Phase II Study of ASP3550 - A Maintenance-dose Finding Study in Patients With Prostate Cancer
Two doses of ASP3550 were administered to patients with prostate cancer. The primary
efficacy variable was the effect of ASP3550 on the maintenance of serum testosterone
suppression. In addition, the safety and pharmacokinetics of ASP3550 will be investigated.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment
Astellas Pharma Inc
Japan: Pharmaceuticals and Medical Devices Agency