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Eryaspase With Modified FOLFIRINOX in Advanced Pancreatic Ductal Adenocarcinoma

NCT04292743 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-06-11

Study results available
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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).

Conditions

Interventions

BIOLOGICAL

Eryaspase

intravenous administration of Eryaspase, starting dose 75 units/kg, dose escalation to 100 units/kg, dose reduction 50 units/kg and 25 units/kg

DRUG

FOLFIRINOX

intravenous administration of FOLFIRINOX

Sponsors & Collaborators

  • ERYtech Pharma

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Marcus S Noel, MD · Georgetown University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-02
Primary Completion
2023-01-18
Completion
2024-03-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04292743 on ClinicalTrials.gov