Back to resultsA Trial of SHR3162 Combined With Apatinib Mesylate Tablets or SHR3162 Monotherapy in Patients With Metastatic Castration Resistant Prostate Cancer
Primary Purpose
Metastatic Castration Resistant Prostate Cancer
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fluzoparib
Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets
Fluzoparib Combined With Apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Castration Resistant Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Fudan University Shanghai Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
Fluzoparib
Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets
Fluzoparib Combined With Apatinib
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Radiological progression-free survival (rPFS)
The time from randomisation until the date of objective radiological disease progression (by RECIST 1.1 and Prostate Cancer Working Group 3 (PGWG-3)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression.
Objective response rate (ORR)
ORR is the percentage of patients with at least one visit response of Complete response (CR) or Partial response (PR), in their soft tissue disease assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), in the absence of progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3)).
PSA response rate
PSA response rate was Defined as the proportion of subjects whose serum PSA level decreased by ≥50% from baseline after treatment.
Time to PSA progression (PSA-TTP)
PSA-TTP was defined as the time from random (cohort 1 and 4) or first medication (cohort 2 and 3) to the first progression of PSA; PSA progression is determined according to the PCWG3 standard, and changes in PSA levels within the 12 weeks before treatment (that is, before C4D1) are not included in this Evaluation.
Overall Survival (OS)
Number of Participants with Overall Survival (OS)
Full Information
NCT ID
NCT04869488
First Posted
April 26, 2021
Last Updated
September 23, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04869488
Brief Title
A Trial of SHR3162 Combined With Apatinib Mesylate Tablets or SHR3162 Monotherapy in Patients With Metastatic Castration Resistant Prostate Cancer
Official Title
An Open, Multi-center, Phase Ⅱ Clinical Study of Fluzoparib Combined With Apatinib or Fluzoparib in the Treatment of Metastatic Castration-resistant Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration Resistant Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluzoparib
Arm Type
Experimental
Arm Title
Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets
Arm Type
Active Comparator
Arm Title
Fluzoparib Combined With Apatinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fluzoparib
Intervention Description
Fluzoparib Orally twice daily（Cohort 1、Cohort 4）
Intervention Type
Drug
Intervention Name(s)
Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets
Intervention Description
Enzalutamide OR abiraterone acetate Orally once daily（Cohort 1）
Intervention Type
Drug
Intervention Name(s)
Fluzoparib Combined With Apatinib
Intervention Description
Fluzoparib Orally twice daily; Apatinib Orally once daily（Cohort 2、Cohort 3、Cohort 4）
Primary Outcome Measure Information:
Title
Comprehensive response rate
Description
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
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Radiological progression-free survival (rPFS)
Description
The time from randomisation until the date of objective radiological disease progression (by RECIST 1.1 and Prostate Cancer Working Group 3 (PGWG-3)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression.
Time Frame
up to 2 years
Title
Objective response rate (ORR)
Description
ORR is the percentage of patients with at least one visit response of Complete response (CR) or Partial response (PR), in their soft tissue disease assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), in the absence of progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3)).
Time Frame
At the time point of every 8 weeks，up to 2 years
Title
PSA response rate
Description
PSA response rate was Defined as the proportion of subjects whose serum PSA level decreased by ≥50% from baseline after treatment.
Time Frame
At the time point of every 4 weeks，up to 2 years
Title
Time to PSA progression (PSA-TTP)
Description
PSA-TTP was defined as the time from random (cohort 1 and 4) or first medication (cohort 2 and 3) to the first progression of PSA; PSA progression is determined according to the PCWG3 standard, and changes in PSA levels within the 12 weeks before treatment (that is, before C4D1) are not included in this Evaluation.
Time Frame
At the time point of every 4 weeks，up to 2 years
Title
Overall Survival (OS)
Description
Number of Participants with Overall Survival (OS)
Time Frame
At the time point of every 2 months，up to 2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Trial of SHR3162 Combined With Apatinib Mesylate Tablets or SHR3162 Monotherapy in Patients With Metastatic Castration Resistant Prostate Cancer
We'll reach out to this number within 24 hrs