Status:
TERMINATED
A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
Lead Sponsor:
AbbVie
Conditions:
Exocrine Pancreatic Insufficiency (EPI)
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief 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 addi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03859869
Start Date
February 25 2020
End Date
March 23 2022
Last Update
June 5 2023
Active Locations (33)
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1
Alabama Oncology /ID# 207770
Birmingham, Alabama, United States, 35223-2437
2
Banner University of Arizona Medical Center Phoenix /ID# 208402
Phoenix, Arizona, United States, 85006
3
UCSF Fresno /ID# 205757
Fresno, California, United States, 93701-2302
4
Stanford University School of Med /ID# 208821
Stanford, California, United States, 94305-2200