- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00626548
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer (ENTHUSE M0)
A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 (Zibotentan) 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients
Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC).
This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve progression-free survival and overall survival against a background of existing prostate cancer treatments.
ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA after surgical or medical castration but have no evidence of metastases.
All patients participating in this clinical trial will receive existing 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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Santa Fe, Argentina
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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Santa Fe
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Rosario, Santa Fe, Argentina
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Sydney, Australia
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New South Wales
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Darlinghurst, New South Wales, Australia
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Hornsby, New South Wales, Australia
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Westmead, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Victoria
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Wodonga, Victoria, Australia
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Western Australia
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Nedlands, Western Australia, Australia
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Graz, Austria
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Innsbruck, Austria
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Wels, Austria
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(Wilrijk) Antwerpen, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Gent, Belgium
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Kortrijk, Belgium
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Leuven, Belgium
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Liege, Belgium
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Sao Paulo, Brazil
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Goias
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Goiania, Goias, Brazil
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil
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PR
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Londrina, PR, Brazil
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Parana
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Curitiba, Parana, Brazil
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RJ
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Rio de Janeiro, RJ, Brazil
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil
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Sao Paulo
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Santo Andre, Sao Paulo, Brazil
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Alberta
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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British Columbia
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Manitoba
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Winnipeg, Manitoba, Canada
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Ontario
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Burlington, Ontario, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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Kitchener, Ontario, Canada
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London, Ontario, Canada
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North York, Ontario, Canada
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Oakville, Ontario, Canada
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Toronto, Ontario, Canada
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Quebec
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Greenfeild Park, Quebec, Canada
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Montreal, Quebec, Canada
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Point-Claire, Quebec, Canada
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Quebec City, Quebec, Canada
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Sherbrooke, Quebec, Canada
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La Serena, Chile
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Santiago, Chile
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Temuco, Chile
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Vina del Mar, Chile
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Beijing, China
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Chongqing, China
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Guangzhou City, China
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Hubei, China
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Jiangsu, China
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Shanghai, China
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Shanxi, China
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Tianjin, China
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Zejiang, China
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Jiangsu
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Nanjing, Jiangsu, China
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Zhejiang
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Hangzhou, Zhejiang, China
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Bogota, Colombia
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Medellin, Colombia
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Brno, Czech Republic
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Hradec Kralove, Czech Republic
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Jablonec nad Nisou, Czech Republic
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Kromeriz, Czech Republic
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Olomouc, Czech Republic
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Prague 2, Czech Republic
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Prague 4, Czech Republic
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Prague 6, Czech Republic
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Praha, Czech Republic
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Usti nad Labem, Czech Republic
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Aalborg, Denmark
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Frederiksberg, Denmark
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Herlev, Denmark
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Holstebro, Denmark
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Kobenhavn, Denmark
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Odense, Denmark
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Roskilde, Denmark
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Helsinki, Finland
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Joensuu, Finland
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Oulu, Finland
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Seinajoki, Finland
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Tampere, Finland
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Caen cedex, France
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Creteil, France
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Lille, France
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Lyon, France
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Lyon cedex 03, France
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Marseille, France
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Montpellier, France
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Orleans Cedex, France
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Paris, France
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Pierre Benite cedex, France
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Poitiers Cedex, France
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Reims, France
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Reims cedex, France
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Rennes cedex 9, France
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Rouen, France
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Suresnes, France
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Toulouse, France
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Vandoeuvre-les-Nancy cedex, France
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Villejuif, France
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Augsburg, Germany
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Bad Ems, Germany
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Berlin, Germany
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Bonn, Germany
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Borken, Germany
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Chemnitz, Germany
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Emmendingen, Germany
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Fuerth, Germany
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Gelsenkirchen-Buer, Germany
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Germering, Germany
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Goettingen, Germany
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Holzminden, Germany
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Kirchheim/Teck, Germany
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Leipzig, Germany
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Lubeck, Germany
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Mannheim, Germany
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Muehlacker, Germany
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Muehlheim an der Ruhr, Germany
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Muenchen, Germany
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Muenchen-Planegg, Germany
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Muenster, Germany
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Reutlingen, Germany
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Rostock, Germany
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Tuebingen, Germany
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Waltshut-Tiengen, Germany
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Wuppertal, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Gyor, Hungary
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Miskolc, Hungary
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Nyiregyhaza, Hungary
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Szeged, Hungary
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Szekesfehervar, Hungary
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New Delhi, India
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Gujarat
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Ahmedabad, Gujarat, India
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Nadiad, Gujarat, India
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Kerala
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Kochi, Kerala, India
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Maharashtra
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Pune, Maharashtra, India
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Tamil Nadu, India
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Chennai, Tamil Nadu, India, India
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Uttar Pradesh
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Lucknow, Uttar Pradesh, India
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West Bengal
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Kolkota, West Bengal, India
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Dublin, Ireland
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Dublin 7, Ireland
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Dublin 8, Ireland
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Be'er Sheva, Israel
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Be'er-Ya'akov, Israel
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Haifa, Israel
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Holon, Israel
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Jeruslaem, Israel
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Petah-Tikva, Israel
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Tel-HaShomer - Ramat Gan, Israel
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Ancona, Italy
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Bari, Italy
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Bergamo, Italy
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Bologna, Italy
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Catania, Italy
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Como, Italy
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Firenze, Italy
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Genova, Italy
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Messina, Italy
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Milano, Italy
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Pisa, Italy
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Rome, Italy
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Terni, Italy
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Varese, Italy
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Kyoto, Japan
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Nagasaki, Japan
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Aomori
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Hirosaki-City, Aomori, Japan
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Chiba
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Chiba-City, Chiba, Japan
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Narashino-city, Chiba, Japan
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Ehime
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Matsuyama-City, Ehime, Japan
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Fukuoka
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Fukuoka-City, Fukuoka, Japan
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Gunma
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Maebashi-City, Gunma, Japan
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Hiroshima
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Otake-City, Hiroshima, Japan
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Hokkaido
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Sapporo-City, Hokkaido, Japan
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Hyogo
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Kobe-City, Hyogo, Japan
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Ibaraki
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Ibaraki-machi, Ibaraki, Japan
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Mito-City, Ibaraki, Japan
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Tsukuba-City, Ibaraki, Japan
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Kagawa
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Kita-gun, Kagawa, Japan
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Kanagawa
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Sagamihara-City, Kanagawa, Japan
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Kyoto
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Kamigyo-ku, Kyoto, Japan
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Kyoto-City, Kyoto, Japan
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Miyagi
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Sendai-City, Miyagi, Japan
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Nagano
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Ueda-City, Nagano, Japan
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Nara
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Kashihara, Nara, Japan
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Oita
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Oita-City, Oita, Japan
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Okayama
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Kurashiki, Okayama, Japan
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Osaka
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Osaka-City, Osaka, Japan
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Osaka-Sayama-City, Osaka, Japan
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Suita-City, Osaka, Japan
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Saitama
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Wako-City, Saitama, Japan
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Shizuoka
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Hamamatsu-city, Shizuoka, Japan
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Sunto-gun, Shizuoka, Japan
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Tokyo
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Bunkyo-ku, Tokyo, Japan
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Fuchu_city, Tokyo, Japan
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Itabashi-Ku, Tokyo, Japan
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Meguro-ku, Tokyo, Japan
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Minato-Ku, Tokyo, Japan
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Mitaka-City, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Gyeonggi-do
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Bundang-Gu, Seongnam-si, Gyeonggi-do, Korea, Republic of
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Pusan
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Seo-gu, Pusan, Korea, Republic of
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Seoul
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Gangnam-gu, Seoul, Korea, Republic of
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Seodaemun-gu, Seoul, Korea, Republic of
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Seongbuk-gu, Seoul, Korea, Republic of
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Songpa-gu, Seoul, Korea, Republic of
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Liepaja, Latvia
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Riga, Latvia
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Ciudad de Mexico
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Distrito Federal, Ciudad de Mexico, Mexico
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Distrito Federal
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Mexico DF, Distrito Federal, Mexico
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Amsterdam, Netherlands
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Arnhem, Netherlands
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Eindhoven, Netherlands
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Hertogenbosch, Netherlands
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Nijmegen, Netherlands
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Rotterdam, Netherlands
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Tilburg, Netherlands
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Tonsberg, Norway
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Trondheim, Norway
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Arequipa, Peru
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Bellavista, Peru
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Jesus Maria, Peru
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Lima, Peru
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Gdynia, Poland
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Kielce, Poland
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Koscierzyna, Poland
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Szczecin, Poland
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Warszawa, Poland
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Wroclaw, Poland
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Coimbra, Portugal
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Porto, Portugal
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Bucuresti, Romania
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Cluj-Napoca, Romania
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Timis
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Timisoara, Timis, Romania
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Barnaul, Russian Federation
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Kursk, Russian Federation
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Moscow, Russian Federation
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Sochi, Russian Federation
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St.Petersburg, Russian Federation
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Voronezh, Russian Federation
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Omsk region
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Omsk, Omsk region, Russian Federation
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Russia
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Izhevsk, Russia, Russian Federation
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Tomsk Region
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Tomsk, Tomsk Region, Russian Federation
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Belgrade, Serbia
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Nis, Serbia
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Novi Sad, Serbia
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Pietermaritzburg, South Africa
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Pretoria, South Africa
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Cape Town
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Observatory, Cape Town, South Africa
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Tygerberg, Cape Town, South Africa
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Durban
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Overport, Durban, South Africa
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Johannesburg
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Parktown, Johannesburg, South Africa
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A Corunna, Spain
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Barcelona, Spain
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Madrid, Spain
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Sevilla, Spain
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Valencia, Spain
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Alicante
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Elche, Alicante, Spain
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Bizkaia
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Barakaldo, Bizkaia, Spain
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Vizcaya
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Bilbao, Vizcaya, Spain
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Gothenburg, Sweden
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Helsingborg, Sweden
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Jonkoping, Sweden
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Orebro, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Aarau, Switzerland
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CH-4031 Basel, Switzerland
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Locarno, Switzerland
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Zuerich, Switzerland
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Taipei, Taiwan
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Ankara, Turkey
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Istanbul, Turkey
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Izmir, Turkey
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Cambridge, United Kingdom
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Coventry, United Kingdom
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Glasgow, United Kingdom
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Huddersfield, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Berkshire
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Reading, Berkshire, United Kingdom
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East Yorkshire
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Cottingham, East Yorkshire, United Kingdom
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Hertfordshire
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Stevenage, Hertfordshire, United Kingdom
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Kent
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Maidstone, Kent, United Kingdom
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Surrey
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Guildford, Surrey, United Kingdom
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Arizona
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Tucson, Arizona, United States
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California
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Greenbrae, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Colorado
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Denver, Colorado, United States
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Connecticut
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Norwich, Connecticut, United States
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District of Columbia
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Washington, District of Columbia, United States
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Florida
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Boca Raton, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Port St. Lucie, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Macon, Georgia, United States
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Kansas
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Kansas City, Kansas, United States
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Louisiana
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New Orleans, Louisiana, United States
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Maryland
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Baltimore, Maryland, United States
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Rockville, Maryland, United States
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Minnesota
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Minneapolis, Minnesota, United States
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Nebraska
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Lincoln, Nebraska, United States
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Nevada
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Las Vegas, Nevada, United States
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New York
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Brooklyn, New York, United States
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North Carolina
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Chapel Hill, North Carolina, United States
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North Dakota
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Bismarck, North Dakota, United States
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Ohio
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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South Carolina
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Charleston, South Carolina, United States
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Mystle Beach, South Carolina, United States
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Raleigh, South Carolina, United States
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Tennessee
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Texas
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San Antonio, Texas, United States
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Vermont
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Burlington, Vermont, United States
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Washington
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Seattle, Washington, United States
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Wenatchee, Washington, United States
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Wisconsin
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Milwaukee, Wisconsin, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients who answer TRUE to the following criteria may be eligible to participate in this study.
- Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has NOT spread to the other parts of the body (metastases). Patients with lymph node involvement may be eligible if specified criteria is met.
- Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
- Currently receiving treatment with surgical or medical castration
Exclusion Criteria:
Patients who answer TRUE to the following may NOT be eligible to participate in this study.
- Currently using opiate based pain killers for cancer related pain
- Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial
- Suffering from heart failure or had a myocardial infarction within last 6 months
- A history of epilepsy or seizures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Matching Placebo
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Matching Plcebo oral tablet once daily
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Experimental: ZD4054
ZD4054 (Zibotentan)
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10 mg once daily oral dose
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: From date of randomization until date of death, assessed up to 33 months
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Number of participants who have died at early analysis data cut off (DCO)
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From date of randomization until date of death, assessed up to 33 months
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Progression Free Survival
Time Frame: Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks
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Number of participants who have a progression event at the early analysis DCO, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline
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Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Health Related Quality of Life
Time Frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
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Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
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Time to Prostate-specific Antigen (PSA) Progression
Time Frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
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Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
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Time to Symptomatic Progression
Time Frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
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Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kurt Miller, Prof., M.D., Charite University, Berlin, Germany
- Principal Investigator: Tia Higano, MD, University of Washington
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D4320C00015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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