A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer - ENTHUSE M1C
Study identifier:D4320C00033
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
prostate cancer
Phase
Phase 3
Healthy volunteers
No
Study drug
Docetaxel, ZD4054, Placebo
Sex
Male
Actual Enrollment
1494
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Jan 2008
Primary Completion Date: 01 May 2011
Study Completion Date: 01 Jul 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Placebo + Docetaxel placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks | Drug: Docetaxel intravenous infusion given every three weeks Other Name: Taxotere® Drug: Placebo placebo oral tablet once daily |
| Experimental: ZD4054 + Docetaxel ZD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks | Drug: Docetaxel intravenous infusion given every three weeks Other Name: Taxotere® Drug: ZD4054 10 mg oral once daily dose Other Name: Zibotentan |
Contacts
Investigators
Principal Investigator
Karim Fizazi
INSTITUT GUSTAVE ROUSSY
