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    Summary
    EudraCT Number:2012-002340-24
    Sponsor's Protocol Code Number:0517-029
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-29
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-002340-24
    A.3Full title of the trial
    A Phase IIb, Partially-Blinded, Randomized, Active Comparator-Controlled Study to Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Fosaprepitant in Pediatric Patients for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated with Emetogenic Chemotherapy
    Estudio de fase IIb, parcialmente enmascarado, aleatorizado, controlado con un comparador activo para evaluar la farmacocinética/farmacodinamia, la seguridad y la tolerabilidad de fosaprepitant en pacientes pediátricos para la prevención de las náuseas y los vómitos inducidos por la quimioterapia (NAVIQ) emetógena
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fosaprepitant PK/PD CINV in Pediatric Cancer Patients
    fosaprepitant PK/PD CINV en pacientes pediátricos
    A.3.2Name or abbreviated title of the trial where available
    Fosaprepitant PK/PD CINV in Pediatric Cancer Patients
    fosaprepitant PK/PD CINV en pacientes pediátricos
    A.4.1Sponsor's protocol code number0517-029
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., 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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck, Sharp & Dohme de España, S.A.
    B.5.2Functional name of contact pointEduardo Portuondo
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcarcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28027
    B.5.3.4CountrySpain
    B.5.4Telephone number+34629145244
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@merck.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 IVEMEND
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namefosaprepitant
    D.3.2Product code MK-0517
    D.3.4Pharmaceutical form Lyophilisate and solvent for suspension 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 INNFOSAPREPITANT
    D.3.9.1CAS number 172673-20-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 Zofran Injection
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Operations UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameZofran Injection
    D.3.2Product code ondansetron hydrochloride
    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.3.8INN - Proposed INNONDANSETRON
    D.3.9.3Other descriptive nameondansetron
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chemotherapy-induced nausea and vomiting (CINV) associated with emetogenic chemotherapy
    Prevención de las náuseas y los vómitos en los pacientes pediátricos tratados con quimioterapia moderada o altamente emetógena.
    E.1.1.1Medical condition in easily understood language
    Nausea and vomiting caused by chemotherapy
    Náuseas y vómitos causados por quimioterapia.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10036899
    E.1.2Term Prophylaxis against chemotherapy induced vomiting
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 appropriate dosing regimen of fosaprepitant for the prevention of CINV in pediatric patients birth to 17 years of age, by assessing the pharmacokinetic and pharmacodynamic parameters, and the safety and tolerability of the administered dose of fosaprepitant, concomitantly with IV ondansetron, in patients from birth to 17 years of age receiving emetogenic chemotherapy (very highly emetogenic chemotherapy [VHEC], highly emetogenic chemotherapy [HEC], or moderately emetogenic chemotherapy [MEC]), or a chemotherapy regimen not previously tolerated due to vomiting, for a documented malignancy.
    Determinar el régimen de dosificación apropiada de fosaprepitant para la prevención de CINV en pacientes pediátricos desde el nacimiento hasta los 17 años de edad, mediante la evaluación de los parámetros farmacocinéticos y farmacodinámicos, y la seguridad y la tolerabilidad de la dosis administrada de fosaprepitant, de forma concomitante con ondansetrón IV, en los pacientes desde el nacimiento hasta los 17 años de edad que recibieron la quimioterapia emetógena (quimioterapia muy altamente emetógena [QMAE], quimioterapia altamente emetógena [QAE], o quimioterapia moderadamente emetógena [QME]), o un régimen de quimioterapia que antes no toleró debido a los vómitos, para un tumor maligno documentado .
    E.2.2Secondary objectives of the trial
    The efficacy, with respect to Complete Response and No Vomiting, of the fosaprepitant regimen when administered concomitantly with ondansetron, with or without dexamethasone, will be explored in pediatric patients birth to 17 years of age receiving emetogenic chemotherapy (VHEC, HEC, or MEC), or a chemotherapy regimen not previously tolerated due to vomiting, for a documented malignancy.
    La eficacia, con respecto a una respuesta completa y la ausencia de vómitos, del régimen de fosaprepitant cuando se administra de forma concomitante con ondansetrón, con o sin dexametasona, se estudiarán en los pacientes pediátricos desde el nacimiento a los17 años de edad que reciben quimioterapia emetógena (QMAE, QAE, o QME) , o un régimen de quimioterapia que no toleró antes debido a los vómitos, para un tumor maligno documentado.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ICF(Version 00 genetic and future samples 4 July 2012). This research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial). The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments.
    ICF (Versión 00 Genético y Muestras Futuras del 4 de Julio de 2012).Esta investigación tendrá por objeto el análisis de biomarcadores para abordar aspectos nuevos que no se describen en otras partes del protocolo (como parte del ensayo principal . El objetivo de la obtención de muestras para investigación biomédica futura consiste en investigar e identificar biomarcadores que proporcionen a los científicos información sobre enfermedades y sus tratamientos.
    E.3Principal inclusion criteria
    - Patient is 0 (at least 37 weeks gestation) to 17 years of age at time of study entry (randomization).
    - Parent/guardian (legally authorized representative) agrees to the patients participation as indicated by parent/legal guardian signature on the informed consent form. Patient 12 to 17 years of age, or as required by local regulation, assents and has the ability to understand the nature and intent of the study including the ability to comply with study procedures, complete study diary, and is willing to keep scheduled study visits. The parent/guardian or patient may also provide consent/assent for Future Biomedical Research. However, the patient may participate in the main trial without participating in the Future Biomedical Research.
    - Patient is scheduled to receive chemotherapeutic agent(s) associated with moderate, high, or very high risk of emetogenicity for no more than 5 consecutive days for a documented malignancy, or a chemotherapy regimen not previously tolerated due to vomiting.
    - Female patient who has begun menses has a negative urine pregnancy test prior to randomization. A female patient who is of reproductive potential agrees to remain abstinent or use a barrier form of contraception for at least 14 days prior to, throughout, and for at least one month following the last dose of study medication. Women taking oral contraception must agree to add a barrier form of contraception. For countries where abstinence is not considered an acceptable method of birth control, a locally acceptable birth control method must be used.
    - Patient has a preexisting functioning central venous catheter available for study drug administration.
    - Patients weight should not be less than the 3rd percentile for age and gender (and no less than 3.0 kg) per investigator judgment using available local growth chart(s).
    -El paciente tiene entre 0 (al menos 37 semanas de gestación) y 17 años de edad en el momento de incorporarse al estudio (aleatorización).
    -El progenitor o tutor (representante legal) accede a la participación del paciente, según lo indicado por la firma del progenitor o tutor en el documento de consentimiento informado. En el caso de un paciente de 12 a 17 años, o según lo exigido por la normativa nacional, otorga su asentimiento y tiene la capacidad de comprender la naturaleza y la finalidad del estudio, incluida la capacidad de cumplir los procedimientos del estudio y cumplimentar el diario del estudio, y está dispuesto a acudir a las visitas del estudio programadas. El progenitor o tutor o el paciente también puede otorgar su consentimiento/asentimiento para investigación biomédica futura. No obstante, el paciente podrá participar en el ensayo principal sin necesidad de participar en la investigación biomédica futura.
    -Está previsto que el paciente reciba quimioterapia asociada a un riesgo moderado, alto o muy alto de potencial emetógeno por una neoplasia maligna documentada durante no más de 5 días consecutivos o bien un régimen de quimioterapia que no haya tolerado previamente por vómitos.
    -Las pacientes en edad fértil deberán dar negativo en una prueba de embarazo en orina realizada antes de la aleatorización. También tendrán que comprometerse a mantener abstinencia sexual o a utilizar un método anticonceptivo de barrera desde al menos 14 días antes del estudio, durante el tratamiento y durante al menos un mes después de la última dosis de la medicación del estudio. Las pacientes que tomen anticonceptivos orales deberán comprometerse a emplear además un método anticonceptivo de barrera. En los países en que la abstinencia no se considere un método anticonceptivo aceptable, deberá utilizarse un método anticonceptivo aceptable en dicho país.
    -El paciente tiene un catéter venoso central funcional preexistente disponible para administrar el fármaco del estudio.
    -El peso del paciente no debe ser inferior al percentil 3 para la edad y el sexo (y no inferior a 3,0 kg) según el criterio del investigador, basándose en las tablas de crecimiento disponibles a nivel local.
    E.4Principal exclusion criteria
    - Patient has vomited in the 24 hours prior to chemotherapy initiation on Treatment Day 1.
    - Patient is currently a user of any illicit drugs (including marijuana) or has current evidence of alcohol abuse (defined using the Diagnostic and Statistical Manual-IV [DSM-IV] criteria) as determined by the investigator.
    - Patient has received or will receive radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 and/or during the course of the study.
    - Patient is allergic to fosaprepitant, aprepitant, ondansetron, or any other 5-HT3 antagonist.
    - Patient has an active infection (e.g., pneumonia), congestive heart failure, bradyarrythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy, or a history of any illness which in the opinion of the investigator, might confound the results of the study or pose unwarranted risk in administering study drug or concomitant therapy to the patient.
    - Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.
    - Patient has a known history of QT prolongation or is taking any medication that is known to lead to QT prolongation.
    - Patient has had benzodiazepine or opioid therapy initiated within 48 hours of study drug administration, except for single daily doses of triazolam, temazepam, or midazolam.
    * Continuation of chronic benzodiazepine or opioid therapy is permitted provided it was initiated at least 48 hours prior to study drug administration.
    - Patient has been started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is planned to receive a corticosteroid as part of the chemotherapy regimen.

    Exceptions:
    ? Patients who are receiving chronic (>72 hours), daily steroid therapy can be enrolled provided the steroid dose is not >0.14 mg/kg (up to 10 mg) of prednisone daily or equivalent.
    ? For supportive care, patients are permitted to receive a single dose of corticosteroid within 3 days prior (but not on the day of study drug administration) provided it is less than the equivalent of 20 mg of prednisone.
    - Patient is currently taking warfarin.
    - Patient has ever participated in a study of aprepitant or fosaprepitant, or has taken a non-approved (investigational) drug within the last 4 weeks. Note: Patients in investigational studies with marketed chemotherapeutic agents (whether explicitly for children or only marketed for adults and usually administered to children with the appropriate dose adjustments) are allowed to enroll if they fulfill all other entry criteria.
    -El paciente ha vomitado en las 24 horas previas al inicio de la quimioterapia el día 1 de tratamiento.
    -El paciente consume activamente algún tipo de droga, incluida la marihuana, o el investigador determina que hay pruebas de un consumo excesivo de alcohol (definido según los criterios del Manual diagnóstico y estadístico-IV [DSM IV]).
    -Está previsto que el paciente reciba tratamiento de rescate con células madre junto con los ciclos de quimioterapia emetógena relacionados con el estudio.
    -El paciente es alérgico a fosaprepitant, aprepitant, ondansetrón o a cualquier otro antagonista de 5 HT3.
    -El paciente presenta una infección activa (por ejemplo, neumonía), insuficiencia cardíaca congestiva, bradiarritmias, alguna enfermedad no controlada (por ejemplo, cetoacidosis diabética u obstrucción digestiva) distinta del tumor maligno o tiene antecedentes de una enfermedad que, en opinión del investigador, podría confundir los resultados del estudio o hacer que la administración del fármaco del estudio o el tratamiento concomitante le suponga un riesgo injustificado.
    -El paciente es mentalmente incapaz o presenta algún trastorno emocional o psiquiátrico importante que, en opinión del investigador, impide su participación en el estudio.

    -El paciente tiene antecedentes conocidos de prolongación del QT o está tomando algún medicamento que se sabe que origina prolongaciones del intervalo QT.
    -El paciente ha empezado a recibir tratamiento con benzodiazepinas o con opiáceos en las 48 horas previas a la administración del fármaco del estudio, excepto dosis únicas diarias de triazolam, temazepam o midazolam.
    -Se permite la continuación del tratamiento crónico con benzodiazepinas u opiáceos siempre que se haya iniciado al menos 48 horas antes de la administración del fármaco del estudio.
    -El paciente ha empezado a recibir tratamiento con corticosteroides sistémicos en las 72 horas previas a la administración del fármaco del estudio o está previsto que reciba un corticosteroide como parte del régimen de quimioterapia.

    -Excepciones:
    -Los pacientes tratados de forma crónica (> 72 horas) con esteroides a diario podrán participar siempre que la dosis del esteroide no sea > 0,14 mg/kg al día (hasta 10 mg) de prednisona o equivalente.
    -Como asistencia de apoyo, los pacientes podrán recibir una sola dosis de un corticosteroide en los 3 días previos (pero no el día de administración del fármaco del estudio) siempre que la dosis sea inferior a un equivalente de 20 mg de prednisona.
    -El paciente está tomando warfarina.
    -El paciente ha participado alguna vez en un estudio de aprepitant o fosaprepitant o ha tomado un fármaco no aprobado (en investigación) en las últimas 4 semanas. Nota: Los pacientes incluidos en estudios experimentales con quimioterápicos comercializados (ya sea explícitamente para niños o solo comercializados para adultos y administrados habitualmente a niños con los ajustes posológicos oportunos) podrán participar si cumplen todos los demás criterios de participación.
    E.5 End points
    E.5.1Primary end point(s)
    - Pharmacokinetic (PK) Endpoints: Cmax, Tmax, AUC0-infinity, t1/2, CL/F estimated by population methods, including the use of historic data in population modeling, in each age group for the 3 fosaprepitant treatment groups in Cycle 1.
    - Safety Endpoints: Clinical and laboratory adverse events that are considered drug-related, serious, serious drug-related, or lead to discontinuation of study therapy.
    -Endpoints de Farmacocinética (PK): Cmáx, Tmáx, AUC 0-infinito, t1 / 2, CL / F estimado por métodos de población, incluyendo el uso de datos históricos en el modelado de población, en cada grupo de edad de los 3 grupos de tratamiento de fosaprepitant en el Ciclo 1 .

    - Endpoints de seguridad: los eventos adversos clínicos y de laboratorio que se consideran relacionados con el fármaco, graves, graves y relacionados con el fármaco, o que conducen a la interrupción del tratamiento del estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For PK: Five scheduled time points for PK sampling
    1. End of the fosaprepitant infusion
    2. 2 to 4 hours after (completion of) fosaprepitant dosing
    3. 5 to 7 hours after fosaprepitant dosing
    4. 8 to 10 hours after fosaprepitant dosing
    5. 23 to 25 hours after fosaprepitant dosing

    For Safety: Throughout the study (Screening, Treatment, Post-Treatment, and/or Follow-Up/DC).
    Para FC: Cinco puntos en el tiempo previsto para la toma de muestras de FC

    1. Final de la infusión con fosaprepitant

    2. 2 a 4 horas después (finalización de) la administración de fosaprepitant

    3. 5 a 7 horas después de la administración de fosaprepitant

    4. 8 a 10 horas después de la dosificación de fosaprepitant

    5. 23 a 25 horas tras la administración de fosaprepitant
    E.5.2Secondary end point(s)
    - Pharmacodynamic (PD) Endpoints: The proportion of patients with Complete Response (CR) in the 25 to 120 hours after initiation of chemotherapy (delayed phase). Other PD endpoints will be the proportion of patients with CR in the 0 to 24 hours after chemotherapy (acute phase); and the proportion of patients with CR in the 0 to 120 hours after chemotherapy (overall phase); and also, the proportion of patients with No Vomiting. Irrespective of use of rescue medication, in the overall, acute, and delayed phases.
    Endpoints de Farmacodinámica (FD): La proporción de pacientes con respuesta completa (RC) en el periodo de 25 a 120 horas después del inicio de la quimioterapia (fase tardía). Otros endpoings de FD serán la proporción de pacientes con RC en el perido de 0 a 24 horas después de la quimioterapia (fase aguda), y la proporción de pacientes con RC de 0 a 120 horas después de la quimioterapia (fase general), y también, la proporción de pacientes sin vómitos. Independientemente del uso de medicación de rescate, en las fases generales, aguda y tardía.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For PD: Over the first 120 hours (to Day 6) following the initiation of chemotherapy (Tzero).
    Para FD: Durante las primeras 120 horas (hasta el día 6) después del comienzo de la quimioterapia (Tzero).
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Parcialmente ciego
    Partial blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Argentina
    Brazil
    Canada
    Chile
    Colombia
    India
    Mexico
    Peru
    Russian Federation
    South Africa
    Turkey
    Ukraine
    United States
    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
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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: 256
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 32
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 32
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 128
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 64
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric cancer patients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 145
    F.4.2.2In the whole clinical trial 256
    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)
    No plans for treatment or care after the maximum of 5 additional optional cycles after Cycle 1.
    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 Decision2012-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-21
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