\<Part I - Phase I trial\> 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. \<Part II - Phase II trial\> 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.
\<Part I - Phase I trial\> The phase I clinical trial is to identify the MTD and DLT 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. * Dose level 0: CG200745 PPA 125 mg/m\^2 puls Gemcitabine 1000 mg/m\^2) and Erlotinib 100 mg * Dose level 1: CG200745 PPA 187.5 mg/m\^2 puls Gemcitabine 1000 mg/m\^2) and Erlotinib 100 mg * Dose level 2: CG200745 PPA 250 mg/m\^2 puls Gemcitabine 1000 mg/m\^2) and Erlotinib 100 mg * Dose level 3: CG200745 PPA 312.5 mg/m\^2 puls Gemcitabine 1000 mg/m\^2) and Erlotinib 100 mg \<Part II - Phase II trial\> 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
CG200745 PPA IV every week three times per cycle (4 weeks)
1000 mg/m\^2 intravenously every week three times per cycle (4 weeks)
100 mg per oral daily per cycle (4 weeks)
Yonsei University Health System
Seoul, South Korea
Overall Response Rate (ORR)
ORR is the proportion of the subjects with CR and PR in comparison to the total subjects at the final tumor assessment point (cycle 6) from the baseline
Time frame: up to 6 cycles (each cycle is 28 days)
Disease control rate (DCR)
DCR is the proportion of the subjects with Complete Response (CR), Partial Response (PR), and stable disease (SD) in comparison to the total subjects at the final tumor assessment point (cycle 6) from the baseline
Time frame: up to 6 cycles (each cycle is 28 days)
Area Under the Curve [AUC]
Pharmacokinetics (PK) parameter
Time frame: before the administration and up to 1440 mins after completion of the IP (Investigational Product) administration
Maximum Plasma Concentration [Cmax]
Pharmacokinetics (PK) parameter
Time frame: before the administration and up to 1440 mins after completion of the IP administration
Adverse Events
safety parameter
Time frame: up to 6 cycles (each cycle is 28 days)
Clinical laboratory tests
safety parameter
Time frame: up to 6 cycles (each cycle is 28 days)
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