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

Trial ID or NCT#

NCT03859869

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Creon (Pancrelipase) Therapy for Subjects With Exocrine Pancreatic Insufficiency (EPI) Due to Pancreatic Cancer: A Double-blind, Randomized, Parallel Design With 2 Dose Cohorts of Pancrelipase in Resected Pancreatic Cancer Subjects and an Open-label Single Dose Cohort in Non-resected Pancreatic Cancer Subjects

Eligibility Criteria

Ages Eligible for Study: Older than 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
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Investigator(s)

Brendan C. Visser, MD
Brendan C. Visser, MD
Hepatobiliary surgeon, Pancreatic surgeon, Surgeon
Professor of Surgery (General Surgery)

Contact us to find out if this trial is right for you.

Contact

Susan Segar
1 650-721-3541

View on ClinicalTrials.gov