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NCT04292743 · ClinicalTrials.gov registry record · Phase 1

Eryaspase With Modified FOLFIRINOX in Advanced Pancreatic Ductal Adenocarcinoma

A Phase 1 study, sponsored by Georgetown University.

Completed
Registry status
Phase 1
Development phase
19
Enrollment target

NCT04292743: Completed Phase 1 study, sponsored by Georgetown University.

NCT04292743 is a Phase 1 study that has completed, run by Georgetown University. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04292743, a Phase 1 study, has completed, sponsored by Georgetown University.

COMPLETED
Registry status
Phase 1
Development phase
19 participants
Enrollment target

Study Summary

This will be a single-arm, multi-center, open-label phase 1 study. The standard 3+3 design will be used to determine the maximum tolerated dose (MTD) from 4 possible dose levels of Eryaspase in combination with mFOLFIRINOX. We hypothesize that the addition of Eryaspase to FOLFIRINOX (5-fluorouracil \[5-FU\], leucovorin, irinotecan, and oxaliplatin) will be safe and demonstrate preliminary signs of efficacy in patients with advanced pancreatic cancer. Safety assessments include adverse events, physical examination abnormalities, vital signs, and clinical laboratory tests (including blood chemistry, hematology, and coagulation panel).

Primary Outcome

The number (percentage) of all subjects who experience Grad 3 or 4 treatment emergent adverse events (AEs), serious adverse events (SAEs), or abnormal laboratory results according to NCI CTCAE Version 5.0, that occur after Cycle 1, Day 1 will be reported until end of treatment visit.

Interventions

  • DRUG FOLFIRINOX
  • BIOLOGICAL Eryaspase

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2020-12-02
Est. Completion 2024-03-04
Phase Phase 1
Georgetown University

227 total trials

What the finished NCT04292743 record still lists

NCT04292743 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 2 interventions - of which FOLFIRINOX is the first listed.

NCT04292743 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04292743 about?

NCT04292743 is a clinical study titled "Eryaspase With Modified FOLFIRINOX in Advanced Pancreatic Ductal Adenocarcinoma". This will be a single-arm, multi-center, open-label phase 1 study. The standard 3+3 design will be used to determine the maximum tolerated dose (MTD) from 4 possible dose levels of Eryaspase in combination with mFOLFIRINOX. We hypothesize that the addition of Eryaspase to FOLFIRINOX (5-fluorouracil ...

What is the current status of trial NCT04292743?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2020-12-02. Estimated completion is 2024-03-04.

What interventions are being tested in trial NCT04292743?

The interventions under investigation include: FOLFIRINOX (DRUG), Eryaspase (BIOLOGICAL).

Who is sponsoring clinical trial NCT04292743?

This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04292743's enrollment target sits among peer trials

19 1716th of 2000 higher than 281 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 NCT04292743, the US trial registry maintained by the National Library of Medicine. NCT04292743 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.