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Asan Medical Center | Clinical Trial Center

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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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Hengrui Medicine

Status and phase

Enrolling
Phase 3

Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Treatments

Drug: Fuzuloparib Placebo, Abiraterone acetate and Prednisone
Drug: Fuzuloparib , Abiraterone acetate and Prednisone

Study type

Interventional

Funder types

Industry

Identifiers

NCT04691804
SHR3162-III-305

Details and patient eligibility

About

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).

Enrollment

804 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

804 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

147

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Central trial contact

Chunlei Jin, M.D.

Data sourced from clinicaltrials.gov

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