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

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)

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 Overview

• Status: Completed
• Conditions: Metastatic Prostate Cancer
• Intervention / Treatment: Drug: abiraterone acetate with Methylprednisolone

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: YONSA with Methylprednisolone; Aberaterone Acetate 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid)	Drug: abiraterone acetate with Methylprednisolone; YONSA 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid); Other Names: YONSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Adverse Events	Adverse events	one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Pharmaceutical Industries Limited
• Investigators: Study Director: Paul Nemeth, Ph.D., Churchill Pharmaceuticals LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ACTUAL): March 1, 2018
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: November 9, 2016
• First Posted (ESTIMATE): November 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Abiraterone Acetate
• Other Study ID Numbers: CHL-AA-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to make individual participant data available