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NCT05642962Active, not recruitingPhase 1/2

Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)

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

Source: ClinicalTrials.gov · Last updated 25 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
17 (actual)
First submitted
30 Nov 2022
Start date
30 Nov 2022
Primary completion date
30 Nov 2026
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT05642962

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 17
  • From 30 Nov 2022 to the primary completion date, 30 Nov 2026
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior history of surgical resection of the pancreas or gastric bypass.
  • Patients cannot receive radiation, IRE, or other localized therapy directed to the pancreas while on study.

Other illness

  • Chronic illness associated with malabsorption (celiac disease, cystic fibrosis, chronic pancreatitis, Crohn's disease).
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pancrelipase.

Other

  • Fibrosing colonopathy.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited Protocol Activities)
Coordinator of this site? Confirm its status
CommackUnited StatesUnknown status
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Coordinator of this site? Confirm its status
HarrisonUnited StatesUnknown status
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Coordinator of this site? Confirm its status
MiddletownUnited StatesUnknown status
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Coordinator of this site? Confirm its status
MontvaleUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Coordinator of this site? Confirm its status
UniondaleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.