Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)

Condition
Metastatic Pancreatic Ductal Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

Basking Ridge

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States, 07920

Middletown

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States, 07645

Commack

Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities), Commack, New York, United States, 11725

Harrison

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, United States, 10604

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Uniondale

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, United States, 11553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Eileen O'Reilly, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2025-11-30