This is a phase I/II trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine (hereafter Genexol-PM plus gemcitabine) and to evaluate the efficacy and safety of Genexol-PM regimens (monotherapy and combination with gemcitabine) and gemcitabine monotherapy in subjects with locally advanced or metastatic pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Enrollment
18
Cremophor EL-free polymeric micelle of paclitaxel
The maximum tolerated dose (MTD) of the combination therapy with Genexol-PM and gemcitabine
Time frame: 1 year
The recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine
Time frame: 1 year
Objective response rate (complete response (CR) + partial response (PR))
Time frame: 1 year
Time to tumor progression
Time frame: 1 year
Progression free survival
Time frame: 1 year
Safety profiles
Time frame: 1 year
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