Spots Global Cancer Trial Database for A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases
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Trial Identification
Brief Title: A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases
Official Title: A Phase III Trial to Test the Efficacy of ZD4054(Zibotentan), an Endothelin A Receptor Antagonist, Versus Placebo in Patients With Hormone Resistant Prostate Cancer (HRPC) and Bone Metastasis Who Are Pain Free and Mildly Symptomatic.
Study ID: NCT00554229
Conditions
Study Description
Brief Summary: Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases. * This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo. * 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. * All patients participating in this clinical trial will receive existing standard prostate cancer treatments in addition to trial therapy. * Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may 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, Tucson, Arizona, United States
Research Site, Greenbrae, California, United States
Research Site, Los Angeles, California, United States
Research Site, Palm Springs, California, United States
Research Site, San Mateo, California, United States
Research Site, Norwich, Connecticut, United States
Research Site, Washington, District of Columbia, United States
Research Site, Gainsville, Florida, United States
Research Site, Port St.Lucie, Florida, United States
Research Site, Des Moines, Iowa, United States
Research Site, Canton, Ohio, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Nashville, Tennessee, United States
Research Site, Salt Lake City, Utah, United States
Research Site, Burlington, Vermont, United States
Research Site, Norfolk, Virginia, United States
Research Site, Seattle, Washington, United States
Research Site, Wheeling, West Virginia, United States
Research Site, Milwaukee, Wisconsin, United States
Research Site, Buenos Aires, Buenos Aires Province, Argentina
Research Site, Santa Fe, Santa Fe Province, Argentina
Research Site, Hornsby, New South Wales, Australia
Research Site, St Leonards, New South Wales, Australia
Research Site, Redcliffe, Queensland, Australia
Research Site, Ashford, South Australia, Australia
Research Site, Subiaco, Western Australia, Australia
Research Site, Graz, , Austria
Research Site, Wels, , Austria
Research Site, Brussels, , Belgium
Research Site, Gent, , Belgium
Research Site, Kortrijk, , Belgium
Research Site, Leuven, , Belgium
Research Site, Fortaleza, Ceara, Brazil
Research Site, Goiania, Goias, Brazil
Research Site, Belo Horizonte, Minas Gerais, Brazil
Research Site, Curitiba, Parana, Brazil
Research Site, Porto Alegre, Rio Grande do Sul, Brazil
Research Site, Ribeirao Preto, Sao Paulo, Brazil
Research Site, Santo Andre, Sao Paulo, Brazil
Research Site, Sao Paulo, , Brazil
Research Site, Calgary, Alberta, Canada
Research Site, Edmonton, Alberta, Canada
Research Site, Vancouver, British Columbia, Canada
Research Site, Kentville, Nova Scotia, Canada
Research Site, Barrie, Ontario, Canada
Research Site, Burlington, Ontario, Canada
Research Site, Hamilton, Ontario, Canada
Research Site, Kitchener, Ontario, Canada
Research Site, London, Ontario, Canada
Research Site, Mississauga, Ontario, Canada
Research Site, North York, Ontario, Canada
Research Site, Oakville, Ontario, Canada
Research Site, Ottawa, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Granby, Quebec, Canada
Research Site, Laval, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Point-Claire, Quebec, Canada
Research Site, Quebec City, Quebec, Canada
Research Site, Quebec, , Canada
Research Site, Haidian District, Beijing, China
Research Site, Xi Cheng District, Beijing, China
Research Site, Xicheng District, Beijing, China
Research Site, Wuhan, Hubei, China
Research Site, Nanjing, Jiangsu, China
Research Site, Pudong New Area, Shanghai, China
Research Site, Shanghai, Shanghai, China
Research Site, Xuhui District, Shanghai, China
Research Site, Xi'an, Shanxi, China
Research Site, Prague 4, Prague, Czech Republic
Research Site, Prague 6, Prague, Czech Republic
Research Site, Brno, , Czech Republic
Research Site, Olomouc, , Czech Republic
Research Site, Usti nad Labem, , Czech Republic
Research Site, Aalborg, , Denmark
Research Site, Aarhus, , Denmark
Research Site, Herlev, , Denmark
Research Site, Kobenhavn, , Denmark
Research Site, Joensuu, , Finland
Research Site, Kajaanintie, , Finland
Research Site, Tampere, , Finland
Research Site, Montpellier, , France
Research Site, Paris, , France
Research Site, Poitiers Cedex, , France
Research Site, Suresnes, , France
Research Site, Toulouse, , France
Research Site, Villejuif, , France
Research Site, Planegg, Muenchen, Germany
Research Site, Kirchheim, Teck, Germany
Research Site, Augsburg, , Germany
Research Site, Bad Gegeberg, , Germany
Research Site, Berlin, , Germany
Research Site, Emmendingen, , Germany
Research Site, Leipzig, , Germany
Research Site, Luebeck, , Germany
Research Site, Mannheim, , Germany
Research Site, Muenchen, , Germany
Research Site, Reutlingen, , Germany
Research Site, Hong Kong, , Hong Kong
Research Site, Shatin, , Hong Kong
Research Site, Tuen Mun, , Hong Kong
Research Site, Budapest, , Hungary
Research Site, Debrecen, , Hungary
Research Site, Miskolc, , Hungary
Research Site, Nyiregyhaza, , Hungary
Research Site, Szeged, , Hungary
Research Site, Rohini, Delhi, India
Research Site, Trivandrum, Kerala, India
Research Site, Bhopal, Madhya Pradesh, India
Research Site, Mumbai, Maharashtra, India
Research Site, Chandigarh, Punjab, India
Research Site, Ludhiana, Punjab, India
Research Site, Bikaner, Rajasthan, India
Research Site, Jaipur, Rajasthan, India
Research Site, Kolkota, West Bengal, India
Research Site, Gujarat, , India
Research Site, New Delhi, , India
Research Site, Milan, , Italy
Research Site, Rome, , Italy
Research Site, Asahi-City, Chiba, Japan
Research Site, Chiba-City, Chiba, Japan
Research Site, Narashino-city, Chiba, Japan
Research Site, Matsuyama-City, Ehime, Japan
Research Site, Fukuoka-City, Fukuoka, Japan
Research Site, Maebashi-City, Gunma, Japan
Research Site, Otake-City, Hiroshima, Japan
Research Site, Sapporo-City, Hokkaido, Japan
Research Site, Kobe-City, Hyogo, Japan
Research Site, Tsukuba-City, Ibaraki, Japan
Research Site, Kita-gun, Kagawa, Japan
Research Site, Sagamihara-City, Kanagawa, Japan
Research Site, Kyoto-City, Kyoto, Japan
Research Site, Sendai-City, Miyagi, Japan
Research Site, Oita-City, Oita, Japan
Research Site, Osaka-City, Osaka, Japan
Research Site, Osaka-Sayama-City, Osaka, Japan
Research Site, Suita-City, Osaka, Japan
Research Site, Wako-City, Saitama, Japan
Research Site, Hamamatsu-city, Shizuoka, Japan
Research Site, Sunto-gun, Shizuoka, Japan
Research Site, Bunkyo-ku, Tokyo, Japan
Research Site, Fuchu_city, Tokyo, Japan
Research Site, Itabashi-Ku, Tokyo, Japan
Research Site, Meguro-ku, Tokyo, Japan
Research Site, Mitaka-City, Tokyo, Japan
Research Site, Shinjuku-ku, Tokyo, Japan
Research Site, Nagasaki, , Japan
Research Site, Heungduk-gu Cheongju, Chungbuk, Korea, Republic of
Research Site, Seongnam-si, Gyeonggi-do, Korea, Republic of
Research Site, Seo-gu, Pusan, Korea, Republic of
Research Site, Gangnam-gu, Seoul, Korea, Republic of
Research Site, Songpa-gu, Seoul, Korea, Republic of
Research Site, Metepec, Estado de Mexico, Mexico
Research Site, Distrito Federal Ciudad, , Mexico
Research Site, Mexico City, , Mexico
Research Site, Amsterdam, , Netherlands
Research Site, Eindhoven, , Netherlands
Research Site, Groningen, , Netherlands
Research Site, Nijmegen, , Netherlands
Research Site, Bialystok, , Poland
Research Site, Koscierzyna, , Poland
Research Site, Krakow, , Poland
Research Site, Rzeszow, , Poland
Research Site, Warszawa, , Poland
Research Site, Wroclaw, , Poland
Research Site, Coimbra, , Portugal
Research Site, Lisboa, , Portugal
Research Site, Porto, , Portugal
Research Site, Stary Oskol, Belgorodskaya region, Russian Federation
Research Site, Barnaul, , Russian Federation
Research Site, Izhevsk, , Russian Federation
Research Site, Kursk, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Sochi, , Russian Federation
Research Site, St. Petersgurg, , Russian Federation
Research Site, Voronezh, , Russian Federation
Research Site, Belgrade, , Serbia
Research Site, Nis, , Serbia
Research Site, Novi Sad, , Serbia
Research Site, Singapore, , Singapore
Research Site, Tygerberg, Cape Town, South Africa
Research Site, Bloemfontein, , South Africa
Research Site, Pietermaritzburg, , South Africa
Research Site, Port Elizabeth, , South Africa
Research Site, Goteborg, , Sweden
Research Site, Gothenburg, , Sweden
Research Site, Stockholm, , Sweden
Research Site, Basel, , Switzerland
Research Site, Bern, , Switzerland
Research Site, Locarno, , Switzerland
Research Site, Sursee, , Switzerland
Research Site, Kaohsiung, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taoyuan, , Taiwan
Research Site, Reading, Berkshire, United Kingdom
Research Site, Cambridge, Cambridgeshire, United Kingdom
Research Site, Maidstone, Kent, United Kingdom
Research Site, Huddersfield, Yorkshire, United Kingdom
Research Site, London, , United Kingdom
Contact Details
Name: Martin Gleave, MD, FRCSC, FACS
Affiliation: The Prostate Centre at Vancouver General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Joel B Nelson, MD
Affiliation: University of Pittsburgh
Role: PRINCIPAL_INVESTIGATOR
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