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This study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of Sinotecean.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sinotecean | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinotecean | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Assessments for Area Under Curve(AUC) | To collect point with single drug:5 min/10 min/15 min/30 min/1 h/2h/4h/6 h/8h/10h/12 h/24 h/32h/48 h | Day 1-2 Single Dose |
| Pharmacokinetic Assessments for Cmax | Day 1-2 Single Dose | |
| Pharmacokinetic Assessments for Tmax | Day 1-2 Single Dose |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | each 42 days up to intolerance the toxicity or progression of disease(PD) (up to 24 months) | |
| Maximum tolerated dose(MTD) | up to 24 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shusen Wang, doctor | Contact | wangshs@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Dose-limiting toxicity(DLT) |
| up to 24 months |