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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 : August 1, 2022
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Metastatic Castration-Resistant Prostate Cancer (mCRPC) Drug: Fuzuloparib , Abiraterone acetate and Prednisone Drug: Fuzuloparib Placebo， Abiraterone acetate and Prednisone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 804 participants
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
Official Title: 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
Actual Study Start Date : March 18, 2021
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment group A
Fuzuloparib plus AA-P
 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
Placebo Comparator: Treatment group B
Fuzuloparib Placebo plus AA-P
 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


Outcome Measures
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Primary Outcome Measures :
  1. rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3 [ Time Frame: up to 3 years ]
    progression-free survival


Secondary Outcome Measures :
  1. OS [ Time Frame: up to 4 years ]
    time from randomization to death due to any cause

  2. 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

  3. 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

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04691804


Contacts
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Contact: Chunlei Jin, M.D. 18036618586 chunlei.jin@hengrui.com

Locations
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Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
More Information
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04691804    
Other Study ID Numbers: SHR3162-III-305
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: August 1, 2022
Last Verified: December 2021

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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Prednisone
Abiraterone Acetate
Anti-Inflammatory Agents
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors