drugset / Trial / NCT01523808

Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase)in Patients With Pancreatic Cancer

NCT01523808 ↗

Phase 1 Completed 12 enrolled ERYtech Pharma
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The interest in using L-asparaginase in pancreatic cancer arose from in vitro and in vivo studies data showing an anti-neoplastic effect on pancreatic tumor cell lines. Interestingly, these studies suggest an additional effect of L-asparaginase associated to gemcitabine.GRASPA is a suspension of red blood cells encapsulating L-asparaginase. The aim of this phase I clinical trial is to evaluate the Maximum Tolerated Dose (MTD) of GRASPA on locally advanced or metastatic pancreatic tumors, after therapy failure of first or second line chemotherapy using gemcitabine.

Timeline

Start
2009-11
Primary completion
2011-03
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject ERY-ASP Protein / enzyme biologic 25 iu/kg —
Subject ERY-ASP Protein / enzyme biologic 50 iu/kg —
Subject ERY-ASP Protein / enzyme biologic 100 iu/kg —
Subject ERY-ASP Protein / enzyme biologic 150 iu/kg —