Pancrelipase In People With Pancreatic Ductal Adenocarcinoma (PDAC)

Study Overview

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.

N/A

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

DRUG: Pertzye

21-419

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-11-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-28
First Submitted that Met QC Criteria 2022-11-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-29
First Posted (ACTUAL) 2022-12-08	Results First Posted N/A	Last Verified 2025-05

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

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 enrollmen
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 enrollmen

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 enrollmen

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 enrollmen

Primary Outcome Measures	Measure Description	Time Frame
Change in body mass index/BMI from baseline to 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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

Collaborators and Investigators

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

Investigators

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

Publications

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

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record