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

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

Study Overview

• Status: Completed
• Conditions: Pancreatic Neoplasms
• Intervention / Treatment: Drug: PEP02

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

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

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

How is the study designed?

Design Details

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

Number of Arms

1

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	Survival rate at 3 months	3-month

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

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.

Study record dates

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: Phase II study; Metastatic; Pancreatic cancer; Second line
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Irinotecan
• Other Study ID Numbers: PEP0208