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The aim of this trial is to evaluate the Drug-Drug interaction with Abiraterone combined with SHR3162 in the Metastatic Castration Resistant Prostate Cancer Patients.
This is a multicenter, open-label Phase I trial and the aim of this trial is to evaluate the drug-drug interaction and safety with SHR3162 combined with Abiraterone in Metastatic Castration Resistant Prostate Cancer Patients. The trial is a dose-escalation and -expansion study. Approximately 35~38 patients in will receive fixed- dose of orally Abiraterone and only one of two dose levels of orally SHR3162. The Primary endpoints are incidence of adverse events(AE) and PK characteristics. The secondary endpoints are efficacy and recommended phase 2 dose(RP2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone+SHR3162 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone+SHR3162 | Drug | Participants will receive Abiraterone combined with SHR3162 orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| AE | The type, frequency, severity, timing, seriousness, and relationship to study therapy | Approximately 24 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Changsha | Hunan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42351007 | Derived | Dai T, Xu Z, Wang H, Han W, Zhang D, Tang K, Wang X, Huang J, He C, Zhou X, Zhang D, Yang C. Pharmacokinetics, safety, and efficacy of fuzuloparib in combination with abiraterone acetate and prednisone in patients with metastatic castration-resistant prostate cancer: a phase 1 dose escalation and expansion study. BMC Cancer. 2026 Jun 25. doi: 10.1186/s12885-026-16182-0. Online ahead of print. |
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