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

NCT02737228 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-06-17

No results posted yet for this study

Summary

\<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.

Conditions

  • Pancreatic Neoplasms

Interventions

DRUG

CG200745 PPA

CG200745 PPA IV every week three times per cycle (4 weeks)

DRUG

Gemcitabine

1000 mg/m\^2 intravenously every week three times per cycle (4 weeks)

DRUG

Erlotinib

100 mg per oral daily per cycle (4 weeks)

Sponsors & Collaborators

  • CrystalGenomics, Inc.

    lead INDUSTRY

Principal Investigators

  • Siyoung Song, M.D., PhD. · Yonsei University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02737228 on ClinicalTrials.gov