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

Study Identifier
M16-142
CT.gov Identifier
NCT03859869
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Protocol
Available Language(s): English
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Statistical Analysis Plan
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Scientific Result Summary
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Study Details

Medical Condition
  • Pancreatic Cancer
    • Study Drug
  • Pancrelipase
  • Placebo
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    21+ years
    Inclusion and Exclusion Criteria
    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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Alabama Oncology /ID# 207770
    Birmingham, Alabama, United States, 35223-2437
    Status
    Not applicable
    Location
    Banner University of Arizona Medical Center Phoenix /ID# 208402
    Phoenix, Arizona, United States, 85006
    Status
    Not applicable
    Location
    UCSF Fresno /ID# 205757
    Fresno, California, United States, 93701-2302
    Status
    Not applicable
    Location
    Stanford University School of Med /ID# 208821
    Stanford, California, United States, 94305-2200
    Status
    Not applicable
    Location
    UCH-MHS Memorial Hospital Central /ID# 207093
    Colorado Springs, Colorado, United States, 80909-4533
    Status
    Not applicable
    Location
    UCHealth Cancer Care and Hematology Clinic /ID# 207091
    Fort Collins, Colorado, United States, 80528-3400
    Status
    Not applicable
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