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    Summary
    EudraCT Number:2014-000804-88
    Sponsor's Protocol Code Number:C26002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-08-06
    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 number2014-000804-88
    A.3Full title of the trial
    A Phase 2 Trial of MLN0264 in Previously Treated Patients With Metastatic or Recurrent Adenocarcinoma of the Stomach or Gastroesophageal Junction Expressing Guanylyl Cyclase C (GCC)
    Ensayo de fase II de MLN0264 en pacientes con adenocarcinoma metastásico o recurrente del estómago o la unión gastroesofágica con expresión de guanilato ciclasa C (GCC) previamente tratados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to evaluate MLN0264 for the treatment of tumors of the stomach or the junction between the esophagus and the stomach and which have a protein called Guanylyl Cyclase C (GCC) present, in patients that have been treated previously but who have relapsed or in whom the cancer has spread.
    Ensayo para evaluar MLN0264 para elñ tratamiento de tumores de estómago o en la unión del estómago y el esófago y que tienen una proteina llamada Guanilato ciclasa C (GCC) PRESENTE, en pacientes que han sido previamente tratatdos pero que han reacido o en los que el cancer se ha expandido.
    A.4.1Sponsor's protocol code numberC26002
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1155-9023
    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 SponsorMillennium Pharmaceuticals, 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 supportMillennium Pharmaceuticals Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMillennium Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointDrug Information Call Center
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne St
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number001510740-2412
    B.5.5Fax number001800881-6092
    B.5.6E-mailmedical@mlnm.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMLN0264
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable at this stage
    D.3.9.1CAS number 1514889-12-3
    D.3.9.2Current sponsor codeMLN0264
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typea novel monclonal antibody drug conjugate (ADC)
    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
    Metastatic or Recurrent Adenocarcinoma of the Stomach or Gastroesophageal Junction Expressing Guanylyl Cyclase C (GCC)
    Adenocarcinoma metastásico o
    recurrente del estómago o la unión gastroesofágica con expresión de guanilato ciclasa C (GCC)
    E.1.1.1Medical condition in easily understood language
    Previously treated tumors consisting of cells from the gastro-intestinal tract located in the stomach or at the junction between the esophagus and the stomach which is recurring or has spread.
    Tumores previamente tratados formados por células del tracto gastrointestinal localizadas en el estómgao o en la conjuncion estómgao esófago que es recurrente o mestastásico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10066354
    E.1.2Term Adenocarcinoma of the gastroesophageal junction
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10001158
    E.1.2Term Adenocarcinoma gastric stage IV with metastases
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10001152
    E.1.2Term Adenocarcinoma gastric recurrent
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the overall response rate of patients with recurrent or metastatic GCC-positive adenocarcinoma of the stomach or gastroesophageal junction treated with MLN0264
    Evaluar la tasa de respuesta general de pacientes con adenocarcinoma recurrente o metastásico del estómago o la unión gastroesofágica positivo para GCC tratados con MLN0264
    E.2.2Secondary objectives of the trial
    - To evaluate the safety profile of MLN0264
    - To evaluate progression-free survival (PFS)
    - To evaluate duration of response
    - To evaluate disease control rate
    - To evaluate overall survival
    - To examine the pharmacokinetic profile
    - To evaluate tumor size reduction
    - To investigate the association between GCC expression level and antitumor effects of MLN0264
    - To assess immunogenicity of MLN0264
    ? Evaluar el perfil de seguridad de MLN0264
    ? Evaluar la supervivencia sin progresión (SSP)
    ? Evaluar la duración de la respuesta
    ? Evaluar la tasa de control de la enfermedad
    ? Evaluar la supervivencia general
    ? Examinar el perfil farmacocinético
    ? Evaluar la reducción del tamaño del tumor
    ? Investigar la asociación entre el nivel de expresión de GCC y los efectos antitumorales de
    MLN0264
    ? Evaluar la inmunogenicidad de MLN0264
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each patient must meet all the following inclusion criteria to be enrolled in the study:

    1. Male or female patients 18 years of age or older when written informed consent is obtained.

    2. Histologically confirmed metastatic or advanced inoperable adenocarcinoma of the stomach or gastroesophageal junction with IHC evidence of GCC expression indicated by an H-score of 10 or greater.

    3. Treatment with 1 or more prior chemotherapies for advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.

    4. Measurable disease as defined by RECIST version 1.1 guidelines.

    5. ECOG performance status of 0 or 1 within 14 days before enrollment.
    6. Female patients who:

    - Are postmenopausal for at least 1 year before the screening visit, OR
    - Are surgically sterile, OR

    - If they are of childbearing potential, agree to practice 2 effective methods ofcontraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or
    - Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)

    Male patients, even if surgically sterilized (ie, status postvasectomy), who:
    - Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or
    - Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)

    7. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.

    8. Adequate organ and hematological function as evidenced by the following laboratory values within 14 days before enrollment:
    - Absolute neutrophil count (ANC) ? 1.5 x109/L
    - Platelet count ? 100 x 109/L
    - Hemoglobin ? 9 g/dL
    - Activated partial thromboplastin time (aPTT) ? 1.5 x the upper limit of the normal range (ULN) per institutional laboratory normal range
    - International normalized ratio (INR) ? 1.5 x ULN
    - Serum creatinine ? 1.5 x ULN
    - Total bilirubin ? 1.5 x ULN
    - Albumin ? 3g/dL
    - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 x ULN
    - Serum lipase ? 3 x ULN and serum amylase within the normal range

    9. Resolution of all toxic effects of prior treatments except alopecia to Grade 0 or 1 by NCI CTCAE version 4.03.

    10. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
    1. Pacientes, hombres o mujeres, de 18 años de edad o mayores cuando se obtenga el
    consentimiento informado por escrito.
    2. Adenocarcinoma de estómago o de la unión gastroesofágica metastásico o avanzado
    inoperable y confirmado histológicamente con evidencia IHQ de expresión de GCC
    indicada por una puntuación de H de 10 o superior.
    3. Tratamiento con 1 o varias quimioterapias anteriores para el adenocarcinoma de
    estómago o de la unión gastroesofágica avanzado o metastásico.
    4. Enfermedad medible según las directrices de la versión 1.1 de RECIST. Todas las
    exploraciones y rayos x utilizados para documentar enfermedad medible se deben
    realizar dentro de los 28 días previos a la inscripción (los ascitos y las lesiones óseas
    no se consideran enfermedades medibles).
    5. Estado funcional según el ECOG de 0 o 1 (véase la sección 14.1) dentro de los 14
    días previos a la inscripción.
    6. Pacientes de sexo femenino que:
    ? lleven siendo posmenopáusicas al menos desde 1 año antes de la visita de
    selección;
    ? hayan sido esterilizadas quirúrgicamente;
    ? si tienen capacidad reproductiva, que acepten el uso de 2 métodos
    anticonceptivos eficaces al mismo tiempo desde el momento de firmar el
    formulario de consentimiento informado y hasta 30 días después de la
    administración de la última dosis del fármaco del estudio; o
    ? acepten la práctica de una abstinencia verdadera, si ello es compatible con el
    estilo de vida preferido y habitual del sujeto. (La abstinencia periódica [por
    ejemplo, los métodos del calendario, de la ovulación, los sintotérmicos o los de
    postovulación] y la interrupción del coito no se consideran métodos
    anticonceptivos aceptables).
    Pacientes varones, aunque hayan sido esterilizados quirúrgicamente (es decir,
    después de someterse a una vasectomía) que:
    ? acepten utilizar métodos anticonceptivos eficaces de barrera durante todo el
    periodo de tratamiento del estudio y durante los 4 meses posteriores a la última
    dosis del fármaco del estudio; o
    ? acepten la práctica de una abstinencia verdadera, si ello es compatible con el
    estilo de vida preferido y habitual del sujeto. (La abstinencia periódica [por
    ejemplo, los métodos del calendario, de la ovulación, los sintotérmicos o los de
    postovulación para la pareja de sexo femenino] y la interrupción del coito no se
    consideran métodos anticonceptivos aceptables).
    7. El consentimiento voluntario por escrito debe otorgarse antes de realizar cualquier
    procedimiento relacionado con el estudio distinto de la atención médica estándar,
    siendo consciente de que el paciente puede retirar su consentimiento en cualquier
    momento sin perjuicio de su atención médica futura.
    8. Una función orgánica y hematológica adecuadas como se evidencia en los siguientes
    valores analíticos dentro de los 14 días previos a la inscripción:
    ? recuento absoluto de neutrófilos (RAN) ?1,5 × 109/l
    ? recuento de plaquetas ? 100 × 109/l
    ? hemoglobina ? 9 g/dl
    ? tiempo de tromboplastina parcial (TTP) ?1,5 × el límite superior de la
    normalidad (LSN) de acuerdo con el rango de normalidad del laboratorio
    institucional
    ? cociente internacional normalizado (CIN) ?1,5 × LSN
    ? creatinina sérica ?1,5 × LSN
    ? bilirrubina total ?1,5 × LSN
    ? albúmina ? 3 g/dl
    ? aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) ?2,5 ×x
    LSN
    ? lipasa en suero ? 3 × LSN y amilasa en suero dentro del rango de la
    normalidad
    9. resolución de todos los efectos tóxicos de tratamientos previos excepto alopecia a
    grado 0 o 1 según la versión 4.03 de los CTCAA del NCI.
    10. disposición y capacidad para cumplir con las visitas programadas, el plan el
    tratamiento, las pruebas analíticas y otros procedimientos del ensayo
    E.4Principal exclusion criteria
    Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

    1. Radiotherapy within 4 weeks before enrollment

    2. Concurrent treatment or treatment within 4 weeks of study entry with any other investigational agent or chemotherapy

    3. Female patients who are lactating and breastfeeding or have a positive pregnancy test during the Screening period

    4. Uncontrolled, clinically significant, symptomatic cardiovascular disease within 6 months before enrollment, including myocardial infarction, unstable angina, Grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient
    medication

    5. Treatment with any medication that has a clinically relevant potential risk of prolonging the QT interval or inducing torsades de pointes that cannot be discontinued or switched to a different medication before starting study drug

    6. Patients with ECG abnormalities considered by the investigator to be clinically significant, or repeated baseline prolongation of the rate-corrected QT interval (QTc)

    7. Ongoing or clinically significant active infection as judged by the investigator

    8. Signs of PN ? NCI CTCAE Grade 2

    9. Concomitant chemotherapy, hormonal therapy, immunotherapy, or any other form of cancer treatment

    10. Use of strong cytochrome P450 (CYP) 3A4 inhibitors within 2 weeks before the first dose of study drug

    11. Any preexisting medical condition of sufficient severity to prevent full compliance with the study

    12. History of or current neoplasm other than gastric adenocarcinoma, except for curatively treated nonmelanoma skin cancer or in situ carcinoma of the cervix uteri

    13. Known diagnosis of human immunodeficiency virus (HIV) infection

    14. Symptomatic brain metastases

    15. Ongoing anticoagulant therapy (eg, aspirin, coumadin, heparin)
    No deben inscribirse en el estudio los pacientes que cumplan cualquiera de los siguientes
    criterios:
    1. radioterapia dentro de las 4 semanas anteriores a la inscripción
    2. tratamiento concurrente o tratamiento dentro de las 4 semanas previas a la entrada al
    estudio con cualquier otro agente en investigación o quimioterapia
    3. las pacientes mujeres que estén en período de lactancia y dando el pecho o que
    tengan una prueba de embarazo positiva durante el período de selección
    4. enfermedad cardiovascular no controlada, clínicamente significativa y sintomática
    dentro de los 6 meses previos a la inscripción, incluido infarto de miocardio, angina
    inestable, enfermedad vascular periférica de grado 2 o superior, accidente
    cerebrovascular, ataque isquémico temporal, insuficiencia cardiaca congestiva o
    arritmias no controladas mediante medicación externa
    5. tratamiento con cualquier medicamento que tenga un riesgo potencial clínicamente
    relevante de prolongar el intervalo QT o de inducir torsades de pointes que no se
    pueda interrumpir o cambiar a una medicación distinta antes de iniciar el fármaco del
    estudio
    6. pacientes con anomalías en el ECG consideradas significativas por el investigador, o
    prolongación inicial repetida del intervalo QT corregido para la frecuencia cardiaca
    (QTc)
    7. infección en curso o activa clínicamente significativa según el juicio del investigador
    8. signos de PN ?CTCAA del NCI de grado 2
    9. quimioterapia concomitante, tratamiento hormonal, inmunoterapia o cualquier otra
    forma de tratamiento contra el cáncer
    10. uso de potentes inhibidores del citocromo P450 (CYP) 3A4 dentro de las 2 semanas
    previas a la primera dosis del fármaco del estudio (véase la sección 14.3 para ver un
    listado de potentes inhibidores de CYP3A)
    11. cualquier afección médica preexistente con una intensidad suficiente como para
    evitar el cumplimiento completo del estudio
    12. Antecedentes de neoplasia o neoplasia actual distinta del adenocarcinoma gástrico,
    excepto cáncer de piel no melanoma tratado curativamente o carcinoma del cuello
    del útero in situ
    13. diagnóstico conocido de infección por el virus de la inmunodeficiencia humana
    (VIH) (la prueba no es obligatoria)
    14. metástasis cerebral sintomática
    15. tratamiento anticoagulante en curso (p. ej., aspirina, coumadina, heparina)
    E.5 End points
    E.5.1Primary end point(s)
    ORR (complete response [CR] + PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
    TRG (tasa de RC + tasa de RP) y se basará en los
    criterios RECIST, versión 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening, Day 21 of every other cycle starting with Cycle 2 (ie, Cycles 2, 4, 6, etc.), at EOT, and during Progression Free Survival Follow-up (PFSFU).
    Seleccion, Día 21 de cada otro ciclo empezando en el ciclo 2 (pej. Ciclos 2, 4, 6, etc.), al EoT y durante la PFSFU.
    E.5.2Secondary end point(s)
    -AEs, serious adverse events (SAEs), clinical laboratory values, and vital sign measurements
    - Efficacy Endpoints: PFS, DOR, DCR, including CR + PR + SD with minimum 12 weeks duration, OS, Tumor size reduction
    - PK parameters
    - - GCC H-score assessed by immunohistochemistry (IHC)
    - Assessment of antitherapeutic antibodies (ATA)
    ? Evaluar el perfil de seguridad de MLN0264
    ? Evaluar la supervivencia sin progresión (SSP)
    ? Evaluar la duración de la respuesta
    ? Evaluar la tasa de control de la enfermedad
    ? Evaluar la supervivencia general
    ? Examinar el perfil farmacocinético
    ? Evaluar la reducción del tamaño del tumor
    ? Investigar la asociación entre el nivel de expresión de GCC y los efectos antitumorales de
    MLN0264
    ? Evaluar la inmunogenicidad de MLN0264
    E.5.2.1Timepoint(s) of evaluation of this end point
    AEs: From the first dose of study drug to 30 days after the last
    dose.

    SAEs: From the signing of the ICF to 30 days after the last dose

    Clinical laboratory values: Day 1, Day 15 Cycle 1&2; Day 1 Cycle 3+; EoT.

    Vital sign measurements: Screening; Day 1 at 5 and 15 minutes after the start of infusion and upon completion of the infusion for all cycles; EoT.

    Efficacy Endpoints: Screening; Day 21 of every other cycle starting with Cycle 2 (ie, Cycles 2, 4, 6, etc.); EOT, and during PFSFU.

    PK parameters: Specified timepoints on Day 1 all cycles; Day 3, Day 4, Day 8 & Day 15 Cycles 1 to 3; Day 4 & Day 8 Cycle 6; EoT.

    GCC H-score assessed by immunohistochemistry (IHC): pre-screening.

    Assessment of antitherapeutic antibodies (ATA): day 1 pre-dose; EoT.
    AA: desde primera dosis del fármaco hasta 30 días después desde la última dosis.

    AAG: desde la firma del consentimiento hasta 30 días posteriores ala última dosis

    Valores clínicos de laboratorio: Día 1, Día 15 ciclo 1y2, Día1 ciclo 3: EoT

    mEDIDAS DE LOS SIGNOS VITALES: Seleccion, Día 1 y5 y 15 minutos tras el inicio de la infusiony hasta que se complete la infusion para todos los ciclos: EoT

    Variables de eficacia: Seleccion, Día 21 de cada otro ciclo empezanco con el ciclo 2 (ej, ciclos 2,4,6 etc); EoT y durante PFSFU

    parámetros de FC: DÍa 1 todos los ciclos; Día 3, Día 4, Día 8 & Día 15 Ciclos 1 al 3; Día 4 & Día 8 Ciclo 6; EoT.

    Puntuación de H de GCC evaluada por inmunohistoquímica (IHQ): pre-selección.
    evaluación de los anticuerpos antiterapéuticos (AAT); EoT.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    biomarkers and immunogenicity
    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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Belgium
    Brazil
    Italy
    Peru
    Spain
    United Kingdom
    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
    Last Patient Last Visit
    Ultimo paciente última visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    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 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 81
    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)
    Standard of Care
    Práctica clínica habitual
    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 TrialNetworks
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-01-15
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