Prostate CancerPhase 3ENTHUSE M0NCT00626548

A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer

A Phase 3 study testing ZD4054 and Palcebo in people with Prostate Cancer, run by AstraZeneca at 322 sites in 39 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: ZD4054 and Palcebo
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,577 participants
Where: 322 sitesin 39 countries
Study dates: Jan 2008to May 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

322 sites in 39 countries.

Country

City, postcode or hospital

322 sites in 39 countries

United States38 sites

Research Site
Atlanta, Georgia
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Baltimore, Maryland
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Bismarck, North Dakota
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Boca Raton, Florida
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Brooklyn, New York
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Burlington, Vermont
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Canton, Ohio
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Chapel Hill, North Carolina
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Charleston, South Carolina
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Cincinnati, Ohio
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Denver, Colorado
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Greenbrae, California
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Kansas City, Kansas
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Las Vegas, Nevada
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Lincoln, Nebraska
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Los Angeles, California
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Macon, Georgia
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Memphis, Tennessee
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Miami, Florida
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Milwaukee, Wisconsin
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Minneapolis, Minnesota
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Mystle Beach, South Carolina
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Nashville, Tennessee
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New Orleans, Louisiana
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Norwich, Connecticut
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Ocala, Florida
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Philadelphia, Pennsylvania
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Pittsburgh, Pennsylvania
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Port Saint Lucie, Florida
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Raleigh, South Carolina
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Rockville, Maryland
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San Antonio, Texas
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San Diego, California
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San Francisco, California
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Seattle, Washington
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Tucson, Arizona
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Washington D.C., District of Columbia
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Wenatchee, Washington

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Japan35 sites

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Bunkyo-ku, Tokyo
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Chiba, Chiba
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Fuchu_city, Tokyo
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Fukuoka, Fukuoka
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Hamamatsu, Shizuoka
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Hirosaki, Aomori
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Ibaraki-machi, Ibaraki
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Kamigyō-ku, Kyoto
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Kashihara, Nara
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Kita-gun, Kagawa-ken
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Kobe, Hyōgo
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Kurashiki, Okayama-ken
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Kyoto, Kyoto
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Maebashi, Gunma
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Matsuyama, Ehime
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Meguro-ku, Tokyo
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Minato-Ku, Tokyo
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Mitaka, Tokyo
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Mito, Ibaraki
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Nagasaki, Nagasaki
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Narashino, Chiba
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Ōita, Oita Prefecture
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Osaka, Osaka
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Ōsaka-sayama, Osaka
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Ōtake, Hiroshima
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Sagamihara, Kanagawa
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Sapporo, Hokkaido
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Sendai, Miyagi
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Shinjuku-ku, Tokyo
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Suita, Osaka
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Sunto-gun, Shizuoka
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tabashi City, Tokyo
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Tsukuba, Ibaraki
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Ueda, Nagano
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Wako, Saitama

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Germany26 sites

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Augsburg
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Bad Ems
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Berlin
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Bonn
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Borken
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Chemnitz
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Emmendingen
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Fürth
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Gelsenkirchen-Buer
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Germering
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Göttingen
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Holzminden
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Kirchheim/Teck
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Leipzig
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Lübeck
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Mannheim
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Muehlheim An Der Ruhr
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Muenchen-Planegg
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Mühlacker
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München
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Münster
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Reutlingen
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Rostock
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Tübingen
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Waltshut-Tiengen
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Wuppertal

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Canada18 sites

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Burlington, Ontario
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Calgary, Alberta
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Edmonton, Alberta
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Greenfeild Park, Quebec
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Hamilton, Ontario
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Kingston, Ontario
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Kitchener, Ontario
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London, Ontario
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Montreal, Quebec
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North York, Ontario
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Oakville, Ontario
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Point-Claire, Quebec
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Québec, Quebec
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Sherbrooke, Quebec
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Toronto, Ontario
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Vancouver, British Columbia
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Victoria, British Columbia
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Winnipeg, Manitoba

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France17 sites

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Caen
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Créteil
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Lille
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Lyon
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Marseille
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Montpellier
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Orléans
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Paris
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Pierre-Bénite
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Poitiers
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Reims
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Rennes
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Rouen
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Suresnes
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Toulouse
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Vandœuvre-lès-Nancy
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Villejuif

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Italy14 sites

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Ancona
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Bari
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Bergamo
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Bologna
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Catania
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Como
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Florence
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Genova
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Messina
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Milan
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Pisa
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Rome
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Terni
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Varese

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United Kingdom13 sites

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Cambridge
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Cottingham, East Yorkshire
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Coventry
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Glasgow
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Guildford, Surrey
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Huddersfield
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Liverpool
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London
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Maidstone, Kent
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Manchester
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Newcastle upon Tyne
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Reading, Berkshire
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Stevenage, Hertfordshire

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China11 sites

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Beijing
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Chongqing
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Guangzhou
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Hangzhou, Zhejiang
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Hubei
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Jiangsu
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Nanjing, Jiangsu
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Shanghai
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Shanxi
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Tianjin
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Zejiang

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Russia9 sites

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Barnaul
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Izhevsk, Russia
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Kursk
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Moscow
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Omsk, Omsk Oblast
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Saint Petersburg
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Sochi
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Tomsk, Tomsk Oblast
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Voronezh

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Brazil8 sites

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Belo Horizonte, Minas Gerais
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Curitiba, Paraná
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Goiânia, Goiás
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Londrina, Paraná
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Porto Alegre, Rio Grande do Sul
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Rio de Janeiro, Rio de Janeiro
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Santo André, São Paulo
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São Paulo, São Paulo

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India8 sites

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Ahmedabad, Gujarat
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Chennai, Tamil Nadu, India
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Kochi, Kerala
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Kolkota, West Bengal
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Lucknow, Uttar Pradesh
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Nadiād, Gujarat
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New Delhi
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Pune, Maharashtra

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Spain8 sites

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A Corunna
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Barakaldo, Bizkaia
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Barcelona
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Bilbao, Vizcaya
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Elche, Alicante
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Madrid
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Seville
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Valencia

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Australia7 sites

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Darlinghurst, New South Wales
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Hornsby, New South Wales
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Nedlands, Western Australia
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Sydney
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Westmead, New South Wales
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Wodonga, Victoria
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Wollongong, New South Wales

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Belgium7 sites

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(Wilrijk) Antwerpen
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Brussels
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Edegem
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Ghent
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Kortrijk
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Leuven
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Liège

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Czechia7 sites

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Brno
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Hradec Králové
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Kroměříž
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Olomouc
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Prague
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Ústí nad Labem

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Denmark7 sites

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Aalborg
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Frederiksberg
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Herlev
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Holstebro
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Odense
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Roskilde

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Hungary7 sites

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Budapest
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Debrecen
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Miskolc
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Szeged
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Israel7 sites

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Be’er Ya‘aqov
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Beersheba
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Haifa
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Holon
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Jeruslaem
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Petah Tikva
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Tel-HaShomer - Ramat Gan

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Netherlands7 sites

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's-Hertogenbosch
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Amsterdam
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Arnhem
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Eindhoven
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Nijmegen
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Rotterdam
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Tilburg

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Poland6 sites

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Gdynia
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Kielce
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Kościerzyna
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Szczecin
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Warsaw
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Wroclaw

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South Africa6 sites

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Observatory, Cape Town
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Overport, Durban
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Parktown, Johannesburg
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Pietermaritzburg
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Pretoria
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Tygerberg, Cape Town

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South Korea6 sites

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Bundang-Gu, Seongnam-si, Gyeonggi-do
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Gangnam-gu, Seoul
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Seo-gu, Busan
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Seodaemun-gu, Seoul
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Seongbuk-gu, Seoul
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Songpa-gu, Seoul

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Sweden6 sites

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Gothenburg
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Helsingborg
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Jönköping
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Örebro
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Stockholm
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Uppsala

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Finland5 sites

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Helsinki
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Joensuu
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Oulu
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Seinäjoki
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Tampere

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Chile4 sites

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La Serena
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Santiago
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Temuco
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Viña del Mar

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Peru4 sites

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Lima

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Switzerland4 sites

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Aarau
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Ch-4031 Basel
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Locarno
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Argentina3 sites

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Ciudad Autonoma de Buenos Aires, Buenos Aires
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Rosario, Santa Fe Province
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Santa Fe, Santa Fe Province

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Austria3 sites

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Graz
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Wels

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Romania3 sites

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Serbia3 sites

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About this study

Official title: 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.

Conditions: Prostate Cancer
Being tested: ZD4054, Palcebo
Keywords: Hormone Resistant Prostate Cancer, Endothelin A Receptor Antagonist, Endothelin A, Endothelin A antagonist
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZD4054Drug
Also called Zibotentan
10 mg once daily oral dose
PalceboDrug
Matching Plcebo oral tablet once daily

Study groups in NCT00626548
Study group	Role	What they receive
Placebo	Placebo comparator	Matching Placebo Receives: Drug: Palcebo
ZD4054	Experimental	ZD4054 (Zibotentan) Receives: Drug: ZD4054

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival
Number of participants who have died at early analysis data cut off (DCO)
Measured: From date of randomization until date of death, assessed up to 33 months
Progression Free Survival
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
Measured: Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks

Secondary outcomes (3)

Health Related Quality of Life
Measured: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Time to Prostate-specific Antigen (PSA) Progression
Measured: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Time to Symptomatic Progression
Measured: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008May 2011

First posted29 Feb 2008 (estimated)
Study startJan 2008
Primary completionJan 2011
Study completionMay 2011

Why it stopped: early efficacy review by the Independent Data Monitoring Committee indicated it was unlikely to meet its primary efficacy endpoints

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 2,577 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00626548
Sponsor's protocol ID: D4320C00015
Acronym: ENTHUSE M0
Status last verified: Apr 2012
First submitted: 24 Jan 2008
Last updated: 3 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00626548
Acronym / sponsor ID: ENTHUSE M0 / D4320C00015
Conditions: Prostate Cancer
Keywords: Hormone Resistant Prostate Cancer, Endothelin A Receptor Antagonist, Endothelin A, Endothelin A antagonist
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: early efficacy review by the Independent Data Monitoring Committee indicated it was unlikely to meet its primary efficacy endpoints
Enrolment: 2,577 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Jan 2011 (actual)
Study completion: May 2011 (actual)
First posted: 29 Feb 2008 (estimated)
Results: Posted 1 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC).

All patients participating in this clinical trial will receive existing prostate cancer treatments in addition to trial therapy.

No patients will be deprived of standard prostate cancer therapy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PalceboMatching Placebo
ZD4054	Experimental	Drug: ZD4054ZD4054 (Zibotentan)

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ZD4054Also: Zibotentan10 mg once daily oral dose	Drug	ZD4054
PalceboMatching Plcebo oral tablet once daily	Drug	Placebo

Primary outcome

Overall Survival
Time frame: From date of randomization until date of death, assessed up to 33 months
Number of participants who have died at early analysis data cut off (DCO)
Progression Free Survival
Time frame: Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks
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

3 secondary outcomes

Health Related Quality of Life
Time frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
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
Time to Symptomatic Progression
Time frame: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks

Results and safety

Results posted to the registry on 1 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ZD4054	705	0
Placebo	716	0

Primary outcome: Overall Survival

Time frame: From date of randomization until date of death, assessed up to 33 months. Number. Unit: Participants

Measure	ZD4054 n = 592	Placebo n = 589
Value	40	39

Population analysed: The analysis population only includes patients recruited by the time of the early analysis (1 October 2010)

Primary outcome: Progression Free Survival

Time frame: Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks. Number. Unit: Participants

Measure	ZD4054 n = 592	Placebo n = 589
Value	131	162

Population analysed: The analysis population only includes patients recruited by the time of the early analysis (1 October 2010)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ZD4054	148 of 703 (21.1%)	531 of 703 (75.5%)	Not reported
Placebo	138 of 712 (19.4%)	392 of 712 (55.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prostate Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
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Prostate Cancer, Urinary Incontinence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kurt Miller, Prof., M.D. principal investigator

Charite University, Berlin, Germany

Tia Higano, MD principal investigator

University of Washington

322 sites in 39 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ZD4054 and Palcebo in people with Prostate Cancer, run by AstraZeneca at 322 sites in 39 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 322 sites in United States, Japan, Germany, Canada, France and 34 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: From date of randomization until date of death, assessed up to 33 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00626548.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2012.