drugset / Trial / NCT04098237

Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency

NCT04098237

Phase 2 Active not recruiting 36 enrolled Andrew Hendifar, MD VIVUS LLC · collab
NaSingle-groupOpen-labelSupportive care

Summary

The objective of this study is to assess weight stability, functional changes, and quality of life when Pancreaze (pancrelipase) delayed-release 84,000-lipase units (capsules), for main meals, and 42,000-lipase units (capsules), for snacks, are added to standard of care in patients with exocrine pancreatic insufficiency due to pancreatic adenocarcinoma. This will be the first prospective study of this particular formulation in addition to standard of care in advanced pancreatic cancer patients. We will treat 40 consecutive patients with borderline resectable, locally advanced and advanced pancreatic cancer patients who present with weight loss and exocrine pancreatic insufficiency with this advanced formulation of Pancreaze.

Timeline

Start
2020-12-17
Primary completion
2024-01-12
Completion
2027-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Pancrelipase Protein / enzyme biologic 42000 iu
Subject Pancrelipase Protein / enzyme biologic 84000 iu