Spots Global Cancer Trial Database for A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer
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Trial Identification
Brief Title: A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer
Official Title: A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 (Zibotentan) in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer
Study ID: NCT00617669
Conditions
Study Description
Brief Summary: Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC). This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further improve survival compared with docetaxel alone. ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases compared with docetaxel. All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies. Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further slow the progression of the tumour. No patients will be deprived of standard prostate cancer therapy.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Research Site, Greenbrae, California, United States
Research Site, San Diego, California, United States
Research Site, Norwich, Connecticut, United States
Research Site, Washington, District of Columbia, United States
Research Site, Fort Myers, Florida, United States
Research Site, Gainsville, Florida, United States
Research Site, Ocala, Florida, United States
Research Site, PORTUGALt St. Lucie, Florida, United States
Research Site, Rockville, Maryland, United States
Research Site, Minneapolis, Minnesota, United States
Research Site, Lincoln, Nebraska, United States
Research Site, Omaha, Nebraska, United States
Research Site, Chapel Hill, North Carolina, United States
Research Site, Durham, North Carolina, United States
Research Site, Winston-Salem, North Carolina, United States
Research Site, Canton, Ohio, United States
Research Site, Cincinnati, Ohio, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Charleston, South Carolina, United States
Research Site, Chattanooga, Tennessee, United States
Research Site, Nashville, Tennessee, United States
Research Site, San Antonio, Texas, United States
Research Site, Richmond, Virginia, United States
Research Site, Seattle, Washington, United States
Research Site, Milwaukee, Wisconsin, United States
Research Site, Bahia Blanca, Buenos Aires, Argentina
Research Site, Buenos Aires, , Argentina
Research Site, Santa Fe, , Argentina
Research Site, Darlinghurst, New South Wales, Australia
Research Site, St Leonards, New South Wales, Australia
Research Site, Wollongong, New South Wales, Australia
Research Site, Redcliffe, Queensland, Australia
Research Site, Ashford, South Australia, Australia
Research Site, Footscray, Victoria, Australia
Research Site, Wodonga, Victoria, Australia
Research Site, Perth, Western Australia, Australia
Research Site, Subiaco, Western Australia, Australia
Research Site, Fortaleza, Ceara/ LA, Brazil
Research Site, Goiania, Goias/ LA, Brazil
Research Site, Goiania, Goias, Brazil
Research Site, Belo Horizonte, Minas GERMANYais, Brazil
Research Site, Curitiba, Parana/ Brazil, Brazil
Research Site, Londrina, PR, Brazil
Research Site, PORTUGALto Alegre, Rio Grande do Sul/ LA, Brazil
Research Site, Rio de Janeiro, RJ, Brazil
Research Site, Ribeirao Preto, Sao Paulo/ LA, Brazil
Research Site, Santo Andre, Sao Paulo, Brazil
Research Site, Sao Paulo, , Brazil
Research Site, Winnipeg, Manitoba, Canada
Research Site, Halifax, Nova Scotia, Canada
Research Site, London, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Quebec City, Quebec, Canada
Research Site, Sherbrooke, Quebec, Canada
Research Site, Brno, CZECHOSLOVAKIA Republic, Czech Republic
Research Site, Jablonec nad Nisou, , Czech Republic
Research Site, Kromeriz, , Czech Republic
Research Site, Olomouc, , Czech Republic
Research Site, Prague 2, , Czech Republic
Research Site, Prague 6, , Czech Republic
Research Site, Usti nad Labem, , Czech Republic
Research Site, Helsinki, , Finland
Research Site, Joensuu, , Finland
Research Site, Seinajoki, , Finland
Research Site, La Roche sur Yon, FRANCEnce, France
Research Site, Marseille, FRANCEnce, France
Research Site, Paris, FRANCEnce, France
Research Site, Reims, FRANCEnce, France
Research Site, Villejuif, FRANCEnce, France
Research Site, Paris, , France
Research Site, Saint Herblain, , France
Research Site, Hannover, GERMANYmany, Germany
Research Site, Berlin, , Germany
Research Site, Bonn, , Germany
Research Site, Dresden, , Germany
Research Site, Emmendingen, , Germany
Research Site, Kirchheim-Teck, , Germany
Research Site, Leipzig, , Germany
Research Site, Luebeck, , Germany
Research Site, Muenster, , Germany
Research Site, Tuebingen, , Germany
Research Site, Wuppertal, , Germany
Research Site, Budapest, HUNGARYary, Hungary
Research Site, Gyor, HUNGARYary, Hungary
Research Site, Miskolc, HUNGARYary, Hungary
Research Site, Ny Regyh Za, HUNGARYary, Hungary
Research Site, Szeged, HUNGARYary, Hungary
Research Site, Bangalore, Karnataka, India
Research Site, Trivandrum, Kerala, India
Research Site, Bhopal, Madhya Pradesh, India
Research Site, Pune, Maharashtra, India
Research Site, Bikaner, Rajasthan, India
Research Site, Jaipur, Rajasthan, India
Research Site, Vellore, Tamil Nadu, India
Research Site, Kolkata, West Bengal, India
Research Site, Kolkota, West Bengal, India
Research Site, Delhi, , India
Research Site, New Delhi, , India
Research Site, Genoa, , Italy
Research Site, Lugo (RA), , Italy
Research Site, Rome, , Italy
Research Site, Cheongju, Chungbuk, Korea, Republic of
Research Site, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Republic of
Research Site, Nowon-gu, Seoul, Korea, Republic of
Research Site, Seodaemun-gu, Seoul, Korea, Republic of
Research Site, Songpa-gu, Seoul, Korea, Republic of
Research Site, Nijmegen, , Netherlands
Research Site, Cercado de Arequipa, Arequipa, Peru
Research Site, Cercado, Arequipa, Peru
Research Site, Callao, , Peru
Research Site, Lima, , Peru
Research Site, Lublin, POLANDand, Poland
Research Site, Swidnica, POLANDand, Poland
Research Site, Warszaa, POLANDand, Poland
Research Site, Koscierzyna, , Poland
Research Site, Wroclaw, , Poland
Research Site, Coimbra, PORTUGALtugal, Portugal
Research Site, PORTUGALto, PORTUGALtugal, Portugal
Research Site, Bucharest, , Romania
Research Site, Sibiu, , Romania
Research Site, Timisoara, , Romania
Research Site, Barnaul, RUSSIAsia, Russian Federation
Research Site, Izhevsk, RUSSIAsia, Russian Federation
Research Site, Kursk, RUSSIAsia, Russian Federation
Research Site, Sochi, RUSSIAsia, Russian Federation
Research Site, Voronezh, RUSSIAsia, Russian Federation
Research Site, Belgrade, SERBIAbia, Serbia
Research Site, Beograd, SERBIAbia, Serbia
Research Site, Nis, SERBIAbia, Serbia
Research Site, Panorama, Cape Town, South Africa
Research Site, TyGERberg, Cape Town, South Africa
Research Site, Overport, Durban, South Africa
Research Site, Bloemfontein, , South Africa
Research Site, PORt Elizabeth, , South Africa
Research Site, Madrid, , Spain
Research Site, Valencia, , Spain
Research Site, Stockholm, , Sweden
Research Site, Uppsala, , Sweden
Research Site, Aarau, , Switzerland
Research Site, Locarno, , Switzerland
Research Site, Sursee, , Switzerland
Research Site, Kaohsiung, TAIWANwan, Taiwan
Research Site, TAIWANpei, TAIWANwan, Taiwan
Research Site, Reading, Berkshire, United Kingdom
Research Site, Westgate Road, Newcastle Upon Tyne, United Kingdom
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Contact Details
Name: Karim Fizazi, MD, PhD
Affiliation: Gustave Roussy, Cancer Campus, Grand Paris
Role: PRINCIPAL_INVESTIGATOR
Name: Judd W Moul, MD, FACS
Affiliation: Duke University
Role: PRINCIPAL_INVESTIGATOR
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