The main objectives of this study are to determine the maximum tolerated dose (MTD) and recommend dose (RD) of Oraxol® in Phase I and to determine the objective response rate of Oraxol® in Phase II.
Administration Schedule: 1 cycle of Oraxol® is 28 days and Oraxol® is administrated twice a week, total 6 times per cycle (day 1,2,8,9,15 and 16).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
HM30181AK 15 mg tablet + Paclitaxel 10mg, 30mg capsules
National Cancer Center
Goyang, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGToxicity evaluation (safety evaluation)
Toxicity will be evaluated by medical history, vital signs, physical examination and laboratory tests performed during the screening period (D-28 to D0) and treatment period based on NCI-CTCAE (version 3.0).
Time frame: DLT will be assessed on 28days of 1 cycle
Overall response rate(ORR) evaluation
It is measured up to confirmation of tumor response(CR, PR) Tumor response will be evaluated by RECIST v1.0.
Time frame: Response will be evaluated every Cycle 2(8weeks)
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