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

NCT ID: NCT02962284

Last Updated: 2021-11-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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YONSA with Methylprednisolone

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

Group Type EXPERIMENTAL

abiraterone acetate with Methylprednisolone

Intervention Type DRUG

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

Interventions

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abiraterone acetate with Methylprednisolone

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

Intervention Type DRUG

Other Intervention Names

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YONSA

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sun Pharmaceutical Industries Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Nemeth, Ph.D.

Role: STUDY_DIRECTOR

Churchill Pharmaceuticals LLC

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CHL-AA-202

Identifier Type: -

Identifier Source: org_study_id