DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Efficacy and Safety of L-asparaginase Encapsulated in RBC Combined With Gemcitabine or FOLFOX in 2nd Line for Progressive Metastatic Pancreatic Carcinoma

Information source: ERYtech Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pancreatic Adenocarcinoma Metastatic

Intervention: ERY001 (Drug); Gemcitabine (Drug); 5-fluoro-uracil/oxaliplatin/leucovorin (folfox) (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: ERYtech Pharma

Official(s) and/or principal investigator(s):
Pascal Hammel, Pr MD, Principal Investigator, Affiliation: Hopital Beaujon


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: PFS

Secondary outcome: Frequency, severity and relationship to study treatments of adverse events


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- Patient unable to receive treatments based on gemcitabine or FOLFOX4 or ERY001, due

to general or visceral conditions unrelated to pancreatic cancer

Locations and Contacts

Hopital Beaujon, Clichy, France; Recruiting
Pascal Hammel, Pr MD, Phone: 01 40 87 50 00
Additional Information

Starting date: July 2014
Last updated: March 24, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017