drugset / Trial / NCT02195180
Efficacy and Safety of L-asparaginase Encapsulated in RBC Combined With Gemcitabine or FOLFOX in 2nd Line for Progressive Metastatic Pancreatic Carcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
A new approach that aims to destroy pancreatic tumor cells through modification of the tumor environment. Asparagine synthetase (ASNS) is an enzyme wich synthetise asparagine. Asparagine is an essential nutriment for pancreatic cancer cells which have no or low level of ASNS. by L-asparaginase encapsulated in erythrocytes deplete (supress) Plasma asparagine. in selected patients having no or low ASNS, may provide a new therapeutic approach.
Timeline
- Start
- 2014-07
- Primary completion
- 2017-02
- Completion
- 2017-11
Publications
- Bachet JB, Blons H, Hammel P, Hariry IE, Portales F, Mineur L, Metges JP, Mulot C, Bourreau C, Cain J, Cros J, Laurent-Puig P. Circulating Tumor DNA is Prognostic and Potentially Predictive of Eryaspase Efficacy in Second-line in Patients with Advanced Pancreatic Adenocarcinoma. Clin Cancer Res. 2020 Oct 1;26(19):5208-5216. doi: 10.1158/1078-0432.CCR-20-0950. Epub 2020 Jun 30.
- Hammel P, Fabienne P, Mineur L, Metges JP, Andre T, De La Fouchardiere C, Louvet C, El Hajbi F, Faroux R, Guimbaud R, Tougeron D, Bouche O, Lecomte T, Rebischung C, Tournigand C, Cros J, Kay R, Hamm A, Gupta A, Bachet JB, El Hariry I. Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial. Eur J Cancer. 2020 Jan;124:91-101. doi: 10.1016/j.ejca.2019.10.020. Epub 2019 Nov 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GRASPA | Protein / enzyme biologic | — | — |
| Background | Gemcitabine | Small molecule | — | — |
| Background | Leucovorin | Small molecule | 200 mg/m2 | — |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Background | fluorouracil | Small molecule | 400 mg/m2 | — |