Efficacy and Safety of L-asparaginase Encapsulated in RBC Combined With Gemcitabine or FOLFOX in 2nd Line for Progressive Metastatic Pancreatic Carcinoma
Conditions
Pancreatic Adenocarcinoma Metastatic
Conditions: official terms
Adenocarcinoma - Pancreatic Neoplasms
Conditions: Keywords
Pancreas, adenocarcinoma, cancer, asparaginase, erythrocytes, red blood cell, Encapsulation, folfox, gemcitabine
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ERY001 Type: Drug
Name: Gemcitabine Type: Drug
Name: 5-fluoro-uracil/oxaliplatin/leucovorin (folfox) Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- progressive metastatic exocrine pancreatic adenocarcinoma

- Patients with available histology specimen, either from primary tumor and/or from metastatic lesions.

- eligible to 2nd line gemcitabine or FOLFOX4 treatment

- Measurable lesion (>1cm) as assessed by CT scan or MRI (Magnetic Resonance Imaging) according to RECIST criteria (version 1.1)

- Patient aged 18 years and older

- ECOG (WHO) performance status 0-1

- Signed Informed Consent

Exclusion Criteria:

- Patient who have received Oxaliplatine in first line will not be eligible in FOLFOX arm; Patient who received Gemcitabine in first line will not be eligible in Gemcitabine arm

- Patient with cerebral metastasis

- Patient with resectable or borderline non metastatic pancreatic adenocarcinoma

- Patient with known hypersensitivity to L-asparaginase or have had prior exposure to any form of L-asparaginase

- Anti-vitamin K treatment. Replacement with low molecular weight heparin treatment if required

- Patient unable to receive treatments based on gemcitabine or FOLFOX4 or ERY001, due to general or visceral conditions unrelated to pancreatic cancer
Location
Hopital Beaujon
Clichy, France
Status: Recruiting
Contact: Pascal Hammel, Pr MD - 01 40 87 50 00
Start Date
July 2014
Completion Date
December 2015
Sponsors
ERYtech Pharma
Source
ERYtech Pharma
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page