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

Phase 4

Terminated

Conditions: Exocrine Pancreatic Insufficiency (EPI)

Interventions: Drug: Pancrelipase
Drug: Placebo

Registration Number: NCT03859869

Lead Sponsor: AbbVie

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 additional cohort in non-resected participants.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase	Placebo	Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase	Placebo	Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase	Pancrelipase	Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase	Pancrelipase	Non-resected participants (those who did not have surgery to remove pancreatic cancer) will receive high dose pancrelipase throughout the study in an open-label cohort. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks.
Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase	Pancrelipase	Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.

Primary Outcome Measures

Name	Time	Method
Change in Stool Fat From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer	Baseline (Day 1), Week 1 (Day 8)	Stool samples were collected during the 48 hours prior to the Day 1 and Week 1 visits and analyzed for fat content.

Secondary Outcome Measures

Name	Time	Method
Change in Average Daily Stool Frequency From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer	Baseline (Day 1), Week 1 (Day 8)	Participants recorded stool frequency using an electronic diary (eDiary). The average daily stool frequency was calculated from the last 3 days prior to the Baseline and Week 1 visits.
Change in Stool Consistency From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer	Baseline (Day 1), Week 1 (Day 8)	Participants recorded stool consistency using an electronic diary (eDiary). The change from Baseline to Week 1 is the proportion of days having watery stool consistency in the last 7 days prior to each of Baseline and Week 1 visits. Negative changes from Baseline indicate less frequent watery stools.
Change in the Total EPI Symptoms Score From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer	Baseline (Day 1), Week 1 (Day 8)	The EPI Symptoms Questionnaire consists of 12 questions. The response scores range from 0 to 4 for each question (0 corresponding to None to 4 corresponding to Very Severe), with the total score ranging from 0 to 48. Positive changes indicate worsening from Baseline.

Trial Locations

Locations (33): Alabama Oncology /ID# 207770
🇺🇸
Birmingham, Alabama, United States
Banner University of Arizona Medical Center Phoenix /ID# 208402
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Phoenix, Arizona, United States
UCSF Fresno /ID# 205757
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Fresno, California, United States
Stanford University School of Med /ID# 208821
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Stanford, California, United States
UCH-MHS Memorial Hospital Central /ID# 207093
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Colorado Springs, Colorado, United States
UCHealth Cancer Care and Hematology Clinic /ID# 207091
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Fort Collins, Colorado, United States
George Washington University Medical Faculty Associates /ID# 203363
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Washington, District of Columbia, United States
University of Florida - Archer /ID# 202679
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Gainesville, Florida, United States
Columbus Regional Research Institute /ID# 211394
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Columbus, Georgia, United States
Northwest Community Hospital /ID# 202270
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Arlington Heights, Illinois, United States
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Alabama Oncology /ID# 207770
🇺🇸Birmingham, Alabama, United States