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

Trial ID: NCT05642962

Interventional - Phase 1/2 - Active, not recruiting

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.

Conditions

• 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

Interventions

• Pertzye

Eligibility

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.

Sponsor

Memorial Sloan Kettering Cancer Center

Source: ClinicalTrials.gov

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