NCT00813163

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

A Phase II Study of PEP02 as a Second Line Therapy for Patients With Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: PharmaEngine · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Pancreatic Neoplasms

Interventions

Type	Name	Description
DRUG	PEP02	120 mg/m2, IV infusion for 90 minutes on day 1 of each 21 days as a treatment cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-12-01
• Completion: 2012-07-01
• First posted: 2008-12-22
• Last updated: 2019-09-06

Locations

3 sites across 2 countries: United States, Taiwan