Education and Training
A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Pancrelipase
- drug: Placebo
Eligibility
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
Ages Eligible for Study
21 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Susan Segar
1 650-721-3541
Not Recruiting