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Brief Title: Efficacy and Safety of L-asparaginase Encapsulated in RBC Combined With Gemcitabine or FOLFOX in 2nd Line for Progressive Metastatic Pancreatic Carcinoma
Official Title: Phase II, Randomized, Controlled, Clinical Trial Exploring Efficacy and Safety of ERY001 (L-asparaginase Encapsulated in Red Blood Cells) in Association With Gemcitabine or FOLFOX4 in Second-line Therapy for Patients With Progressive Metastatic Pancreatic Carcinoma
Study ID: NCT02195180
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Saint Catherine Institute, Avignon, , France
Institut de Cancerologie, Brest, , France
Hopital Beaujon, Clichy, , France
Hospital Henri Mondor, Creteil, , France
Groupe Hospitalier Mutualiste Grenoble, Grenoble, , France
Centre Hospitalier Departemental Vendee - Les Oudairies, La Roche-sur-Yon, , France
Centre Oscar Lambret, Lille, , France
Cnetre Leon Berard, Lyon, , France
Institut Regional du Cancer-Montpellier Val d'Aurelle, Montpellier, , France
Institute Mutualiste Montsouris, Paris, , France
Hospital Saint Antoine, Paris, , France
Hospital Pitie Salpetriere, Paris, , France
CHU de Poitiers, Poitiers, , France
CHU Reims, Reims, , France
CHU Toulouse - Rangueil, Toulouse, , France
CHU de Tours, Tours, , France
Name: Pascal Hammel, Pr MD
Affiliation: Hopital Beaujon
Role: PRINCIPAL_INVESTIGATOR