A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer
ENTHUSE M1C
A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 (Zibotentan) in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer
1 other identifier
interventional
1,494
25 countries
145
Brief Summary
Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC). This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further improve survival compared with docetaxel alone. 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 compared with docetaxel. All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies. Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further 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 Jan 2008
145 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
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 24, 2008
CompletedFirst Posted
Study publicly available on registry
February 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
May 31, 2012
CompletedSeptember 10, 2012
April 1, 2012
3.3 years
January 24, 2008
April 26, 2012
September 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Median time (in months) from randomisation until death using the Kaplan-Meier method.
Patients were followed for survival up to 40 months
Secondary Outcomes (7)
Progression Free Survival
Patients were followed for progression up to 40 months
Incidence of Skeletal Related Events
While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
Time to Prostate-specific Antigen (PSA) Progression
While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
Time to Pain Progression
While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
Pain Response
While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
- +2 more secondary outcomes
Study Arms (2)
Placebo + Docetaxel
ACTIVE COMPARATORplacebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
ZD4054 + Docetaxel
EXPERIMENTALZD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
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 metastasis)
- Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
- Currently receiving treatment with surgical or medical castration
You may not qualify if:
- Patients who answer TRUE to the following ARE NOT eligible to participate in this trial.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (147)
Research Site
Greenbrae, California, United States
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San Diego, 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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Fort Myers, Florida, United States
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Gainsville, Florida, United States
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Ocala, Florida, United States
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PORTUGALt Saint Lucie, Florida, United States
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Rockville, Maryland, United States
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Minneapolis, Minnesota, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Chapel Hill, North Carolina, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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San Antonio, Texas, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Bahía Blanca, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Santa Fe, Santa Fe Province, Argentina
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Darlinghurst, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Redcliffe, Queensland, Australia
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Ashford, South Australia, Australia
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Footscray, Victoria, Australia
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Wodonga, Victoria, Australia
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Perth, Western Australia, Australia
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Subiaco, Western Australia, Australia
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Fortaleza, Ceara/ LA, Brazil
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Goiânia, Goias/ LA, Brazil
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Goiânia, Goiás, Brazil
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Belo Horizonte, Minas GERMANYais, Brazil
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Curitiba, Parana/ Brazil, Brazil
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Londrina, Paraná, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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PORTUGALto Alegre, Rio Grande Do Sul/ LA, Brazil
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Ribeirão Preto, Sao Paulo/ LA, Brazil
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Santo André, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Olomouc, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Ústí nad Labem, Czech Republic, Czechia
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Brno, Czechoslovakia Republic, Czechia
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Jablonec nad Nisou, Czechia
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Kroměříž, Czechia
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Prague, Czechia
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Helsinki, Finland, Finland
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Joensuu, Finland
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Seinäjoki, Finland
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La Roche-sur-Yon, FRANCEnce, France
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Marseille, FRANCEnce, France
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Paris, FRANCEnce, France
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Reims, FRANCEnce, France
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Villejuif, FRANCEnce, France
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Paris, Paris, France
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Saint-Herblain, Saint Herblain, France
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Paris, France
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Hanover, GERMANYmany, Germany
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Berlin, Germany
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Bonn, Germany
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Dresden, Germany
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Emmendingen, Germany
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Kirchheim-Teck, Germany
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Leipzig, Germany
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Lübeck, Germany
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Münster, Germany
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Tübingen, Germany
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Wuppertal, Germany
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Budapest, HUNGARYary, Hungary
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Győr, HUNGARYary, Hungary
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Miskolc, HUNGARYary, Hungary
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Ny Regyh Za, HUNGARYary, Hungary
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Szeged, HUNGARYary, Hungary
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Bangalore, Karnataka, India
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Trivandrum, Kerala, India
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Bhopal, Madhya Pradesh, India
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Pune, Maharashtra, India
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Bikaner, Rajasthan, India
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Jaipur, Rajasthan, India
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Vellore, Tamil Nadu, India
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Kolkata, West Bengal, India
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Kolkota, West Bengal, India
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Delhi, India
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New Delhi, India
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Genoa, Italy, Italy
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Lugo (RA), Italy, Italy
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Rome, Italy, Italy
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Nijmegen, Netherlands
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Cercado de Arequipa, Arequipa, Peru
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Cercado, Arequipa, Peru
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Callao, Peru
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Lima, Peru
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Lublin, POLANDand, Poland
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Swidnica, POLANDand, Poland
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Warszaa, POLANDand, Poland
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Kościerzyna, Poland
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Wroclaw, Poland
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Coimbra, PORTUGALtugal, Portugal
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PORTUGALto, PORTUGALtugal, Portugal
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Bucharest, Romania
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Sibiu, Romania
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Timișoara, Romania
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Barnaul, RUSSIAsia, Russia
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Izhevsk, RUSSIAsia, Russia
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Kursk, RUSSIAsia, Russia
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Sochi, RUSSIAsia, Russia
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Voronezh, RUSSIAsia, Russia
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Belgrade, SERBIAbia, Serbia
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Niš, SERBIAbia, Serbia
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Panorama, Cape Town, South Africa
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TyGERberg, Cape Town, South Africa
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Overport, Durban, South Africa
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Bloemfontein, South Africa
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Port Elizabeth, South Africa
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Ilsandong-gu, Goyang-si, Gyeonggi-do, South Korea
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Cheongju-si, North Chungcheong, South Korea
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Nowon-gu, Seoul, South Korea
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Seodaemun-gu, Seoul, South Korea
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Songpa-gu, Seoul, South Korea
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Madrid, Spain, Spain
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Valencia, Spain, Spain
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Stockholm, Sweden, Sweden
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Uppsala, Sweden
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Aarau, Switzerland
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Locarno, Switzerland
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Sursee, Switzerland
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Kaohsiung City, TAIWANwan, Taiwan
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TAIWANpei, TAIWANwan, Taiwan
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Reading, Berkshire, United Kingdom
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Manchester, Manchester, United Kingdom
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Westgate Road, Newcastle Upon Tyne, United Kingdom
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London, United Kingdom
Related Publications (1)
Fizazi K, Higano CS, Nelson JB, Gleave M, Miller K, Morris T, Nathan FE, McIntosh S, Pemberton K, Moul JW. Phase III, randomized, placebo-controlled study of docetaxel in combination with zibotentan in patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2013 May 10;31(14):1740-7. doi: 10.1200/JCO.2012.46.4149. Epub 2013 Apr 8.
PMID: 23569308DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Karim Fizazi, MD, PhD
Gustave Roussy, Cancer Campus, Grand Paris
- PRINCIPAL INVESTIGATOR
Judd W Moul, MD, FACS
Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2008
First Posted
February 18, 2008
Study Start
January 1, 2008
Primary Completion
May 1, 2011
Study Completion
July 1, 2011
Last Updated
September 10, 2012
Results First Posted
May 31, 2012
Record last verified: 2012-04