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 (OS) is superior to placebo.
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 Resistant Prostate Cancer Patients Previously Treated With Abiraterone and Docetaxel whether the patient's overall survival (OS) is superior to placebo. The Stage I part is a dose-escalation and -expansion study. Approximately 18\~24 patients in Stage I will receive fixed-dose of orally SHR3680 and only one of two dose levels of orally SHR3162. The Primary endpoints of the Stage I are incidence of adverse events(AE) and recommended phase 2 dose(RP2D). The Stage II part is a randomized , double-blind study. Approximately 90\~120 patients in Stage II will receive SHR3162 combined with SHR3680, in which one fixed-dose levels of SHR3162 will be selected based on the result of the Stage I.The Primary endpoint of the Stage II is overall survival(OS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Tablet. Specifications of 80mg
Tablet. Specifications of 10mg、40mg、50mg and 100mg
Tablet. Specifications of 80mg
Ye Dingwei
Shanghai, China
Adverse Event(AE)
The type, frequency, severity, timing, seriousness, and relationship to study therapy
Time frame: Approximately 70 months
Overall Survival(OS)
Time from randomisation to death due to any cause
Time frame: Approximately 70 months
Time to prostate specific antigen (PSA) progression
Time from randomisation to the first time of PSA progression according to the criterion of PCGW3
Time frame: Approximately 70 months
Radiographic Progression Free Survival(rPFS)
Time from randomisation to radiologically confirmed progressive disease or death due to any cause
Time frame: Approximately 70 months
Objective response rate (ORR)
The percentage of patients with measureable disease at baseline who achieved a complete or partial response in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
Time frame: Approximately 70 months
Time to skeletal-related events
Time from randomisation to the first occurrence of a skeletal-related event. The skeletal-related event is defined as the occurrence of either pathological or clinical fracture, spinal cord compression, bone-related radiotherapy or surgery.
Time frame: Approximately 70 months
PSA response rate
After the continuous therapy from randomisation to the end of the 12 weeks, the percentage of patients whose levels of PSA decreased by more than 50% compared with baseline.
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Tablet. Specifications of 10mg、40mg、50mg and 100mg
Time frame: Approximately 70 months
Area Under the Curve (AUC)
The single dose and multiple dose PK will be calculated as data permits including AUC
Time frame: Approximately 12 months
Maximum Observed Plasma Concentration (Cmax)
The single-dose and multiple dose PK will be calculated as data permits including Cmax
Time frame: Approximately 12 months
Minimum Observed Plasma Concentration (Cmin)
The single-dose and multiple dose PK will be calculated as data permits including Cmin
Time frame: Approximately 12 months