A Multicenter, Randomized, Double-Blind, Placebo-Controll... | NCT04691804

Studies
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

NCT04691804

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Status

Active, not recruiting

Last Update Posted

Dec 31, 2024Actual

Enrollment

496Actual

Phase

Phase 3

Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Interventions

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

Countries

United States
Australia
Belgium
China
Czechia
France
Hungary
Poland
Russia
South Korea
Spain
Taiwan
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 18, 2021Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Dec 30, 2020

First Submission Date that Met QC Criteria

Dec 30, 2020

First Posted Date

Dec 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2024

Last Update Posted Date

Dec 31, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

496Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group A	Experimental	Fuzuloparib plus AA-P	Drug: Fuzuloparib , Abiraterone acetate and Prednisone
Treatment group B	Placebo Comparator	Fuzuloparib Placebo plus AA-P	Drug: Fuzuloparib Placebo， Abiraterone acetate and Prednisone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fuzuloparib , Abiraterone acetate and Prednisone	Drug	Fuzuloparib capsules (strength: 50 mg),150mg, Bid,po Abiraterone acetate tablets (strength: 250 mg) 1000mg Qd,po Prednisone tablets (strength: 5 mg) 5mg, Bid po

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3	progression-free survival	up to 3 years

Secondary Outcomes

Measure	Description	Time Frame
OS	time from randomization to death due to any cause	up to 4 years
ORR	The percentage of subjects with measureable disease at baseline who achieved a complete or partial response in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Alaska Oncology and Hematology LLC		Anchorage	Alaska	99508	United States
Urological Associates of Southern Arizona PC

ID	Term
D000069501	Abiraterone Acetate
D011241	Prednisone
C000722917	fluzoparib

ID	Term
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes