Status:
COMPLETED
Study of PEP02 as a Second Line Therapy for Metastatic Pancreatic Cancer
Lead Sponsor:
PharmaEngine
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see the effect of PEP02 in the treatment of metastatic pancreatic cancer.
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 availabl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00813163
Start Date
January 1 2009
End Date
July 1 2012
Last Update
September 6 2019
Active Locations (3)
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1
Comprehensive Cancer Center, UCSF
San Francisco, California, United States, 94115
2
National Health Research Institutes/National Chen-Kung Uiversity Hospital
Tainan, Taiwan, 704
3
National Taiwan University Hospital
Taipei, Taiwan, 100