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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 is a Phase 1 study that has completed, run by Georgetown University. The registered enrollment target is 19 participants.

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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).

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

Sponsor

Georgetown University

227 total trials

What the Registry Record Tells You About NCT04292743

The ClinicalTrials.gov registry entry for NCT04292743 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.

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

NCT04292743 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.