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NCT04088786 · ClinicalTrials.gov registry record · Phase 1

Phase I Trial HIPEC With Nal-irinotecan

A Phase 1 study, sponsored by Stony Brook University.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target

NCT04088786: Completed Phase 1 study, sponsored by Stony Brook University.

NCT04088786 is a Phase 1 study that has completed, run by Stony Brook University. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04088786, a Phase 1 study, has completed, sponsored by Stony Brook University.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study Summary

The purpose of this study is to assess the effectiveness and safety of intraperitoneal administration of heated nanoliposomal Irinotecan in cytoreductive surgery (CRS), which is surgery designed to remove as much of the cancer as possible, and heated intraperitoneal chemotherapy (HIPEC) procedures.

Primary Outcome

To assess the safety and feasibility of administering nanoliposmal irinotecan intraperitoneally following cytoreductive surgery.

Interventions

  • DRUG nanoliposomal irinotecan

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2019-10-22
Est. Completion 2022-04-14
Phase Phase 1
Stony Brook University

127 total trials

What the finished NCT04088786 record still lists

NCT04088786 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 1 intervention - of which nanoliposomal irinotecan is the first listed.

NCT04088786 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04088786 about?

NCT04088786 is a clinical study titled "Phase I Trial HIPEC With Nal-irinotecan". The purpose of this study is to assess the effectiveness and safety of intraperitoneal administration of heated nanoliposomal Irinotecan in cytoreductive surgery (CRS), which is surgery designed to remove as much of the cancer as possible, and heated intraperitoneal chemotherapy (HIPEC) procedures.

What is the current status of trial NCT04088786?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2019-10-22. Estimated completion is 2022-04-14.

What interventions are being tested in trial NCT04088786?

The interventions under investigation include: nanoliposomal irinotecan (DRUG).

Who is sponsoring clinical trial NCT04088786?

This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04088786's enrollment target sits among peer trials

18 1720th of 2000 higher than 216 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 NCT04088786, the US trial registry maintained by the National Library of Medicine. NCT04088786 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.