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Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC

NCT03665441 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2022-10-18

Study results available
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Summary

This is an open-label, multicenter, randomized, Phase 3 study in patients with ductal adenocarcinoma of the pancreas who have failed only one prior line of systemic anti-cancer therapy for advanced pancreatic cancer and have measurable disease.

Conditions

  • Pancreatic Adenocarcinoma

Interventions

DRUG

eryaspase

L-asparaginase encapsulated in erythrocytes (red blood cells)

DRUG

Gemcitabine plus Abraxane

gemcitabine, Abraxane

DRUG

Irinotecan plus 5-FU plus leucovorin

irinotecan, 5-FU, leucovorin

Sponsors & Collaborators

  • ERYtech Pharma

    lead INDUSTRY

Principal Investigators

  • Manuel Hidalgo, MD, PhD · Weill Cornell, NY, US

  • Pascal Hammel, MD, PhD · Hospital Beaujon, Clichy, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-15
Primary Completion
2021-08-30
Completion
2022-01-18
FDA Drug
Yes

Countries

  • United States
  • France
  • United Kingdom

Study Locations

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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 NCT03665441 on ClinicalTrials.gov