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

January 16, 2012
March 7, 2013
June 2009
March 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01523808 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
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
  • Experimental: GRASPA 25
    Intervention: Drug: GRASPA
  • Experimental: GRASPA 50
    Intervention: Drug: GRASPA
  • Experimental: GRASPA 100
    Intervention: Drug: GRASPA
  • Experimental: GRASPA 150
    Intervention: Drug: GRASPA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01523808
GRASPANC2008-02
Yes
ERYtech Pharma
ERYtech Pharma
Not Provided
Not Provided
ERYtech Pharma
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP