CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 512 enrolled
Drug / intervention
eryaspase +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03665441
NCT03665441Phase 3Completed

A Randomized, Phase 3 Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment of Patients With Pancreatic Adenocarcinoma

ERYtech Pharma·interventional·Posted Sep 11, 2018·Updated Oct 18, 2022

In Brief

A Phase 3 clinical trial evaluating eryaspase, Gemcitabine plus Abraxane, and 1 other intervention for Pancreatic Adenocarcinoma. Completed, enrolled 512 participants across 16 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 11, 2018
Enrollment StartSep 15, 2018
Primary CompletionAug 30, 2021
Study CompletionJan 18, 2022
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.8 years ago

Interventions

eryaspasedrug

L-asparaginase encapsulated in erythrocytes (red blood cells)

Gemcitabine plus Abraxanedrug

gemcitabine, Abraxane

Irinotecan plus 5-FU plus leucovorindrug

irinotecan, 5-FU, leucovorin