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OpenTrials
Active, Not Recruiting

NCT Number: NCT05642962

Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pertzye

Drug

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.

Other names: Pancrelipase

Primary outcomes

  1. Change in body mass index/BMI from baseline to 4 months

    Time frame: 4 months

    The primary objective is a change in body mass index (BMI) 4 months from baseline while on pancreatic enzyme replacement therapy (PERT).

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2022
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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