Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 deoxy...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
Key Trial Info
Start Date :
March 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
496 Patients enrolled
Trial Details
Trial ID
NCT04691804
Start Date
March 18 2021
End Date
December 31 2026
Last Update
December 31 2024
Active Locations (147)
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1
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States, 99508
2
Urological Associates of Southern Arizona PC
Tucson, Arizona, United States, 85741
3
Desert Hematology Oncology Medical Group Inc
Rancho Mirage, California, United States, 92270
4
San Bernardino Urological Associates Medical Group
San Bernardino, California, United States, 92404