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NCT04098237 · ClinicalTrials.gov registry record · Phase 2
Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency
A Phase 2 study of Pancreatic Adenocarcinoma, sponsored by Andrew Hendifar, MD.
- Active
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT04098237: Active Phase 2 study of Pancreatic Adenocarcinoma, sponsored by Andrew Hendifar, MD.
NCT04098237 is a Phase 2 study of Pancreatic Adenocarcinoma that is active but no longer recruiting, run by Andrew Hendifar, MD. The registered enrollment target is 36 participants, below the 99,465-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04098237, a Phase 2 study of Pancreatic Adenocarcinoma, is active but no longer recruiting, sponsored by Andrew Hendifar, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Adherence to therapy of at least 50% of the needed total lipase units, recorded using a daily compliance diary.
Conditions Studied
Interventions
- DRUG Pancrelipase
Study Locations (1)
California
- Cedars-Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-12-17 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
What the registry record for NCT04098237 still lists
NCT04098237 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 99,465-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which Pancrelipase is the first listed.
NCT04098237 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04098237 about?
NCT04098237 is a clinical study titled "Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency". 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 pan...
What is the current status of trial NCT04098237?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2020-12-17. Estimated completion is 2027-01.
What conditions does trial NCT04098237 study?
This clinical trial studies the following conditions: Pancreatic Adenocarcinoma.
What interventions are being tested in trial NCT04098237?
The interventions under investigation include: Pancrelipase (DRUG).
Who is sponsoring clinical trial NCT04098237?
This trial is sponsored by Andrew Hendifar, MD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04098237 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04098237's enrollment target sits among peer trials
36 43rd of 62 higher than 20 of 62 other Pancreatic Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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