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Trial record 1 of 1 for:    SHR3162-III-305
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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

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ClinicalTrials.gov Identifier: NCT04691804
Recruitment Status : Recruiting
First Posted : December 31, 2020
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Tracking Information
First Submitted Date  ICMJE December 30, 2020
First Posted Date  ICMJE December 31, 2020
Last Update Posted Date May 18, 2022
Actual Study Start Date  ICMJE March 18, 2021
Estimated Primary Completion Date December 31, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2020)
rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3 [ Time Frame: up to 3 years ]
progression-free survival
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2020)
  • OS [ Time Frame: up to 4 years ]
    time from randomization to death due to any cause
  • ORR [ Time Frame: up to 3 years ]
    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
  • Time to PSA progression [ Time Frame: up to 3 years ]
    Time from randomisation to the first time of PSA progression according to the criterion of PCGW3
  • Time to skeletal-related events [ Time Frame: up to 4 years ]
    Time from randomisation to the first occurrence of a fracture or treatment for the fracture. The skeletal-related event is defined as the occurrence of either pathological or clinical fracture, spinal cord compression, bone-related radiotherapy or surgery.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Fuzuloparib Combined with Abiraterone Acetate and Prednisone (AA-P) versus Placebo Combined with AA-P
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Intervention  ICMJE
  • Drug: Fuzuloparib , Abiraterone acetate and Prednisone
    1. Fuzuloparib capsules (strength: 50 mg),150mg, Bid,po
    2. Abiraterone acetate tablets (strength: 250 mg) 1000mg Qd,po
    3. Prednisone tablets (strength: 5 mg) 5mg, Bid po
    Other Name: SHR3162
  • Drug: Fuzuloparib Placebo, Abiraterone acetate and Prednisone
    1. Fuzuloparib capsules Placebo (strength: 50 mg),150mg, Bid,po
    2. Abiraterone acetate tablets (strength: 250 mg)1000mg Qd,po
    3. Prednisone tablets (strength: 5 mg)5mg, Bid po
Study Arms  ICMJE
  • Experimental: Treatment group A
    Fuzuloparib plus AA-P
    Intervention: Drug: Fuzuloparib , Abiraterone acetate and Prednisone
  • Placebo Comparator: Treatment group B
    Fuzuloparib Placebo plus AA-P
    Intervention: Drug: Fuzuloparib Placebo, Abiraterone acetate and Prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 30, 2020)
804
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2026
Estimated Primary Completion Date December 31, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chunlei Jin, M.D. 18036618586 chunlei.jin@hengrui.com
Listed Location Countries  ICMJE Australia,   Belgium,   China,   Czechia,   France,   Hungary,   Korea, Republic of,   Poland,   Russian Federation,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04691804
Other Study ID Numbers  ICMJE SHR3162-III-305
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jiangsu HengRui Medicine Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP