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