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

Sponsor
Sun Pharmaceutical Industries Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT02962284
Collaborator
(none)
20
Enrollment
1
Arm
19
Actual Duration (Months)

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: abiraterone acetate with Methylprednisolone
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Jun 1, 2018

Arms and Interventions

ArmIntervention/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
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Subjects With Adverse Events [one year]

      Adverse events

    Secondary Outcome Measures

    1. Proportion of Subjects With Disease Progression [one year]

      Number of participants who had disease progression

    2. Testosterone Levels [Baseline and 360 days]

      Change in serum testosterone levels from baseline

    3. Prostate Specific Antigen Levels [One year]

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

    4. Testosterone Complete Suppression [360 days]

      Proportion of subjects with complete suppression of testosterone levels

    5. Percentage of Subjects With Prostate Specific Antigen - 50 Response [360 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sun Pharmaceutical Industries Limited

    Investigators

    • Study Director: Paul Nemeth, Ph.D., Churchill Pharmaceuticals LLC

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Sun Pharmaceutical Industries Limited
    ClinicalTrials.gov Identifier:
    NCT02962284
    Other Study ID Numbers:
    • CHL-AA-202
    First Posted:
    Nov 11, 2016
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021

    Study Results

    Participant Flow

    Recruitment DetailsA total of 20 subjects were enrolled in the study. Of these, 9 subjects were previously treated with YONSA and 11 subjects were previously treated with Zytiga in CHL-AA-201. Twelve (60.0%) subjects completed the study
    Pre-assignment Detail
    Arm/Group TitlePreceding Treatment - YonsaPreceding Treatment - Zytiga
    Arm/Group Description84-days treatment: Yonsa 500 mg orally once daily with methylprednisolonYonsa 500 mg orally once daily with methylprednisolon
    Period Title: Overall Study
    STARTED911
    COMPLETED48
    NOT COMPLETED53

    Baseline Characteristics

    Arm/Group TitlePreceding Treatment - YonsaPreceding Treatment - ZytigaTotal
    Arm/Group Description84-days treatment84 day treatmentTotal of all reporting groups
    Overall Participants91120
    Age, Customized (Count of Participants)
    <75 years
    4
    44.4%
    5
    45.5%
    9
    45%
    ≥75 years
    5
    55.6%
    6
    54.5%
    11
    55%
    Sex/Gender, Customized (Count of Participants)
    Male
    9
    100%
    11
    100%
    20
    100%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    2
    22.2%
    0
    0%
    2
    10%
    Not Hispanic or Latino
    7
    77.8%
    11
    100%
    18
    90%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    TitleNumber of Subjects With Adverse Events
    DescriptionAdverse events
    Time Frameone year

    Outcome Measure Data

    Analysis Population Description
    subjects who were enrolled and who received at least 1 dose of study drug of Yonsa
    Arm/Group TitlePreceding Treatment - YonsaPreceding Treatment - Zytiga
    Arm/Group Descriptionone year treatmentone year treatment
    Measure Participants911
    Number [Participants]
    8
    88.9%
    9
    81.8%
    2. Secondary Outcome
    TitleProportion of Subjects With Disease Progression
    DescriptionNumber of participants who had disease progression
    Time Frameone year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePreceding Treatment - YonsaPreceding Treatment - Zytiga
    Arm/Group Description84-days treatment84 day treatment
    Measure Participants911
    Count of Participants [Participants]
    1
    11.1%
    3
    27.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Preceding Treatment - Yonsa, Preceding Treatment - Zytiga
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value>0.1
    Comments
    MethodANCOVA
    Comments
    3. Secondary Outcome
    TitleTestosterone Levels
    DescriptionChange in serum testosterone levels from baseline
    Time FrameBaseline and 360 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePreceding Treatment - YonsaPreceding Treatment - Zytiga
    Arm/Group Description84-days treatment84 day treatment
    Measure Participants36
    Mean (Standard Deviation) [ng/dL]
    -6.24
    (2.02)
    -5.87
    (3.64)
    4. Secondary Outcome
    TitleProstate Specific Antigen Levels
    DescriptionChange in serum testosterone levels after one year of treatment against baseline
    Time FrameOne year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePreceding Treatment - YonsaPreceding Treatment - Zytiga
    Arm/Group Description84-days treatment84 day treatment
    Measure Participants59
    Mean (Standard Deviation) [ng/dL]
    -60.12
    (115.63)
    -112.76
    (239.85)
    5. Secondary Outcome
    TitleTestosterone Complete Suppression
    DescriptionProportion of subjects with complete suppression of testosterone levels
    Time Frame360 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePreceding Treatment - YonsaPreceding Treatment - Zytiga
    Arm/Group Descriptionone year treatmentone year treatment
    Measure Participants58
    Number [percentage of subjects]
    100
    87.5
    6. Secondary Outcome
    TitlePercentage of Subjects With Prostate Specific Antigen - 50 Response
    DescriptionA decrease of ≥50% reduction from baseline of the study CHL-AA-201
    Time Frame360 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePreceding Treatment - YonsaPreceding Treatment - Zytiga
    Arm/Group Descriptionone year treatmentone year treatment
    Measure Participants59
    Number [percentage of number of subjects]
    60.0
    55.6

    Adverse Events

    Time FrameOne year
    Adverse Event Reporting Description
    Arm/Group TitlePreceding Treatment - YonsaPreceding Treatment - Zytiga
    Arm/Group Descriptionone year treatmentone year treatment
    All Cause Mortality
    Preceding Treatment - YonsaPreceding Treatment - Zytiga
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total2/9 (22.2%) 0/11 (0%)
    Serious Adverse Events
    Preceding Treatment - YonsaPreceding Treatment - Zytiga
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total3/9 (33.3%) 1/11 (9.1%)
    General disorders
    Abasia1/9 (11.1%) 0/11 (0%)
    Asthenia1/9 (11.1%) 0/11 (0%)
    Non-cardiac chest pain1/9 (11.1%) 0/11 (0%)
    Infections and infestations
    Septic shock1/9 (11.1%) 0/11 (0%)
    Right leg cellulitis0/9 (0%) 1/11 (9.1%)
    Injury, poisoning and procedural complications
    Head injury1/9 (11.1%) 0/11 (0%)
    Metabolism and nutrition disorders
    Dehydration1/9 (11.1%) 0/11 (0%)
    Other (Not Including Serious) Adverse Events
    Preceding Treatment - YonsaPreceding Treatment - Zytiga
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total8/9 (88.9%) 9/11 (81.8%)
    Blood and lymphatic system disorders
    Iron deficiency anaemia1/9 (11.1%) 0/11 (0%)
    Leukocytosis0/9 (0%) 1/11 (9.1%)
    Cardiac disorders
    Supraventricular tachycardia0/9 (0%) 1/11 (9.1%)
    Tachycardia0/9 (0%) 1/11 (9.1%)
    Ear and labyrinth disorders
    Vertigo0/9 (0%) 1/11 (9.1%)
    Gastrointestinal disorders
    -Dry mouth0/9 (0%) 1/11 (9.1%)
    Gastrooesophageal reflux disease0/9 (0%) 1/11 (9.1%)
    Nausea1/9 (11.1%) 0/11 (0%)
    Vomiting1/9 (11.1%) 0/11 (0%)
    General disorders
    Abasia1/9 (11.1%) 0/11 (0%)
    Asthenia1/9 (11.1%) 0/11 (0%)
    Face oedema1/9 (11.1%) 0/11 (0%)
    Fatigue1/9 (11.1%) 1/11 (9.1%)
    Mass1/9 (11.1%) 0/11 (0%)
    Nodule1/9 (11.1%) 0/11 (0%)
    Non-cardiac chest pai1/9 (11.1%) 0/11 (0%)
    Peripheral swelling1/9 (11.1%) 1/11 (9.1%)
    Ulcer1/9 (11.1%) 0/11 (0%)
    Infections and infestations
    Bronchitis0/9 (0%) 2/11 (18.2%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Results Point of Contact

    Name/TitleHarin Mehta
    OrganizationSun Pharma Global FZE
    Phone97145520096, 912266455645
    Emailclinicaltrials@sparcmail.com, harin.mehta@sparcmail.com
    Responsible Party:
    Sun Pharmaceutical Industries Limited
    ClinicalTrials.gov Identifier:
    NCT02962284
    Other Study ID Numbers:
    • CHL-AA-202
    First Posted:
    Nov 11, 2016
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021