Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC) (NCT05642962) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)
United States17 participantsStarted 2022-11-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in body mass index/BMI from baseline to 4 months