One-year, Open Extension to Evaluate the Treatment of Patients With Castration-Resistant Prostate Cancer With YONSA™
Status:
Completed
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
This is an open-label, single-arm, multi-center extension study to evaluate safety in
patients with mCRPC of YONSA 500 mg (4 x 125 mg qd) with methylprednisolone (4 mg bid).
Patients will have successfully completed an 84-day treatment with abiraterone acetate in a
previous trial. Results from the final visit of the previous study will be used to determine
patient's eligibility for this study. Patients in this study will be eligible to receive
open-label YONSA with methylprednisolone for up to 12 months. Pharmacodynamic parameters of
serum testosterone and PSA levels will be monitored. Disease progression will be assessed by
PCWG2 criteria.
Phase:
Phase 2
Details
Lead Sponsor:
Churchill Pharmaceutical LLC Sun Pharma Global FZE