A Trial of SHR3162 Combined With Apatinib Mesylate Tablets or SHR3162 Monotherapy in Patients With Metastatic Castration Resistant Prostate Cancer
NCT ID: NCT04869488
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
93 participants
INTERVENTIONAL
2021-07-19
2023-02-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fluzoparib
Fluzoparib
Fluzoparib Orally twice daily（Cohort 1、Cohort 4）
Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets
Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets
Enzalutamide OR abiraterone acetate Orally once daily（Cohort 1）
Fluzoparib Combined With Apatinib
Fluzoparib Combined With Apatinib
Fluzoparib Orally twice daily; Apatinib Orally once daily（Cohort 2、Cohort 3、Cohort 4）
Interventions
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Fluzoparib
Fluzoparib Orally twice daily（Cohort 1、Cohort 4）
Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets
Enzalutamide OR abiraterone acetate Orally once daily（Cohort 1）
Fluzoparib Combined With Apatinib
Fluzoparib Orally twice daily; Apatinib Orally once daily（Cohort 2、Cohort 3、Cohort 4）
Eligibility Criteria
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Inclusion Criteria
2. Age ≥18 years old;
3. Pathologically diagnosed metastatic castration-resistant prostate adenocarcinoma;
4. 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);
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
6. Has a life expectancy of ≥ 12 weeks.
Exclusion Criteria
2. 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;
3. 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;
4. The subject has cancerous meningitis, or untreated central nervous system metastasis;
5. Those who cannot swallow pills normally, or have abnormal gastrointestinal function, which may affect drug absorption by the researcher;
6. 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 );
7. 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.
18 Years
MALE
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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SHR3162-Ⅱ-202
Identifier Type: -
Identifier Source: org_study_id
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