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

NCT ID: NCT01523808

Last Updated: 2021-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-03-31

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 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

Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GRASPA 25

Group Type: EXPERIMENTAL

GRASPA

Intervention Type: DRUG

Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose

GRASPA 50

Group Type: EXPERIMENTAL

GRASPA

Intervention Type: DRUG

Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose

GRASPA 100

Group Type: EXPERIMENTAL

GRASPA

Intervention Type: DRUG

Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose

GRASPA 150

Group Type: EXPERIMENTAL

GRASPA

Intervention Type: DRUG

Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose

Interventions

GRASPA

Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ERYtech Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Bachet 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.

Reference Type: DERIVED

PMID: 26355551 (View on PubMed)

Other Identifiers

GRASPANC2008-02

Identifier Type: -

Identifier Source: org_study_id