Clinical trial · Interventional
Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)
A Randomized Double Blind Study of Pancreatic Enzyme Replacement Therapy for Patients With Metastatic Pancreatic Ductal Adenocarcinoma
NCT05642962CI-TRIAL-00103979active not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | CURATED_BROADER | 0.78 |
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Pancreatic Carcinoma | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | CURATED_BROADER | 0.78 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer Metastatic | — | UNRESOLVED | — |
| Pancreatic Cancer Non-resectable | — | UNRESOLVED | — |
| Pancreatic Cancer Stage IV | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Pancreatic Carcinoma | Pancreatic Carcinoma |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pertzye | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 384 units lipase/kg of body weight per meal or snack
- interventionNames
- Drug: Pertzye
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 1350 units lipase/kg of body weight per meal or snack
- interventionNames
- Drug: Pertzye
Primary outcomes (1)
- measure
- Change in body mass index/BMI from baseline to 4 months
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.