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

Information source: ERYtech Pharma
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pancreatic Cancer

Intervention: GRASPA (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: ERYtech Pharma

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: limiting toxicity

Secondary outcome:

Immunogenicity : Titers of anti-L-asparaginase antibodies

Tumor response Evaluation by one or several tumor (bio)markers evolution

Serum concentrations of asparagine, aspartate, glutamine, glutamate, and asparaginase

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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 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 (CEA and CA 19. 9)

- 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

Locations and Contacts

Additional Information

Starting date: June 2009
Last updated: March 7, 2013

Page last updated: August 20, 2015

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