Status:
TERMINATED
A Study of SHR3680 in Combination With SHR3162 in the Treatment of mCRPC
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Prostate Cancer
Castration-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The aim of this trial is to evaluate SHR3680 combined with SHR3162 and SHR3680 single drug to improve Metastatic Castration Resistant Prostate Cancer Patients whether the patient's overall survival (O...
Detailed Description
This is a multicenter, randomized , double-blind Phase II trial and the aim of this trial is to evaluate SHR3680 combined with SHR3162 and SHR3680 single drug to improve Metastatic Castration Resistan...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed prostate cancer; does not suggest neuroendocrine or small cell characteristics
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1;
- Radiographic evidence of metastasis;
- Sustained therapy of luteinizing hormone-releasing hormone analogue(LHRHA)or received bilateral orchiectomy; patients who did not receive bilateral orchiectomy are willing to receive sustained therapy of LHRHA;
- Evidence of prostate cancer progression under the sustained therapy of LHRHA or bilateral orchiectomy;
- Adequate hepatic, renal, heart, and hematological functions;
- Patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- Patient has been treated with Abiraterone and treatment failed（Treatment failure is defined as the progression of disease during treatment）
- Patient has been treated with Docetaxel and treatment failed or can not tolerate docetaxel chemotherapy or patients who are not suitable for docetaxel treatment at the time of screening.
Exclusion
- Have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immuntherapy, and endocrinotherapy;
- Planned to initiate any other anti-tumor therapies during the study;
- Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption;
- Clinically significant cardiovascular diseases;
- History of seizure or certain conditions that may predispose to seizure;
- Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.
Key Trial Info
Start Date :
April 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04102124
Start Date
April 8 2019
End Date
August 31 2021
Last Update
June 24 2025
Active Locations (1)
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1
Ye Dingwei
Shanghai, China