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
1 other identifier
interventional
41
2 countries
3
Brief Summary
The purpose of this study is to see the effect of PEP02 in the treatment of metastatic pancreatic cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2009
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2008
CompletedFirst Posted
Study publicly available on registry
December 22, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedSeptember 6, 2019
August 1, 2019
1.9 years
December 18, 2008
August 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival Rate
Survival rate at 3 months
3-month
Secondary Outcomes (3)
other efficacy endpoints
6-8 weeks
toxicities
36 months
pharmacogenetics
24 months
Study Arms (1)
PEP02
EXPERIMENTALLiposome Irinotecan
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PharmaEnginelead
Study Sites (3)
Comprehensive Cancer Center, UCSF
San Francisco, California, 94115, United States
National Health Research Institutes/National Chen-Kung Uiversity Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Related Publications (1)
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.
PMID: 23880820DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2008
First Posted
December 22, 2008
Study Start
January 1, 2009
Primary Completion
December 1, 2010
Study Completion
July 1, 2012
Last Updated
September 6, 2019
Record last verified: 2019-08