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To evaluate the efficacy and safety of SPH7485 tablets in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPH7485 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPH7485 | Drug | SPH7485: Orally, once daily, 50-400mg, 21 days per cycle |
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| Measure | Description | Time Frame |
|---|---|---|
| DLT(Dose-limiting toxicity) | Measurement of DLT of SPH7485 in all subjects | Approximately 24 days |
| Maximum tolerated dose(MTD) | Measurement of MTD of SPH7485 in all subjects | Approximately 24 days |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR(Objective Response Rate) | Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1. | Approximately 2 years |
| DoR(Duration of response) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohua Wu | Contact | 0086-021-34778299 | shanboer@126.com | |
| Jian Zhang | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| XiangYa Hospital CentralSouth University | Recruiting | Changsha | China |
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DOR was defined as the time interval between the date of the first documented response (CR or PR) and the date of the first documented disease progression or death due to any cause
| Approximately 2 years |
| DCR(Disease Control Rate) | DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease | Approximately 2 years |
| PFS(Progression-free survival) | PFS was defined as the time interval between study treatment initiation and the first occurrence of progression disease or death, whichever occurred first. | Approximately 2 years |
| PK(Pharmacokinetics):Tmax | Time to peak plasma concentration (Tmax) | Approximately 3 days |
| PK(Pharmacokinetics):Cmax | Maximum serum concentration(Cmax) | Approximately 3 days |
| PK(Pharmacokinetics):AUC | Area under the plasma concentration versus time curve (AUC) | Approximately 3 days |
| Fujian Cancer Hospital | Recruiting | Fuzhou | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | China |
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| Yunnan Cancer Hospital | Recruiting | Kunming | China |
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| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | China |
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