A Randomized, Double-blind Phase II Trial to Assess the Efficacy and Safety of Bicalutamide (Casodex® ) Associated to ZD6474 (Zactima™ ) or to Placebo in Patients With Castration-refractory Metastatic Prostate Cancer Without Any Clinical Symptom Related to Disease Progression
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Prostate Specific Antigen (PSA) Progression Free Rate at 4 Months
To assess the effect of vandetanib on biological progression free rate based on PSA level (assessable set). PSA progression free rate defined as the number of participants with : After decline from baseline: a 25% increase above the nadir No decline from baseline: a 25% increase above the baseline (min. increase of 2 ng/mL)
4 months
No
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
D4200C00080
NCT00659438
February 2008
July 2011
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