A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)

• Status: Active, not recruiting
• Trial end date: 2022-12-29
• Target enrollment: 0
• Participant gender: All

Summary

This is a study in participants with Exocrine Pancreatic Insufficiency (EPI) due to pancreatic cancer that has been resected. This study will include resected participants who are post pancreatic cancer surgery, and an additional cohort in non-resected participants.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Pancreatin; Pancrelipase

Criteria

Inclusion Criteria:

• Participant has diagnosed cancer of pancreas with biopsy and/or radiography, with a life expectancy of at least 5 months at screening.

• Participant's pancreatic cancer must involve the head and/or neck of the pancreas.

• Confirmed EPI as evidenced by fecal elastase-1 (FE-1) <= 150 microgram/gram stool at screening.

• A positive Sudan stain for participants without history of fat malabsorption (fat malabsorption is defined as clinical steatorrhea, or measured stool fat > 7 g/day, or positive stool results by Sudan stain) within 1 week of screening.

• Positive stool results are defined as increased level of neutral OR total fats.

Exclusion Criteria:

• Participant has neuroendocrine pancreatic cancer.

• Participant has fibrosing colonopathy

• Participant has any other malignancy within 1 year of screening.

• Participant has uncontrolled gout, including those with a recent flare within 60 days of screening.

• Participant has other significant organ or bone marrow abnormality within 60 days of screening.