Phase 2
Completed N=20
One-year, Open Extension to Evaluate the Treatment of Patients With Castration-Resistant Prostate Cancer With YONSA™
Source: ClinicalTrials.gov NCT02962284 ↗Enrolled (actual)
20
Serious AEs
20.0%
Results posted
Jul 2019
Primary outcomePrimary: Number of Subjects With Adverse Events — 8; 9 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Adverse Events |
8; 9 | — |
| SECONDARY Proportion of Subjects With Disease Progression |
1; 3 | >0.1 |
| SECONDARY Testosterone Levels |
-6.24; -5.87 | — |
| SECONDARY Prostate Specific Antigen Levels |
-60.12; -112.76 | — |
| SECONDARY Testosterone Complete Suppression |
100; 87.5 | — |
| SECONDARY Percentage of Subjects With Prostate Specific Antigen - 50 Response |
60.0; 55.6 | — |
Eligibility Criteria
Inclusion Criteria
- 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 treatment in this study
- Written informed consent obtained prior to any study-related procedure being performed
- Has in the investigator's opinion, the potential to gain clinical benefit with YONSA treatment
- Ongoing therapy with a GnRH agonist or antagonist AND serum testosterone level <50 ng/dL at screening
- Life expectancy of at least 9 months at screening
- Subject is willing and able to comply with all protocol requirements assessments
- Agrees to protocol-defined use of effective contraception.
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT02962284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.