At a glance
ClinicalIndex Comparison Record- ✓Successful completion of 84 days of treatment with YONSA in Churchill Pharmaceuticals clinical trial CHL-AA-201
- ✓Last dose of YONSA or Zytiga within 45 days prior to study entry
- ✓Ongoing therapy with a GnRH agonist or antagonist with serum testosterone <50 ng/dL at screening
- ✓Life expectancy of at least 9 months
- ✕Serious concurrent illness, including psychiatric illness, that would interfere with study participation
- ✕Inability to swallow tablets whole
- ✕Known hypersensitivity to YONSA, methylprednisolone, or any excipients in study medications
- ✕Moderate to severe hepatic impairment (Child-Pugh Classes B and C)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Single-Arm, Multiple Center Extension Study to Evaluate One Year of Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer With YONSA™ 500 mg (4 x 125 mg qd) With Methylprednisolone (4 mg Bid)
In Brief
A Phase 2 clinical trial evaluating abiraterone acetate with Methylprednisolone for Metastatic Prostate Cancer. Completed, enrolled 20 participants.
Detailed 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.
Study Details
Timeline
Interventions
YONSA 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid)