Clinical trial NCT05642962: Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)
Official title: A Randomized Double Blind Study of Pancreatic Enzyme Replacement Therapy for Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: 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
Keywords: Metastatic Pancreatic Ductal Adenocarcinoma
Metastatic Pancreatic Cancer
Pancrelipase
Memorial Sloan Kettering Cancer Center
21-419
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in body mass index/BMI from baseline to 4 months
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Eileen O'Reilly, MD
role: PRINCIPAL_INVESTIGATOR
References: