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    Summary
    EudraCT Number:2016-003498-16
    Sponsor's Protocol Code Number:LOXO-TRK-15003
    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:2016-12-09
    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 number2016-003498-16
    A.3Full title of the trial
    A Phase 1/2 Study of the Oral TRK Inhibitor LOXO-101 in Pediatric Patients with Advanced Solid or Primary Central Nervous System Tumors
    Estudio de fase 1/2 del inhibidor oral de la TRK LOXO 101 en pacientes pediátricos con tumores sólidos avanzados o tumores primarios del sistema nervioso central
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2 Clinical Trial of Pediatric Cancer Patients With Solid Tumors Treated with LOXO-101
    Estudio de fase 1/2 del inhibidor oral de la TRK LOXO 101 en pacientes pediátricos con tumores sólidos avanzados o tumores primarios del sistema nervioso central
    A.3.2Name or abbreviated title of the trial where available
    SCOUT
    A.4.1Sponsor's protocol code numberLOXO-TRK-15003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02637687
    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 SponsorLoxo Oncology 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 supportLoxo Oncology Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace Spain S.L.
    B.5.2Functional name of contact pointMonica Bermejo
    B.5.3 Address:
    B.5.3.1Street AddressC/ Jorge Juan, s/n. Portal 54, Pl 2ª, Puerta Izqda
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28001
    B.5.3.4CountrySpain
    B.5.4Telephone number+349179005655454
    B.5.5Fax number+3491900981853
    B.5.6E-mailSpain.Regulatory@medpace.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/3/15/1606
    D.3 Description of the IMP
    D.3.1Product nameLOXO-101
    D.3.2Product code LOXO-101
    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 INNLOXO-101
    D.3.9.3Other descriptive nameLOXO-101
    D.3.9.4EV Substance CodeSUB179762
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/15/1606
    D.3 Description of the IMP
    D.3.1Product nameLOXO-101
    D.3.2Product code LOXO-101
    D.3.4Pharmaceutical form Oral solution
    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 INNLOXO-101
    D.3.9.3Other descriptive nameLOXO-101
    D.3.9.4EV Substance CodeSUB179762
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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
    Central Nervous System Neoplasms and advanced solid tumors
    Neoplasias del Sistema Nervioso Central y tumores sólidos avanzados
    E.1.1.1Medical condition in easily understood language
    Pediatric Cancer
    Cancer Pediátrico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10007959
    E.1.2Term Central nervous system neoplasm NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10049516
    E.1.2Term Malignant tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10007958
    E.1.2Term Central nervous system neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level HLT
    E.1.2Classification code 10007960
    E.1.2Term Central nervous system neoplasms malignant NEC
    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
    Phase I :
    To determine the safety of oral LOXO-101, including Dose-Limiting Toxicity (DLT), in pediatric patients with advanced solid or primary Central Nervous System tumors.
    Phase II:
    To determine the overall response rate (ORR) as determined by an independent radiology review committee and measured by the proportion of subjects with best overall confirmed response of complete response (CR) or partial response (PR) by the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), or
    Response Assessment in Neuro-Oncology (RANO) criteria, as appropriate, following treatment with LOXO-101 in pediatric subjects with an advanced cancer harboring a fusion involving NTRK1, NTRK2, or NTRK3 (collective referred to as NTRK fusions).
    Fase I:
    Determinar la seguridad de LOXO 101 oral, incluida la toxicidad limitante
    de la dosis en pacientes pediátricos con tumores sólidos avanzados o
    tumores primarios del sistema nervioso central (SNC).
    Fase II:
    Determinar la tasa de respuesta global (TRG) determinada por un comité
    independiente de revisión radiológica y medida mediante el porcentaje
    de pacientes con mejor respuesta global confirmada con respuesta
    completa (RC) o respuesta parcial (RP) según los criterios de evaluación
    de la respuesta en tumores sólidos (Response Evaluation Criteria in Solid
    Tumors), versión 1.1 (RECIST 1.1) o los criterios de evaluación de la
    respuesta en neurooncología (Response Assessment in Neuro-Oncology,
    RANO), según proceda, después del tratamiento con LOXO-101 en
    pacientes pediátricos con cáncer avanzado que fueran portadores de un
    gen de fusión con NTRK1, NTRK2 o NTRK3 (colectivamente denominados
    genes de fusión NTRK).
    E.2.2Secondary objectives of the trial
    To determine the ORR based on the treating investigator's response assessment using RECIST 1.1 or RANO criteria
    To evaluate the duration of response in subjects with best overall response of CR or PR as determined by 1) an independant radilogy review committee and 2) the treating investigator
    To estimate the proportion of subjects that are in tumor regression as a best response
    To evaluate the duration of PPFS following initiation of LOXO 101
    To evaluate the duration of OS following initiation of LOXO 101
    Determinar la TRG basada en la evaluación de la respuesta por el
    investigador responsable del tratamiento, usando los criterios RECIST
    1.1 o RANO, según el tipo de tumor.
    Evaluar la duración de la respuesta (DR) en pacientes con RC o RP como
    mejor respuesta global, determinada por 1) un Comité independiente de
    revisión radiológica y 2) el investigador responsable del tratamiento.
    Estimar el porcentaje de pacientes con cualquier tipo de regresión del
    tumor como mejor respuesta.
    Evaluar la duración de la supervivencia sin progresión (SSP) después del
    inicio de la administración de LOXO-101.
    Evaluar la duración de la supervivencia global (SG) después del inicio de
    la administración de LOXO-101.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Phase 1: between 1 and 21 years of age at C1D1 with a locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was nonresponsive to available therapies for whIch no standard or available systemic curative therapy or
    ≥ 1 month old with a diagnosis of malignancy and with a documented NTRK fusion that hAs progressed or was nonresponsive to available therapies for which no standard or systemic curative therapy exists or
    Patients with locally advanced infantile fibrosarcom who would require in the opinion of the Investigator disfiguring surgery or limb amputation to achieve a complete surgical resection
    Phase 2: ages≥1 month of age at C1D1 with locally advanced or metastatic infantile fibrosarcom who would require in the opinion of the Investigator disfiguring surgery or limb amputation to achieve a complete surgical resection or
    Ages ≥1 month through 21 years of age at C1D1 with a locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was nonresponsive to available therapies for whIch no standard or available systemic curative therapy with a documented NTRK gene fusion
    Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy
    Willingness of male and female patients with reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following study completion
    Ability to swallow capsules, liquid or gastric access via a naso- or gastric tube
    1. Fase I:: Entre 1 y 21 años el día 1 del C1 con un tumor sólido
    metastásico o localmente avanzado o un tumor primario del SNC que
    haya recidivado, progresado o no haya respondido a los tratamientos
    disponibles y para el que no existe tratamiento sistémico curativo
    disponible o de referencia, o:
    De un mes de edad o más con un diagnóstico de neoplasia maligna y
    portador de un gen fusión NTRK documentado que haya progresado o no
    haya respondido a los tratamientos disponibles y para el que no existe
    tratamiento sistémico curativo disponible o de referencia, o:
    Pacientes con fibrosarcoma infantil localmente avanzado que
    necesitaría, en opinión del Investigador, cirugía desfigurante o la
    amputación de un miembro para lograr la resección quirúrgica completa.
    Fase II: : De un mes de edad o más el D1 del C1 con fibrosarcoma
    infantil localmente avanzado o mestastásico, pacientes con fibrosarcoma
    infantil localmente avanzado que necesitarían, en opinión del
    Investigador, cirugía desfigurante o la amputación de un miembro para
    lograr la resección quirúrgica completa o:
    De edades entre 1 mes y 21 años el día 1 del C1 con un tumor sólido
    metastásico o localmente avanzado o un tumor primario del SNC que
    haya recidivado, progresado o no haya respondido a los tratamientos
    disponibles y para el que no Los pacientes deben haberse recuperado
    totalmente de los efectos tóxicos agudos de toda la quimioterapia
    antineoplásica anterior.
    Disposición de los varones y las mujeres en edad potencialmente fértil
    para utilizar métodos anticonceptivos eficaces habituales durante la
    administración del tratamiento y los 3 meses posteriores a que se
    complete el estudio
    Capacidad para tragar las cápsulas, el líquido o acceso gástrico mediante
    tubo nasal o gástrico.
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria are to be excluded from study participation:
    1. Major surgery within 14 days (2 weeks) prior to C1D1 and able to tolerate oral medications.
    2. Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to C1D1; ongoing cardiomyopathy; or current prolonged QTc interval > 480 milliseconds.
    3. Active uncontrolled systemic bacterial, viral, or fungal infection.
    4. Malabsorption syndrome or other condition affecting oral absorption.
    5. Current treatment with a strong CYP3A4 inhibitor or inducer other than those allowed per Section 6.3.2 of the study protocol.
    6. Pregnancy or lactation.
    7. Phase 2 only: Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK, including entrectinib, crizotinib and lestaurtanib. Patients who received a TRK inhibitor for less than 28 days of treatment and discontinued because of intolerance remain eligible.
    Se excluirá del estudio a los pacientes que cumplan alguno de los
    criterios siguientes:
    1.Cirugía mayor en el plazo de 14 días (2 semanas) antes del D1 del C1 y
    capaz de tolerar medicamentos orales.
    2.Enfermedad cardiovascular activa clínicamente significativa o
    antecedentes de infarto agudo de miocardio en los 6 meses anteriores al
    D1 del C1; cardiomiopatía actual; o intervalo QTc prolongado actual
    superior a 480 milisegundos.
    3.Infección bacteriana, vírica o fúngica sistémica activa no controlada.
    4.Síndrome de malabsorción u otro proceso patológico que afecte a la
    absorción oral.
    5.Tratamiento actual con inhibidores potentes o inductores de CYP3A4
    distintos de los permitidos conforme al apartado 6.3.2.
    6.Embarazo o lactancia.
    7.Solo en la fase II: Progresión previa mientras recibía inhibidores de la
    actividad tirosina-cinasa dirigidos a TRK, aprobados o en investigación,
    entre otros entrectenib, crizotinib y lestaurtanib. Son aptos los pacientes
    que hayan recibido un inhibidor de la actividad de TRK durante menos de
    28 días de tratamiento y que lo suspendieran por intolerancia.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I: Safety of oral LOXO-101, including dose-limiting toxicity (DLT) until the Maximum Tolerated Dose or suitable dose based on PK exposure or unacceptable DLT are reached.
    Pase II: Overall response rate (ORR) as determined by an independent radiology review committee and measured by the proportion of subjects with best overall confirmed response of complete response (CR) or partial response (PR) by the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), or
    Response Assessment in Neuro-Oncology (RANO) criteria, as appropriate.
    Fase I:Determinar la seguridad de LOXO 101 oral, incluida la toxicidad limitante hasta la Dosis máxima tolerada o dosis adecuada basada en la exposición a PK o TLD inaceptable.
    Fase II:Determinar la tasa de respuesta global (TRG) determinada por un comité independiente de revisión radiológica y medida mediante el porcentaje de pacientes con mejor respuesta global confirmada con respuesta completa (RC) o respuesta parcial (RP) según los criterios de evaluación de la respuesta en tumores sólidos (Response Evaluation Criteria in Solid Tumors), versión 1.1 (RECIST 1.1) o los criterios de evaluación de la respuesta en neurooncología (Response Assessment in Neuro-Oncology, RANO), según proceda
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every cohort from baseline until disease progression,unacceptable toxicity, patient’s withdrawal of consent, or death.
    Cada cohorte desde la línea de base hasta la progresión de la enfermedad, la toxicidad inaceptable, la retirada del consentimiento del paciente o la muerte.
    E.5.2Secondary end point(s)
    PK analysis: Plasm and CSF concentrations of Loxo-101 will be determined with a validtaed bioanalytical assay.
    Pain and Health related QoL: in patients 3 years age or older pain will be assessed by the Wong-Baker Faces scale.
    Análisis FC: las concentraciones en Plasma y LCR de LOXO-101 se
    determinarán medienta una prueba bioanalítica validada.
    Cuestionarios CVRL y de dolor: Se evaluará el dolor en los pacientes de 3
    años de edad o más mediante la escala facial Wong-Baker
    E.5.2.1Timepoint(s) of evaluation of this end point
    The PK parameters will be calculated from the C1D1 and C2D1 (cohorts 1&2)and C4D1 and every 4 cycles thereafter (cohortes 3 and higher) data.
    Pain and Health related QoL: Mean changes over time will be analyzed descriptively by time-point.
    Los parámetros FC se calcularán a partir de los datos del C1D1 y C2 D1
    (cohortes 1 y 2) y C4D1 y cada 4 ciclos a después de ese (cohorte 3 y
    superiores).
    Cuestionarios CVRL y de dolor: Los cambios medios a lo largo del tiempo
    serán analizados descriptivamente mediante punto-tiempo.
    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 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
    Dose escalation
    Escalado de Dosis
    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 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 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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    France
    Germany
    Italy
    Spain
    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
    Last Patient Last Visit
    Última Visita del 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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 84
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 30
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 25
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 25
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4
    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
    Patients from 1 year old to their legal majority age
    ≥ 1 month old with a diagnosis malignancy and with a documented NTRK fusion and for patients with a locally advanced or metastatic infantile fibrosarcoma
    Pacientes de 1 año de edad hasta su mayoría legal
    ≥ de 1 mes de edad con un diagnóstico de neoplasia maligna y
    portador de un gen fusión NTRK documentado y para pacientes con
    fibrosarcoma infantil localmente avanzado o metastatico
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 84
    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 Decision2017-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-03
    P. End of Trial
    P.End of Trial StatusOngoing
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    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.

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