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    Summary
    EudraCT Number:2014-004299-41
    Sponsor's Protocol Code Number:ERMES
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-11-11
    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 number2014-004299-41
    A.3Full title of the trial
    ERbitux MEtastatic colorectal cancer Strategy Study: A phase III randomized two arm study with FOLFIRI + Cetuximab until disease progression compared to FOLFIRI + Cetuximab for 8 cycles followed by Cetuximab alone until disease progression in first line treatment of patients with RAS and BRAF wild type metastatic colorectal cancer.
    Studio Strategico Erbitux sul carcinoma colorettale metastatico: Studio di fase III randomizzato a due bracci di trattamento con FOLFIRI + Cetuximab fino a progressione della malattia rispetto a FOLFIRI + Cetuximab per 8 cicli seguiti solo da Cetuximab fino alla progressione della malattia, trattamento di prima linea in pazienti con cancro colorettale metastatico (mCRC) di tipo RAS e BRAF non mutato.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the standard therapy with FOLFIRI + Cetuximab until disease progression compared to FOLFIRI + Cetuximab for 8 cycles followed by Cetuximbab until disease progression in first line treatment of patients with RAS and BRAF wild type metastatic colorectal cancer.
    Studio per verificare l'associazione della terapia standard di FOLFIRI + Cetuximab fino a progressione della malattia verso FOLFIRI + Cetuximab per 8 cicli seguiti da Cetuximab fino a progressione in pazienti affetti da carcinoma metastatico del colon-retto di tipo RAS e BRAF non mutato.
    A.3.2Name or abbreviated title of the trial where available
    ERMES
    A.4.1Sponsor's protocol code numberERMES
    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 SponsorDipartimento di Scienze Mediche Oncologia Medica Policlinico Gemelli
    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 supportMerck Serono
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTC Clinical Trial Center " A. Gemelli"
    B.5.2Functional name of contact pointAntonino Amato
    B.5.3 Address:
    B.5.3.1Street AddressLargo Francesco Vito
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number00390630158762
    B.5.6E-mailantonino.amato@unicatt.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 Erbitux
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameCETUXIMAB
    D.3.4Pharmaceutical form 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 INNCETUXIMAB
    D.3.9.1CAS number 205923-56-4
    D.3.9.4EV Substance CodeSUB01178MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameFolinic Acid
    D.3.4Pharmaceutical form Powder for solution for injection/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 INNFOLINIC ACID
    D.3.9.1CAS number 1492-18-8
    D.3.9.3Other descriptive nameFOLINIC ACID
    D.3.9.4EV Substance CodeSUB13910MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number175
    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: 3
    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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product name5-Fluorouracile
    D.3.4Pharmaceutical form 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 INNFLUOROURACIL
    D.3.9.1CAS number 51-21-8
    D.3.9.3Other descriptive nameFLUOROURACIL
    D.3.9.4EV Substance CodeSUB07721MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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: 4
    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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameIrinotecan
    D.3.4Pharmaceutical form 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 INNIRINOTECAN
    D.3.9.1CAS number 97682-44-5
    D.3.9.4EV Substance CodeSUB08295MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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: 5
    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 Erbitux
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameCetuximab
    D.3.4Pharmaceutical form 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 INNCETUXIMAB
    D.3.9.1CAS number 205923-56-4
    D.3.9.4EV Substance CodeSUB01178MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Patients with unresectable RAS and BRAF wild-type metastatic colorectal cancer.
    Pazienti con cancro colorettale metastatico di tipo RAS e BRAF non mutato
    E.1.1.1Medical condition in easily understood language
    Patients with metastatic colorectal cancer.
    Pazienti con cancro colorettale metastatico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    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
    To investigate whether Cetuximab alone (given until progression or cumulative toxicity) after 8 cycles of FOLFIRI + Cetuximab results in a non-inferior Progression Free Survival when compared with continuous FOLFIRI + Cetuximab (given until progression or cumulative toxicity).
    The co-primary objective is to assess whether an improvement in the incidence of grade 3-4 adverse events can be achieved in the experimental arm as compared to the continuous chemotherapy arm.
    Stabilire se Cetuximab in monoterapia (somministrato fino a progressione o tossicità cumulativa) dopo 8 cicli di FOLFIRI + Cetuximab genera una sopravvivenza libera da progressione non inferiore rispetto a un trattamento continuo a base di FOLFIRI + Cetuximab (somministrato fino a progressione o tossicità cumulativa).
    L'obiettivo co-primario è valutare se nel braccio sperimentale è possibile ottenere un miglioramento dell’incidenza di eventi avversi , di grado 3-4, rispetto al braccio di chemioterapia continua.
    E.2.2Secondary objectives of the trial
    - Response Rate
    - Overall Survival
    - Quality of Life
    - To explore the possibility of using Liquid Biopsies for Molecular Profiling as well as monitoring treatment activity in mCRC pts receiving Cetuximab-based therapy
    - Tasso di risposta
    - Sopravvivenza globale
    - Qualità della vita
    - Studiare il possibile uso di Biopsie Liquide ai fini della determinazione del Profilo Molecolare e del monitoraggio dell’attività del trattamento in pazienti con mCRC sottoposti ad una terapia a base di Cetuximab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically proven diagnosis of colorectal adenocarcinoma;
    - Diagnosis of metastatic disease;
    - RAS and BRAF wild-type;
    - Measurable disease according to RECIST criteria v1.1;
    - Male or female pts > 18 years of age;
    - ECOG Performance Status ≤ 2;
    - Life expectancy of at least 3 months;
    - Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment;
    - If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment;
    - If female and of childbearing potential, or if male, agreement to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method);
    - Signed informed consent obtained at screening.
    - Diagnosi di adenocarcinoma del colon-retto confermata istologicamente;
    - Diagnosi di malattia metastatica;
    - RAS e BRAF non mutato;
    - Malattia misurabile secondo i criteri RECIST, versione 1.1;
    - Pazienti di sesso maschile o femminile di età >18 anni;
    - Performance status ECOG ≤2;
    - Aspettativa di vita di almeno 3 mesi;
    - Adeguata funzionalità renale, epatica e midollare valutata nei 14 giorni precedenti all’inizio del trattamento in studio;
    - Per le pazienti donne in età fertile, risultato negativo al test di gravidanza ottenuto al massimo 7 giorni prima dell’avvio del trattamento in studio;
    - Per gli uomini e per le donne in età fertile, consenso all’uso di un metodo contraccettivo adeguato (ad es., astinenza, dispositivo intrauterino, contraccettivo orale o metodo a doppia barriera);
    - Ottenimento del consenso informato sottoscritto allo screening.
    E.4Principal exclusion criteria
    - Any contraindication to use cetuximab, irinotecan, 5-FU or folinic acid
    - Active uncontrolled infections or active disseminated intravascular coagulation
    - Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
    - Pregnancy.
    - Breastfeeding.
    - Grade III or IV heart failure (NYHA classification)
    - Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study
    - Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin
    - Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study
    - Previous chemotherapy for colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study
    - Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or during participation in the study
    - Known or clinically suspected brain metastases
    - History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea
    - Severe, non-healing wounds, ulcers or bone fractures
    - Uncontrolled hypertension
    - Marked proteinuria (nephrotic syndrome)
    - Known DPD deficiency (specific screening not required)
    - Known history of alcohol or drug abuse
    - A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
    - Absent or restricted legal capacity
    - Qualsiasi controindicazione all’uso di cetuximab, irinotecan, 5-FU o acido folinico;
    - Infezioni attive non controllate o coagulazione intravascolare disseminata attiva.
    - Anamnesi passata o attuale di neoplasie maligne diverse da carcinoma del colon-retto, ad eccezione del carcinoma in situ della cervice e del carcinoma cutaneo a cellule basali o squamose trattato con fini curativi;
    - Gravidanza;
    - Allattamento;
    - Insufficienza cardiaca di grado III o IV (classificazione NYHA);
    - Infarto del miocardio, angina pectoris instabile, angioplastica con palloncino (percutaneous transluminal coronary angioplasty, PTCA) con o senza stent nei 12 mesi precedenti all’inclusione nello studio;
    - Aritmie cardiache che necessitano di terapia antiaritmica, ad eccezione dei beta-bloccanti o della digossina;
    - Menomazioni mediche o psicologiche associate ad una capacità limitata di fornire il proprio consenso o che non consentono il corretto svolgimento dello studio;
    - Precedente chemioterapia per il carcinoma del colon-retto, ad eccezione del trattamento adiuvante, completata almeno 6 mesi prima dell’ingresso nello studio;
    - Partecipazione ad uno studio clinico o assunzione di un trattamento a base di un farmaco sperimentale nei 30 giorni precedenti all’ inclusione nello studio o durante la partecipazione alla sperimentazione;
    - Metastasi cerebrali note o clinicamente sospette;
    - Anamnesi di occlusione intestinale acuta o subacuta, malattia infiammatoria cronica intestinale o diarrea cronica;
    - Fratture ossee, ulcere o ferite gravi non cicatrizzanti;
    - Ipertensione non controllata;
    - Marcata proteinuria (sindrome nefrosica);
    - Carenza nota di diidropirimidina deidrogenasi (DPD) (non è necessario uno screening specifico);
    - Precedenti noti di abuso di alcol o sostanze stupefacenti;
    - Malattia concomitante significativa che, a giudizio dello sperimentatore, preclude la partecipazione del paziente allo studio;
    - Capacità giuridica assente o limitata.
    E.5 End points
    E.5.1Primary end point(s)
    Co-Primary:
    - Progression-free survival (PFS)
    - Incidence of grade 3-4 AEs
    Co-Primario:
    - Progressione libera da malattia
    - Incidenza di eventi avversi di grado 3-4
    E.5.1.1Timepoint(s) of evaluation of this end point
    Until progression
    Fino a progressione
    E.5.2Secondary end point(s)
    Secondary:
    - Response rate
    - Early tumor shrinkage (8 weeks)
    - Overall survival
    - Cetuximab-related skin toxicity
    - Safety profile
    - Quality of life
    - Molecular profiles of tumor tissue and liquid biopsy
    - Potential predictive factors (somatic mutations identified in tumor tissue by next generation sequencing) and surrogate markers of treatment activity (changes in molecular profile of liquid biopsies)
    Secondari:
    - Tasso di risposta
    - Riduzione precoce della massa tumorale (8 settimane)
    - Sopravvivenza globale
    - Tossicità cutanea correlata a Cetuximab
    - Profilo di sicurezza
    - Qualità della vita
    - Profili molecolari del tessuto tumorale e biopsia liquida
    - Potenziali fattori predittivi (mutazioni somatiche individuate nel tessuto tumorale mediante sequenziamento di nuova generazione) e marcatori surrogati dell’attività del trattamento (variazioni del profilo molecolare delle biopsie liquide)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Until death
    Fino a sopravvivenza
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned60
    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 Yes
    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 years
    E.8.9.1In the Member State concerned months43
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state600
    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)
    At study conclusion the patients will be followed according to Clinical Practice
    Al termine dello studio i pazienti continueranno ad essere seguiti in accordo alla Pratica 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 Decision2014-12-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-23
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