Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-002801-12
    Sponsor's Protocol Code Number:ONT-380-206
    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:2021-06-18
    Trial results View 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 number2015-002801-12
    A.3Full title of the trial
    Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs. Placebo in Combination with Capecitabine and Trastuzumab in
    Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB)
    Studio di fase 2 randomizzato, controllato, in doppio cieco su tucatinib vs. placebo in associazione a capecitabina e trastuzumab in pazienti con carcinoma mammario HER2+ metastatico o localmente avanzato, non resecabile, precedentemente trattato (HER2CLIMB)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial comparing tucatinib against placebo in patients who have advanced breast cancer and are being treated with capecitabine and trastuzamab
    Un studio clinico di confronto tucatinib contro placebo in pazienti che hanno avanzato il cancro al seno e che sono in trattamento con capecitabina e trastuzamab
    A.3.2Name or abbreviated title of the trial where available
    A clinical trial comparing tucatinib against placebo in patients who have advanced breast cancer and
    Un studio clinico di confronto tucatinib contro placebo in pazienti che hanno avanzato il cancro al
    A.4.1Sponsor's protocol code numberONT-380-206
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02614794
    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 SponsorCASCADIAN THERAPEUTICS INC
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCASCADIAN THERAPEUTICS INC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCascadian Therapeutics Inc
    B.5.2Functional name of contact pointClinical
    B.5.3 Address:
    B.5.3.1Street Address2601 Fourth Avenue, Suite 500
    B.5.3.2Town/ citySeattle
    B.5.3.3Post codeWA 98121
    B.5.3.4CountryUnited States
    B.5.4Telephone number0012068012900
    B.5.5Fax number0012068012101
    B.5.6E-mailHER2CLIMBinquiries@cascadianrx.com
    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 No
    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 nameTucatinib
    D.3.2Product code ONT-380
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTucatinib
    D.3.9.1CAS number 937263-43-9
    D.3.9.2Current sponsor codeONT-380
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 No
    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 nameTucatinib
    D.3.2Product code ONT-380
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTucatinib
    D.3.9.1CAS number 937263-43-9
    D.3.9.2Current sponsor codeONT-380
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma
    Carcinoma mammario HER2+ metastatico o localmente avanzato, non resecabile, precedentemente trattato
    E.1.1.1Medical condition in easily understood language
    Breast cancer which may have spread
    Il cancro al seno, che pu¿ essere diffuso
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10065430
    E.1.2Term HER2 positive breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of tucatinib vs. placebo in combination with capecitabine and trastuzumab on progression-free survival (PFS) per RECIST 1.1 based on independent central review
    Valutare l'effetto di tucatinib vs. placebo in associazione con capecitabina e trastuzumab sulla sopravvivenza libera da progressione (PFS) sulla base di una valutazione centrale indipendente effettuata secondo i criteri RECIST 1.1
    E.2.2Secondary objectives of the trial
    To assess the effect of tucatinib vs. placebo in combination with capecitabine and trastuzumab
    -In patients with brain metastases at baseline using RECIST 1.1 based on independent central review
    -On OS
    To assess the health-related quality of life and health economics associated with tucatinib vs. placebo in combination with capecitabine and trastuzumab based on patient health status collected using the Eq-5D-5L instrument and health resources utilized patient care
    Safety Objective To assess the safety and tolerability of tucatinib in combination with capecitabine and trastuzumab
    Pharmacokinetic Objective
    To evaluate the pharmacokinetics of tucatinib and metabolite ONT-993 when administered in combination with capecitabine and trastuzumab
    Valutare l'effetto di tucatinib vs. placebo in associazione con capecitabina e trastuzumab in pazienti con metastasi cerebrali al basale sulla base di una valutazione centrale indipendente effettuata secondo i criteri RECIST 1.1
    - sulla sopravvivenza globale
    Valutare la qualità della vita correlata allo stato di salute e l'economia sanitaria collegate a tucatinib vs. placebo in associazione con capecitabina e trastuzumab sullabase dello stato di salute del paziente accertato attraverso lo strumento EQ-5D-5L e le risorse sanitarie utilizzate nell'assistenza ai pazienti.
    Obiettivo di sicurezza
    - Valutare la sicurezza e la tollerabilit¿ di tucatinib in associazione a capecitabina e trastuzumab
    Obiettivo di farmacocinetica
    - Valutare la farmacocinetica di tucatinib e del metabolita ONT-993 quando tucatinib viene somministrato in associazione a capecitabina e
    trastuzumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Have histologically confirmed HER2+ breast carcinoma, with HER2+ defined by fluorescence in situ hybridization (FISH) and/or 3+ staining by immunohistochemistry (IHC)
    Have received previous treatment with a taxane, trastuzumab, pertuzumab, and T-DM1
    Have progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by investigator), or be
    intolerant of last systemic therapy Have measurable or non-measureable disease assessable by RECIST 1.1
    At least 18 years of age at time of consent Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
    Have adequate hepatic function
    Have adequate baseline hematological parameters
    Have creatinine clearance = 50 mL/min
    Have left ventricular ejection fraction (LVEF) = 50%
    If female of childbearing potential, must have a negative result of serum pregnancy test.
    Women of childbearing potential and men with partners of childbearing potential must agree to use a highly effective birth control methods.
    CNS Inclusion – Based on screening brain magnetic resonance imaging (MRI), patients must have one of the following:
    - No evidence of brain metastases
    - Untreated brain metastases not needing immediate local therapy.
    - Previously treated brain metastases
    a. Brain metastases previously treated with local therapy my either be stable since treatment or may have progressed since prior local CNS therapy.
    b. Patients treated with CNS local therapy for newly identified lesions found on initial MRI performed during screening for this study may be eligible to enrol if all of the following criteria are met:
    i. Time since whole brain radiation therapy (WBRT) is > 21 days prior to first dose of treatment, time since stereotactic radiosurgery (SRS) is > 7 days prior to first dose of treatment, or time since surgical resection is > 28 days
    ii. Other sites of evaluable disease are present
    c. Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions
    Diagnosi istologicamente confermata di carcinoma mammario HER2+, con valutazione dello stato di HER2+ effettuata mediante ibridazione in situ (ISH) e/o immunoistochimica (IHC) con score 3+ Precedente trattamento con un tassano, trastuzumab, pertuzumab e TDM1
    Evidenze di progressione di carcinoma mammario metastatico o localmente avanzato, non resecabile, dopo l'ultima terapia sistemica (con conferma dello sperimentatore) o intolleranza all'ultima terapia
    sistemica
    Malattia misurabile o non misurabile, valutabile sulla base dei criteri RECIST 1.1
    Età =18 anni al momento del consenso
    Indice di performance ECOG PS (Eastern Cooperative Oncology Group Performance Status) pari a 0 o 1
    Funzionalità epatica adeguata
    Parametri ematologici adeguati al basale
    Clearance della creatinina =50 mL/min o, nei pazienti con peso = 45 chili, creatinina sierica entro i limiti normali secondo le suddette linee guida locali
    Frazione di eiezione ventricolare sinistra (FEVS) =50%
    Per le donne in età fertile: risultato negativo a un test di gravidanza.
    Le donne in età fertile e gli uomini con partner in età fertile devono acconsentire a usare un metodo contraccettivo altamente efficace.
    Criteri di inclusione per il sottogruppo con metastasi del SNC – In base alla risonanza magnetica (RM) cerebrale con mezzo di contrasto effettuata allo screening, i pazienti devono soddisfare uno dei criteri seguenti
    -Nessuna evidenza di metastasi cerebrali
    - Metastasi cerebrali non trattate che non necessitano di terapia locale immediata.
    - Metastasi cerebrali precedentemente trattate
    a.Le metastasi cerebrali precedentemente trattate con terapia locale possono essere stabili dal trattamento o essere andate incontro a progressione dopo la precedente terapia locale del SNC.
    b. I pazienti trattati con terapia locale del SNC per lesioni di nuova identificazione riscontrate alla RM cerebrale con mezzo di contrasto eseguita durante lo screening per questo studio possono essere considerati idonei all'arruolamento se soddisfano tutti i criteri seguenti:
    i.la radioterapia panencefalica (whole brain radiation therapy, WBRT) deve essere stata effettuata =21 giorni prima della prima dose di
    farmaco in studio; nel caso della radiochirurgia stereotassica (SRS) e della resezione chirurgica, devono essere trascorsi rispettivamente =7 giorni e =28 giorni prima della prima dose di farmaco in studio
    ii.Presenza di altri siti di malattia valutabile
    Disponibilità di documentazione rilevante di qualsiasi trattamento del SNC, per consentire la classificazione delle lesioni target e non-target
    E.4Principal exclusion criteria
    Have previously been treated with:
    a. lapatinib within 12 months of starting study treatment or
    b. neratinib, afatinib, or other investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) at any time previously.
    Have previously been treated with capecitabine for metastatic disease.
    Note patients who have received capecitabine for adjuvant or neoadjuvant treatment at least 12 months prior to starting study treatment are eligible.
    Have any toxicity related to prior cancer therapies that has not resolved to = Grade 1
    Have clinically significant cardiac disease
    Are known carriers of Hepatitis B or Hepatitis C or have other known chronic liver disease
    Are known to be positive for human immunodeficiency virus (HIV)
    Require therapy with warfarin or other coumarin derviatives
    Unable for any reason to undergo MRI of the brain
    CNS Exclusion – Based on screening brain MRI, patients must not have any of the following:
    Any untreated brain metastases > 2.0 cm in size unless discussed with medical monitor and approval for enrolment is given
    Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total dose of > 2mg dexamethasone.
    Any lesion thought to require immediate local therapy. Patients who undergo local treatment for such lesions identified by screening MRI may
    still be eligible for the study based on criteria described under CNS inclusion criteria 20b
    Known or concurrent leptomeningeal disease (LMD)
    Trattamento precedente con:
    a.lapatinib nei 12 mesi precedenti l'inizio del trattamento in studio oppure
    b.neratinib, afatinib o altro HER2/recettore per il fattore di crescita epidermico (EGFR) o inibitore della tirosin-chinasi (TKI) dell'EGFR sperimentali in qualsiasi momento precedente
    Precedente trattamento con capecitabina per la malattia metastatica
    Nota: sono idonei alla partecipazione i pazienti che hanno ricevuto capecitabina in un contesto adiuvante o neoadiuvante almeno 12 mesi prima di iniziare il trattamento in studio
    Tossicità correlate a precedenti trattamenti oncologici che non si siano risolte scendendo a un grado =1.
    Malattia cardiaca clinicamente significativa
    Soggetto portatore noto di epatite B o C o affetto da altre malattie epatiche croniche note
    Positività nota al virus dell'immunodeficienza umana (HIV)
    Necessità di terapia con warfarin o altri derivati cumarinici
    Impossibilità, per qualsiasi motivo, di sottoporsi a RM cerebrale
    Criteri di esclusione per il sottogruppo con metastasi del SNC – In base alla RM cerebrale effettuata allo screening, i pazienti non devono soddisfare nessuno dei criteri seguenti.
    Presenza di metastasi cerebrali >2,0 cm non trattate, salvo discussione del caso e approvazione dell'arruolamento da parte del monitor medico
    Uso continuo di corticosteroidi sistemici con dose giornaliera totale >2 mg di desametasone.
    Qualsiasi lesione per la quale si considera necessaria una terapia locale immediata. I pazienti che si sottopongono a trattamento locale per tali
    lesioni identificate alla RM di screening potranno comunque essere considerati idonei per la partecipazione allo studio sulla base dei criteri
    descritti al punto 19b dei criteri di inclusione per il sottogruppo con metastasi del SNC
    Malattia leptomeningea (LMD) nota o concomitante
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival
    Sopravvivenza libera da progressione
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from randomization to centrally-reviewed documented disease progression (per RECIST 1.1), or death from any cause, whichever occurs first
    Il tempo che intercorre tra la randomizzazione e la progressione documentata della malattia, confermata da valutazione centrale (sulla base dei criteri RECIST 1.1), o il decesso per qualsiasi causa, a seconda di quale evento si verifichi per primo
    E.5.2Secondary end point(s)
    Efficacy
    - PFS in patients with brain metastases at baseline using RECIST 1.1, based on independent central review
    - OS
    Safety
    - Adverse events (AEs)
    Pharmacokinetics
    - Plasma concentrations of tucatinib and metabolites
    Efficacia
    - PFS nei pazienti con metastasi cerebrali al basale sulla base di una valutazione centrale indipendente effettuata secondo i criteri RECIST 1.1
    - OS
    Sicurezza
    - Eventi avversi (AE)
    Farmacocinetica
    - Concentrazioni plasmatiche di tucatinib e del metabolita
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy - Time from randomization to investigator-assessed documented disease progression (per RECIST 1.1), or death from any cause, whichever occurs first
    OS - End of the study
    Safety - Time from randomization to 30 days of last dose.
    Efficacia - il tempo che intercorre tra la randomizzazione e la progressione documentata della malattia, confermata dalla valutazione
    degli sperimentatori (sulla base dei criteri RECIST 1.1), o il decesso per qualsiasi causa, a seconda di quale evento si verifichi per primo
    OS - fine dello studio
    Sicurezza - tempo dalla randomizzazione a 30 giorni di ultima dose.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Israel
    United States
    Austria
    Belgium
    Denmark
    France
    Germany
    Italy
    Netherlands
    Portugal
    Spain
    European Union
    United Kingdom
    Czechia
    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
    The primary analysis study period will be considered completed when approximately 426 centrally-reviewed PFS events have been reported for the randomized population (214 in the subset of patients with brain metastases at baseline). These results will be the basis for the clinical study report. This study will continue to collect relevant clinical and survival follow-up data (which will be analyzed and reported as addenda to the CSR) at the time
    when approximately 350 deaths have been recorded.
    Questo studio continuer¿ a raccogliere dati di follow-up clinico e di sopravvivenza rilevanti (che saranno analizzati e segnalati come addendum alla CSR) nel momento in cui sono state registrate circa 350 morti. Questa ¿ definita come la fine dello studio. Prima di questo, lo sponsor ha il diritto di recedere dal presente studio in qualsiasi momento.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 451
    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 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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 178
    F.4.2.2In the whole clinical trial 480
    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)
    None
    nessuna
    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 Decision2017-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-17
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 28 22:14:49 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA