A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With … (NCT03859869) | Clinical Trial Compass
TerminatedPhase 4
A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
Stopped: Business Considerations (difficulty with enrollment)
United States1 participantsStarted 2020-02-25
Plain-language summary
This is a study in participants with Exocrine Pancreatic Insufficiency (EPI) due to pancreatic cancer. This study will include resected participants who are post pancreatic cancer surgery, and an additional cohort in non-resected participants.
Who can participate
Age range21 Years
SexALL
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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 exocrine pancreatic insufficiency (EPI) as evidenced by fecal elastase-1 (FE-1) ≤ 150 µg/g 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
What they're measuring
1
Change in Stool Fat From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer