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    Summary
    EudraCT Number:2012-003505-10
    Sponsor's Protocol Code Number:ERIGE
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-10-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-003505-10
    A.3Full title of the trial
    Phase II study of Eribulin in combination with Gemcitabine for the First-line Treatment of Patients with Locally Recurrent or Metastatic Triple Negative Breast Cancer. Protocol ERIGE.
    Studio di fase 2 della combinazione Eribulina-Gemcitabina come trattamento di I linea in pazienti con carcinoma della mammella triplo negativo metastatico o con recidiva locale. Protocollo ERIGE.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Gemcitabine and Eribulin as first line treatment of advanced triple-negative breast cancer.
    Gemcitabina ed Eribulina come trattamento di prima linea nel carcinoma mammario triplo-negativo in fase avanzata.
    A.3.2Name or abbreviated title of the trial where available
    ERIGE
    ERIGE
    A.4.1Sponsor's protocol code numberERIGE
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGRUPPO ONCOLOGICO ITALIANO DI RICERCA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEISAI Srl
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGruppo Oncologico Italiano di Ricerca Clinica
    B.5.2Functional name of contact pointUfficio Sperimentazioni Cliniche
    B.5.3 Address:
    B.5.3.1Street Addressvia Gramsci 14
    B.5.3.2Town/ cityParma
    B.5.3.3Post code43126
    B.5.3.4CountryItaly
    B.5.4Telephone number0521702682
    B.5.5Fax number0521995448
    B.5.6E-mailrcamisa@ao.pr.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name GEMCITABINA HOS.IT*INF FL 1G
    D.2.1.1.2Name of the Marketing Authorisation holderHOSPIRA ITALIA Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGEMCITABINE
    D.3.9.1CAS number 122111-03-9
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name HALAVEN*EV 6FL 2ML 0,44MG/ML
    D.2.1.1.2Name of the Marketing Authorisation holderEISAI Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNERIBULIN MESYLATE
    D.3.9.2Current sponsor codeE7389
    D.3.9.4EV Substance CodeSUB31126
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.88
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally recurrent or metastatic triple negative breast cancer.
    Pazienti con tumore della mammella triplo negativo con recidiva locale o metastatico.
    E.1.1.1Medical condition in easily understood language
    Advanced breast cancer.
    Tumore della mammella in stadio avanzato.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10006197
    E.1.2Term Breast cancer NOS stage IV
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Attività della combinazione eribulina più gemcitabina.
    Activity of the combination eribulin plus gemcitabine
    E.2.2Secondary objectives of the trial
    Fattibilità, sicurezza.
    Feasibility, safety.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENETIC:
    Vers:1
    Date:2012/08/20
    Title:Prediction of Eribulin/Gemcitabine Toxicity and Activity in Patients with Metastatic Triple Negative Breast Cancer by Pharmacogenetic Profiling. Ancillary biologic study to ERIGE protocol.
    Objectives:To assess the role of study polymorphisms in predicting activity and toxicity with the combination of eribulin plus gemcitabine in patients with TNBC.

    FARMACOGENETICA:
    Vers:1
    Data:2012/08/20
    Titolo:Utilizzo di un profilo farmacogenetico nel predire attività e tossicità della combinazione di eribulina e gemcitabina in una popolazione di pazienti affette da carcinoma mammario metastatico a fenotipo “triple negative”. Studio biologico ancillare al protocollo ERIGE.
    Obiettivi:Valutare il ruolo dei polimorfismi genetici in studio nel predire attività e tossicità di una terapia con eribulina e gemcitabina in pazienti affette da carcinoma mammario metastatico a fenotipo “triple negative”.

    E.3Principal inclusion criteria
    Patients must have locally recurrent or metastatic breast cancer. Patients must have estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), human epidermal growth factor receptor 2-negative (Her2-) (0, 1+) or, e.g. in HER2 2+ cases, fluorescent in situ hybridization (FISH) < ratio of 1.8. Cancer recurrent after previous neoadjuvant and/or adjuvant chemotherapy including an anthracycline and a taxane (unless one or both were clinically contraindicated). Measurable disease. Prior diagnosis of cancer is allowed as long as patient is free of disease and has been off treatment for the prior malignancy for a minimal interval of 3 years. Patients must have a life expectancy of > 12 weeks. Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky >= 50%). Adequate bone marrow reserve, liver and renal function. All patients must have given signed, informed consent prior to registration on study.
    Pazienti con carcinoma della mammella con recidiva locale o metastatico· Pazienti con recettori estrogenici negativi (ER-), recettori progestinici negativi (PR-), recettori per fattore di crescita epidermico 2-negativi (Her2-) (0, 1+) oppure, nei casi HER2 2+, con rapporto FISH (fluorescent in situ hybridization) &lt; 1.8. Prima ripresa di malattia dopo una precedente chemioterapia neadiuvante e/o adiuvante con antracicline e taxani (eccetto quando uno o entrambi fossero stati clinicamente controindicati). Malattia misurabile. E’ammessa una precedente diagnosi di tumore se la paziente sia libera da malattia e abbia terminato il trattamento per la precedente neoplasia da almeno tre anni. Pazienti con aspettativa di vita&gt; 12 settimane. Pazienti con Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky &gt;= 50%). Adeguata funzionalità midollare, epatica e renale. Tutte le pazienti devono aver firmato il consenso informato dello studio prima di essere inclusi nello studio
    E.4Principal exclusion criteria
    Prior gemcitabine or eribulin. Any prior chemotherapy for metastatic disease. Patients with brain metastases
    Precedente trattamento con gemcitabina ed eribulina. Precedente chemioterapia per la malattia metastatica. Presenza di metastasi cerebrali
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR) of the combination of Eribulin plus Gemcitabine based on local investigator’s assessment according to RECIST v1.1.
    Tasso di risposte obiettive(ORR), valutato dall’investigatore locale secondo i criteri RECIST v 1.1, della combinazione di Eribulina più Gemcitabina.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mesi
    E.5.2Secondary end point(s)
    Progression-free survival(PFS), duration of response (DOR), time to treatment failure (TTF) and overall survival (OS)of the combination Eribulin plus Gemcitabin.
    Sopravvivenza libera da progressione(PFS), durata della risposta (DOR), tempo al fallimento del trattamento (TTF) e sopravvivenza globale (OS) della combinazione di Eribulina più Gemcitabina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    6 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned22
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 29
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state83
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Follow-up or treatments as per standard care or clinical decision.
    Follow-up o trattamenti secondo pratica clinica/decisione clinica.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-16
    P. End of Trial
    P.End of Trial StatusOngoing
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