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Trial record 67 of 185 for:    ERYTHROMYCIN

Efficacy and Safety of L-asparaginase Encapsulated in RBC Combined With Gemcitabine or FOLFOX in 2nd Line for Progressive Metastatic Pancreatic Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02195180
Recruitment Status : Completed
First Posted : July 21, 2014
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
ERYtech Pharma

Brief Summary:

A new approach that aims to destroy pancreatic tumor cells through modification of the tumor environment.

Asparagine synthetase (ASNS) is an enzyme wich synthetise asparagine. Asparagine is an essential nutriment for pancreatic cancer cells which have no or low level of ASNS.

by L-asparaginase encapsulated in erythrocytes deplete (supress) Plasma asparagine.

in selected patients having no or low ASNS, may provide a new therapeutic approach.


Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Metastatic Drug: ERY001 Drug: Gemcitabine Drug: 5-fluoro-uracil/oxaliplatin/leucovorin (folfox) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Randomized, Controlled, Clinical Trial Exploring Efficacy and Safety of ERY001 (L-asparaginase Encapsulated in Red Blood Cells) in Association With Gemcitabine or FOLFOX4 in Second-line Therapy for Patients With Progressive Metastatic Pancreatic Carcinoma
Actual Study Start Date : July 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : November 2017


Arm Intervention/treatment
Experimental: standard of care combined with ERY001
standard of care = Gemcitabine or folfox
Drug: ERY001
Other Name: L asparaginase encapsulated in erythrocytes

Drug: Gemcitabine
Drug: 5-fluoro-uracil/oxaliplatin/leucovorin (folfox)
oxaliplatin 85 mg/m2 levo-leucovorin 200 mg/m2 5-FU 400 mg/m2

Sham Comparator: standard of care alone
standard of care = Gemcitabine or folfox
Drug: Gemcitabine
Drug: 5-fluoro-uracil/oxaliplatin/leucovorin (folfox)
oxaliplatin 85 mg/m2 levo-leucovorin 200 mg/m2 5-FU 400 mg/m2




Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: From last study treatment assessment visit until patient's death, loss to follow up, or study closure, assessed up to 36 months. ]
    Evaluate the effects of eryaspase when combined with chemotherapy for the second line treatment of patients with pancreatic adenocarcinoma in terms of OS, whose tumors has low or no ASNS expression (ASNS 0 or 1+)

  2. Progression free survival (PFS) [ Time Frame: From date of randomization to first documented progression of disease, death for any cause or until start of new anti-cancer treatment, whcihever came first, assessed up to 24 months. ]
    Evaluate the effects of eryaspase when combined with chemotherapy for the second line treatment of patients with pancreatic adenocarcinoma in terms of PFS, whose tumors has low or no ASNS expression (ASNS 0 or 1+)


Secondary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) [ Time Frame: collected from time of informed consent until 4 weeks after last study treatment ]
    Compare the safety profile in patients treated with eryaspase in combination with chemotherapy versus chemotherapy alone, including adverse events, vital signs and clinical laboratory assessments

  2. Overall survival [ Time Frame: From last study treatment assessment visit until patient's death, loss to follow up, or study closure, assessed up to 36 months. ]
    Evaluate the effects of eryaspase in combination with chemotherapy on investigator-assessed OS in all randomized patients (all patients) and in patients with ASNS 2+/3+ expressing tumors.

  3. Progression free survival [ Time Frame: From date of randomization to first documented progression of disease, death for any cause or until start of new anti-cancer treatment, whcihever came first, assessed up to 24 months. ]
    Evaluate the effects of eryaspase in combination with chemotherapy on investigator-assessed PFS in all randomized patients (all patients) and in patients with ASNS 2+/3+ expressing tumors.

  4. Objective response rate (ORR) [ Time Frame: From date of randomization to last tumor assessment data collected for each patient, assessed up to 24 months. ]
    Evaluate the effect of eryaspase in combination with chemotherapy on the ORR, and the duration in all comers, patients with ASNS 0/1+ expressing tumors, and those with ASNS 2+/3+ expressing tumors.

  5. Disease control rate (DCR) [ Time Frame: From date of randomization to 16 and 24 weeks. ]
    Evaluate the effect of eryaspase in combination with chemotherapy on the DCR in all comers, patients with ASNS 0/1+ expressing tumors, and those with ASNS 2+/3+ expressing tumors.

  6. Duration of response (DoR) [ Time Frame: From date of first response of complete or partial response until tumor progression, assessed up to 24 months. ]
    Evaluate the effect of eryaspase in combination with chemotherapy on the DoR in all comers, patients with ASNS 0/1+ expressing tumors, and those with ASNS 2+/3+ expressing tumors.

  7. Evaluate the relationship of clinical outcomes with tumor markers [ Time Frame: From date of randomiztion to end of treatment visit, assessed up to 20 months. ]
    Evaluate the relationship of clinical outcome (i.e. OS, PFS, ORR, DCR and DoR) with tumor markers, namely cancer antigen (CA19-9), and carcinoembryonic antigen test (CEA).

  8. Optical density reading [ Time Frame: From date of randomization to first documented progression of disease, death for any cause or until start of new anti-cancer treatment, whcihever came first, assessed up to 24 months. ]
    Assess the effect of eryaspase in combination with chemotherapy on PFS, OS, ORR, BOR, and other clinical outcomes in ASNS subsets, as determined by optical density reading.

  9. Quality of Life status [ Time Frame: From date of randomiztion to end of treatment visit, assessed up to 20 months. ]
    Compare the 2 treatment arms with respect to change in quality of life status, the change of QOL relative to baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A patient is eligible for the study if all of the following criteria are met:

  • Advanced or metastatic exocrine pancreatic adenocarcinoma, confirmed histologically
  • Available archival tumor tissue block with sufficient tissue either from primary tumor and/or from metastatic lesions for biomarker testing; alternatively, unstained slides with sufficient tissue may be substituted
  • Only 1 prior systemic therapy for advanced or metastatic disease. NOTE: Patient must be eligible to 2nd line gemcitabine or mFOLFOX6 treatment Documented disease progression during or following first-line therapy for advanced disease
  • Measurable lesion (>1cm) as assessed by CT scan or MRI (Magnetic Resonance Imaging) according to RECIST criteria (version 1.1)
  • Age 18 years and older
  • ECOG performance status 0 or 1
  • Ability to understand, and willingness to sign, a written informed consent and to comply with the scheduled visits, treatment plans, laboratory tests, and other study procedures.
  • Patient beneficiary of a Social Security Insurance if applicable

Exclusion Criteria:

A patient is excluded from the study if any of the following criteria are met:

  • Patient who have received Oxaliplatin in first line will not be eligible in FOLFOX arm; Patient who received Gemcitabine in first line will not be eligible in Gemcitabine arm
  • Resectable pancreatic adenocarcinoma
  • 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
  • Inadequate organ functions:

    • 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 > 2 x ULN with suggestive clinical sign of pancreatitis 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 in the last month

    • 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
  • Known 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 NOTE: chemotherapy or radiation therapy given in less than 3 weeks is allowed, provided patient recovered from all related toxicities
  • History of grade 3 blood transfusion reaction (life threatening situation)
  • Presence of anti-erythrocyte antibodies (auto-antibodies or anti-public antibodies) preventing from getting a compatible packed Red Blood Cells for the patient
  • Participation in another concurrent clinical trial
  • Women of child-bearing potential and men with partners of childbearing potential without effective contraception as well as pregnant or breast feeding women
  • Other severe acute/chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02195180


Locations
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France
Saint Catherine Institute
Avignon, France, 84918
Institut de Cancerologie
Brest, France, 29609
Hopital Beaujon
Clichy, France, 92118
Hospital Henri Mondor
Creteil, France, 94010
Groupe Hospitalier Mutualiste Grenoble
Grenoble, France, 38028
Centre Hospitalier Departemental Vendee - Les Oudairies
La Roche-sur-Yon, France, 85925
Centre Oscar Lambret
Lille, France, 59020
Cnetre Leon Berard
Lyon, France, 69373
Institut Regional du Cancer-Montpellier Val d'Aurelle
Montpellier, France, 34298
Institute Mutualiste Montsouris
Paris, France, 75014
Hospital Saint Antoine
Paris, France, 75571
Hospital Pitie Salpetriere
Paris, France, 75651
CHU de Poitiers
Poitiers, France, 42109
CHU Reims
Reims, France, 51100
CHU Toulouse - Rangueil
Toulouse, France, 31059
CHU de Tours
Tours, France, 37044
Sponsors and Collaborators
ERYtech Pharma
Investigators
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Principal Investigator: Pascal Hammel, Pr MD Hopital Beaujon

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Responsible Party: ERYtech Pharma
ClinicalTrials.gov Identifier: NCT02195180    
Other Study ID Numbers: GRASPANC 2013-03
2013-004262-34 ( EudraCT Number )
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: November 2017
Keywords provided by ERYtech Pharma:
Pancreas
adenocarcinoma
cancer
asparaginase
erythrocytes
red blood cell
Encapsulation
folfox
gemcitabine
Additional relevant MeSH terms:
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Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Fluorouracil
Oxaliplatin
Asparaginase
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs