A Phase I-II Clinical Trial to Determine Recommended Dose and to Assess the Efficacy, Safety and Pharmacokinetic Profile of Oral Paclitaxel(Oraxol®) in Patients With Advanced/Metastatic or Recurrent Gastric Cancer
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).
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity 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).
DLT will be assessed on 28days of 1 cycle
Yung-Jue Bang, MD. Ph.D
Seoul National University Hospital
Korea: Food and Drug Administration