This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose of docetaxel-PNP (polymeric nanoparticle formulation of docetaxel) and to evaluate the safety and pharmacokinetics of docetaxel-PNP in subjects with advanced solid malignancies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel
Asan Medical Center
Seoul, South Korea
The maximum tolerated dose (MTD) of Docetaxel-PNP
Administration of docetaxel-PNP was well tolerated up 6mg/m² every 3weeks by heavily pretreated patients.
Time frame: up to 6 cycle
The recommended phase II dose of Docetaxel-PNP
Futher phase Ⅱ Trials are recommended at this dose level
Time frame: up to 6 cycle
The Dose Limiting Toxicity (DLT)
Time frame: up to 6 cycle
The pharmacokinetics of Docetaxel-PNP on Day 1 of 1st cycle (AUC, CL, T1/2, Tmax, Cmax, Vdss)
Time frame: up to 6 cycle
Objective response rate
Time frame: up to 6 cycle
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