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COMPLETEDPHASE2

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

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

NCT02195180•ERYtech Pharma

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A patient is eligible for the study if all of the following criteria are met:
•Advanced or metastatic exocrine pancreatic adenocarcinoma, confirmed histologically
•Available archival tumor tissue block with sufficient tissue either from primary tumor and/or from metastatic lesions for biomarker testing; alternatively, unstained slides with sufficient tissue may be substituted
•Only 1 prior systemic therapy for advanced or metastatic disease. NOTE: Patient must be eligible to 2nd line gemcitabine or mFOLFOX6 treatment Documented disease progression during or following first-line therapy for advanced disease
•Measurable lesion (\>1cm) as assessed by CT scan or MRI (Magnetic Resonance Imaging) according to RECIST criteria (version 1.1)
•Age 18 years and older
•ECOG performance status 0 or 1
•Ability to understand, and willingness to sign, a written informed consent and to comply with the scheduled visits, treatment plans, laboratory tests, and other study procedures.
•Patient beneficiary of a Social Security Insurance if applicable

Exclusion Criteria

•A patient is excluded from the study if any of the following criteria are met:
•Patient who have received Oxaliplatin in first line will not be eligible in FOLFOX arm; Patient who received Gemcitabine in first line will not be eligible in Gemcitabine arm
•Resectable pancreatic adenocarcinoma
•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
•Inadequate organ functions:
•* hemoglobin \< 9.0 g/dl, neutrophil count \< 1.5 x 109/L, platelets \< 100 x 109/L.
•* Liver or pancreatic function abnormalities
•* AST or ALT \> 3 x ULN, or
•* Total bilirubin \> 1.5 x ULN, or
+16 more criteria

Locations (16)

Saint Catherine Institute

Avignon, France

Institut de Cancerologie

Brest, France

Hopital Beaujon

Clichy, France

Hospital Henri Mondor

Créteil, 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

Key Dates

Start Date

July 1, 2014

Primary Completion Date

February 1, 2017

Completion Date

November 1, 2017

Last Updated

July 27, 2018

Enrollment

141

ACTUAL participants

Conditions

Pancreatic Adenocarcinoma Metastatic

Interventions

ERY001

DRUG

Gemcitabine

DRUG

5-fluoro-uracil/oxaliplatin/leucovorin (folfox)

DRUG

Open-Label Phase 2 Efficacy Trial of Cancer Macrobeads in Patients With Treatment-Resistant Pancreatic/Colorectal Cancer

NCT01053013

Pancreatic Adenocarcinoma Non-resectablePancreatic Adenocarcinoma Metastatic+1 more

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COMPLETEDEARLY_PHASE1

Effect on Tumor Perfusion of a Chemotherapy Combining Gemcitabine and Nab-paclitaxel (Abraxane) in Pancreatic Cancer

NCT01715142

Pancreatic Adenocarcinoma ResectablePancreatic Adenocarcinoma Locally Advanced+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Open-Label Phase 2 Efficacy Trial of Cancer Macrobeads in Patients With Treatment-Resistant Pancreatic/Colorectal Cancer

Effect on Tumor Perfusion of a Chemotherapy Combining Gemcitabine and Nab-paclitaxel (Abraxane) in Pancreatic Cancer

To Assess the Safety of Continuous IV Administration of Plerixafor in Patients With Advanced Pancreatic, Ovarian and Colorectal Cancers

Scheduling Nab-paclitaxel With Gemcitabine