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Spots Global Cancer Trial Database for A Study to Evaluate Pazopanib as an Adjuvant Treatment for Localized Renal Cell Carcinoma (RCC)

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Trial Identification

Brief Title: A Study to Evaluate Pazopanib as an Adjuvant Treatment for Localized Renal Cell Carcinoma (RCC)

Official Title: A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Pazopanib as Adjuvant Therapy for Subjects With Localized or Locally Advanced RCC Following Nephrectomy

Study ID: NCT01235962

Study Description

Brief Summary: This randomized Phase III study is to evaluate whether pazopanib compared with placebo can prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of developing recurrence after undergoing kidney cancer surgery.

Detailed Description: The primary objective of this ongoing study was to evaluate DFS with pazopanib 600 mg daily initial dose as compared with placebo as adjuvant therapy for subjects with localized/locally advanced RCC following nephrectomy. Subjects with locally recurrent renal cell carcinoma (RCC), bilateral RCC, or history of another malignancy were excluded from enrolling in the study. The study was comprised of three successive study periods: 1) the Screening/Baseline period, 2) the study treatment period, and 3) the DFS /OS follow-up period. The Screening/Baseline period had a maximum duration of 12 weeks from the date of nephrectomy to the date of randomization. After a subject met all the eligibility criteria and completed all the required baseline assessments, the subject was randomized in a 1:1 ratio to receive once daily blinded treatment with either pazopanib 600 mg as initial dose or matching placebo based on pre-defined stratification factors. Subjects received continuous daily treatment until completion of the 12-month treatment period, disease recurrence, or unacceptable toxicity/intolerance. Subsequent adjuvant therapies for RCC were not allowed. During the study treatment and DFS follow-up periods, subjects received routine safety and efficacy assessments. The study treatment period was 12 months. Subjects received continuous daily treatment until completion of the 12 month treatment period, disease recurrence, or unacceptable toxicity/intolerance. Subsequent adjuvant therapies for RCC were not allowed. All subjects, regardless of study treatment status (i.e. premature discontinuation or completion of the 12-month treatment), were to be followed with routine imaging assessments and remain blinded until objective evidence of disease recurrence was obtained or until the study achieved the required number of events for the primary endpoint of DFS (319 events). After objective evidence of disease recurrence was obtained, subjects could be unblinded and received the first-line treatment for metastatic RCC per local standard of care. All subjects were off treatment for at least 4 years at the end of study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Novartis Investigative Site, Jonesboro, Arkansas, United States

Novartis Investigative Site, Antioch, California, United States

Novartis Investigative Site, Beverly Hills, California, United States

Novartis Investigative Site, Fresno, California, United States

Novartis Investigative Site, La Jolla, California, United States

Novartis Investigative Site, Los Angeles, California, United States

Novartis Investigative Site, Los Angeles, California, United States

Novartis Investigative Site, Los Angeles, California, United States

Novartis Investigative Site, Oakland, California, United States

Novartis Investigative Site, Sacramento, California, United States

Novartis Investigative Site, San Francisco, California, United States

Novartis Investigative Site, South San Francisco, California, United States

Novartis Investigative Site, Stanford, California, United States

Novartis Investigative Site, Vallejo, California, United States

Novartis Investigative Site, Fort Collins, Colorado, United States

Novartis Investigative Site, Washington, District of Columbia, United States

Novartis Investigative Site, Fort Myers, Florida, United States

Novartis Investigative Site, Tampa, Florida, United States

Novartis Investigative Site, Athens, Georgia, United States

Novartis Investigative Site, Macon, Georgia, United States

Novartis Investigative Site, Chicago, Illinois, United States

Novartis Investigative Site, Indianapolis, Indiana, United States

Novartis Investigative Site, Iowa City, Iowa, United States

Novartis Investigative Site, Baltimore, Maryland, United States

Novartis Investigative Site, Boston, Massachusetts, United States

Novartis Investigative Site, Boston, Massachusetts, United States

Novartis Investigative Site, Boston, Massachusetts, United States

Novartis Investigative Site, Burlington, Massachusetts, United States

Novartis Investigative Site, Detroit, Michigan, United States

Novartis Investigative Site, Rochester, Minnesota, United States

Novartis Investigative Site, Saint Louis Park, Minnesota, United States

Novartis Investigative Site, Saint Louis, Missouri, United States

Novartis Investigative Site, Lincoln, Nebraska, United States

Novartis Investigative Site, Omaha, Nebraska, United States

Novartis Investigative Site, Omaha, Nebraska, United States

Novartis Investigative Site, Las Vegas, Nevada, United States

Novartis Investigative Site, Hackensack, New Jersey, United States

Novartis Investigative Site, Albany, New York, United States

Novartis Investigative Site, Buffalo, New York, United States

Novartis Investigative Site, New York, New York, United States

Novartis Investigative Site, New York, New York, United States

Novartis Investigative Site, New York, New York, United States

Novartis Investigative Site, Durham, North Carolina, United States

Novartis Investigative Site, Cincinnati, Ohio, United States

Novartis Investigative Site, Cleveland, Ohio, United States

Novartis Investigative Site, Columbus, Ohio, United States

Novartis Investigative Site, Portland, Oregon, United States

Novartis Investigative Site, Springfield, Oregon, United States

Novartis Investigative Site, Philadelphia, Pennsylvania, United States

Novartis Investigative Site, Philadelphia, Pennsylvania, United States

Novartis Investigative Site, Philadelphia, Pennsylvania, United States

Novartis Investigative Site, Philadelphia, Pennsylvania, United States

Novartis Investigative Site, Providence, Rhode Island, United States

Novartis Investigative Site, Providence, Rhode Island, United States

Novartis Investigative Site, Charleston, South Carolina, United States

Novartis Investigative Site, Chattanooga, Tennessee, United States

Novartis Investigative Site, Memphis, Tennessee, United States

Novartis Investigative Site, Nashville, Tennessee, United States

Novartis Investigative Site, Nashville, Tennessee, United States

Novartis Investigative Site, Bedford, Texas, United States

Novartis Investigative Site, Dallas, Texas, United States

Novartis Investigative Site, Houston, Texas, United States

Novartis Investigative Site, Houston, Texas, United States

Novartis Investigative Site, San Antonio, Texas, United States

Novartis Investigative Site, Tyler, Texas, United States

Novartis Investigative Site, Hampton, Virginia, United States

Novartis Investigative Site, Richmond, Virginia, United States

Novartis Investigative Site, Virginia Beach, Virginia, United States

Novartis Investigative Site, Seattle, Washington, United States

Novartis Investigative Site, Berazategui, Buenos Aires, Argentina

Novartis Investigative Site, Capital Federal, Buenos Aires, Argentina

Novartis Investigative Site, Ciudad Aut6noma de Buenos Aires, Buenos Aires, Argentina

Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Novartis Investigative Site, Quilmes, Buenos Aires, Argentina

Novartis Investigative Site, Cordoba, Córdova, Argentina

Novartis Investigative Site, Cordoba, Córdova, Argentina

Novartis Investigative Site, Cipolletti, Río Negro, Argentina

Novartis Investigative Site, Rosario, Santa Fe, Argentina

Novartis Investigative Site, San Miguel de Tucuman, , Argentina

Novartis Investigative Site, Santa Fe, , Argentina

Novartis Investigative Site, Graz, , Austria

Novartis Investigative Site, Innsbruck, , Austria

Novartis Investigative Site, Salzburg, , Austria

Novartis Investigative Site, Salzburg, , Austria

Novartis Investigative Site, Vienna, , Austria

Novartis Investigative Site, Vienna, , Austria

Novartis Investigative Site, Hasselt, , Belgium

Novartis Investigative Site, Jette, , Belgium

Novartis Investigative Site, Liege, , Belgium

Novartis Investigative Site, Namur, , Belgium

Novartis Investigative Site, Roeselare, , Belgium

Novartis Investigative Site, Wilrijk, , Belgium

Novartis Investigative Site, Belo Horizonte, Minas Gerais, Brazil

Novartis Investigative Site, Curitiba, Paraná, Brazil

Novartis Investigative Site, Ijui, Rio Grande Do Sul, Brazil

Novartis Investigative Site, Porto Alegre, Rio Grande Do Sul, Brazil

Novartis Investigative Site, Barretos, São Paulo, Brazil

Novartis Investigative Site, Campinas, São Paulo, Brazil

Novartis Investigative Site, Sao Paulo, São Paulo, Brazil

Novartis Investigative Site, Sao Paulo, São Paulo, Brazil

Novartis Investigative Site, Sao Paulo, São Paulo, Brazil

Novartis Investigative Site, Sao Paulo, São Paulo, Brazil

Novartis Investigative Site, Rio de Janeiro, , Brazil

Novartis Investigative Site, Rio de Janeiro, , Brazil

Novartis Investigative Site, Calgary, Alberta, Canada

Novartis Investigative Site, Edmonton, Alberta, Canada

Novartis Investigative Site, Vancouver, British Columbia, Canada

Novartis Investigative Site, Moncton, New Brunswick, Canada

Novartis Investigative Site, Halifax, Nova Scotia, Canada

Novartis Investigative Site, Hamilton, Ontario, Canada

Novartis Investigative Site, London, Ontario, Canada

Novartis Investigative Site, Oshawa, Ontario, Canada

Novartis Investigative Site, Ottawa, Ontario, Canada

Novartis Investigative Site, Toronto, Ontario, Canada

Novartis Investigative Site, Toronto, Ontario, Canada

Novartis Investigative Site, Montreal, Quebec, Canada

Novartis Investigative Site, Quebec, , Canada

Novartis Investigative Site, Santiago, Región Metro De Santiago, Chile

Novartis Investigative Site, Vina del Mar, Valparaíso, Chile

Novartis Investigative Site, Wuhan, Hubei, China

Novartis Investigative Site, Hangzhou, Zhejiang, China

Novartis Investigative Site, Hangzhou, Zhejiang, China

Novartis Investigative Site, Beijing, , China

Novartis Investigative Site, Beijing, , China

Novartis Investigative Site, Beijing, , China

Novartis Investigative Site, Beijing, , China

Novartis Investigative Site, Shanghai, , China

Novartis Investigative Site, Shanghai, , China

Novartis Investigative Site, Shanghai, , China

Novartis Investigative Site, Shanghai, , China

Novartis Investigative Site, Tianjin, , China

Novartis Investigative Site, Brno, , Czechia

Novartis Investigative Site, Brno, , Czechia

Novartis Investigative Site, Hradec Kralove, , Czechia

Novartis Investigative Site, Novy Jicin, , Czechia

Novartis Investigative Site, Olomouc, , Czechia

Novartis Investigative Site, Ostrava - Poruba, , Czechia

Novartis Investigative Site, Plzen, , Czechia

Novartis Investigative Site, Praha 2, , Czechia

Novartis Investigative Site, Praha 8, , Czechia

Novartis Investigative Site, Usti nad Labem, , Czechia

Novartis Investigative Site, Aarhus, , Denmark

Novartis Investigative Site, Dk-2730 Herlev, , Denmark

Novartis Investigative Site, Odense C, , Denmark

Novartis Investigative Site, ANGERS Cedex 2, , France

Novartis Investigative Site, Besancon cedex, , France

Novartis Investigative Site, Bordeaux, , France

Novartis Investigative Site, Caen Cedex, , France

Novartis Investigative Site, Hyeres, , France

Novartis Investigative Site, Le Mans, , France

Novartis Investigative Site, Marseille cedex 5, , France

Novartis Investigative Site, Montpellier Cedex 5, , France

Novartis Investigative Site, Paris Cedex 15, , France

Novartis Investigative Site, Paris, , France

Novartis Investigative Site, Poitiers Cedex, , France

Novartis Investigative Site, Reims, , France

Novartis Investigative Site, Rennes, , France

Novartis Investigative Site, Saint Herblain, , France

Novartis Investigative Site, Strasbourg cedex, , France

Novartis Investigative Site, Strasbourg Cedex, , France

Novartis Investigative Site, Toulouse, , France

Novartis Investigative Site, Tours Cedex 9, , France

Novartis Investigative Site, Kirchheim, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Ravensburg, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Sigmaringen, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Stuttgart, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Tuebingen, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Ulm, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Erlangen, Bayern, Germany

Novartis Investigative Site, Fuerth, Bayern, Germany

Novartis Investigative Site, Muenchen, Bayern, Germany

Novartis Investigative Site, Regensburg, Bayern, Germany

Novartis Investigative Site, Weiden, Bayern, Germany

Novartis Investigative Site, Frankfurt, Hessen, Germany

Novartis Investigative Site, Marburg, Hessen, Germany

Novartis Investigative Site, Offenbach, Hessen, Germany

Novartis Investigative Site, Braunschweig, Niedersachsen, Germany

Novartis Investigative Site, Goslar, Niedersachsen, Germany

Novartis Investigative Site, Hannover, Niedersachsen, Germany

Novartis Investigative Site, Aachen, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Bergisch Gladbach, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Bonn, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Duisburg, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Essen, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Moenchengladbach, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Muenster, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Neuss, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Velbert, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Mainz, Rheinland-Pfalz, Germany

Novartis Investigative Site, Homburg, Saarland, Germany

Novartis Investigative Site, Dessau, Sachsen-Anhalt, Germany

Novartis Investigative Site, Eisleben, Sachsen-Anhalt, Germany

Novartis Investigative Site, Halle, Sachsen-Anhalt, Germany

Novartis Investigative Site, Chemnitz, Sachsen, Germany

Novartis Investigative Site, Leipzig, Sachsen, Germany

Novartis Investigative Site, Plauen, Sachsen, Germany

Novartis Investigative Site, Luebeck, Schleswig-Holstein, Germany

Novartis Investigative Site, Jena, Thueringen, Germany

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Bremen, , Germany

Novartis Investigative Site, Hamburg, , Germany

Novartis Investigative Site, Athens, , Greece

Novartis Investigative Site, Heraklion, Crete, , Greece

Novartis Investigative Site, Patra, , Greece

Novartis Investigative Site, Thessaloniki, , Greece

Novartis Investigative Site, Budapest, , Hungary

Novartis Investigative Site, Budapest, , Hungary

Novartis Investigative Site, Budapest, , Hungary

Novartis Investigative Site, Miskolc, , Hungary

Novartis Investigative Site, Nyiregyhaza, , Hungary

Novartis Investigative Site, Szombathely, , Hungary

Novartis Investigative Site, Cork, , Ireland

Novartis Investigative Site, Dublin, , Ireland

Novartis Investigative Site, Dublin, , Ireland

Novartis Investigative Site, Galway, , Ireland

Novartis Investigative Site, Tallaght, Dublin, , Ireland

Novartis Investigative Site, Haifa, , Israel

Novartis Investigative Site, Jerusalem, , Israel

Novartis Investigative Site, Petach-Tikva, , Israel

Novartis Investigative Site, Rehovot, , Israel

Novartis Investigative Site, Tel Aviv, , Israel

Novartis Investigative Site, Zrifin, , Israel

Novartis Investigative Site, Napoli, Campania, Italy

Novartis Investigative Site, Bologna, Emilia-Romagna, Italy

Novartis Investigative Site, Meldola (FC), Emilia-Romagna, Italy

Novartis Investigative Site, Modena, Emilia-Romagna, Italy

Novartis Investigative Site, Roma, Lazio, Italy

Novartis Investigative Site, Roma, Lazio, Italy

Novartis Investigative Site, Milano, Lombardia, Italy

Novartis Investigative Site, Rozzano (MI), Lombardia, Italy

Novartis Investigative Site, Candiolo (TO), Piemonte, Italy

Novartis Investigative Site, Arezzo, Toscana, Italy

Novartis Investigative Site, Terni, Umbria, Italy

Novartis Investigative Site, Negrar, Veneto, Italy

Novartis Investigative Site, Fukuoka, , Japan

Novartis Investigative Site, Hokkaido, , Japan

Novartis Investigative Site, Hokkaido, , Japan

Novartis Investigative Site, Kanagawa, , Japan

Novartis Investigative Site, Okayama, , Japan

Novartis Investigative Site, Osaka, , Japan

Novartis Investigative Site, Shizuoka, , Japan

Novartis Investigative Site, Tokyo, , Japan

Novartis Investigative Site, Tokyo, , Japan

Novartis Investigative Site, Tokyo, , Japan

Novartis Investigative Site, Yamagata, , Japan

Novartis Investigative Site, Daejeon, , Korea, Republic of

Novartis Investigative Site, Goyang-si, Gyeonggi-do, , Korea, Republic of

Novartis Investigative Site, Jeonju-si, , Korea, Republic of

Novartis Investigative Site, Seongnam-si Gyeonggi-do, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Songpa-gu, Seoul, , Korea, Republic of

Novartis Investigative Site, Luxembourg, , Luxembourg

Novartis Investigative Site, Gdansk, , Poland

Novartis Investigative Site, Konin, , Poland

Novartis Investigative Site, Krakow, , Poland

Novartis Investigative Site, Krakow, , Poland

Novartis Investigative Site, Lublin, , Poland

Novartis Investigative Site, Warszawa, , Poland

Novartis Investigative Site, Warszawa, , Poland

Novartis Investigative Site, Warszawa, , Poland

Novartis Investigative Site, Wroclaw, , Poland

Novartis Investigative Site, Arkhangelsk, , Russian Federation

Novartis Investigative Site, Barnaul, , Russian Federation

Novartis Investigative Site, Chelyabinsk, , Russian Federation

Novartis Investigative Site, Ekaterinburg, , Russian Federation

Novartis Investigative Site, Kazan, , Russian Federation

Novartis Investigative Site, Moscow, , Russian Federation

Novartis Investigative Site, Moscow, , Russian Federation

Novartis Investigative Site, Obninsk, , Russian Federation

Novartis Investigative Site, Omsk, , Russian Federation

Novartis Investigative Site, Rostov-na-Donu, , Russian Federation

Novartis Investigative Site, Ryazan, , Russian Federation

Novartis Investigative Site, Saint Petersburg, , Russian Federation

Novartis Investigative Site, St. Petersburg, , Russian Federation

Novartis Investigative Site, Stavropol, , Russian Federation

Novartis Investigative Site, Ufa,, , Russian Federation

Novartis Investigative Site, Banska Bystrica, , Slovakia

Novartis Investigative Site, Bratislava, , Slovakia

Novartis Investigative Site, Kosice, , Slovakia

Novartis Investigative Site, Martin, , Slovakia

Novartis Investigative Site, Zilina, , Slovakia

Novartis Investigative Site, Badalona, , Spain

Novartis Investigative Site, Barcelona, , Spain

Novartis Investigative Site, Cordoba, , Spain

Novartis Investigative Site, Dos Hermanas (Sevilla), , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Malaga, , Spain

Novartis Investigative Site, Oviedo, , Spain

Novartis Investigative Site, Sevilla, , Spain

Novartis Investigative Site, Valencia, , Spain

Novartis Investigative Site, Ankara, , Turkey

Novartis Investigative Site, Ankara, , Turkey

Novartis Investigative Site, Istanbul, , Turkey

Novartis Investigative Site, Izmir, , Turkey

Novartis Investigative Site, Brighton, , United Kingdom

Novartis Investigative Site, Cornwall, , United Kingdom

Novartis Investigative Site, Guildford, , United Kingdom

Novartis Investigative Site, London, , United Kingdom

Novartis Investigative Site, London, , United Kingdom

Novartis Investigative Site, Manchester, , United Kingdom

Novartis Investigative Site, Preston, , United Kingdom

Novartis Investigative Site, Swansea, , United Kingdom

Novartis Investigative Site, Wolverhampton, , United Kingdom

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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