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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaEngine
• Treatments: Irinotecan

Criteria

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