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

NCT04869488 | Completed Phase 2

• 1 other identifier: SHR3162-Ⅱ-202
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Castration Resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Comprehensive response rate

  Comprehensive remission rate means the proportion of objective remission or PSA remission evaluated by the investigator based on the RECIST v1.1 standard and the PCWG3 standard

  up to 2 years

Secondary Outcomes (5)

• Radiological progression-free survival (rPFS)

  up to 2 years

• Objective response rate (ORR)

  At the time point of every 8 weeks，up to 2 years

• PSA response rate

  At the time point of every 4 weeks，up to 2 years

• Time to PSA progression (PSA-TTP)

  At the time point of every 4 weeks，up to 2 years

• Overall Survival (OS)

  At the time point of every 2 months，up to 2 years

Study Arms (3)

Fluzoparib

EXPERIMENTAL

Drug: Fluzoparib

Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets

ACTIVE COMPARATOR

Drug: Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets

Fluzoparib Combined With Apatinib

EXPERIMENTAL

Drug: Fluzoparib Combined With Apatinib

Interventions

Fluzoparib DRUG

Fluzoparib Orally twice daily（Cohort 1、Cohort 4）

Fluzoparib

Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets DRUG

Enzalutamide OR abiraterone acetate Orally once daily（Cohort 1）

Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets

Fluzoparib Combined With Apatinib DRUG

Fluzoparib Orally twice daily; Apatinib Orally once daily（Cohort 2、Cohort 3、Cohort 4）

Fluzoparib Combined With Apatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation and written informed consent;
• Age ≥18 years old;
• Pathologically diagnosed metastatic castration-resistant prostate adenocarcinoma;
• It is confirmed by the central laboratory based on tumor tissue or ctDNA detection that it is accompanied by germline or system homologous recombination repair-related gene mutations (Cohorts 4) or not accompanied by homologous recombination repair-related gene mutations (Cohort 2);
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Has a life expectancy of ≥ 12 weeks.

You may not qualify if:

• Past (within 5 years) or concurrently suffering from other malignant tumors, except for cured skin basal cell carcinoma;
• Subjects have used PARP inhibitors in the past, including but not limited to olaparib, niraparib, and lukapanib; or have used apatinib in the past; or have received mitoxantrone and cyclophosphamide in the past Treatment with amide or platinum-containing chemotherapeutics;
• Severe bone injury caused by tumor bone metastasis, pathological fractures or spinal cord compression in important parts that occurred within 6 months before being informed or is expected to occur in the near future;
• The subject has cancerous meningitis, or untreated central nervous system metastasis;
• Those who cannot swallow pills normally, or have abnormal gastrointestinal function, which may affect drug absorption by the researcher;
• Subjects with congenital or acquired immune deficiencies (such as HIV infection), or active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥500 IU/ml; hepatitis C reference: HCV antibody positive and HCV virus copy number\> upper limit of normal );
• According to the judgment of the investigator, the subject has other factors that may cause the study to be terminated halfway, such as other serious diseases (including mental illness) that require combined treatment, severe laboratory abnormalities, family or society, etc. Factors that will affect the safety of subjects or the collection of data and samples.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Interventions

fluzoparib; enzalutamide; Abiraterone Acetate; Prednisone; apatinib

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Fluzopali in combination with apatinib mesylate or fluzopali monotherapy with or without homologous recombinant repair-related gene mutations in metastatic castration-resistant prostate in subjects

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 3, 2021
• Study Start: July 19, 2021
• Primary Completion: February 14, 2023
• Study Completion: February 14, 2023
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

CN (1)