- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04869488
A Trial of SHR3162 Combined With Apatinib Mesylate Tablets or SHR3162 Monotherapy in Patients With Metastatic Castration Resistant Prostate Cancer
September 23, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.
An Open, Multi-center, Phase Ⅱ Clinical Study of Fluzoparib Combined With Apatinib or Fluzoparib in the Treatment of Metastatic Castration-resistant Prostate Cancer
Main research purpose: To evaluate the effectiveness of Fluzoparib combined with apatinib mesylate in the treatment of patients with metastatic castration-resistant prostate cancer.
Study Overview
Status
Active, not recruiting
Study Type
Interventional
Enrollment (Actual)
93
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200433
- Fudan University Shanghai Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fluzoparib
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Fluzoparib Orally twice daily(Cohort 1、Cohort 4)
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Active Comparator: Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets
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Enzalutamide OR abiraterone acetate Orally once daily(Cohort 1)
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Experimental: Fluzoparib Combined With Apatinib
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Fluzoparib Orally twice daily; Apatinib Orally once daily(Cohort 2、Cohort 3、Cohort 4)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comprehensive response rate
Time Frame: up to 2 years
|
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
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up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiological progression-free survival (rPFS)
Time Frame: up to 2 years
|
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.
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up to 2 years
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Objective response rate (ORR)
Time Frame: At the time point of every 8 weeks,up to 2 years
|
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)).
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At the time point of every 8 weeks,up to 2 years
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PSA response rate
Time Frame: At the time point of every 4 weeks,up to 2 years
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PSA response rate was Defined as the proportion of subjects whose serum PSA level decreased by ≥50% from baseline after treatment.
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At the time point of every 4 weeks,up to 2 years
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Time to PSA progression (PSA-TTP)
Time Frame: At the time point of every 4 weeks,up to 2 years
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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.
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At the time point of every 4 weeks,up to 2 years
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Overall Survival (OS)
Time Frame: At the time point of every 2 months,up to 2 years
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Number of Participants with Overall Survival (OS)
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At the time point of every 2 months,up to 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 26, 2021
Primary Completion (Anticipated)
April 30, 2023
Study Completion (Anticipated)
April 30, 2023
Study Registration Dates
First Submitted
April 26, 2021
First Submitted That Met QC Criteria
April 29, 2021
First Posted (Actual)
May 3, 2021
Study Record Updates
Last Update Posted (Actual)
September 26, 2022
Last Update Submitted That Met QC Criteria
September 23, 2022
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protein Kinase Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Prednisone
- Abiraterone Acetate
- Apatinib
Other Study ID Numbers
- SHR3162-Ⅱ-202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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