問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberSHR3162-III-305
NCT Number(ClinicalTrials.gov Identfier)NCT04691804
Active

2021-08-01 - 2028-01-30

Phase III

Recruiting6

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer

  • Trial Applicant

    Syneos Health

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator YU-CHUAN LU Division of Urology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator See-Tong Pang Division of Urology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃冠華 Division of Urology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Kuang Tien General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 歐宴泉 Division of Urology
童綜合醫療社團法人童綜合醫院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Pin Su
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Objectives

1. Primary Objectives: ● Evaluate whether fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessing radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (mCRPC) who were not selected for deoxyribonucleic acid (DRD) damage repair deficiency (DRD) status (Group 1). ● Evaluate whether fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessing rPFS in mCRPC patients with DRD (Group 2). 2. Secondary Objectives: ● Key Secondary Objective: Evaluate overall survival (OS) separately for unselected mCRPC patients (Group 1) and mCRPC patients with DRD (Group 2).

Test Drug

膠囊劑

Active Ingredient

Fuzuloparib

Dosage Form

130

Dosage

MG

Endpoints

Primary endpoints:

● Radiographic progression-free survival in unselected mCRPC subjects (Group 1) (assessed by a blinded independent central review committee (BICR) according to the Responsiveness to Solid Tumor Response (RECIST) 1.1 and the Prostate Cancer Working Group 3 (PCWG3) criteria);

● Radiographic progression-free survival in mCRPC subjects with DNA Damage Repair Deficiency (DRD) (Group 2) (assessed by BICR according to RECIST 1.1 and PCWG3 criteria);

Inclution Criteria

Inclusion Criteria

Able and willing to provide a written informed consent
A score of 0 to 1 for ECOG performance status
Age of ≥ 18 years old
Prostate adenocarcinoma confirmed
Disease progression of metastatic prostate cancer while the subject was on androgen deprivation therapy.
The functional level of the organs must meet the requirements
Blood and tumor tissue samples are provided during screening to determine the DRD status

Exclusion Criteria

Exclusion Criteria

Prior treatment with any PARP inhibitor
Have received any systemic anti-tumor treatment during the mCRPC stage or non-metastatic CRPC stage
Have used any CYP3A4 inducers or inhibitors within 14 days prior to the first dose
Plan to receive any other anti-tumor treatment
Presence of radiologically confirmed tumor lesions in the brain
Contraindications to the use of Prednisone
History of uncontrolled pituitary or adrenal dysfunction
Uncontrolled hypertension
Presence of active heart diseases
Human immunodeficiency virus-positive
Presence of dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption
Active HBV or HCV infection
Presence of concomitant diseases

The Estimated Number of Participants

  • Taiwan

    63 participants

  • Global

    804 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB