Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this trial is to evaluate SHR3680 combined with Docetaxel to improve Metastatic Castration Resistant Prostate Cancer Patients whether the patient's Time to prostate specific antigen (PSA) progression is superior to SHR3680 or Docetaxel single drug.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR3680+Docetaxel | Experimental |
| |
| SHR3680 | Active Comparator |
| |
| Docetaxel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR3680+Docetaxel | Drug | Participants will receive SHR3680 combined with Docetaxel |
| |
| 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 | [Time Frame: Approximately 24 months] |
| Adverse Event(AE) | The type, frequency, severity, timing, seriousness, and relationship to study therapy | [Time Frame: Approximately 24 months] |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Progression Free Survival(rPFS) | Time from randomisation to radiologically confirmed progressive disease or death due to any cause | [Time Frame: Approximately 24 months] |
| Objective response rate (ORR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunlei Jin, Ph.D. | Contact | 86-021-23511999 | jinchunlei@hrglobe.cn | |
| Qiang Wei, Ph.D. | Contact | 028-85423237 |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SHR3680 |
| Drug |
Participants will receive SHR3680 |
|
| Docetaxel | Drug | Participants will receive Docetaxel |
|
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 24 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 | [Time Frame: Approximately 3 months] |
| Overall Survival(OS) | Time from randomisation to death due to any cause | [Time Frame: Approximately 24 months] |
| Area Under the Curve (AUC) | The single dose and multiple dose PK will be calculated as data permits including AUC | [Time Frame: Approximately 2 months] |
| Maximum Observed Plasma Concentration (Cmax) | The single-dose and multiple dose PK will be calculated as data permits including Cmax | [Time Frame: Approximately 2 months] |
| Minimum Observed Plasma Concentration (Cmin) | The single-dose and multiple dose PK will be calculated as data permits including Cmin | [Time Frame: Approximately 2 months] |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |