Prostate Cancer Clinical Trial
— ENTHUSE M0Official 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
| Verified date | April 2012 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 2577 |
| Est. completion date | May 2011 |
| Est. primary completion date | January 2011 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Ciudad Autonoma de Buenos Aires | Buenos Aires |
| Argentina | Research Site | Rosario | Santa Fe |
| Argentina | Research Site | Santa Fe | |
| Australia | Research Site | Darlinghurst | New South Wales |
| Australia | Research Site | Hornsby | New South Wales |
| Australia | Research Site | Nedlands | Western Australia |
| Australia | Research Site | Sydney | |
| Australia | Research Site | Westmead | New South Wales |
| Australia | Research Site | Wodonga | Victoria |
| Australia | Research Site | Wollongong | New South Wales |
| Austria | Research Site | Graz | |
| Austria | Research Site | Innsbruck | |
| Austria | Research Site | Wels | |
| Belgium | Research Site | (Wilrijk) Antwerpen | |
| Belgium | Research Site | Brussels | |
| Belgium | Research Site | Edegem | |
| Belgium | Research Site | Gent | |
| Belgium | Research Site | Kortrijk | |
| Belgium | Research Site | Leuven | |
| Belgium | Research Site | Liege | |
| Brazil | Research Site | Belo Horizonte | Minas Gerais |
| Brazil | Research Site | Curitiba | Parana |
| Brazil | Research Site | Goiania | Goias |
| Brazil | Research Site | Londrina | PR |
| Brazil | Research Site | Porto Alegre | Rio Grande do Sul |
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| Canada | Research Site | Burlington | Ontario |
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| Canada | Research Site | Hamilton | Ontario |
| Canada | Research Site | Kingston | Ontario |
| Canada | Research Site | Kitchener | Ontario |
| Canada | Research Site | London | Ontario |
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| Canada | Research Site | Oakville | Ontario |
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| Canada | Research Site | Quebec City | Quebec |
| Canada | Research Site | Sherbrooke | Quebec |
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| China | Research Site | Guangzhou City | |
| China | Research Site | Hangzhou | Zhejiang |
| China | Research Site | Hubei | |
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| China | Research Site | Nanjing | Jiangsu |
| China | Research Site | Shanghai | |
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| Czech Republic | Research Site | Prague 2 | |
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| Ireland | Research Site | Dublin | |
| Ireland | Research Site | Dublin 7 | |
| Ireland | Research Site | Dublin 8 | |
| Israel | Research Site | Be'er Sheva | |
| Israel | Research Site | Be'er-Ya'akov | |
| Israel | Research Site | Haifa | |
| Israel | Research Site | Holon | |
| Israel | Research Site | Jeruslaem | |
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| Japan | Research Site | Chiba-City | Chiba |
| Japan | Research Site | Fuchu_city | Tokyo |
| Japan | Research Site | Fukuoka-City | Fukuoka |
| Japan | Research Site | Hamamatsu-city | Shizuoka |
| Japan | Research Site | Hirosaki-City | Aomori |
| Japan | Research Site | Ibaraki-machi | Ibaraki |
| Japan | Research Site | Itabashi-Ku | Tokyo |
| Japan | Research Site | Kamigyo-ku | Kyoto |
| Japan | Research Site | Kashihara | Nara |
| Japan | Research Site | Kita-gun | Kagawa |
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| Japan | Research Site | Kyoto | |
| Japan | Research Site | Kyoto-City | Kyoto |
| Japan | Research Site | Maebashi-City | Gunma |
| Japan | Research Site | Matsuyama-City | Ehime |
| Japan | Research Site | Meguro-ku | Tokyo |
| Japan | Research Site | Minato-Ku | Tokyo |
| Japan | Research Site | Mitaka-City | Tokyo |
| Japan | Research Site | Mito-City | Ibaraki |
| Japan | Research Site | Nagasaki | |
| Japan | Research Site | Narashino-city | Chiba |
| Japan | Research Site | Oita-City | Oita |
| Japan | Research Site | Osaka-City | Osaka |
| Japan | Research Site | Osaka-Sayama-City | Osaka |
| Japan | Research Site | Otake-City | Hiroshima |
| Japan | Research Site | Sagamihara-City | Kanagawa |
| Japan | Research Site | Sapporo-City | Hokkaido |
| Japan | Research Site | Sendai-City | Miyagi |
| Japan | Research Site | Shinjuku-ku | Tokyo |
| Japan | Research Site | Suita-City | Osaka |
| Japan | Research Site | Sunto-gun | Shizuoka |
| Japan | Research Site | Tsukuba-City | Ibaraki |
| Japan | Research Site | Ueda-City | Nagano |
| Japan | Research Site | Wako-City | Saitama |
| Korea, Republic of | Research Site | Bundang-Gu, Seongnam-si | Gyeonggi-do |
| Korea, Republic of | Research Site | Gangnam-gu | Seoul |
| Korea, Republic of | Research Site | Seo-gu | Pusan |
| Korea, Republic of | Research Site | Seodaemun-gu | Seoul |
| Korea, Republic of | Research Site | Seongbuk-gu | Seoul |
| Korea, Republic of | Research Site | Songpa-gu | Seoul |
| Latvia | Research Site | Liepaja | |
| Latvia | Research Site | Riga | |
| Mexico | Research Site | Distrito Federal | Ciudad de Mexico |
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| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Arnhem | |
| Netherlands | Research Site | Eindhoven | |
| Netherlands | Research Site | Hertogenbosch | |
| Netherlands | Research Site | Nijmegen | |
| Netherlands | Research Site | Rotterdam | |
| Netherlands | Research Site | Tilburg | |
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| Portugal | Research Site | Coimbra | |
| Portugal | Research Site | Porto | |
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| Romania | Research Site | Timisoara | Timis |
| Russian Federation | Research Site | Barnaul | |
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| Russian Federation | Research Site | Omsk | Omsk region |
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| United States | Research Site | Atlanta | Georgia |
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| United States | Research Site | Charleston | South Carolina |
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| United States | Research Site | Denver | Colorado |
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| United States | Research Site | Kansas City | Kansas |
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| United States | Research Site | Lincoln | Nebraska |
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| United States | Research Site | Memphis | Tennessee |
| United States | Research Site | Miami | Florida |
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| United States | Research Site | Mystle Beach | South Carolina |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | Norwich | Connecticut |
| United States | Research Site | Ocala | Florida |
| United States | Research Site | Philadelphia | Pennsylvania |
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| United States | Research Site | Port St. Lucie | Florida |
| United States | Research Site | Raleigh | South Carolina |
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| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Francisco | California |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Washington | District of Columbia |
| United States | Research Site | Wenatchee | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival | Number of participants who have died at early analysis data cut off (DCO) | From date of randomization until date of death, assessed up to 33 months | No |
| Primary | 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 | Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks | No |
| Secondary | Health Related Quality of Life | Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks | No | |
| Secondary | Time to Prostate-specific Antigen (PSA) Progression | Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks | No | |
| Secondary | Time to Symptomatic Progression | Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks | No |
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