Status:
COMPLETED
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
1494 Patients enrolled
Trial Details
Trial ID
NCT00617669
Start Date
January 1 2008
End Date
July 1 2011
Last Update
September 10 2012
Active Locations (147)
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1
Research Site
Greenbrae, California, United States
2
Research Site
San Diego, California, United States
3
Research Site
Norwich, Connecticut, United States
4
Research Site
Washington D.C., District of Columbia, United States