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

August 27, 2019 updated by: PharmaEngine

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • National Health Research Institutes/National Chen-Kung Uiversity Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
  • United States
    • California
      • San Francisco, California, United States, 94115
        • Comprehensive Cancer Center, UCSF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEP02
Liposome Irinotecan
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.

Other Names:
  • Liposome irinotecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Rate
Time Frame: 3-month
Survival rate at 3 months
3-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
other efficacy endpoints
Time Frame: 6-8 weeks
objective tumor response, PFS, duration of response, overall survival, tumor marker response of CA19-9, clinical benefit response
6-8 weeks
toxicities
Time Frame: 36 months
All adverse events
36 months
pharmacogenetics
Time Frame: 24 months
UGT1A1 polymorphism
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PharmaEngine

Investigators

  • Principal Investigator: Li-Tzong Chen, M.D., National Health Research Institutes, Taiwan
  • Principal Investigator: Andrew H Ko, M.D., University of California, San Francisco
  • Principal Investigator: Yu-Lin Lin, M.D., National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (Estimate)

December 22, 2008

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEP0208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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