Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)

• Status: Recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Pancrelipase

Criteria

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.