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    Summary
    EudraCT Number:2014-001633-84
    Sponsor's Protocol Code Number:CFZ008
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2015-01-26
    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 number2014-001633-84
    A.3Full title of the trial
    Phase 1b/2 Study of Carfilzomib in Combination with Dexamethasone, Mitoxantrone, PEG-asparaginase, and Vincristine (UK R3 Induction Backbone) in Children with Relapsed or Refractory Acute Lymphoblastic Leukemia
    Estudio de fase Ib/II de carfilzomib en combinación con dexametasona, mitoxantrona, PEG-asparaginasa y vincristina (esquema de inducción de UK R3) en niños con leucemia linfoblástica aguda recurrente o resistente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 1b/2 Study of Carfilzomib in Combination with Dexamethasone, Mitoxantrone, PEG-asparaginase, and Vincristine (UK R3 Induction Backbone) in Children with Relapsed or Refractory Acute Lymphoblastic Leukemia
    Estudio de fase Ib/II de carfilzomib en combinación con dexametasona, mitoxantrona, PEG-asparaginasa y vincristina (esquema de inducción de UK R3) en niños con leucemia linfoblástica aguda recurrente o resistente
    A.4.1Sponsor's protocol code numberCFZ008
    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 SponsorOnyx Therapeutics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOnyx Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOnyx Pharmaceuticals, Inc
    B.5.2Functional name of contact pointDawn Pinchasik, MD
    B.5.3 Address:
    B.5.3.1Street Address249 E. Grand Avenue
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post code94103
    B.5.3.4CountryUnited States
    B.5.4Telephone number0034917088600
    B.5.5Fax number001650266-0387
    B.5.6E-maildpinchasik@onyx.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 Yes
    D.2.1.1.1Trade name Kyprolis
    D.2.1.1.2Name of the Marketing Authorisation holderOnyx Therapeutics Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameCarfilzomib Lyophilisate for Solution for Injection
    D.3.2Product code PR-171
    D.3.4Pharmaceutical form Powder for 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.3.8INN - Proposed INNcarfilzomib
    D.3.9.1CAS number 868540-17-4
    D.3.9.2Current sponsor codePR-171
    D.3.9.3Other descriptive nameCARFILZOMIB
    D.3.9.4EV Substance CodeSUB32911
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Relapsed or Refractory Acute Lymphoblastic Leukemia
    Leucemia linfoblástica aguda recurrente o resistente
    E.1.1.1Medical condition in easily understood language
    A group of cancers that usually begins in the bone marrow and results in high numbers of abnormal white blood cells.
    Un grupo de cánceres que normalmente comienzan en la médula ósea y que ocasionan un elevado número de glóbulos blancos anormales
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10025230
    E.1.2Term Lymphatic leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1b
    - To assess the safety and tolerability of carfilzomib, alone and in combination with induction chemotherapy, for the treatment of children with relapsed or refractory acute lymphoblastic leukemia (ALL)
    -To determine the maximum tolerated dose (MTD) of carfilzomib in combination with induction chemotherapy.

    Phase 2
    -To estimate the combined rate of bone marrow CR and bone marrow CRp at the end of the Induction Cycle
    Fase Ib
    - Evaluar la seguridad y tolerabilidad de carfilzomib, solo y en combinación con quimioterapia de inducción, para el tratamiento de niños con leucemia linfoblástica aguda (LLA) recurrente o resistente al tratamiento
    - Determinar la dosis máxima tolerada (DMT) de carfilzomib en combinación con quimioterapia de inducción

    Fase II
    - Estimar la tasa combinada de RC medular y RCp medular al final del ciclo de inducción
    E.2.2Secondary objectives of the trial
    Phase 1b
    -To characterize the pharmacokinetics (PK) of carfilzomib alone and in
    combination with induction chemotherapy
    -To evaluate the combined rate of bone marrow complete response (CR) and bone marrow CR without platelet recovery (CRp) at the end of the Induction Cycle
    -To estimate the proportion of subjects who achieve minimal residual disease (MRD) status < 10-3 and < 10-4 lymphoblasts at the end of the Induction Cycle

    Phase 2
    -To estimate the proportion of subjects who achieve MRD status < 10-3 and < 10-4 lymphoblasts at the end of the Induction Cycle
    -To assess the safety and tolerability of carfilzomib in combination with induction chemotherapy, for the treatment of children with multiply relapsed ALL
    -To characterize the PK of carfilzomib in combination with induction
    chemotherapy
    Fase Ib
    - Caracterizar la farmacocinética (FC) del carfilzomib solo y en combinación con quimioterapia de inducción
    - Evaluar la tasa combinada de respuesta completa (RC) medular y de RC medular sin recuperación plaquetaria (RCp) al final del ciclo de inducción
    - Estimar la proporción de sujetos que logran un estado de enfermedad residual mínima (ERM) <10 3 y <10 4 linfoblastos al final del ciclo de inducción

    Fase II
    - Estimar la proporción de sujetos que logran un estado de ERM <10 3 y <10 4 linfoblastos al final del ciclo de inducción
    - Evaluar la seguridad y tolerabilidad de carfilzomib en combinación con quimioterapia de inducción para el tratamiento de niños con LLA con múltiples recidivas
    - Caracterizar la FC de carfilzomib en combinación con quimioterapia de inducción
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 years or younger at the time of study treatment initiation.
    2. Subjects must have a diagnosis of relapsed (Phase 1b and 2) or refractory (Phase 1b only) ALL with ? 5% blasts in the bone marrow (M2 or M3 disease), with or without extramedullary disease.
    ?- To be eligible for Phase 1b, subjects must have had 1 or more prior
    therapeutic attempts, defined as:
    o Early first relapse (< 36 months from original diagnosis) after
    achieving a CR OR
    o Relapse after achieving a CR following the first or subsequent relapse
    (i.e., ? 2 relapses) OR
    o Failing to achieve a CR from original diagnosis after at least 1 induction attempt
    ?- To be eligible for Phase 2, subjects must have had 2 or more prior
    therapeutic attempts and have relapsed, but not refractory disease, defined as relapse after achieving a CR following the first or subsequent relapse (i.e., ? 2 relapses)
    3. Subjects must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy treatment before enrollment.
    4. Subjects must have a serum creatinine level that is ? 1.5 × institutional upper limit of normal (ULN) according to age. If serum creatinine level is > 1.5 × ULN, the subject must have a calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) ? 70 mL/min/1.73 m2.
    5. Adequate liver function, defined as both of the following:
    ? Total bilirubin ? 1.5 × institutional ULN
    ? AST and ALT ? 5 × institutional ULN
    6. Performance status: Karnofsky or Lansky scores ? 50 for subjects > 16 years old or ? 16 years old, respectively.
    1. Edad de 18 años o menos en el momento del inicio del tratamiento del estudio.
    2. Los sujetos deben haber sido diagnosticados de LLA recurrente (fase Ib o II) o resistente al tratamiento (fase Ib solamente) con ?5% de blastos en la médula ósea (enfermedad M2 o M3), con o sin enfermedad extramedular.
    - Para ser elegibles para la fase Ib, los sujetos deben haber recibido una o varias iniciativas terapéuticas, lo que se define como:
    o Primera recidiva temprana (<36 meses desde el diagnóstico original) después de lograr una RC
    O BIEN
    o Recidiva después de lograr una RC después de la primera recidiva o una recidiva posterior (esto es, ?2 recidivas)
    O BIEN
    o Ausencia de RC desde el diagnóstico original después de al menos 1 ciclo de inducción
    - Para poder participar en la fase II, los sujetos deben haber recibido 2 o más iniciativas terapéuticas y haber experimentado una recidiva, pero no enfermedad resistente al tratamiento, lo que se define como una recidiva tras lograr una RC después de la primera recidiva o una recidiva posterior (esto es, ?2 recidivas)
    3. Los sujetos deben haberse recuperado por completo de los efectos tóxicos agudos de todos los tratamientos quimioterapéuticos, inmunoterapéuticos o radioterapéuticos antes de la inscripción.
    4. Los sujetos deben presentar un nivel de creatinina sérica que sea ?1,5 × el límite superior de la normalidad (LSN) del centro según la edad. Si el nivel de creatinina sérica es >1,5 × LSN, el sujeto debe presentar un aclaramiento de la creatinina calculado o una tasa de filtración glomerular (TFG) con radioisótopos ?70 ml/min/1,73 m2.
    5. Función hepática adecuada, definida como la que cumple las dos condiciones siguientes:
    ? Bilirrubina total ?1,5 veces el LSN del centro
    ? ASAT y ALAT ?5 × LSN del centro
    6. Estado funcional: puntuaciones de Karnofsky o Lansky ?50 para los sujetos >16 años o ?16 años respectivamente.
    E.4Principal exclusion criteria
    1. Known allergy to any of the drugs used in the study. (Subjects who have had a previous allergy to PEG-asparaginase but can receive
    Erwinia are eligible.)
    2. Known allergy to Captisol (a cyclodextrin derivative used to solubilize
    carfilzomib; for a complete listing of Captisol-enabled drugs, see the Ligand Pharmaceuticals, Inc. website)
    3. Left ventricular fractional shortening < 30%
    4. History of pancreatitis; serum amylase > 2 × the institutional ULN
    5. Active treatment for graft-versus-host disease
    6. Positive culture for bacteria or fungus within 14 days of the initiation of therapy
    7. Down Syndrome
    8. Prior therapy restrictions:
    ? -Subjects must have completed therapy with granulocyte-colony stimulating factor (G-CSF) or other myeloid growth factors at least 7 days before enrollment, or at least 14 days before enrollment, if pegylated myeloid growth factors were administered.
    ? -Subjects must have received the last dose of a non-monoclonal antibody biologic agent at least 7 days before enrollment. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be approved by the Onyx study medical monitor.
    ? -At least 3 antibody half-lives must have elapsed since the last dose of monoclonal antibody (i.e., 66 days for rituximab and 69 days for
    epratuzumab) before subjects may enroll in the study.
    ? -Subjects must have completed any type of active immunotherapy
    (e.g., tumor vaccines) at least 42 days before enrollment.
    ? -Subjects must not have received any other antineoplastic agents within 7 days prior to enrollment.
    1. Alergia conocida a alguno de los fármacos utilizados en el estudio.
    (Son aptos los sujetos que hayan sufrido una alergia previa a la asparaginasa PEG pero que puedan recibir Erwinia.)
    2. Alergia conocida a Captisol (un derivado de la ciclodextrina utilizado para solubilizar carfilzomib; en la página web de Ligand Pharmaceuticals, Inc. se hallará una lista completa de los fármacos con Captisol).
    3. Acortamiento fraccional ventricular izquierdo <30%
    4. Antecedentes de pancreatitis; amilasa sérica >2 × LSN del centro
    5. Tratamiento activo para la enfermedad del injerto contra el huésped
    6. Cultivo positivo para bacterias u hongos en los 14 días previos al inicio del tratamiento
    7. Síndrome de Down
    8. Restricciones de tratamientos previos:
    ? Los sujetos deben haber finalizado el tratamiento con factores estimulantes de las colonias de granulocitos (G CSF) u otros factores de crecimiento mieloides al menos 7 días antes de la inscripción, o al menos 14 días antes de la inscripción si se administraron factores de crecimiento mieloides pegilados.
    ? Los sujetos deben haber recibido la última dosis de un fármaco biológico sin anticuerpos monoclonales al menos 7 días antes de la inscripción. Para los fármacos que produzcan acontecimientos adversos conocidos más de 7 días después de la administración, este período debe extenderse hasta después del momento en que se sabe que se producen los acontecimientos adversos. El monitor médico del estudio de Onyx debe aprobar la duración de este intervalo.
    ? Para que los sujetos puedan inscribirse en el estudio, deben haber transcurrido al menos 3 semividas desde la última dosis de un anticuerpo monoclonal (esto es, 66 días para rituximab y 69 días para epratuzumab).
    ? Los sujetos deben haber finalizado todo tipo de inmunoterapia activa (p. ej., vacunas tumorales) al menos 42 días antes de la inscripción.
    ? Los sujetos no deben haber recibido ningún otro antineoplásico en los 7 días previos a la inscripción.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1b
    ?-Safety and tolerability of carfilzomib alone and in combination with induction chemotherapy as defined by the type, incidence, severity, and outcome of AEs; changes from baseline in key laboratory analytes, vital signs, and physical findings. Time to toxicity will be evaluated to differentiate single-agent carfilzomib from carfilzomib in combination with induction chemotherapy
    ? -Determination of the MTD as the dose that has the highest posterior probability of having a DLT rate within the target toxicity interval (20%?33%), while the posterior probability of excessive /unacceptable toxicity (>33%?100%) is less than 40%

    Phase 2
    ? -Combined proportion of subjects who achieve CR or CRp at the end of the Induction Cycle
    Fase Ib
    - Seguridad y tolerabilidad de carfilzomib solo y en combinación con quimioterapia de inducción, definidas por el tipo, la incidencia, la intensidad y el resultado de los AA; alteraciones con respecto al inicio en los analitos de laboratorio, las constantes vitales y los hallazgos de la exploración física. El tiempo hasta la toxicidad se evaluará para diferenciar carfilzomib en monoterapia de carfilzomib en combinación con quimioterapia de inducción
    - Determinación de la DMT como la dosis con la mayor probabilidad posterior de mostrar una tasa de TLD situada dentro del intervalo de toxicidad deseado (20%?33%), mientras que la probabilidad posterior de toxicidad excesiva/inaceptable (>33%?100%) es inferior al 40%

    Fase II
    - Proporción combinada de sujetos que logran RC o RCp al final del ciclo de inducción
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of the Induction Cycle
    Final del ciclo de inducción
    E.5.2Secondary end point(s)
    Phase 1b
    ? -Pharmacokinetic parameters, principally maximum plasma concentration (Cmax) and area under the curve (AUC), alone and in combination with induction chemotherapy, derived from levels of carfilzomib assayed in PK samples
    ? -Combined proportion of subjects who achieve CR or CRp at the end of the Induction Cycle
    ? -Proportion of subjects who achieve MRD status < 10-3 and < 10-4 lymphoblasts at the end of the Induction Cycle as assessed by quantitative immunoglobulin/T-cell receptor (Ig/TcR) polymerase chain reaction (PCR)

    Phase 2
    ? -Proportion of subjects who achieve MRD status < 10-3 and < 10-4 lymphoblasts at the end of the Induction Cycle as assessed by quantitative Ig/TcR PCR
    ? -Safety and tolerability of carfilzomib in combination with induction
    chemotherapy as defined by the type, incidence, severity, and outcome of AEs; changes from baseline in key laboratory analytes, vital signs, and physical findings
    ? -Pharmacokinetic parameters, principally Cmax and AUC, of carfilzomib in combination with induction chemotherapy derived from levels of carfilzomib assayed in PK samples.
    Fase Ib
    ? Parámetros farmacocinéticos, principalmente la concentración plasmática máxima Cmáx y el área bajo la curva (ABC), de carfilzomib solo o en combinación con quimioterapia de inducción, derivados de los niveles de carfilzomib analizados en las muestras FC
    ? Proporción combinada de sujetos que logran RC o RCp al final del ciclo de inducción
    ? Proporción de sujetos que logran un estado de ERM <10 3 y <10 4 de linfoblastos al final del ciclo de inducción evaluada por la reacción en cadena de la polimerasa (RCP) cuantitativa del receptor de inmunoglobulinas/linfocitos T (Ig/TcR).

    Fase II
    ? Proporción de sujetos que logran un estado de ERM <10 3 y <10 4 de linfoblastos al final del ciclo de inducción evaluada por la RCP cuantitativa del Ig/TcR
    ? Seguridad y tolerabilidad de carfilzomib en combinación con quimioterapia de inducción, definidas por el tipo, la incidencia, la intensidad y el resultado de los AA; alteraciones con respecto al inicio en los analitos de laboratorio, las constantes vitales y los hallazgos de la exploración física.
    ? Parámetros farmacocinéticos, principalmente la concentración plasmática máxima Cmáx y el ABC, de carfilzomib en combinación con quimioterapia de inducción, derivados de los niveles de carfilzomib analizados en las muestras FC
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of the Induction Cycle
    Final del ciclo de inducción
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 study
    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) Information not present in EudraCT
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Australia
    Austria
    Belgium
    Canada
    Denmark
    France
    Germany
    Netherlands
    Spain
    Switzerland
    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
    End of study per protocol is defined as, the end of study assessments must be completed 30 days (± 4 days) following the last dose of study treatment.
    El fin del estudio por protocolo se define como, las evaluaciones del fin del estudio deben tener lugar 30 días (± 4 días) después de la última dosis del tratamiento del estudio
    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 days0
    E.8.9.2In all countries concerned by the trial years3
    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.1.1Number of subjects for this age range: 39
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 5
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    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) 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 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
    Subjects are under 18 years old.
    Sujetos menores de 18 años.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 17
    F.4.2.2In the whole clinical trial 39
    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)
    As per protocol
    Según se indica en el protocolo
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation ITCC ? Gustave Roussy ? ENCCA
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-25
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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