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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41046   clinical trials with a EudraCT protocol, of which   6718   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    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:2014-004438-24
    Sponsor's Protocol Code Number:M14-483
    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:2021-09-07
    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 number2014-004438-24
    A.3Full title of the trial
    ABT-414 alone or ABT-414 plus temozolomide versus lomustine or temozolomide for recurrent glioblastoma: a randomized phase II study of the EORTC Brain Tumor Group.
    ABT 414 in monoterapia o ABT 414 in associazione a temozolomide versus lomustina o temozolomide nel trattamento del glioblastoma recidivante: sperimentazione randomizzata di fase 2 dell’EORTC Brain Tumor Group
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ABT-414 alone or ABT-414 plus temozolomide versus temozolomide or lomustine alone in subjects with recurrent glioblastoma.
    ABT-414 in monoterapia o ABT-414 in associazione a temozolomide versus lomustina o temozolomide in monoterapia nel trattamento di soggetti con glioblastoma recidivante
    A.3.2Name or abbreviated title of the trial where available
    not available
    non disponibile
    A.4.1Sponsor's protocol code numberM14-483
    A.5.4Other Identifiers
    Name:1410-BTG EORTC Protocol NumberNumber:1410-BTG EORTC Protocol Number
    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 SponsorABBVIE DEUTSCHLAND GMBH & CO. KG
    B.1.3.4CountryGermany
    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 supportAbbvie Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 1628 773355
    B.5.5Fax number+44 1628 672566
    B.5.6E-maileu-clinical-trials@abbvie.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1305
    D.3 Description of the IMP
    D.3.1Product nameABT-414
    D.3.2Product code ABT-414
    D.3.4Pharmaceutical form Powder 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 INNABT-414
    D.3.9.2Current sponsor codeABT-414
    D.3.9.4EV Substance CodeSUB83643
    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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 RoleComparator
    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 TEMOZOLOMIDE CRINOS - 140 MG CAPSULE RIGIDE 5 CAPSULE IN FLACONE IN VETRO CON CHIUSURA A PROVA DI BAMBINO
    D.2.1.1.2Name of the Marketing Authorisation holderCRINOS S.P.A.
    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.3.1Product nameTEMOZOLOMIDE
    D.3.2Product code TEMOZOLOMIDE
    D.3.4Pharmaceutical form Capsule, hard
    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 INNTEMOZOLOMIDE
    D.3.9.2Current sponsor codenon applicabile
    D.3.9.3Other descriptive nameTEMOZOLOMIDE
    D.3.9.4EV Substance CodeSUB10889MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 Information not present in EudraCT
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 TEMOZOLOMIDE CRINOS - 140 MG CAPSULE RIGIDE 5 CAPSULE IN FLACONE IN VETRO CON CHIUSURA A PROVA DI BAMBINO
    D.2.1.1.2Name of the Marketing Authorisation holderCRINOS S.P.A.
    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.3.1Product nameTEMOZOLOMIDE
    D.3.2Product code TEMOZOLOMIDE
    D.3.4Pharmaceutical form Capsule, hard
    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 INNTEMOZOLOMIDE
    D.3.9.2Current sponsor codeNON APPLICABILE
    D.3.9.3Other descriptive nameTEMOZOLOMIDE
    D.3.9.4EV Substance CodeSUB10889MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 TEMOZOLOMIDE CRINOS - 140 MG CAPSULE RIGIDE 5 CAPSULE IN FLACONE IN VETRO CON CHIUSURA A PROVA DI BAMBINO
    D.2.1.1.2Name of the Marketing Authorisation holderCRINOS S.P.A.
    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.3.1Product nameTEMOZOLOMIDE
    D.3.2Product code TEMOZOLOMIDE
    D.3.4Pharmaceutical form Capsule, hard
    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 INNTEMOZOLOMIDE
    D.3.9.2Current sponsor codeNON APPLICABILE
    D.3.9.3Other descriptive nameTEMOZOLOMIDE
    D.3.9.4EV Substance CodeSUB10889MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    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: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 nameLOMUSTINA
    D.3.2Product code LOMUSTINA
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLOMUSTINA
    D.3.9.2Current sponsor codeNON APPLICABILE
    D.3.9.3Other descriptive nameLOMUSTINE
    D.3.9.4EV Substance CodeSUB08567MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Glioblastoma Multiforme
    Glioblastoma Multiforme
    E.1.1.1Medical condition in easily understood language
    Recurrent Glioblastoma, a rare and aggressive type of brain tumor.
    Glioblastoma recidivante, una tipologia di tumore cerebrale raro ed aggressivo
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018336
    E.1.2Term Glioblastoma
    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
    Overall Survival and Progression Free survival according to RANO criteria and assessed at interim analysis.
    Sopravvivenza globale e sopravvivenza libera da progressione in accordo ai criteri RANO valutate in occasione dell’analisi ad interim.
    E.2.2Secondary objectives of the trial
    Progression Free Survival according to RANO criteria, Objective Response Rate, Overall Survival in the subgroup with EGFRvIII mutation.
    Sopravvivenza libera da progressione in base ai criteri RANO, tasso di risposta oggettiva, Sopravvivenza globale nel sottogruppo di soggetti con mutazione EGFRvIII
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenetics
    Version: si veda protocollo principale
    Date: 15/04/2015
    Title: see main protocol
    Objectives: There is a pharmacogenetic sub-study where the samples will be stored at AbbVie.
    There is also an optional translational and genetic sub-study where the samples will be biobanked with EORTC.

    Farmacogenetica
    Versione: si veda protocollo principale
    Data: 15/04/2015
    Titolo: si veda protocollo principale
    Obiettivi: E' previsto un sottostudio di farmacogenetica in cui campioni verranno conservati presso AbbVie.
    Inoltre è prevista una ricerca traslazionale opzionale e un sottostudio genetico nei quali I campioni verranno conservati presso la biobanca dell'EORTC
    E.3Principal inclusion criteria
    1. Histologically confirmed de novo (primary) GBM with unequivocal tumor progression or recurrence.
    2. In case of testing at the time of first progression: either at least 3 months after the end of radiotherapy or have tumor progression that is clearly outside the radiation field or have tumor progression
    unequivocally proven by surgery/biopsy
    3. Age = 18 years
    4. Absence of any psychological, familial, sociological or geographical
    factors potentially hampering compliance with the study protocol and
    follow-up schedule; such conditions should be assessed with the patient before registration in the trial.
    5. Availability of adequate biological material (formalin-fixed paraffin embedded [FFPE] tumor) for central testing of EGFR amplification
    6. Presence of EGFR amplification confirmed by central assessment; patients with undetermined EGFR status are excluded
    7. WHO Performance status 0 - 2
    8. No more than one line of chemotherapy (concurrent and adjuvant TMZ based chemotherapy including in combination with another
    investigational agent is considered one line of chemotherapy).
    Chemotherapy must have been completed at least 4 weeks prior to randomization.
    1)Soggetti con glioblastoma de novo (primario) confermato istologicamente, con evidenza univoca di progressione tumorale o recidivanti.
    2)Se l’esame istologico è stato eseguito al momento della prima progressione, è necessario che siano trascorsi almeno 3 mesi dalla fine della radioterapia oppure che vi sia evidenza di progressione tumorale nettamente al di fuori del sito irradiato oppure che la progressione tumorale sia inequivocabilmente confermata da chirurgia/biopsia
    3)Soggetti di età = 18 anni
    4)Soggetti che non presentano alcun fattore di natura psicologica, familiare, sociologica o geografica che potrebbero interferire con l’adesione ai requisiti del protocollo di sperimetazione e al programma di follow-up; è necessario verificare l’eventuale presenza di tali condizioni prima di arruolare il paziente nella sperimentazione.
    5)Soggetti per cui è disponibile un campione adeguato di materiale biologico (campione tumorale fissato in formalina e incluso in paraffina (FFPE) da inviare al laboratorio centralizzato per essere sottoposto ad analisi per rilevare l’amplificazione del gene per l’EGFR
    6)Soggetti con amplificazione del gene per l’EGFR confermata dal laboratorio centralizzato; saranno esclusi i pazienti con lo status EGFR non definito.
    7)Soggetti con punteggio WHO Performance status 0 – 2
    8)Soggetti che non hanno ricevuto più di una linea di chemioterapia (si considera una linea di chemioterapia il trattamento con TMZ concomitante e adiuvante, anche se in combinazione con altro agente sperimentale). La chemioterapia deve essere stata completata almeno 4 settimane prima della randomizzazione
    E.4Principal exclusion criteria
    1. Prior treatment with nitrosoureas
    2. Prior treatment with bevacizumab
    3. Previous exposure to EGFR targeted agents, including EGFRvIII
    targeting agents
    4. Prior discontinuation of temozolomide chemotherapy for toxicity
    reasons
    5. Prior RT with a dose over 65 Gy, stereotactic radiosurgery or
    brachytherapy unless the recurrence is histologically proven
    6. Previous other malignancies, except for any previous malignancy
    which was treated with curative intent more than 5 years prior to
    randomization, and except for adequately controlled limited basal cell
    carcinoma of the skin, squamous carcinoma of the skin or carcinoma in
    situ of the cervix
    7. Women of childbearing potential must have a negative serum or urine
    pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG)
    within 72 hours prior to randomization
    1)Trattamento pregresso con nitrosouree
    2)Trattamento progresso con bevacizumab
    3)Esposizione pregressa ad agenti anti-EGFR, compresi agenti diretti contro l’EGFRvIII
    4)Soggetti che non abbiano interrotto un pregresso trattamento chemioterapico con temozolomide a causa di tossicità
    5)Soggetti che hanno ricevuto radioterapia pregressa a dosi superiori a 65 Gy, radiochirurgia stereotassica oppure brachiterapia, eccetto se la recidiva viene confermata istologicamente
    6)Storia di altre neoplasie maligne, ad eccezione di qualsiasi neoplasia maligna trattata con intento curativo oltre 5 anni prima della randomizzazione e ad eccezione di limitato e adeguatamente controllato: carcinoma cutaneo basocellulare, carcinoma cutaneo squamocellulare oppure carcinoma in situ della cervice uterina
    7)Le donne in età fertile devono avere un risultato negativo al test di gravidanza su siero o urine (sensibilità minima 25 IU/L oppure unità equivalenti di HCG) nelle 72 ore precedenti la randomizzazione.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival and Progression Free survival according to RANO criteria and assessed at interim analysis.
    Sopravvivenza globale e sopravvivenza libera da progressione in accordo ai criteri RANO valutate in occasione dell’analisi ad interim
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall Survival at final analysis and Progression Free Survival at interim futility analysis after observation of 45 PFS events.
    Sopravvivenza globale rilevata all’analisi finale e sopravvivenza libera da progressione in base ai criteri RANO valutate in occasione dell’analisi ad interim dopo l’osservazione di 45 eventi PFS
    E.5.2Secondary end point(s)
    • Progression Free Survival
    • Overall Response Rate (ORR)
    • Overall Survival in the subgroup with Epithelial Growth Factor
    Receptor (EGFRvIII) mutation.
    •Sopravvivenza libera da progressione
    •Tasso di risposta oggettiva (ORR)
    •Sopravvivenza globale nel sottogruppo di soggetti con mutazione EGFRvIII
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Progression Free Survival as assessed by RANO from date of randomization to date of first objective progression (or death).
    • The overall response rate will be evaluated at each assessment of disease according to RANO criteria.
    • Subgroup with EGFR vIII mutation will be measured up to 28 months (study length), until death, or lost to follow up.
    •Sopravvivenza libera da progressione in base ai criteri RANO valutata dalla data della randomizzazione alla data della prima progressione obiettiva (o morte)
    •Il tasso di risposta oggettiva sarà calcolato ad ogni valutazione della patologa in base ai criteri RANO
    •Il sottogruppo con mutazione EGFRvIII sarà misurato fino a 28 mesi (lunghezza della sperimentazione), fino alla morte, o fino a perdita del follow-up
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Translational research
    Ricerca traslazionale
    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 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 trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Austria
    Belgium
    Canada
    Czechia
    Finland
    France
    Germany
    Hungary
    Ireland
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Puerto Rico
    Singapore
    Spain
    Switzerland
    Taiwan
    United Kingdom
    United States
    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
    Subjects will be followed until death or lost to follow up
    I pazienti verranno seguiti fino alla morte o fino alla fine del follow-up
    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 months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Brain Cancer Patients - terminally ill.
    Pazienti con cancro al cervello - malati terminali.
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 240
    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)
    Will be discussed between Investigator and subject. Informed consent states that there will be follow up contact, and also arrangement for continuing care.
    Sarà discusso tra lo Sperimentatore ed il soggetto. Il consenso informato stabilisce che verranno effettuati dei contatti di follow-up ed inoltre descrive le cure successive
    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 Decision2015-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-25
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA