Phase 1 Completed N=12 Treatment

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

Source: ClinicalTrials.gov NCT01523808 ↗

Enrolled (actual)

Serious AEs

25.0%

Results posted

Oct 2021

Primary outcomePrimary: Number of Patients With Dose-limiting Toxicities up to Week 4 After Treatment — 0; 0; 0; 0 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Dose-limiting Toxicities up to Week 4 After Treatment	0; 0; 0; 0	—
SECONDARY Number of Patients With Limiting Toxicities From Week 4 to Week 8 (End of Study)	0; 0; 0; 0	—
SECONDARY Encapsulated L-asparaginase Pharmacokinetic Parameters Terminal Half-life	19.34; 22.71	—
SECONDARY Encapsulated L-asparaginase Pharmacokinetic Parameters Cmax	255.33; 1812.57	—
SECONDARY Encapsulated L-asparaginase Pharmacokinetic Parameters Area Under the Curve to Infinity	189363.84; 1331430.20	—
SECONDARY Change of Asparagine Levels From Baseline (Pharmacodynamics)	0.00; 0.00; 0.00; 0.00; -98.10; -98.36	—
SECONDARY Number of Patient Positive for Anti-L-asparaginase Antibodies	0; 0; 1; 0; 0; 0	—
SECONDARY Summary of CEA Level Over Time	21.3; 10.2; 6.4; 354.8; 22.8; 26.3	—
SECONDARY Summary of CA 19.9 Over Time	18440.0; 184.3; 1625.0; 54.5; 37196.5; 748.3	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01523808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.