NCT03665441

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 512 (actual)
• Sponsor: ERYtech Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients who meet all inclusion and exclusion criteria will be randomized in a 1:1 ratio to one of the following treatment arms (see figure below): * Arm A (investigational arm): eryaspase in combination with either gemcitabine/Abraxane or irinotecan-based therapy (FOLFIRI \[FOLinic acid-Fluorouracil-IRInotecan regimen\] or Onivyde®/5 fluorouracil/leucovorin), or * Arm B (control arm): gemcitabine/Abraxane or irinotecan-based therapy (FOLFIRI or Onivyde/5-FU/leucovorin) The chemotherapy will be investigator's choice and based on what patient has received in first line treatment. Treatment will continue until disease progression, unacceptable toxicity, or the patient's withdrawal of consent. An End of Treatment visit should occur within approximately 30 days from last dose of eryaspase or chemotherapy regimen. A survival follow-up period will include the collection of survival, progression of disease if applicable, treatment updates, and quality of life assessments every 8 weeks.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-09-15
• Primary completion: 2021-08-30
• Completion: 2022-01-18
• First posted: 2018-09-11
• Last updated: 2022-10-18
• Results posted: 2022-09-28

Locations

16 sites across 3 countries: United States, France, United Kingdom

Regulatory

• FDA-regulated drug study