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

Metastatic Prostate Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02962284
• Other study ID #: CHL-AA-202
• Status: Completed
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: June 2018

Study information

• Verified date: November 2021
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• abiraterone acetate with Methylprednisolone
YONSA 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Outcome

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