Spots Global Cancer Trial Database for A Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer
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Trial Identification
Brief Title: A Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer
Study ID: NCT01234311
Conditions
Study Description
Brief Summary: This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo. Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1 ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day; n=800) or Treatment Group B (placebo; n=400).
Detailed Description: This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo. Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1 ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day; n=800) or Treatment Group B (placebo; n=400).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
, Tucson, Arizona, United States
, Oxnard, California, United States
, Santa Monica, California, United States
, Santa Rosa, California, United States
, Wellington, Florida, United States
, Atlanta, Georgia, United States
, Meridian, Idaho, United States
, Melrose Park, Illinois, United States
, Park Ridge, Illinois, United States
, Jeffersonville, Indiana, United States
, Baltimore, Maryland, United States
, Rockville, Maryland, United States
, Boston, Massachusetts, United States
, Jefferson City, Missouri, United States
, Las Vegas, Nevada, United States
, Hackensack, New Jersey, United States
, Lawrenceville, New Jersey, United States
, Buffalo, New York, United States
, Poughkeepsie, New York, United States
, Concord, North Carolina, United States
, Durham, North Carolina, United States
, Raleigh, North Carolina, United States
, Springfield, Oregon, United States
, Bala Cynwyd, Pennsylvania, United States
, Lancaster, Pennsylvania, United States
, Pittsburgh, Pennsylvania, United States
, Myrtle Beach, South Carolina, United States
, Nashville, Tennessee, United States
, Dallas, Texas, United States
, Salt Lake, Utah, United States
, Fairfax, Virginia, United States
, Norfolk, Virginia, United States
, Salem, Virginia, United States
, Burien, Washington, United States
, Ciudad Autonoma de Buenos Aires, , Argentina
, Santa Rosa, , Argentina
, Venado Tuerto, , Argentina
, Camperdown, New South Wales, Australia
, Coffs Harbour, New South Wales, Australia
, Darlinghurst, New South Wales, Australia
, Tweed Heads, New South Wales, Australia
, Richmond, Victoria, Australia
, Subiaco, Western Australia, Australia
, Bruxelles, , Belgium
, Gent, , Belgium
, Kortrijk, , Belgium
, Liege, , Belgium
, Botucatu, Sao Paulo, , Brazil
, Cachoeiro de Itapemirim - ES, , Brazil
, Curitiba, Parana, , Brazil
, Florianopolis, , Brazil
, Juiz de Fora, Minas Gerais, , Brazil
, Mogi das Cruzes, Sao Paulo, , Brazil
, Natal, Rio Grande do Norte, , Brazil
, Passo Fundo, , Brazil
, Porto Alegre, RS, , Brazil
, Rio de Janeiro, , Brazil
, Salvador/BA, , Brazil
, Sao Paulo, , Brazil
, Volta Redonda - RJ, , Brazil
, Pleven, , Bulgaria
, Plovdiv, , Bulgaria
, Sofia, , Bulgaria
, Varna, , Bulgaria
, Kelowna, British Columbia, Canada
, Victoria, British Columbia, Canada
, Brantford, Ontario, Canada
, North York, Ontario, Canada
, Oakville, Ontario, Canada
, Santiago, , Chile
, Temuco, , Chile
, Vina del Mar, , Chile
, Beijing, , China
, Chengdu, , China
, Shanghai, , China
, Shantou, , China
, Wuhan, , China
, Bogota, , Colombia
, Cali, , Colombia
, Novy Jicin, , Czech Republic
, Olomouc, , Czech Republic
, Praha 2, , Czech Republic
, Praha 5, , Czech Republic
, Usti nad Labem, , Czech Republic
, Tartu, , Estonia
, Angers, , France
, Cannes, , France
, Marseille, , France
, Montpellier, , France
, Paris, , France
, Pierre Benite, , France
, Rennes, , France
, Suresnes, , France
, Dresden, , Germany
, Hamburg, , Germany
, Koln, , Germany
, Mannheim, , Germany
, Marburg, , Germany
, Munchen, , Germany
, Munster, , Germany
, Nurtingen, , Germany
, Tubingen, , Germany
, Weiden, , Germany
, Athens, , Greece
, Patras, , Greece
, Thessaloniki, , Greece
, Pune, , India
, Beer-Sheva, , Israel
, Haifa, , Israel
, Jerusalem, , Israel
, Petach Tikva, , Israel
, Ramat-Gan, , Israel
, Tel-Aviv, , Israel
, Zerifin, , Israel
, Cremona, , Italy
, Lecco, , Italy
, Meldola, , Italy
, Milano, , Italy
, Padova, , Italy
, Ravenna, , Italy
, Roma, , Italy
, Torino, , Italy
, Gwangju, , Korea, Republic of
, Seoul, , Korea, Republic of
, Liepaja, , Latvia
, Riga, , Latvia
, Beirut, , Lebanon
, Bsalim, , Lebanon
, Kaunas, , Lithuania
, Vilnius, , Lithuania
, Chihuahua, Chih., , Mexico
, Culiacan, Sinaloa, , Mexico
, Leon, GTO, , Mexico
, Puebla, , Mexico
, Zapopan, Jalisco, , Mexico
, Amsterdam, , Netherlands
, Groningen, , Netherlands
, Leiden, , Netherlands
, Nijmegen, , Netherlands
, Tilburg, , Netherlands
, Christchurch, , New Zealand
, Nelson, , New Zealand
, Palmerston North, , New Zealand
, Tauranga, , New Zealand
, Panama, , Panama
, Arequipa, , Peru
, Bialystok, , Poland
, Lodz, , Poland
, Myslowice, , Poland
, Poznan, , Poland
, Warszawa, , Poland
, Wroclaw, , Poland
, Baia Mare, , Romania
, Bucharest, , Romania
, Cluj-Napoca, , Romania
, Craiova, , Romania
, Ploiesti, , Romania
, Suceava, , Romania
, Timisoara, , Romania
, Ekaterinburg, , Russian Federation
, Moscow, , Russian Federation
, Novosibirsk, , Russian Federation
, Omsk, , Russian Federation
, St. Petersburg, , Russian Federation
, Vladimir, , Russian Federation
, Bratislava, , Slovakia
, Trencin, , Slovakia
, Sevilla, Andalucia, Spain
, Zaragoza, Aragon, Spain
, Oviedo, Asturias, Spain
, Santander, Cantabria, Spain
, Sabadell, Cataluna, Spain
, Alcorcon, Madrid, Communidad de, Spain
, Pamplona, Navarra, Spain
, Barcelona, , Spain
, San Sebastian de los Reyes, , Spain
, Valencia, , Spain
, Göteborg, , Sweden
, Karlstad, , Sweden
, Stockholm, , Sweden
, Kaohsiung, , Taiwan
, Taichung, , Taiwan
, Taipei, , Taiwan
, Taoyuan, , Taiwan
, Istanbul, , Turkey
, Chernivtsi, , Ukraine
, Dnipropetrovsk, , Ukraine
, Donetsk, , Ukraine
, Ivano-Frankivsk, , Ukraine
, Kharkiv, , Ukraine
, Kyiv, , Ukraine
, Lutsk, , Ukraine
, Lviv, , Ukraine
, Odesa, , Ukraine
, Uzhgorod, , Ukraine
, Zaporizhzhya, , Ukraine
, Birmingham, , United Kingdom
, Chichester, , United Kingdom
, Leeds, , United Kingdom
, London, , United Kingdom
, Northwood, , United Kingdom
, Nottingham, , United Kingdom
, Oxford, , United Kingdom
, Scunthorpe, , United Kingdom
, Sutton, , United Kingdom
Contact Details
Name: Michael A Carducci, MD
Affiliation: Johns Hopkins Kimmel Cancer Center, Baltimore, MD
Role: PRINCIPAL_INVESTIGATOR
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