Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)

Phase 1

Recruiting

• Conditions: Metastatic Pancreatic Carcinoma; Pancreatic Carcinoma; Pancreatic Carcinoma Non-resectable; Pancreatic Cancer; Pancreatic Cancer Metastatic; PDAC - Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Adenocarcinoma; Pancreatic Cancer Non-resectable; PDAC
• Interventions: Drug: Pertzye

• Registration Number: NCT05642962
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-30
• Study First Submitted: 2022-11-30
• Study First Submitted QC: 2022-11-30
• Study First Posted: 2022-12-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (7)

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities); 🇺🇸 Middletown, New Jersey, United States