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Aachen, Germany

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Berlin, Germany

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Dresden, Germany

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Essen, Germany

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Frankfurt, Germany

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Freiburg, Germany

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Hamburg, Germany

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Hannover, Germany

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Homburg/Saar, Germany

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Jena, Germany

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Kassel, Germany

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Muenchen, Germany

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Nuernberg, Germany

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Rostock, Germany

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Ulm, Germany

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Athens, Attiki, Greece

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Athens, Greece

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Patras, Greece

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Thessaloniki, Greece

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Hong Hong, Hong Kong

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Budapest, Hungary

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New Delhi, Delhi, India

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Pune, Maharashtra, India

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Parel, Mumbai, India

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Jaipur, Rajasthan, India

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New Delhi, India

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Dublin 24, Ireland

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Dublin, Ireland

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Jerusalem, Israel

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Tel Hashomer, Israel

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Bergamo, Italy

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Brescia, Italy

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Cattolica (RN), Italy

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Cuneo, Italy

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Legnago, VR, Italy

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Modena, Italy

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Napoli, Italy

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Padova, Italy

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Parma, Italy

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Pavia, Italy

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Perugia, Italy

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Pordenone, Italy

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Rimini, Italy

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Roma, Italy

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Roma, Italy

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Roma, Italy

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Torino, Italy

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Seoul, Korea, Republic of

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Seoul, Korea, Republic of

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Beirut, Lebanon

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Petaling Jaya, Selangor, Malaysia

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Kuala Lumpur, Malaysia

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Mexico, DF, Mexico

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Mexico, DF, Mexico

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Toluca, Estado de Mexico, Mexico

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Guadalajara, Jalisco, Mexico

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Merida, Yucatan, Mexico

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Chihuahua, Mexico

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Puebla, Mexico

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Groningen, GR, Netherlands

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Amsterdam, NH, Netherlands

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Amsterdam, Netherlands

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Rotterdam, Netherlands

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Oslo, Norway

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Ciudad de Panama, Panama

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Panama, Panama

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Lima, Peru

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Lima, Peru

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Quezon City, Philippines

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Quezon City, Philippines

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Gdansk, Poland

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Lodz, Poland

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Poznan, Poland

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Warszawa, Poland

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Wroclaw, Poland

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Lisboa, Portugal

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Porto, Portugal

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Bucuresti, Romania

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Cluj-Napoca, Romania

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Obninsk, Kaluga region, Russian Federation

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Chelyabinsk, Russian Federation

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Moscow, Russian Federation

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Belgrade, Serbia

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Singapore, Singapore

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Bratislava, Slovakia

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Zilina, Slovakia

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Ljubljana, Slovenia

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Oviedo, Asturias, Spain

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L'hospitalet Del Llobregat, Barcelona, Spain

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Pamplona, Navarra, Spain

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Baracaldo, Vizcaya, Spain

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Barcelona, Spain

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Barcelona, Spain

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La Coruña, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Salamanca, Spain

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Sevilla, Spain

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Valencia, Spain

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Göteborg, Sweden

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Lund, Sweden

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Stockholm, Sweden

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Umeå, Sweden

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Basel, Switzerland

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Bellinzona, Switzerland

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Bern, Switzerland

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Biel, Switzerland

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CH-4058 Basel, Switzerland

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CH-4101 Bruderholz, Switzerland

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CH-4410 Liesthal, Switzerland

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Chur, Switzerland

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Genève 14, Switzerland

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyun, Taiwan

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Bangkok, Thailand

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Bangkok, Thailand

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Istanbul, Capa, Turkey

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Istanbul, Cerrahpasa, Turkey

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Whitchurch, Cardiff, United Kingdom

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London, Se1 9rt, United Kingdom

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Sutton, Surrey, United Kingdom

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Leeds, West Yorkshire, United Kingdom

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Belfast, United Kingdom

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Birmingham, United Kingdom

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Birmingham, United Kingdom

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Bristol, United Kingdom

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Cottingham, United Kingdom

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Edinburgh, United Kingdom

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Guildford, United Kingdom

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London, United Kingdom

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London, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Northwood, United Kingdom

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Nottingham, United Kingdom

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Sheffield, United Kingdom

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Southampton, United Kingdom

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Swansea, United Kingdom

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Caracas, Distrito Capital, Venezuela

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Caracas, Estado Miranda, Venezuela

Pfizer CT.gov Call Center, Study Director
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NCT Number
MeSH Terms
Carcinoma
Carcinoma, Renal Cell
Sunitinib