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

Sun Pharma

Status and phase: Completed; Phase 2

Conditions: Metastatic Prostate Cancer

Treatments: Drug: abiraterone acetate with Methylprednisolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02962284

CHL-AA-202

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

YONSA with Methylprednisolone

Experimental group

Description:

Aberaterone Acetate 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid)

Treatment:

Drug: abiraterone acetate with Methylprednisolone