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

Clinicaltrials.gov ID: NCT04691804
db-list-check Status RECRUITING
b-loader Phase PHASE3
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 804

Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Drugs

Fuzuloparib , Abiraterone acetate and Prednisone, Fuzuloparib Placebo, Abiraterone acetate and Prednisone

Summary

To evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of radiographic progression-free survival (rPFS) in mCRPC subjects unselected for deoxyribonucleic acid (DNA) damage repair deficiencies (DRD) status (Cohort 1) to evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of rPFS in mCRPC subjects harboring DRD (Cohort 2).

Locations

9 locations Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Steven Liu

Status

  • RECRUITING

Contact Person

  • Curtis Dunshee

Status

  • RECRUITING

Contact Person

  • Luke Dreisbach

Status

  • RECRUITING

Contact Person

  • Michael Castine

Status

  • RECRUITING

Contact Person

  • Channing Paller

Status

  • RECRUITING

Contact Person

  • Clara Hwang

Status

  • RECRUITING

Contact Person

  • Luke Nordquist

Status

  • RECRUITING

Contact Person

  • Christopher Chay

Status

  • RECRUITING

Contact Person

  • Edward Arrowsmith

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Study Plan

Treatment group A

EXPERIMENTAL

Fuzuloparib plus AA-P

  • DRUG:

    Fuzuloparib , Abiraterone acetate and Prednisone

    Description:

    1. Fuzuloparib capsules (strength: 50 mg),150mg, Bid,pon2. Abiraterone acetate tablets (strength: 250 mg) 1000mg Qd,pon3. Prednisone tablets (strength: 5 mg) 5mg, Bid po

Treatment group B

PLACEBO_COMPARATOR

Fuzuloparib Placebo plus AA-P

  • DRUG:

    Fuzuloparib Placebouff0c Abiraterone acetate and Prednisone

    Description:

    1. Fuzuloparib capsules Placebo (strength: 50 mg),150mg, Bid,pon2. Abiraterone acetate tablets (strength: 250 mg)1000mg Qd,pon3. Prednisone tablets (strength: 5 mg)5mg, Bid po

Outcome Measures

Primary Outcome Measures

rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3

Time Frame: up to 3 years

Secondary Outcome Measures

OS

Time Frame: up to 4 years

ORR

Time Frame: up to 3 years

Time to PSA progression

Time Frame: up to 3 years

Time to skeletal-related events

Time Frame: up to 4 years

Timeline

  • Last Updated
    August 1, 2022
  • Start Date
    December 31, 2020
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    December 31, 2026

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