search
Back to results

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

Primary Purpose

Metastatic Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
abiraterone acetate with Methylprednisolone
Sponsored by
Sun Pharmaceutical Industries Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    YONSA with Methylprednisolone

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Number of Subjects With Adverse Events
    Adverse events

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 31, 2016
    Last Updated
    November 18, 2021
    Sponsor
    Sun Pharmaceutical Industries Limited
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02962284
    Brief Title
    One-year, Open Extension to Evaluate the Treatment of Patients With Castration-Resistant Prostate Cancer With YONSA™
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2016 (Actual)
    Primary Completion Date
    March 2018 (Actual)
    Study Completion Date
    June 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sun Pharmaceutical Industries Limited

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metastatic Prostate Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    YONSA with Methylprednisolone
    Arm Type
    Experimental
    Arm Description
    Aberaterone Acetate 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid)
    Intervention Type
    Drug
    Intervention Name(s)
    abiraterone acetate with Methylprednisolone
    Other Intervention Name(s)
    YONSA
    Intervention Description
    YONSA 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid)
    Primary Outcome Measure Information:
    Title
    Number of Subjects With Adverse Events
    Description
    Adverse events
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    Proportion of Subjects With Disease Progression
    Description
    Number of participants who had disease progression
    Time Frame
    one year
    Title
    Testosterone Levels
    Description
    Change in serum testosterone levels from baseline
    Time Frame
    Baseline and 360 days
    Title
    Prostate Specific Antigen Levels
    Description
    Change in serum testosterone levels after one year of treatment against baseline
    Time Frame
    One year
    Title
    Testosterone Complete Suppression
    Description
    Proportion of subjects with complete suppression of testosterone levels
    Time Frame
    360 days
    Title
    Percentage of Subjects With Prostate Specific Antigen - 50 Response
    Description
    A decrease of ≥50% reduction from baseline of the study CHL-AA-201
    Time Frame
    360 days

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul Nemeth, Ph.D.
    Organizational Affiliation
    Churchill Pharmaceuticals LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    We do not plan to make individual participant data available

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs