Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GRASPA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- GRASPA 25
- interventionNames
- Drug: GRASPA
- type
- EXPERIMENTAL
- label
- GRASPA 50
- interventionNames
- Drug: GRASPA
- type
- EXPERIMENTAL
- label
- GRASPA 100
- interventionNames
- Drug: GRASPA
- type
- EXPERIMENTAL
- label
- GRASPA 150
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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 * 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
References
Publications (1)
- DERIVEDBachet JB, Gay F, Marechal R, Galais MP, Adenis A, MsC DS, Cros J, Demetter P, Svrcek M, Bardier-Dupas A, Emile JF, Hammel P, Ebenezer C, Berlier W, Godfrin Y, Andre T. Asparagine Synthetase Expression and Phase I Study With L-Asparaginase Encapsulated in Red Blood Cells in Patients With Pancreatic Adenocarcinoma. Pancreas. 2015 Oct;44(7):1141-7. doi: 10.1097/MPA.0000000000000394. PMID 26355551