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Completed

NCT Number: NCT02962284

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

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.

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Key information

Conditions

Metastatic Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

abiraterone acetate with Methylprednisolone

Drug

YONSA 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid)

Other names: YONSA

Primary outcomes

  1. Number of Subjects With Adverse Events

    Time frame: one year

    Adverse events

Secondary outcomes

  1. Proportion of Subjects With Disease Progression

    Time frame: one year

    Number of participants who had disease progression

  2. Testosterone Levels

    Time frame: Baseline and 360 days

    Change in serum testosterone levels from baseline

  3. Prostate Specific Antigen Levels

    Time frame: One year

    Change in serum testosterone levels after one year of treatment against baseline

  4. Testosterone Complete Suppression

    Time frame: 360 days

    Proportion of subjects with complete suppression of testosterone levels

  5. Percentage of Subjects With Prostate Specific Antigen - 50 Response

    Time frame: 360 days

    A decrease of ≥50% reduction from baseline of the study CHL-AA-201

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries Limited

Industry

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 11, 2016
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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