Expired Study
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San Francisco, California 94115


Purpose:

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


Study summary:

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.


Criteria:

Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas - Metastatic disease - Documented disease progression after treatment with 1 line of prior gemcitabine-based regimen - Karnofsky performance status equal or more than 70 Exclusion Criteria: - With active CNS metastases - With clinically significant gastrointestinal disorder (e.g., bleeding, inflammation, occlusion, or diarrhea > grade 1) - Major surgery or radiotherapy within 4 weeks - Prior participation in any investigational drug study within 4 weeks - With prior irinotecan treatment


NCT ID:

NCT00813163


Primary Contact:

Principal Investigator
Li-Tzong Chen, M.D.
National Health Research Institutes, Taiwan


Backup Contact:

N/A


Location Contact:

San Francisco, California 94115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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