CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 36 enrolled
Drug / intervention
Pancrelipasedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04098237
NCT04098237Phase 2Active

Pancreatic-enzyme Replacement Therapy With Pancreaze (Pancrelipase) Delayed-release in Addition to Standard of Care for Borderline Resectable, Locally Advanced, and Advanced Pancreatic Adenocarcinoma Patients (PANCAX-3) With Cachexia and Exocrine Pancreatic Insufficiency

Andrew Hendifar, MD·interventional·Posted Sep 23, 2019·Updated Jan 23, 2026

In Brief

A Phase 2 clinical trial evaluating Pancrelipase for Pancreatic Adenocarcinoma. Active but no longer recruiting, targeting 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsVIVUS LLC

Timeline

Phase 2Active
20202021202220232024202520262027
First PostedSep 23, 2019
Enrollment StartDec 17, 2020
Primary CompletionJan 12, 2024
Study CompletionJan 1, 2027
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.8 years ago

Interventions

Pancrelipasedrug

Pancrelipase delayed-release capsules