NCT02962284

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 22, 2019

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

1.3 years

First QC Date

October 31, 2016

Results QC Date

May 2, 2019

Last Update Submit

November 18, 2021

Conditions

Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Adverse Events

    Adverse events

    one year

Secondary Outcomes (5)

  • Proportion of Subjects With Disease Progression

    one year

  • Testosterone Levels

    Baseline and 360 days

  • Prostate Specific Antigen Levels

    One year

  • Testosterone Complete Suppression

    360 days

  • Percentage of Subjects With Prostate Specific Antigen - 50 Response

    360 days

Study Arms (1)

YONSA with Methylprednisolone

EXPERIMENTAL

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

Drug: abiraterone acetate with Methylprednisolone

Interventions

abiraterone acetate with MethylprednisoloneDRUG

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

Also known as: YONSA
YONSA with Methylprednisolone

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone AcetateMethylprednisolone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPrednisolonePregnadienetriolsPregnadienesPregnanes

Results Point of Contact

Title
Harin Mehta
Organization
Sun Pharma Global FZE
clinicaltrials@sparcmail.com, harin.mehta@sparcmail.com
97145520096, 912266455645

Study Officials

  • Paul Nemeth, Ph.D.

    Churchill Pharmaceuticals LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 11, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2018

Study Completion

June 1, 2018

Last Updated

November 19, 2021

Results First Posted

July 22, 2019

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

We do not plan to make individual participant data available