Study of PEP02 as a Second Line Therapy for Metastatic Pancreatic Cancer

Status Completed

Clinical Trial Summary

The purpose of this study is to see the effect of PEP02 in the treatment of metastatic pancreatic cancer.

Clinical Trial Description

Gemcitabine monotherapy or a gemcitabine-based combination regimen is the standard first line therapy for advanced pancreatic cancer. After disease progression, there is no standard treatment available. In animal studies and a previous phase I trial, PEP02 has shown anti-tumor activity and preliminary efficacy in pancreatic cancer. In addition, a phase II study of free-form irinotecan single agent has already shown encouraging activity as second-line treatment for patients with advanced pancreatic cancer refractory to gemcitabine. The liposome formulation of PEP02 theoretically has therapeutic advantages over free-form irinotecan, such as site-specific delivery and extended release of drug. Hence PEP02 may be able to provide better efficacy than free-form irinotecan.

The primary purpose of this phase II study is to evaluate the activity of PEP02 as a second-line therapy in patients with metastatic pancreatic cancer failed to gemcitabine treatment. The primary goal is to measure the 3-month survival rate. An optimal Simon's 2-stage design will be used for this exploratory phase II study. ;

Study Design

Related Conditions & MeSH terms

Pancreatic Neoplasms

Clinical Trial Details

NCT number	NCT00813163
Study type	Interventional
Source	PharmaEngine
Contact
Status	Completed
Phase	Phase 2
Start date	January 2009
Completion date	July 2012

View Details

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