NCT02737228

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

A Phase I/II Study of Combination Therapy of CG200745 PPA With Gemcitabine and Erlotinib to Determine the Maximum Tolerated Dose (MTD) and Evaluate the Safety and Efficacy for Locally Advanced Unresectable, or Metastatic Pancreatic Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: CrystalGenomics, Inc. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

\<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.

Conditions

• Pancreatic Neoplasms

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2016-04-13
• Last updated: 2019-06-17

Locations

1 site across 1 country: South Korea