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    Summary
    EudraCT Number:2015-002185-23
    Sponsor's Protocol Code Number:DIPG
    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:2020-11-04
    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 number2015-002185-23
    A.3Full title of the trial
    Phase 2 open label randomized study of radiotherapy, concomitant nimotuzumab and vinorelbine and re-irradiation at relapse versus radiotherapy and multiple elective radiotherapy courses with concomitant vinorelbine and nimotuzumab for newly diagnosed childhood and adolescence diffuse intrinsic pontine glioma (DIPG)
    Studio randomizzato di radioterapia, nimotuzumab e vinorelbina concomitanti e re-irradiazione alla recidiva rispetto a radioterapia a più cicli elettiva con vinorelbina e nimotuzumab concomitanti, in bambini e adolescenti con nuova diagnosi glioma diffuso intrinseco del ponte (DIPG)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study is designed for patients diagnosed with a brain tumor (diffuse intrinsic pontine glioma) aged from 2 to 21 years old.
    Lo studio è pensato per pazienti affetti da un tumore cerebrale (glioma diffuso intrinseco del ponte) che abbiano età compresa tra 2 e 21 anni.
    A.3.2Name or abbreviated title of the trial where available
    INT - DIPG 2015
    INT - DIPG 2015
    A.4.1Sponsor's protocol code numberDIPG
    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 SponsorFONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
    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 supportdonazioni modali
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Istituto Nazionale dei Tumori
    B.5.2Functional name of contact pointS.C. Pediatria Oncologica
    B.5.3 Address:
    B.5.3.1Street Addressvia Giacomo Venezian, 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number0223902590
    B.5.5Fax number0223902648
    B.5.6E-mailluna.boschetti@istitutotumori.mi.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 NAVELBINE - 10 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONE 1 ML
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE PHARMA S.R.L.
    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 nameVinorelbina
    D.3.2Product code [vinorelbina]
    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.3.9.1CAS number 71486-22-1
    D.3.9.2Current sponsor codeVinorelbina
    D.3.9.3Other descriptive nameVinorelbine
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 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 CIMAher
    D.2.1.1.2Name of the Marketing Authorisation holderCECMED
    D.2.1.2Country which granted the Marketing AuthorisationCuba
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberORPHA82913
    D.3 Description of the IMP
    D.3.1Product nameCimaher
    D.3.2Product code [Cimaher]
    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.3.9.1CAS number 0828933-51-3
    D.3.9.2Current sponsor codeNimotuzumab
    D.3.9.3Other descriptive nameNimotuzumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200 to 400
    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) Yes
    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
    diffuse intrinsic pontine glioma
    glioma diffuso intrinseco del ponte
    E.1.1.1Medical condition in easily understood language
    children and adolescent affected by malignant glioma of the brain stem
    bambini e adolescenti di età superiore a 2 anni affetti da glioma maligno del tronco encefalico
    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 10006143
    E.1.2Term Brain stem glioma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary aim of this study will be to compare the best response up to 36 weeks (CR+PR) between conventional and experimental irradiation. Such an end point was chosen since tumor reduction has been demonstrated to be correlated with better PFS and OS. The response will be evaluated according to radiological and clinical criteria
    Esaminare la fattibilità, il tasso di risposta e i risultati di progressione libera da malattia (PFS) e sopravvivenza globale (OS) in uno studio randomizzato che confronta due diversi schemi di irradiazione per DIPG durante la somministrazione dello stesso trattamento sistemico
    E.2.2Secondary objectives of the trial
    To compare the disease stabilization rate (considering SD only) up to week 36 between the two arms. The evaluation will be done according to radiological and clinical criteria; to compare PFS and OS between the two arms; to assess safety of radiotherapy; to assess the quality of life and life situation. • To assess PFS and OS of diffuse midline glioma with K27 mutation using the standard arm of the main protocol
    Confrontare il tasso di stabilizzazione della malattia (considerando solo SD) fino a 36 settimane nei due bracci. La valutazione sarà fatta in accordo con criteri radiologici e clinici; confrontare PFS e OS nei due bracci; valutare la sicurezza della radioterapia; valutare la qualità di vita. Valutare PFS e OS dei gliomi diffusi della linea mediana con mutazione k27 usando come confronto il braccio standard dello studio principale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients from 2 to 21 years old will be eligible
    - No previous treatment consented apart from steroids
    - Strict eligibility criteria will radiologically-verified DIPG (an intrinsic, pontine-based infiltrative lesion hypointense on T1- and hyperintense on T2-weighted sequences, involving at least 2/3 of the pons)
    - Symptoms lasting less than 6 months
    - Life expectancy =4 weeks
    - Karnowski/Lansky performance status > or = 40 %
    - No organ dysfunction
    - No pregnancy or breast-feeding
    - Patients undergo baseline cranial MRI with gadolinium, to be repeated if treatment begins more than 2 weeks; spinal MRI due to the occurrence of metastatic cases at diagnosis will also be mandatory
    - Written and signed informed consent from parents or legal guardians will be obtained before starting the treatment-
    - For diffuse midline glioma observational arm, central reviewed pathology of the disease according to standard Italian procedure, i.e. referral to the Neuropathology at Sapienza University in Rome.
    - pazienti di età compresa tra 2 e 21 anni
    - pazienti che non abbiano ricevuto alcun trattamento pregresso a parte l’assunzione di steroidi
    - verifica radiologica di DIPG (una lesione intrinseca, pontina infiltrante ipointensa in T1 ed iperintensa in T2 in sequenze pesate, che coinvolgono almeno 2/3 del ponte)
    - pazienti con sintomatologia da meno di 6 mesi
    - aspettativa di vita di almeno 4 settimane
    - Karnowski/Lansky > o = 40 %
    - nessuna disfunzione d’organo
    - pazienti non in gravidanza o allattamento
    - risonanza magnetica (RM) basale dell’encefalo con gadolinio, che va ripetuta nel caso in cui il trattamento non cominci entro due settimane; sarà inoltre obbligatoria una risonanza del midollo per casi metastatici alla diagnosi
    - ottenimento della firma sul consenso informato scritto da parte dei genitori/tutori legali prima dell’inizio dello studio.
    - per i pazienti con glioma diffuso del braccio osservazionale verrà fatta una revisione istologica in accordo alle procedure italiane standard facendo riferimento al reparto di Neuropatologia dell’Università la Sapienza di Roma.
    E.4Principal exclusion criteria
    - Patients below 2 years or over 21
    - Pre-treatment with radio or chemotherapy
    - Neurofibromatosis 1
    - Non-typical imaging
    - Symptoms duration over 6 months, Lansky/Karnowski scores below 40
    - Metastatic disease as shown by MRI
    - Organ disfunction, pregnancy or breast-feeding
    - Absence of parents, patient or tutor consent
    - Not central review diagnosis of diffuse midline glioma histone H3, K27 mutated
    - Pazienti di età inferiore ai 2 anni e superiore ai 21
    - Pazienti pre-trattati con radio o chemioterapia
    - Pazienti affetti da Neurofibromatosi 1
    - Immagini radiologiche non tipiche per la malattia
    - Durata dei sintomi superiore ai 6 mesi, Lansky/Karnowski inferiore al 40%
    - Malattia metastatica dimostrata dalla RM
    - Disfunzione d’organo, gravidanza o allattamento
    - Mancanza del consenso da parte dei genitori, del paziente o dei tutori legali
    - Nessuna revisione centrale alla diagnosi di glioma diffuso della linea mediana con mutazione di K27
    E.5 End points
    E.5.1Primary end point(s)
    number of best responses (complete and partial responses) up to week 36 will be calculated in the conventional and experimental irradiation arms, and the comparison between the response rates will be performed
    numero di risposte (complete e parziali) entro la 36esima settimana calcolato nei due bracci di trattamento. Verrà eseguito il confronto tra i tassi di risposta
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 months
    36 mesi
    E.5.2Secondary end point(s)
    first progression of disease, first recurrence, secondary malignancy, death
    prima progressione di malattia, prima recidiva, diagnosi di secondo tumore, morte
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    assessment of quality of life and life situation
    valutazione della qualità della vita
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 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 concerned7
    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 Information not present in EudraCT
    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 years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    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 Yes
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 38
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 6
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    in children and adolescents who are too young to give consent, according to local law, will be required to sign an informed consent to parents / guardians. The consent of the patient may be required or not according to the local legislation.
    a bambini e adolescenti che sono troppo piccoli per dare il proprio consenso, in base alla legislazione locale, verrà richiesta la sottoscrizione di un consenso informato da parte dei genitori/tutori. L’assenso dei pazienti può essere richiesto o men
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state79
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 79
    F.4.2.2In the whole clinical trial 79
    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)
    patients will be kept in follow-up
    i pazienti vengono mantenuti in follow-up
    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 Decision2015-07-29
    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
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