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The sponsor's R&D strategy is adjusted.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR3680+SHR3162 | Experimental | Participants will receive SHR3680 combined with SHR3162 orally |
|
| SHR3680+SHR3162(Placebo) | Experimental | Participants will receive SHR3680 combined with SHR3162(Placebo) orally |
|
| SHR3680(Placebo)+SHR3162(Placebo) | Placebo Comparator | Participants will receive SHR3680(Placebo) combined with SHR3162(Placebo) orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR3680 | Drug | Tablet. Specifications of 80mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event(AE) | The type, frequency, severity, timing, seriousness, and relationship to study therapy | Approximately 70 months |
| Overall Survival(OS) | Time from randomisation to death due to any cause | Approximately 70 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to prostate specific antigen (PSA) progression | Time from randomisation to the first time of PSA progression according to the criterion of PCGW3 | Approximately 70 months |
| Radiographic Progression Free Survival(rPFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ye Dingwei | Shanghai | China |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
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| SHR3162 |
| Drug |
Tablet. Specifications of 10mg、40mg、50mg and 100mg |
|
| SHR3680(Placebo) | Drug | Tablet. Specifications of 80mg |
|
| SHR3162(Placebo) | Drug | Tablet. Specifications of 10mg、40mg、50mg and 100mg |
|
Time from randomisation to radiologically confirmed progressive disease or death due to any cause
| 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 | 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. | 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. | Approximately 70 months |
| Area Under the Curve (AUC) | The single dose and multiple dose PK will be calculated as data permits including AUC | Approximately 12 months |
| Maximum Observed Plasma Concentration (Cmax) | The single-dose and multiple dose PK will be calculated as data permits including Cmax | Approximately 12 months |
| Minimum Observed Plasma Concentration (Cmin) | The single-dose and multiple dose PK will be calculated as data permits including Cmin | Approximately 12 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |