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Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase)in Patients With Pancreatic Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase)in Patients With Pancreatic Cancer

Phase I, Dose Escalation Clinical Trial of GRASPA (Red Blood Cells Encapsulating L-Asparaginase) in Patients With Pancreatic Carcinoma

NCT01523808•ERYtech Pharma

View on ClinicalTrials.gov

Summary

The interest in using L-asparaginase in pancreatic cancer arose from in vitro and in vivo studies data showing an anti-neoplastic effect on pancreatic tumor cell lines. Interestingly, these studies suggest an additional effect of L-asparaginase associated to gemcitabine.GRASPA is a suspension of red blood cells encapsulating L-asparaginase. The aim of this phase I clinical trial is to evaluate the Maximum Tolerated Dose (MTD) of GRASPA on locally advanced or metastatic pancreatic tumors, after therapy failure of first or second line chemotherapy using gemcitabine.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Exocrine pancreatic adenocarcinoma cytologically or histologically confirmed
•Locally advanced and non-resectable with invasion of the superior mesenteric artery (stage III) or metastatic (stage IV) as defined by TNM (primary tumor, regional nodes, metastasis) 2002 classification (UICC 2002)
•resistant to a first or second line chemotherapy with gemcitabine
•Patient aged between 18 to 70 years
•Signed Informed Consent Form
•Life expectancy ≥ 12 weeks
•Accurate measurement of tumor volume by imagery (in at least one dimension)
•Presence of one or several tumor markers (carcinoembryonic antigen \[CEA\] and cancer antigen \[CA\] 19.9)
•Eastern Cooperative Oncology Group \[ECOG\] Prognostic Score : 0, 1 or 2
•Patient beneficiary of a Social Security Insurance

Exclusion Criteria

•Patient with an endocrine or acinar pancreatic tumor
•Patient with known or suspected cerebro-meningeal metastases
•Haemoglobin level greater than 13 g/L
•Patient hypersensitive to L-asparaginase or have had prior exposure to any form of L-asparaginase
•Splenic vein thrombosis \< 3 months or under active treatment
•Anti-vitamin K treatment
•Hepatic Insufficiency unrelated to pancreatic cancer
•Renal insufficiency unrelated to pancreatic cancer
•Pancreatitis or pancreatitis history unrelated to pancreatic cancer
•Insulin-dependant diabetes mellitus unrelated to pancreatic cancer
+7 more criteria

Key Dates

Start Date

November 1, 2009

Primary Completion Date

March 1, 2011

Completion Date

March 1, 2011

Last Updated

October 15, 2021

Enrollment

ACTUAL participants

Conditions

Pancreatic Cancer

Interventions

GRASPA

DRUG

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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: October 15, 2021Data 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.

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Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase)in Patients With Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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