One-year, Open Extension to Evaluate the Treatment of Patients With Castration-Resistant Prostate Cancer With YONSA™

Phase 2

Completed

• Conditions: Metastatic Prostate Cancer
• Interventions: Drug: abiraterone acetate with Methylprednisolone

• Registration Number: NCT02962284
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-31
• Study Start: 2016-11
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-11
• Primary Completion: 2018-03
• Study Completion: 2018-06
• Results First Submitted: 2019-05-02
• Results First Submitted QC: 2019-07-02
• Results First Posted: 2019-07-22
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
YONSA with Methylprednisolone	abiraterone acetate with Methylprednisolone	Aberaterone Acetate 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid)

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Adverse Events	one year	Adverse events

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects With Disease Progression	one year	Number of participants who had disease progression
Testosterone Levels	Baseline and 360 days	Change in serum testosterone levels from baseline
Prostate Specific Antigen Levels	One year	Change in serum testosterone levels after one year of treatment against baseline
Testosterone Complete Suppression	360 days	Proportion of subjects with complete suppression of testosterone levels
Percentage of Subjects With Prostate Specific Antigen - 50 Response	360 days	A decrease of ≥50% reduction from baseline of the study CHL-AA-201