A Trial of SHR3162 Combined With Apatinib Mesylate Tablets or SHR3162 Monotherapy in Patients With Metastatic Castration Resistant Prostate Cancer

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT04869488
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Castration Resistant Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fluzoparib — DRUG
    Fluzoparib Orally twice daily（Cohort 1、Cohort 4）
  • Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets — DRUG
    Enzalutamide OR abiraterone acetate Orally once daily（Cohort 1）
  • Fluzoparib Combined With Apatinib — DRUG
    Fluzoparib Orally twice daily; Apatinib Orally once daily（Cohort 2、Cohort 3、Cohort 4）

Study Details

Main research purpose: To evaluate the effectiveness of Fluzoparib combined with apatinib mesylate in the treatment of patients with metastatic castration-resistant prostate cancer.

Key Dates

Start date
Jul 19, 2021
Status verified
Jan 2025
Primary completion
Feb 14, 2023
Completion
Feb 14, 2023

Study Design

Enrollment
93 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fluzoparib
  • Active Comparator: Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets
  • Experimental: Fluzoparib Combined With Apatinib

Primary Outcome Measure

Comprehensive response rate [ Time Frame: up to 2 years ]

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