Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)

Study Overview
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Brief Summary
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The main purpose of this study is to see how pancrelipase affects the body mass index (BMI) in people with metastatic PDAC. BMI is a measure based on a person's height and weight. Other study goals are to explore two different dosing schedules of pancrelipase and to evaluate pancrelipase in people who do not have symptoms of EPI.

Official Title
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A Randomized Double Blind Study of Pancreatic Enzyme Replacement Therapy for Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Conditions
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Metastatic Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma, Metastatic Pancreatic Carcinoma, Pancreatic Carcinoma, Pancreatic Carcinoma Metastatic, Pancreatic Carcinoma Non-resectable, Pancreatic Cancer, Pancreatic Cancer Non-resectable, Pancreatic Cancer Stage IV, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Drug: Pertzye


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histopathologic or cytologic diagnosis of pancreatic adenocarcinoma, or adenosquamous cancer, or any non-neuroendocrine primary pancreas variant, including acinar cancer. De novo or recurrent diagnosis of previously untreated stage IV PDAC with intent to receive FOLFIRINOX/mFOLFIRINOX. ECOG 0-2. No use of pancreatic enzyme replacement therapy within prior 2 weeks. Patients with biliary obstruction are eligible provided biliary stenting has or will occur before treatment with FOLFIRINOX. Ability to understand and the willingness to sign an informed consent document. Ability to swallow capsules. Age ≥18 years. Anticipated life expectancy of at least 6 months. Exclusion Criteria: Chronic illness associated with malabsorption (celiac disease, cystic fibrosis, chronic pancreatitis, Crohn's disease). Fibrosing colonopathy. Prior history of surgical resection of the pancreas or gastric bypass. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pancrelipase. Patients cannot receive radiation, IRE, or other localized therapy directed to the pancreas while on study.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 384 units lipase/kg of body weight per meal or snack | Drug: Pertzye<br>* Treatment with standard dose or higher dose Pancrelipase will continue for 20 weeks from enrollment. Participants will consume assigned blinded weight based Pancrelipase dose concurrent with first bite of every meal and snack for the duration of enrollment.<br>* Other names: Pancrelipase;|
| Experimental: Arm 2<br>Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 1350 units lipase/kg of body weight per meal or snack | Drug: Pertzye<br>* Treatment with standard dose or higher dose Pancrelipase will continue for 20 weeks from enrollment. Participants will consume assigned blinded weight based Pancrelipase dose concurrent with first bite of every meal and snack for the duration of enrollment.<br>* Other names: Pancrelipase;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass index/BMI from baseline to 4 months | The primary objective is a change in body mass index (BMI) 4 months from baseline while on pancreatic enzyme replacement therapy (PERT). | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer, Pancrelipase, Memorial Sloan Kettering Cancer Center, 21-419