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Clinical Trial Record

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

2009-01

2010-12

2012-07

41

Study Overview

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

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

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.

  • Pancreatic Neoplasms
  • DRUG: PEP02
  • PEP0208

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 Registration Dates Results Reporting Dates Study Record Updates

2008-12-18  

N/A  

2019-08-27  

2008-12-19  

N/A  

2019-09-06  

2008-12-22  

N/A  

2019-08  

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/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.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Survival RateSurvival rate at 3 months3-month
Secondary Outcome MeasuresMeasure DescriptionTime Frame
other efficacy endpointsobjective tumor response, PFS, duration of response, overall survival, tumor marker response of CA19-9, clinical benefit response6-8 weeks
toxicitiesAll adverse events36 months
pharmacogeneticsUGT1A1 polymorphism24 months

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

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

    • PRINCIPAL_INVESTIGATOR: Li-Tzong Chen, M.D., National Health Research Institutes, Taiwan

    Publications

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

    General Publications

    • Ko AH, Tempero MA, Shan YS, Su WC, Lin YL, Dito E, Ong A, Wang YW, Yeh CG, Chen LT. A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer. Br J Cancer. 2013 Aug 20;109(4):920-5. doi: 10.1038/bjc.2013.408. Epub 2013 Jul 23.