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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ERYtech Pharma

ClinicalTrials.gov Identifier:

NCT01523808

First received: January 16, 2012

Last updated: March 7, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	January 16, 2012
Last Updated Date	March 7, 2013
Start Date ^ICMJE	June 2009
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 30, 2012)	limiting toxicity [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ] Toxicity(ies) considered as dose limiting, defined according to the "Common Terminology Criteria for Adverse Events v3.0" (CTCAE v3.0) scale toxicities are : grade 2,3 or 4 for pancreatic toxicities, grade 3 or 4 for allergies (hypersensitivity), neurological, hepatic and /or coagulation toxicities all other grade 4 toxicity
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01523808 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 30, 2012)	Immunogenicity : Titers of anti-L-asparaginase antibodies [ Time Frame: 0,1,28,56 days post-dose ] [ Designated as safety issue: No ] Tumor response Evaluation by one or several tumor (bio)markers evolution [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] Serum concentrations of asparagine, aspartate, glutamine, glutamate, and asparaginase [ Time Frame: 0,1,3,7,14,21,28,35,42,56 days post-dose ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase)in Patients With Pancreatic Cancer
Official Title ^ICMJE	Phase I, Dose Escalation Clinical Trial of GRASPA (Red Blood Cells Encapsulating L-Asparaginase) in Patients With Pancreatic Carcinoma
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Pancreatic Cancer
Intervention ^ICMJE	Drug: 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
Study Arm (s)	Experimental: GRASPA 25 Intervention: Drug: GRASPA Experimental: GRASPA 50 Intervention: Drug: GRASPA Experimental: GRASPA 100 Intervention: Drug: GRASPA Experimental: GRASPA 150 Intervention: Drug: GRASPA
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	12
Completion Date	March 2011
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01523808
Other Study ID Numbers ^ICMJE	GRASPANC2008-02
Has Data Monitoring Committee	Yes
Responsible Party	ERYtech Pharma
Study Sponsor ^ICMJE	ERYtech Pharma
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	ERYtech Pharma
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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