A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases
ENTHUSE M1
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.
2 other identifiers
interventional
896
29 countries
189
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Nov 2007
189 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 2, 2007
CompletedFirst Posted
Study publicly available on registry
November 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
May 31, 2012
CompletedFebruary 8, 2016
April 1, 2012
2.7 years
November 2, 2007
April 26, 2012
January 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Median time (in months) from randomisation until death using the Kaplan-Meier method
From date of randomization until date of death, assessed up to 32 months
Secondary Outcomes (9)
Progression Free Survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months
Time to Use of Opiates
From date of randomization until use of opiates for disease-related symptoms for a duration ≥1 week, assessed up to 31 months
Incidence of Skeletal Related Events
From date of randomization until occurrence of a skeletal related event, assessed up to 31 months
Bone Metastases Formation
Patients were assessed every 12 weeks
Health Related Quality of Life
Patients were assessed at every visit
- +4 more secondary outcomes
Study Arms (2)
ZD4054
EXPERIMENTALZD4054 10 mg oral tablet once daily
Placebo
PLACEBO COMPARATORMatching Placebo, oral tablets once daily
Interventions
Eligibility Criteria
You may qualify if:
- Patients who answer TRUE to the following criteria may be eligible to participate in this trial.
- Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastases)
- Increasing Prostate Specific Antigen (PSA) over a one month period
- No pain, or mild pain from prostate cancer
- Currently receiving treatment with surgical or medical castration
You may not qualify if:
- Patients who answer TRUE to the following may NOT eligible to participate in this trial.
- Currently using opiates based pain killers)
- Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone)
- Suffering from heart failure or had a myocardial infarction within last 6 months
- A history of epilepsy or seizures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (197)
Research Site
Tucson, Arizona, United States
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Greenbrae, California, United States
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Los Angeles, California, United States
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Palm Springs, California, United States
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San Mateo, California, United States
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Norwich, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Gainsville, Florida, United States
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Port St.Lucie, Florida, United States
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Des Moines, Iowa, United States
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Canton, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Nashville, Tennessee, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, United States
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Norfolk, Virginia, United States
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Seattle, Washington, United States
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Wheeling, West Virginia, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, Buenos Aires, Argentina
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Santa Fe, Santa Fe Province, Argentina
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Hornsby, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Redcliffe, Queensland, Australia
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Ashford, South Australia, Australia
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Subiaco, Western Australia, Australia
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Graz, Graz, Austria
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Wels, Wels, Austria
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Brussels, Brussels Capital, Belgium
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Ghent, Gent, Belgium
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Kortrijk, Kortrijk, Belgium
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Leuven, Leuven, Belgium
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Fortaleza, Ceará, Brazil
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Goiânia, Goiás, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Curitiba, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Ribeirão Preto, São Paulo, Brazil
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Santo André, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Kentville, Nova Scotia, Canada
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Barrie, Ontario, Canada
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Burlington, Ontario, Canada
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Hamilton, Ontario, Canada
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Kitchener, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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North York, Ontario, Canada
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Oakville, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Granby, Quebec, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Point-Claire, Quebec, Canada
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Québec, Quebec, Canada
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Haidian District, Beijing Municipality, China
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XI Cheng District, Beijing Municipality, China
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Xicheng District, Beijing Municipality, China
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Wuhan, Hubei, China
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Nanjing, Jiangsu, China
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Pudong New Area, Shanghai Municipality, China
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Shanghai, Shanghai Municipality, China
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Xuhui District, Shanghai Municipality, China
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Xi’an, Shanxi, China
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Brno, Brno, Czechia
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Olomouc, Olomouc, Czechia
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Prague, Prague, Czechia
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Ústí nad Labem, Usti nad Labem, Czechia
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Aalborg, Aalborg, Denmark
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Aarhus, Aarhus, Denmark
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Herlev, Herlev, Denmark
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Copenhagen, Kobenhavn, Denmark
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Joensuu, Joensuu, Finland
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Kajaanintie, Kajaanintie, Finland
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Tampere, Pirkanmaa, Finland
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Montpellier, Montpellier, France
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Paris, Paris, France
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Poitiers, Poitiers Cedex, France
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Suresnes, Suresnes, France
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Toulouse, Toulouse, France
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Villejuif, Villejuif, France
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Augsburg, Augsburg, Germany
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Bad Gegeberg, Bad Gegeberg, Germany
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Emmendingen, Emmendingen, Germany
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Leipzig, Leipzig, Germany
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Lübeck, Luebeck, Germany
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Mannheim, Mannheim, Germany
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München, Muenchen, Germany
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Planegg, Muenchen, Germany
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Reutlingen, Reutlingen, Germany
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Berlin, State of Berlin, Germany
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Kirchheim, Teck, Germany
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Hong Kong, Hong Kong, Hong Kong
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Tuenmen, Hong Kong, Hong Kong
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Shatin, Shatin, Hong Kong
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Budapest, Budapest, Hungary
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Debrecen, Debrecen, Hungary
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Miskolc, Miskolc, Hungary
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Nyíregyháza, Nyiregyhaza, Hungary
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Szeged, Szeged, Hungary
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Gujarat, Gujarat, India
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Trivandrum, Kerala, India
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Bhopal, Madhya Pradesh, India
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Mumbai, Maharashtra, India
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Rohini, National Capital Territory of Delhi, India
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New Delhi, New Delhi, India
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Chandigarh, Punjab, India
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Ludhiana, Punjab, India
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Bikaner, Rajasthan, India
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Jaipur, Rajasthan, India
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Kolkota, West Bengal, India
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Milan, Milan, Italy
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Rome, Rome, Italy
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Asahi, Chiba, Japan
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Chiba, Chiba, Japan
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Narashino, Chiba, Japan
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Matsuyama, Ehime, Japan
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Fukuoka, Fukuoka, Japan
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Maebashi, Gunma, Japan
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Ōtake, Hiroshima, Japan
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Sapporo, Hokkaido, Japan
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Kobe, Hyōgo, Japan
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Tsukuba, Ibaraki, Japan
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Kita-gun, Kagawa-ken, Japan
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Sagamihara, Kanagawa, Japan
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Kyoto, Kyoto, Japan
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Sendai, Miyagi, Japan
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Nagasaki, Nagasaki, Japan
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Ōita, Oita Prefecture, Japan
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Osaka, Osaka, Japan
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Ōsaka-sayama, Osaka, Japan
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Suita, Osaka, Japan
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Wako, Saitama, Japan
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Hamamatsu, Shizuoka, Japan
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Sunto-gun, Shizuoka, Japan
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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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Mitaka, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Mexico City, Mexico City, Mexico
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Distrito Federal Ciudad, Mexico, Mexico
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Metepec, State of Mexico, Mexico
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Amsterdam, Amsterdam, Netherlands
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Eindhoven, Eindhoven, Netherlands
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Nijmegen, Nijmegen, Netherlands
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Groningen, Provincie Groningen, Netherlands
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Bialystok, Bialystok, Poland
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Kościerzyna, Koscierzyna, Poland
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Krakow, Krakow, Poland
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Rzeszów, Rzeszow, Poland
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Warsaw, Warszawa, Poland
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Wroclaw, Wroclaw, Poland
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Coimbra, Coimbra District, Portugal
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Lisbon, Lisbon District, Portugal
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Porto, Porto District, Portugal
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Barnaul, Barnaul, Russia
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Stary Oskol, Belgorod Oblast, Russia
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Izhevsk, Izhevsk, Russia
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Kursk, Kursk Oblast, Russia
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Moscow, Moscow, Russia
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Saint Petersgurg, Saint Petersgurg, Russia
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Sochi, Sochi, Russia
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Voronezh, Voronezh Oblast, Russia
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Belgrade, Belgrade, Serbia
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Niš, Nis, Serbia
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Novi Sad, Novi Sad, Serbia
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Singapore, Singapore, Singapore
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Bloemfontein, Bloemfontein, South Africa
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Tygerberg, Cape Town, South Africa
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Pietermaritzburg, Pietermaritzburg, South Africa
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Port Elizabeth, Port Elizabeth, South Africa
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Seo-gu, Busan, South Korea
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Seongnam-si, Gyeonggi-do, South Korea
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Heungduk-gu Cheongju, North Chungcheong, South Korea
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Gangnam-gu, Seoul, South Korea
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Songpa-gu, Seoul, South Korea
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Gothenburg, Goteborg, Sweden
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Gothenburg, Gothenburg, Sweden
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Stockholm, Stockholm County, Sweden
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Basel, Basel, Switzerland
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Bern, Canton of Bern, Switzerland
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Locarno, Locarno, Switzerland
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Sursee, Sursee, Switzerland
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Kaohsiung City, Kaohsiung, Taiwan
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Taipei, Taipei, Taiwan
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Taoyuan District, Taiwan, Taiwan
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Reading, Berkshire, United Kingdom
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Cambridge, Cambridgeshire, United Kingdom
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Maidstone, Kent, United Kingdom
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London, London, United Kingdom
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Huddersfield, Yorkshire, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Gleave, MD, FRCSC, FACS
The Prostate Centre at Vancouver General Hospital
- PRINCIPAL INVESTIGATOR
Joel B Nelson, MD
University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2007
First Posted
November 6, 2007
Study Start
November 1, 2007
Primary Completion
July 1, 2010
Study Completion
August 1, 2011
Last Updated
February 8, 2016
Results First Posted
May 31, 2012
Record last verified: 2012-04