Study of CG200745 PPA in Combination With Gemcitabine and Erlotinib for Advanced Pancreatic Cancer

Sponsor
CrystalGenomics, Inc.
Study ID
NCT02737228
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Pancreatic Neoplasms

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CG200745 PPA — DRUG
    CG200745 PPA IV every week three times per cycle (4 weeks)
  • Gemcitabine — DRUG
    1000 mg/m\^2 intravenously every week three times per cycle (4 weeks)
  • Erlotinib — DRUG
    100 mg per oral daily per cycle (4 weeks)

Study Details

\<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.

Key Dates

First listed
Apr 13, 2016
Start date
Mar 31, 2016
Status verified
Jun 2019
Primary completion
Aug 31, 2019
Completion
Aug 31, 2019

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CG200745 PPA
    CG200745 PPA plus Gemcitabine and Erlotinib

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: up to 6 cycles (each cycle is 28 days) ]

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