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Spots Global Cancer Trial Database for Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

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Trial Identification

Brief Title: Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

Official Title: A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

Study ID: NCT01193244

Conditions

Prostate Cancer

Study Description

Brief Summary: This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

, Anchorage, Alaska, United States

, Tucson, Arizona, United States

, Duarte, California, United States

, Highland, California, United States

, Orange, California, United States

, Sacramento, California, United States

, San Francisco, California, United States

, Aurora, Colorado, United States

, Denver, Colorado, United States

, Deerfield Beach, Florida, United States

, Fort Myers, Florida, United States

, Jacksonville, Florida, United States

, Orlando, Florida, United States

, Port St Lucie, Florida, United States

, Jeffersonville, Indiana, United States

, Kansas City, Kansas, United States

, New Orleans, Louisiana, United States

, Baltimore, Maryland, United States

, Boston, Massachusetts, United States

, Lansing, Michigan, United States

, Duluth, Minnesota, United States

, Corinth, Mississippi, United States

, Columbia, Missouri, United States

, Jefferson City, Missouri, United States

, Omaha, Nebraska, United States

, Las Vegas, Nevada, United States

, Hackensack, New Jersey, United States

, East Syracuse, New York, United States

, New York, New York, United States

, Durham, North Carolina, United States

, Raleigh, North Carolina, United States

, Kettering, Ohio, United States

, Tualatin, Oregon, United States

, Hershey, Pennsylvania, United States

, Lancaster, Pennsylvania, United States

, Philadelphia, Pennsylvania, United States

, Piitsburgh, Pennsylvania, United States

, Charleston, South Carolina, United States

, Columbia, South Carolina, United States

, Chattanooga, Tennessee, United States

, Nashville, Tennessee, United States

, Amarillo, Texas, United States

, Bedford, Texas, United States

, Dallas, Texas, United States

, Denton, Texas, United States

, Tyler, Texas, United States

, Salt Lake City, Utah, United States

, Norfolk, Virginia, United States

, Garran, , Australia

, Hobart, , Australia

, Kurralta Park, , Australia

, Nedlands, , Australia

, Perth, , Australia

, Redcliffe, , Australia

, Wodonga, , Australia

, Graz, , Austria

, Linz, , Austria

, Wien, , Austria

, Minsk, , Belarus

, Edegem, , Belgium

, Hasselt, , Belgium

, Kortrijk, , Belgium

, Leuven, , Belgium

, Namur, , Belgium

, Bairro Nazare - Salvador, , Brazil

, Barretos/sp, , Brazil

, Belo Horizonte, , Brazil

, Campinas, , Brazil

, Caxias Do Sul, , Brazil

, Curitiba, , Brazil

, Fortaleza/ce, , Brazil

, Ijui, , Brazil

, Joinville, , Brazil

, Lajeado - Rs, , Brazil

, Piracicaba - Sp, , Brazil

, Porto Alegre- Rs, , Brazil

, Porto Alegre/rs, , Brazil

, Ribeirao Preto - Sp, , Brazil

, Rio de Janeiro Rj, , Brazil

, Rio de Janeiro, , Brazil

, Santo Andre, , Brazil

, Sao Jose Do Rio Preto, , Brazil

, Sao Jose Dos Campos, , Brazil

, Sao Paulo, , Brazil

, Sorocaba - Sp, , Brazil

, Plovdiv, , Bulgaria

, Sofia, , Bulgaria

, Varna, , Bulgaria

, Kelowna, British Columbia, Canada

, Burlington, Ontario, Canada

, Hamilton, Ontario, Canada

, London, Ontario, Canada

, Owen Sound, Ontario, Canada

, Toronto, Ontario, Canada

, Montreal, Quebec, Canada

, Pointe Claire, Quebec, Canada

, Quebec City, Quebec, Canada

, Sherbrooke, Quebec, Canada

, Las Condes, , Chile

, Santiago, , Chile

, Temuco, , Chile

, Valparaiso, , Chile

, Cali, , Colombia

, Hradec Kralove, , Czech Republic

, Praha 4, , Czech Republic

, Praha 5, , Czech Republic

, Joensuu, , Finland

, Oulu, , Finland

, Seinajoki, , Finland

, Tampere, , Finland

, Angers, , France

, Bordeaux, , France

, Caen, , France

, Creteil, , France

, La Roche Sur Yon, , France

, Lyon, , France

, Marseille, , France

, Nancy, , France

, Nantes, , France

, Paris Cedex 13, , France

, Paris Cedex 14, , France

, Paris, , France

, Poitiers, , France

, Saint-etienne, , France

, Villejuif, , France

, Braunschweig, , Germany

, Dresden, , Germany

, Hamburg, , Germany

, Hannover, , Germany

, Kassel, , Germany

, Kempen, , Germany

, Nurtingen, , Germany

, Tubingen, , Germany

, Wuppertal, , Germany

, Athens, , Greece

, Heraklion Crete, , Greece

, Larissa, , Greece

, Patras, , Greece

, Thessaloniki, , Greece

, Kowloon, , Hong Kong

, Shatin, , Hong Kong

, Dublin, , Ireland

, Galway, , Ireland

, Haifa, , Israel

, Holon, , Israel

, Jerusalem, , Israel

, Petach Tikva, , Israel

, Ramat-gan, , Israel

, Tel Aviv, , Israel

, Zerifin, , Israel

, Aviano, , Italy

, Novara, , Italy

, Roma, , Italy

, Torino, , Italy

, Chiba-city, , Japan

, Chiba, , Japan

, Fukuoka, , Japan

, Hamamatsu City, , Japan

, Hokkaido, , Japan

, Kanazawa, , Japan

, Kita-gun, , Japan

, Maebashi-city, , Japan

, Mito-city, , Japan

, Osaka-city, , Japan

, Osaka, , Japan

, Sakura City, , Japan

, Sayama, , Japan

, Sendai City, , Japan

, Shimizucho Sunto-gun, , Japan

, Suntou-gun, , Japan

, Tokyo, , Japan

, Yamagata City, , Japan

, Yokohama City, , Japan

, Yufu-city, , Japan

, Riga, , Latvia

, Kaunas, , Lithuania

, Klaipeda, , Lithuania

, Vilnius, , Lithuania

, Durango Durango, , Mexico

, Mexico City Distrito Federal, , Mexico

, Zapopan Jalisco, , Mexico

, Amsterdam, , Netherlands

, Arnhem, , Netherlands

, Breda, , Netherlands

, Eindhoven, , Netherlands

, Heerlen, , Netherlands

, Nieuwegein, , Netherlands

, Nijmegen, , Netherlands

, Rotterdam, , Netherlands

, Auckland, , New Zealand

, Christchurch, , New Zealand

, Dunedin, , New Zealand

, Takapuna, , New Zealand

, Tauranga, , New Zealand

, Lima, , Peru

, Bielsko-biala, , Poland

, Wroclaw, , Poland

, Liepaja, , Portugal

, Lisboa, , Portugal

, Porto, , Portugal

, San Juan, , Puerto Rico

, Bucharest, , Romania

, Cluj-napoca, , Romania

, Moscow, , Russian Federation

, St Petersburg, , Russian Federation

, Singapore, , Singapore

, Nitra, , Slovakia

, Presov, , Slovakia

, Trencin, , Slovakia

, Zilina, , Slovakia

, Cape Town, , South Africa

, Durban, , South Africa

, George, , South Africa

, Port Elizabeth, , South Africa

, Barcelona, , Spain

, La Coruna, , Spain

, Madrid, , Spain

, Majadahonda, , Spain

, Pamplona, , Spain

, Sevilla, , Spain

, Valencia, , Spain

, Goteborg, , Sweden

, Stockholm, , Sweden

, Uppsala, , Sweden

, Aarau, , Switzerland

, Lausanne, , Switzerland

, Winterthur, , Switzerland

, Zurich, , Switzerland

, Taichung, , Taiwan

, Taipei, , Taiwan

, Dnipropetrovsk, , Ukraine

, Donetsk, , Ukraine

, Kyiv, , Ukraine

, Zaporizhzhya, , Ukraine

, Aberdeen, , United Kingdom

, Belfast, , United Kingdom

, Bristol, , United Kingdom

, Cottingham, , United Kingdom

, Coventry, , United Kingdom

, Glasgow, , United Kingdom

, London, , United Kingdom

, Manchester, , United Kingdom

, Northwood, , United Kingdom

, Preston, , United Kingdom

, Southampton, , United Kingdom

Contact Details

Name: Medical Monitor

Affiliation: Millennium Pharmaceuticals, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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