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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Exocrine Pancreatic Insufficiency (EPI)

Intervention / Treatment
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* Drug: Pancrelipase
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase<br>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. | Drug: Pancrelipase<br>* Pancrelipase is administered orally as capsules with a meal or snack<br>* Other names: Creon;Drug: Placebo<br>* Placebo is administered orally as capsules with a meal or snack<br>|
| Experimental: Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase<br>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. | Drug: Pancrelipase<br>* Pancrelipase is administered orally as capsules with a meal or snack<br>* Other names: Creon;Drug: Placebo<br>* Placebo is administered orally as capsules with a meal or snack<br>|
| Experimental: Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase<br>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. | Drug: Pancrelipase<br>* Pancrelipase is administered orally as capsules with a meal or snack<br>* Other names: Creon;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Average Daily Stool Frequency From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer | 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. | Baseline (Day 1), Week 1 (Day 8) | 
| Change in Stool Consistency From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer | 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. | Baseline (Day 1), Week 1 (Day 8) | 
| Change in the Total EPI Symptoms Score From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer | 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. | Baseline (Day 1), Week 1 (Day 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exocrine Pancreatic Insufficiency (EPI), Pancreatic Cancer, Creon, Pancrelipase