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    Summary
    EudraCT Number:2016-001577-33
    Sponsor's Protocol Code Number:D24-DIPG
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-08-18
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-001577-33
    A.3Full title of the trial
    Phase I Trial of DNX-2401 for Diffuse Intrinsic Pontine Glioma newly diagnosed in pediatric patients.
    Ensayo en fase I del virus DNX2401 para los gliomas difusos de protuberancia de nuevo diagnóstico en pacientes pediátricos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase I Trial of DNX-2401 for Diffuse Intrinsic Pontine Glioma newly diagnosed in pediatric patients.
    Ensayo en fase I del virus DNX2401 para los gliomas difusos de protuberancia de nuevo diagnóstico en pacientes pediátricos
    A.4.1Sponsor's protocol code numberD24-DIPG
    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 SponsorClínica Universidad de Navarra
    B.1.3.4CountrySpain
    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 supportClínica Universidad de Navarra
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClínica Universidad de Navarra
    B.5.2Functional name of contact pointUCEC
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de Pío XII, 36
    B.5.3.2Town/ cityPamplona
    B.5.3.3Post code31008
    B.5.3.4CountrySpain
    B.5.4Telephone number349482554002725
    B.5.5Fax number34948296667
    B.5.6E-mailucicec@unav.es
    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 nameadenovirus DNX-2401
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntratumoral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAd-DNX-2401
    D.3.9.3Other descriptive nameAdenovirus DNX-2401
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50000000000
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    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 newly diagnosed in pediatric patients.
    Glioma pontino intrísseco difuso recién diagnosticada en pacientes pediátricos.
    E.1.1.1Medical condition in easily understood language
    Diffuse Intrinsic Pontine Glioma newly diagnosed in pediatric patients.
    Glioma pontino intrísseco difuso recién diagnosticada en pacientes pediátricos.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety, tolerability and toxicity of DNX-2401 injected in the cerebellar peduncle in pediatric subjects with DIPG. The trial will look for hematologic and neurologic toxicity (NCI-CTCAE v 4.03).
    Determinar la seguridad, tolerabilidad y toxicidad de DNX-2401 inyectada en el pedúnculo cerebeloso en sujetos pediátricos con DIPG. El ensayo buscará la toxicidad hematológica y neurológica (NCI-CTCAE v 4.03).
    E.2.2Secondary objectives of the trial
    •To determine Overall Survival at 12 months (OS12), complete/partial response in MRI, immune response induced by DNX-2401.
    •To measure quality of life (QoL) baseline assessment and any changes over time
    •To collect tumor and blood samples for futures molecular and immune studies.
    • Determinar la supervivencia global a los 12 meses (OS12), respuesta completa / parcial en la resonancia magnética, la respuesta inmune inducida por DNX-2401.
    • Medir la calidad de vida (CdV) evaluación inicial y cualquier cambio en el tiempo
    • Recoger muestras de tumor y de sangre para futuros estudios moleculares y inmunes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent OF PATIENT OR PARENTS
    2. Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
    3. Age 1 - 18 years
    4. Negative pregnant blood test in case of fertile women (A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
    5. Patient newly diagnosed of DIPG in MRI
    6. Lansky Performance Status ≥ 70 before inclusion
    7. Lesion considered by the investigator to be accessible for stereotactic biopsy. Lesion location will allow injection without entrance of virus in the ventricular system.
    8. No previous treatment for DIPG
    1. Consentimiento informado del paciente o PADRES
    2. El paciente debe ser, en opinión del investigador, capaz de cumplir con todos los procedimientos de protocolo.
    3. Edad 1 - 18 años
    4. Negativo para la prueba de embarazado en sangre en el caso de las mujeres fértiles (Una mujer se considera en edad fértil (WOCBP), es decir, fértil, después de la menarquia y a menos que sea estéril de manera permanente. Métodos de esterilización permanente incluyen la histerectomía, salpingectomía bilateral y ooforectomía bilateral.
    5. El paciente recién diagnosticado de DIPG en la RM
    6. Estado funcional Lansky de ≥ 70 antes de la inclusión
    7. Lesión consideradas por el investigador sea accesible para la biopsia estereotáctica. localización de la lesión permitirá inyección sin entrada de virus en el sistema ventricular.
    8. No hay un tratamiento previo para DIPG
    E.4Principal exclusion criteria
    1. Severe infections or intercurrent medical conditions including, but not limited to, severe renal, hepatic, heart or bone marrow failure, that, on investigator´s criteria, do not allow the inclusion. Patients must be afebrile at baseline [i.e., < 38 degrees (Cº)].
    2. Investigational medication in the previous 30 days.
    3. Subjects with immunodeficiency, autoimmune conditions or active hepatitis.
    4. Any medical or psychological condition that might interfere with the subject's ability to participate if older than 16 years or parents ability when younger than 16, or give informed consent or would compromise the patient’s ability to tolerate therapy or any disease that will obscure toxicity or dangerously alter drug metabolism.
    5. Tumor with multiple locations or doubt in MRI of a DIPG.
    6. Pregnant or breast-feeding females will be excluded, due to the risk for the fetal development of a recombinant virus containing genes related to cellular growth and differentiation.
    7. Severe bone marrow hypoplasia.
    8. AST and/or ALT > 3 times over upper normal laboratory level
    9. Neutrophils < 1 x 109/L
    10. Thrombocytes ≤ 100 x 109/L
    11. Hemoglobin < 9g/dl
    13. Patients with Li-Fraumini Syndrome or with a known germ line deficit in the retinoblastoma gene or its related pathways.
    14. Vaccinations of any kind within 30 days prior to DNX-2401 administration.
    15. Transfusions or medications (G-CSF) to treat pancytopenia or other hematological conditions within 28 days of baseline.
    1. Las infecciones graves o condiciones médicas intercurrentes incluyendo, pero no limitado a, renal grave, insuficiencia hepática, insuficiencia cardíaca o la médula ósea, que, en los criterios del investigador, no permite la inserción. Los pacientes deben estar sin fiebre al inicio del estudio [es decir, <38 grados (Cº)].
    2. medicamento en investigación en los 30 días anteriores.
    3. Los sujetos con inmunodeficiencia, enfermedades autoinmunes o hepatitis activa.
    4. Cualquier condición médica o psicológica que pueda interferir con la capacidad del sujeto para participar, de ser mayor de 16 años o los padres la capacidad de joven de 16 años, o de dar su consentimiento informado o pondría en peligro la capacidad del paciente para tolerar la terapia o cualquier enfermedad que va a oscurecer toxicidad o peligrosamente alterar el metabolismo de fármacos.
    5. tumor con varias ubicaciones o duda en resonancia magnética de un DIPG.
    serán excluidos 6. Las mujeres embarazadas o en periodo de lactancia, debido al riesgo para el desarrollo fetal de un virus recombinante que contiene los genes relacionados con el crecimiento y la diferenciación celular.
    7. severa hipoplasia de la médula ósea.
    8. AST y / o ALT> 3 veces sobre el nivel normal de laboratorio superior
    9. Los neutrófilos <1 x 109 / L
    10. Los trombocitos ≤ 100 x 109 / l
    11. La hemoglobina <9 g / dl
    13. Los pacientes con el síndrome de Li-Fraumini o con un déficit línea germinal conocido en el gen del retinoblastoma o sus vías relacionadas.
    14. Las vacunas de ningún tipo dentro de los 30 días antes de la administración DNX-2401.
    15. Las transfusiones o medicamentos (G-CSF) para tratar la pancitopenia u otras afecciones hematológicas dentro de los 28 días del inicio del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    To determine the safety, tolerability and toxicity of DNX-2401 injected in the cerebellar peduncle in pediatric subjects with DIPG. The trial will look for hematologic and neurologic toxicity.
    Determinar la seguridad, tolerancia y toxicidad del virus DNX-2401 inyectado en el pedúnculo cerebral de pacientes pediátricos con glioma difuso de protuberancia. El ensayo buscará espeficamente toxicidad hematológica y neurológica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For each individual patient the timepoint of evaluation will be two months after DNX.2401 injection, Fort he whole trial, could be 26-30 months (if the 12 patients are recruited along 24 months)
    Para cada individuo, la evaluación del objetivo primario se realizará pasados dos meses de la inyección de DNX-2401. Para todo el ensayo clínico podría ser tras 26-30 meses (si se reclutan los 12 pacientes a lo largo de 24 meses).
    E.5.2Secondary end point(s)
    - To determine Overall Survival at 12 months (OS12), complete/partial response in MRI and immune response induced by DNX-2401.
    - To measure quality of life (QoL) baseline assessment and any changes over time.
    - To collect tumor and blood samples for futures molecular and immune studies.
    - Determinar la supervivencia global a 12 meses, respuesta completa/parcial en resonancia magnética y respuesta inmune inducida por DNX-2401.
    - Cuantificar la calidad vida alcanzada y los cambios a lo largo del tiempo.
    - Recoger muestras de tumor y de sangre para futuros estudios moleculares e inmunológicos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months after virus injection.
    12 meses tras la inyección del virus.
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    First administration in pediatric population
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 Yes
    E.8.1.7.1Other trial design description
    3x3
    3x3
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Última visita último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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 Yes
    F.1.1Number of subjects for this age range: 12
    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: 4
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 8
    F.1.2Adults (18-64 years) No
    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 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 state12
    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
    Ninguno
    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 Decision2016-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-30
    P. End of Trial
    P.End of Trial StatusOngoing
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