Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05642962

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
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	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 30, 2022

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

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

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

Other Names:

Pancrelipase

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.