Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Pancreatic Cancer Non-resectable; Pancreatic Carcinoma Metastatic; PDAC; Pancreatic Cancer Stage IV; Pancreatic Carcinoma Non-resectable; Pancreatic Cancer Metastatic; PDAC - Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Adenocarcinoma; Metastatic Pancreatic Carcinoma; Metastatic Pancreatic Cancer; Metastatic Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer; Pancreatic Carcinoma

Treatments: Drug: Pertzye

Study type: Interventional

Funder types: Other

Identifiers

NCT05642962

21-419

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Arm 1

Experimental group

Description:

Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 384 units lipase/kg of body weight per meal or snack

Treatment:

Drug: Pertzye

Arm 2

Experimental group

Description:

Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 1350 units lipase/kg of body weight per meal or snack

Treatment:

Drug: Pertzye