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NCT03207724 · ClinicalTrials.gov registry record · Phase 1

Study of Onivyde and 5-FU in Combination With Xilonix for Pancreatic Cancer With Cachexia

A Phase 1 study, sponsored by Andrew Hendifar, MD.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT03207724: Completed Phase 1 study, sponsored by Andrew Hendifar, MD.

NCT03207724 is a Phase 1 study that has completed, run by Andrew Hendifar, MD. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03207724, a Phase 1 study, has completed, sponsored by Andrew Hendifar, MD.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

This study is being conducted to examine the safety of the investigational drug, Xilonix(™), in addition to standard doses of Onivyde® (nanoliposomal irinotecan) and 5- fluorouracil (5FU)/folinic acid (leucovorin) for pancreatic cancer patients with cachexia. Cachexia is a syndrome that includes involuntary weight loss and physical deterioration that can contribute to poor outcomes of cancer treatment. In other studies, Xilonix has increased lean body mass in advanced cancer patients. This increase could lead to improved weight maintenance and quality of life.

Primary Outcome

Assess safety of novel combination

Interventions

  • DRUG Xilonix plus Onivyde and 5FU

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2017-10-16
Est. Completion 2020-10-27
Phase Phase 1
Andrew Hendifar, MD

5 total trials

What the finished NCT03207724 record still lists

NCT03207724 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 1 intervention - of which Xilonix plus Onivyde and 5FU is the first listed.

NCT03207724 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03207724 about?

NCT03207724 is a clinical study titled "Study of Onivyde and 5-FU in Combination With Xilonix for Pancreatic Cancer With Cachexia". This study is being conducted to examine the safety of the investigational drug, Xilonix(™), in addition to standard doses of Onivyde® (nanoliposomal irinotecan) and 5- fluorouracil (5FU)/folinic acid (leucovorin) for pancreatic cancer patients with cachexia. Cachexia is a syndrome that includes inv...

What is the current status of trial NCT03207724?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2017-10-16. Estimated completion is 2020-10-27.

What interventions are being tested in trial NCT03207724?

The interventions under investigation include: Xilonix plus Onivyde and 5FU (DRUG).

Who is sponsoring clinical trial NCT03207724?

This trial is sponsored by Andrew Hendifar, MD, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03207724's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03207724, the US trial registry maintained by the National Library of Medicine. NCT03207724 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.