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
Professor of Surgery (General Surgery)

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Contact

Susan Segar
1 650-721-3541

View on ClinicalTrials.gov