Metastatic Pancreatic Adenocarcinoma, Metastatic Pancreatic Cancer, Metastatic Pancreatic Carcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer, Pancreatic Cancer Metastatic, Pancreatic Cancer Non-resectable, Pancreatic Cancer Stage IV, Pancreatic Carcinoma, Pancreatic Carcinoma Metastatic, Pancreatic Carcinoma Non-resectable, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma
Conditions
Keywords
Metastatic Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer, Pancrelipase, Memorial Sloan Kettering Cancer Center, 21-419
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.
Interventions
DRUGPertzye
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREileen O'Reilly, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed