Study of CG200745 PPA in Combination With Gemcitabine and Erlotinib for Advanced Pancreatic Cancer
Status:
Unknown status
Trial end date:
2019-08-01
Target enrollment:
Participant gender:
Summary
The phase I clinical trial is to identify the MTD (Maximum Tolerated Dose) and DLT (Dose
Limiting Toxicity) of CG200745 PPA in combination use of Gemcitabine and Erlotinib. Initial
dose of CG200745 PPA is 187.5 mg/m^2, and it will be extended to 250 mg/m^2, 312.5 mg/m^2 or
it will be reduced to 125 mg/m^2 based on the results of the cohort of 3 subjects per dose
level.
Based on the 3+3 dose escalation study design, Gemcitabine and Erlotinib are administered as
fixed doses, whereas CG200745 PPA is to be administered as in four different cohorts
according to the dose level. Each cohort consists of 3 or 6 subjects.
In the phase II clinical trial, the subjects will be administered with the dose which is to
be identified as a recommended dose based on the results of Phase I study. The whole one
cycle is consisted of 28 days, same as the phase I. The entire treatment period is 6 cycles
and tumor assessment is evaluated every 2 cycles.