Clinical trial with L-asparaginase encapsulated in erythrcoytes in patients affected by metastatic pancreatic cancer after first line treatment

Phase 1

• Conditions: Pancreatic cancer; MedDRA version: 16.1Level: LLTClassification code 10051971Term: Pancreatic adenocarcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004262-34-FR
• Lead Sponsor: ERYTECH Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-28
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

- Patients with progressive metastatic exocrine pancreatic adenocarcinoma, confirmed histologically
- Patients with available histology specimen, either from primary tumor and/or from metastatic lesions. The IHC analyses (done in a central laboratory) issued from these specimens MUST allow determining the level of asparagine synthetase expression. Such result is mandatory for the final analysis
- Patient eligible to 2nd line gemcitabine or FOLFOX4 treatment according investigator’s decision.
- Measurable lesion (>1cm) as assessed by CT scan or MRI (Magnetic Resonance Imaging) according to RECIST criteria (version 1.1)
- Patient aged 18 years and older
- ECOG (WHO) performance status 0-1
- Signed Informed Consent
- Patient beneficiary of a Social Security Insurance if applicable
During the selection period, any study related examination not required for the standard diagnosis must be performed after signature of the informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Patient with cerebral metastasis
- Patient with resectable or borderline non metastatic pancreatic adenocarcinoma
- Patient with known hypersensitivity to L-asparaginase or have had prior exposure to any form of L-asparaginase
- Anti-vitamin K treatment. Replacement with low molecular weight heparin treatment if required
- Patient unable to receive treatments based on gemcitabine or FOLFOX4 or ERY001, due to general or visceral conditions unrelated to pancreatic cancer such as:
* Bone marrow impairment as evidenced by hemoglobin < 9.0 g/dl, neutrophil count < 1.5 x 109/L, platelets < 100 x 109/L.
* Liver or pancreatic function abnormalities
AST or ALT > 3 x ULN, or
Total bilirubin > 1.5 x ULN, or
Lipase > 2N (grade 2) with suggestive clinical sign or > 3N without suggestive clinical sign
* Renal insufficiency: Renal clearance determined by the Cockroft and Gault Formula ? 60 mL/min
* Current or prior coagulopathy disorders
PT =1.5 fold the upper limit of normal value or
INR =1.5 fold the upper limit of normal value or
Fibrinogen = 0.75 fold the lower limit of normal value
* Infection: HIV, active hepatitis related to B or C virus
* Concurrent active malignancies (with the exception of in situ carcinoma of the cervix and inactive non melanoma skin cancer)
* Other serious conditions than pancreatic cancer according to investigator's opinion
* NYHA Grade = 2 congestive heart failure
- Systemic chemotherapy or radiation within the last 3 weeks or major surgery within 4 weeks
- 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, 30 days prior inclusion
- Women of child-bearing potential and men with partners of childbearing potential without effective contraception as well as pregnant or breast feeding women.
- Patients whose regular follow-up is impossible due to psychological, family, social or geographical reasons

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified