Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)
Running, not enrolling · Phase 1/Phase 2
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT05642962
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 17
- Starts
- 2022-11-30
- Expected to finish
- 2026-11-30
- Last updated by the study team
- 2026-02-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States
- Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States
- 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
Full record on ClinicalTrials.gov
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