Tracking Information
Start Date ICMJE | January 2008 |
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Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: February 21, 2008) | Progression-free survival and Overall survival [ Time Frame: Assessed at study visits and assessments every 4 weeks for first 16 weeks then every 16 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00626548 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: February 21, 2008) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | A Phase III Trial of ZD4054 (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer |
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Official Title ICMJE | A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients |
Brief Summary | Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 in hormone resistant prostate cancer (HRPC). This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 can improve progression-free survival and overall survival against a background of existing prostate cancer treatments. ZD4054 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 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, 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. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Prostate Cancer |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 1500 | ||||||||
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Estimated Completion Date | November 2012 | ||||||||
Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Patients who answer TRUE to the following criteria may be eligible to participate in this study.
Exclusion Criteria: Patients who answer TRUE to the following may NOT be eligible to participate in this study.
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Gender | Male | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | 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 | ||||||||
Administrative Information
NCT ID ICMJE | NCT00626548 | ||||||||
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Responsible Party | Thomas Morris, BSc, MB BCh, MRCP, FFPM, ZD4054 Medical Science Director, AstraZeneca | ||||||||
Study ID Numbers ICMJE | D4320C00015 | ||||||||
Study Sponsor ICMJE | AstraZeneca | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
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Information Provided By | AstraZeneca |