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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGPharmacokinetic 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
Time frame: Day 1-2 Single Dose
Pharmacokinetic Assessments for Cmax
Time frame: Day 1-2 Single Dose
Pharmacokinetic Assessments for Tmax
Time frame: Day 1-2 Single Dose
Objective Response Rate (ORR)
Time frame: each 42 days up to intolerance the toxicity or progression of disease(PD) (up to 24 months)
Maximum tolerated dose(MTD)
Time frame: up to 24 months
Dose-limiting toxicity(DLT)
Time frame: up to 24 months
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