Status:
COMPLETED
Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase)in Patients With Pancreatic Cancer
Lead Sponsor:
ERYtech Pharma
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 su...
Eligibility Criteria
Inclusion
- 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
- 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
- Current or prior coagulopathy disorders unrelated to pancreatic cancer
- ECOG Prognostic Score 3 or 4
- History of grade 3 blood transfusion reaction (life threatening situation)
- Presence of rare and dangerous anti-erythrocyte antibodies preventing from getting a compatible packed Red Blood Cells for the patient
- Patient already included in another clinical trial
- Pregnancy, breast-feeding or absence of secured contraception
- Unwillingness to sign the informed consent form
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01523808
Start Date
November 1 2009
End Date
March 1 2011
Last Update
October 15 2021
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