Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)

February 23, 2026 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 384 units lipase/kg of body weight per meal or snack
Drug: Pertzye
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
Experimental: Arm 2
Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 1350 units lipase/kg of body weight per meal or snack
Drug: Pertzye
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Eileen O'Reilly, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2022

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Actual)

December 8, 2022

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-419

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on Pertzye

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe