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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Exocrine Pancreatic Insufficiency (EPI)

In brief

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.

Key facts

Study ID

NCT03859869

Run by

AbbVie

People needed

1

Starts

2020-02-25

Expected to finish

2022-03-23

Last updated by the study team

2023-06-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alabama Oncology /ID# 207770 — Birmingham, Alabama, United States
• Banner University of Arizona Medical Center Phoenix /ID# 208402 — Phoenix, Arizona, United States
• UCSF Fresno /ID# 205757 — Fresno, California, United States
• Stanford University School of Med /ID# 208821 — Stanford, California, United States
• UCH-MHS Memorial Hospital Central /ID# 207093 — Colorado Springs, Colorado, United States
• UCHealth Cancer Care and Hematology Clinic /ID# 207091 — Fort Collins, Colorado, United States
• George Washington University Medical Faculty Associates /ID# 203363 — Washington D.C., District of Columbia, United States
• University of Florida - Archer /ID# 202679 — Gainesville, Florida, United States
• Columbus Regional Research Institute /ID# 211394 — Columbus, Georgia, United States
• Northwest Community Hospital /ID# 202270 — Arlington Heights, Illinois, United States
• NorthShore University HealthSystem /ID# 209026 — Evanston, Illinois, United States
• Ingalls Memorial Hosp /ID# 203962 — Harvey, Illinois, United States
• Advocate Christ Medical Center /ID# 203132 — Oak Lawn, Illinois, United States
• University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 204407 — Ann Arbor, Michigan, United States
• Ascension Providence Hospital /ID# 203449 — Southfield, Michigan, United States
• St. Louis University /ID# 205769 — St Louis, Missouri, United States
• Mercy Hospital South /ID# 221766 — St Louis, Missouri, United States
• Northwell Health Center for Liver Diseases /ID# 207321 — Manhasset, New York, United States
• NYU Winthrop Hospital /ID# 207513 — Mineola, New York, United States
• New York University Langone Me /ID# 202290 — New York, New York, United States
• Columbia University Medical Center /ID# 204165 — New York, New York, United States
• East Carolina University /ID# 206661 — Greenville, North Carolina, United States
• Gabrail Cancer Center Research /ID# 208030 — Canton, Ohio, United States
• Ohio State Cancer Center /ID# 203131 — Columbus, Ohio, United States
• Fox Chase Cancer Center /ID# 202288 — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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