Summary

for people ages 21 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

This is a study in participants with Exocrine Pancreatic Insufficiency (EPI) due to pancreatic cancer that has been resected. This study will include resected participants who are post pancreatic cancer surgery, and an exploratory 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

Keywords

Exocrine Pancreatic Insufficiency (EPI) Pancreatic Cancer Creon Pancrelipase Pancreatic Neoplasms Exocrine Pancreatic Insufficiency Pancreatin

Eligibility

You can join if…

Open to people ages 21 years and up

  • 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 EPI as evidenced by fecal elastase-1 (FE-1) <= 150 microgram/gram 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 CAN'T join if...

  • Participant has neuroendocrine pancreatic cancer.
  • Participant has a surgical removal of the entire pancreas.
  • 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.

Locations

  • UC San Diego Moores Cancer Center /ID# 202678 not yet accepting patients
    La Jolla California 92093 United States
  • Ironwood Cancer & Res Ctr /ID# 204307 not yet accepting patients
    Chandler Arizona 85224-5665 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related Info
ID
NCT03859869
Phase
Phase 4
Study Type
Interventional
Last Updated