drugset / Trial / NCT01523808
Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase)in Patients With Pancreatic Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |