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    Summary
    EudraCT Number:2012-003798-25
    Sponsor's Protocol Code Number:MM-111-13-02-04
    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:2013-04-09
    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 number2012-003798-25
    A.3Full title of the trial
    Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel with or
    without Trastuzumab in Patients with ?Traditional? and ?Non-Traditional? HER2 Expressing
    Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have
    Failed Front Line Metastatic or Locally Advanced Therapy.
    Estudio en fase II, abierto, aleatorizado, de MM-111 y paclitaxel con o sin trastuzumab, en pacientes con carcinoma que expresa HER2 "tradicional" y "no tradicional" de esófago distal, unión gastroesofágica (GE) o estómago, en los que ha fracasado el tratamiento de primera línea para la enfermedad metastásica o localmente avanzada
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of MM-111 and Paclitaxel with or without Trastuzumab in patients with Metastatic or Locally Advanced Cancer of the Esophagus, Gastroesophageal Junction and Stomach
    Estudio de MM-111 y paclitaxel con o sin trastuzumab en pacientes con carcinoma con cáncer de esófago, unión gastroesofágica o estómago con metastástasis o localmente avanzado.
    A.4.1Sponsor's protocol code numberMM-111-13-02-04
    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 SponsorMerrimack 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 supportMerrimack Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerrimack Pharmaceuticals
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressOne Kendall Square, Suite B7201
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016174417667
    B.5.5Fax number0016178128419
    B.5.6E-mailsfrye@merrimackpharma.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.3.2Product code MM-111
    D.3.4Pharmaceutical form 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 INNMM-111
    D.3.9.2Current sponsor codeMM-111
    D.3.9.3Other descriptive namebispecific antibody which binds to ErbB2 and ErbB3 receptors
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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
    HER2 distal esophageal, Gastroesophageal (GE) junction or gastric carcinoma.
    Cáncer HER2 de esófago, unión gastroesofágica o gástrico
    E.1.1.1Medical condition in easily understood language
    Cancer of the esophagus, gastroesophageal (GE) junction or stomach.
    Cáncer de esófago, unión gastroesofáfica o estómago.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10015362
    E.1.2Term Esophageal cancer
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10056267
    E.1.2Term Gastroesophageal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to compare the Progression Free Survival (PFS) between the experimental and comparator arms within two distinct patient populations: Patients with
    ?Traditional? and ?Non-Traditional? HER2 expressing tumors.
    El objetivo principal del estudio es comparar la supervivencia libre de progresión (SLP) de los pacientes entre el grupo experimental y el grupo comparador en dos poblaciones de pacientes diferentes: Pacientes con tumores que expresan HER2 "tradicional" y "no tradicional".
    E.2.2Secondary objectives of the trial
    To compare the following measures between the two treatment arms within each group:

    - Overall Survival (OS)
    - Time to treatment failure (TTF)
    - Objective response rate
    - Duration of Response (DOR)
    - Safety Profiles
    - Health-Related Quality of Life (HRQOL) scores

    To evaluate the following in treatment arm regimens that include MM-111:

    - Pharmacokinetic (PK) profile and pharmacodynamic activity of MM-111 in distal esophageal, GE junction, and gastric carcinoma
    - Immunogenicity of MM-111 when administered in combination with paclitaxel with/without trastuzumab
    Comparar las siguientes medidas entre los dos grupos de tratamiento dentro de cada grupo:
    -Supervivencia global (SG)
    -Tiempo hasta el fracaso terapéutico (TFT)
    -Tasa de respuesta objetiva
    -Duración de la respuesta (DR).
    -Perfiles de seguridad
    -Puntuaciones de la calidad de vida relacionada con la salud (CVRS)

    Evaluar lo siguiente en los regímenes del grupo de tratamiento que incluyen MM-111:

    -Perfil farmacocinético (FC) y perfil de la actividad farmacodinámica de MM-111 en el carcinoma de esófago distal, unión GE y estómago
    -Inmunogenicidad de MM-111 cuando se administra en combinación con paclitaxel con/sin trastuzumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be qualified for study participation based on the following inclusion criteria:

    - Patients must have documentation of histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the distal esophagus, GE junction or stomach
    - Patients must have documentation of histologically or cytologically confirmed HER2
    expression as follows:
    o Traditional HER2 Group 1: Patients who are HER2 3+ by IHC OR HER 2 2+ by IHC and HER2 gene amplified by FISH or CISH
    o Non-Traditional HER2 Group 2: Patients who are HER2 2+ by IHC and HER2 gene nonamplified by FISH or CISH
    - For Traditional HER2 Group 1
    o Patients must have received one prior systemic therapy for metastatic disease, which must be a standard fluoropyrimidine/platinum-based frontline therapy given with or without trastuzumab
    - Non-Traditional HER2 Group 2
    o Patients must have received one prior systemic therapy for metastatic disease which must be a standard fluoropyrimidine/platinum-based frontline therapy given without trastuzumab
    - Patients must be ?18 years of age
    - Patients or their legal representatives must be able to understand and sign an informed consent
    - Patients should have evaluable or measurable disease ?1 cm per RECIST 1.1
    - Patients must have ECOG PS of 0, 1, or 2
    - Patients must have adequate hematologic status as evidenced by:
    o Absolute neutrophil count (ANC) ?1500 cells/mm3
    o Platelet count ?100,000 platelets/mm3
    o Hemoglobin ?9 g/dL
    - Patients must have adequate hepatic function as evidenced by:
    o Serum total bilirubin ?1.5 × the upper limit of normal (ULN)
    o Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ?2.5 x ULN (5 × ULN is acceptable if liver metastases are present)
    - Patients must have adequate renal function as evidenced by:
    o Serum creatinine ?1.5 × ULN or calculated clearance 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
    - Patients must be recovered from the effects of any prior surgery, radiotherapy or other
    antineoplastic therapy. NCI CTCAE v.4.0 up to grade 1 is acceptable for patients with preexisting peripheral neuropathy
    - Women of childbearing potential as well as fertile men and their partners must agree to
    abstain from sexual intercourse or to use an effective form of contraception during the study
    and for 60 days following the last dose of assigned study drug(s)
    - Patients must have an archived formalin-fixed, paraffin-embedded (FFPE) tumor tissue
    sample
    - Patients must be willing and able to undergo a pre-treatment biopsy (this applies to the first
    30 patients in each treatment group i.e. 30 for Traditional HER2 and 30 for Non-Traditional
    HER2)
    Los pacientes serán aptos para la participación en el estudio si cumplen los siguientes criterios de inclusión:
    -Los pacientes deben presentar la documentación de la confirmación histológica o citológica de adenocarcinoma metastásico o localmente avanzado en el esófago distal, la unión GE o el estómago.
    -Los pacientes deben presentar la documentación de la confirmación histológica o citológica de la expresión de HER2, de la siguiente forma:
    o Grupo 1 HER2 tradicional: Pacientes HER2 3+ mediante IHQ O HER2 2+ mediante IHQ y amplificación génica de HER2 mediante FISH o CISH.
    -Grupo 2 HER2 no tradicional: Pacientes HER2 2+ mediante IHQ y sin amplificación génica de HER2 mediante FISH o CISH.
    -Grupo 1 HER2 tradicional:
    -Los pacientes deben haber recibido un tratamiento sistémico previo para la enfermedad metastásica, que debe ser un tratamiento estándar de primera línea basado en fluoropirimidinas/platino administrado con o sin trastuzumab
    -Grupo 2 HER2 no tradicional:
    -Los pacientes deben haber recibido un tratamiento sistémico previo para la enfermedad metastásica, que debe ser un tratamiento estándar de primera línea con fluoropirimidinas/platino administrado sin trastuzumab
    -Los pacientes deben ser ? de 18 años
    -Los pacientes o sus representantes legales deberán ser capaces de entender y firmar un formulario de consentimiento informado
    -Los pacientes deben presentar enfermedad evaluable o medible ? 1 cm según los criterios RECIST 1.1.
    -Los pacientes deben presentar un EF del ECOG de 0, 1 o 2
    -Los pacientes deben disponer de un estado hematológico adecuado, demostrado por:
    -Recuento absoluto de neutrófilos (RAN) ? 1500 células/mm3
    -Recuento plaquetario ? 100.000 plaquetas/mm3
    -Hemoglobina ? 9 g/dl
    -Los pacientes deben disponer de una función hepática adecuada, demostrada por:
    -Bilirrubina total sérica ? 1,5 veces el límite superior de normalidad (LSN).
    -Aspartato aminotransferasa (AST), alanina aminotransferasa (ALT) y fosfatasa alcalina ? 2,5 x LSN (5 x LSN es aceptable si existe metástasis hepática)
    -Los pacientes deben disponer de una función renal adecuada, demostrada por:
    Creatinina sérica ? 1,5 x LSN o aclaramiento calculado de 60 ml/min/1,73 m2 para pacientes con niveles de creatinina superiores a la normalidad
    -Los pacientes deben estar recuperados de los efectos de cualquier cirugía previa, radioterapia u otros tratamientos antineoplásicos. Se permite hasta un grado 1 de los criterios CTCAE del NCI v. 4.0 para los pacientes con neuropatía periférica previa.
    -Las mujeres en edad fértil, así como los hombres en edad fértil y sus parejas, deben aceptar abstenerse de mantener relaciones sexuales o bien utilizar un método anticonceptivo eficaz durante el estudio y durante los 60 días posteriores a la última dosis del fármaco del estudio asignado.
    -Los pacientes deben tener una muestra de tejido tumoral conservada fijada en formol e incluida en parafina (FFIP).
    -Los pacientes deben estar dispuestos a someterse a una biopsia antes del tratamiento (aplicable a los primeros 30 pacientes en cada grupo de tratamiento, es decir, 30 para HER2 tradicional, 30 para HER2 no tradicional)
    E.4Principal exclusion criteria
    Patients will be disqualified from study participation based on the following exclusion criteria:
    - Patients for whom potentially curative antineoplastic therapy is available
    - Patients who previously received paclitaxel or other taxane treatment in the frontline or locally advanced setting
    - Patients who are pregnant or lactating
    - Patients with an active infection or with an unexplained fever >38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, patients
    with tumor fever may be enrolled)
    - Patients with known brain metastasis
    - Patients with known hypersensitivity to any of the components of MM-111 or who have had
    hypersensitivity reactions to fully human monoclonal antibodies
    - Patients with a known history of hypersensitivity to paclitaxel or other drugs formulated in
    Cremophor® EL, unless a patient has been de-sensitized in accordance with institutional
    guidelines
    - Patients with a known history of hypersensitivity to trastuzumab or any of its components
    (for group 1 only)
    - Patients who have received other recent anti-tumor therapy. This includes the following:
    o Investigational therapy administered within the 28 days prior to the first scheduled day of dosing MM-111
    - Dosing within <28 days since receiving investigational therapy is acceptable once a time interval equal to at least five half-lives of the investigational agent has passed
    - Patients in the Traditional HER2 group already receiving trastuzumab do not require a wash-out period from trastuzumab (for group 1 only)
    o Any standard chemotherapy or radiation or other therapy within 14 days prior to the
    first scheduled dose of MM-111
    o Patients who have not recovered from clinically significant effects of any prior surgery, radiotherapy or any other antineoplastic therapies. Patients with a known peripheral neuropathy must present with a grade 1 severity or less according to NCI CTCAE 4.0
    Patients with active or prior history of New York Heart Association (NYHA) congestive heart failure or left ventricular ejection fraction (LVEF) <50%
    - History of myocardial infarction within 12 months of enrollment
    - Uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure
    >100 mm Hg)
    - Known angina pectoris requiring medication
    - Known clinically significant heart valve disease
    - Known history of high-risk arrhythmias requiring medical attention (chronic stable well controlled atrial fibrillation is permissible)
    - Active gastrointestinal bleeding
    - Patients who have received prior maximum cumulative anthracycline doses:
    o Doxorubicin or liposomal doxorubicin doses >360 mg/m2
    o Mitoxantrone >120 mg/m2 and idarubicin >90 mg/m2
    o Epirubicin doses higher than 720 mg/m2
    o Other (e.g., liposomal doxorubicin or other anthracycline equivalent of 360 mg/m2 of doxorubicin)
    o If more than 1 anthracycline has been used, the cumulative dose must not exceed the equivalent of 360mg/m2 of doxorubicin
    - Patients with known human immunodeficiency virus (HIV). Patients with Hepatitis B surface antigen (carriers) may be enrolled but must receive nucleoside/nucleotide analogue or other suitable treatment for Hepatitis B per institutional guidelines
    - Patients with any other medical or psychological condition, deemed by the investigator to
    likely interfere with a patient's ability to sign informed consent or cooperate and participate
    in the study, or interfere with the interpretation of the study results
    -Patients with any medical history and/or systemic diseases which in the investigator’s opinion may impede the study treatment
    Los pacientes serán excluidos de la participación en el estudio si cumplen los siguientes criterios de exclusión:
    -Pacientes para los que haya disponible un posible tratamiento curativo antineoplásico
    -Pacientes que hayan recibido previamente paclitaxel u otro tratamiento con taxanos en un contexto de tratamiento de primera línea o localmente avanzado
    -Mujeres embarazadas o en periodo de lactancia
    -Pacientes con una infección activa o con fiebre inexplicable > 38,5 °C durante las visitas de selección o en el primer día de dosis programado (según el criterio del investigador, se podrán incluir pacientes con fiebre relacionada con el tumor)
    -Pacientes con metástasis cerebral
    -Pacientes con hipersensibilidad conocida a cualquiera de los componentes de MM-111 o que hayan sufrido reacciones de hipersensibilidad a anticuerpos monoclonales completamente humanos
    -Pacientes con antecedentes de hipersensibilidad a paclitaxel o a otros fármacos formulados en Cremophor® EL, a menos que un paciente se haya desensibilizado conforme a las directrices institucionales
    -Pacientes con antecedentes de hipersensibilidad a trastuzumab o a cualquiera de sus componentes (solo en el grupo 1)
    -Pacientes que hayan recibido recientemente otro tratamiento antitumoral. Esto incluye los siguientes:
    -Tratamientos en investigación administrados en los 28 días previos al primer día programado de administración de MM-111
    -Se permite la administración en los 28 días previos desde que se recibió el tratamiento en investigación si ha transcurrido un intervalo igual a al menos cinco semividas del fármaco en investigación
    -Los pacientes en el grupo HER2 tradicional que ya están recibiendo tratamiento con trastuzumab no requieren un periodo de lavado de trastuzumab (solo en el grupo 1)
    -Cualquier quimioterapia estándar o radiación u otro tipo de tratamiento en los 14 días previos a la primera dosis programada de MM-111
    -Pacientes que no se hayan recuperado de efectos clínicamente importantes de cualquier cirugía previa, radioterapia u otros tratamientos antineoplásicos Los pacientes con una neuropatía periférica diagnosticada deberán presentar una gravedad de grado 1 o menos según los criterios CTCAE del NCI 4.0
    -Pacientes con antecedentes previos o con actividad de insuficiencia cardíaca congestiva según la New York Heart Association (NYHA) o fracción de eyección del ventrículo izquierdo (FEVI) < 50 %
    -Antecedentes de infarto de miocardio en los 12 meses previos a la inclusión
    -Hipertensión incontrolada (presión arterial sistólica >180 mmHg o presión arterial diastólica >100 mmHg)
    -Angina de pecho diagnosticada que requiera medicación
    -Antecedentes diagnosticados de valvulopatía cardíaca clínicamente significativa
    -Antecedentes diagnosticados de arritmias de alto riesgo que requieren atención médica (se permite la fibrilación auricular crónica bien controlada)
    -Hemorragia gastrointestinal activa
    -Pacientes que hayan recibido previamente dosis máximas acumuladas de una antraciclina:
    -Dosis > 360 mg/m2 de doxorubicina o doxorubicina liposomal
    -Mitoxantrona > 120 mg/m2 e idarubicina > 90 mg/m2
    -Dosis de epirubicina superiores a 720 mg/m2
    -Otros (por ejemplo, doxorubicina liposomal u otras antraciclinas equivalentes a 360 mg/m2 de doxorubicina)
    -Si se ha utilizado más de una antraciclina, la dosis acumulada no debe superar el equivalente a 360 mg/m2 de doxorubicina
    -Pacientes con diagnóstico del virus de la inmunodeficiencia humana (VIH). Se puede incluir a los pacientes con antígeno de superficie de la Hepatitis B (portadores), pero deben recibir análogos de nucleósidos o nucleótidos u otro tratamiento adecuado para la Hepatitis B, según las directrices institucionales
    -Pacientes con cualquier otra enfermedad médica o psicológica, que el investigador considere que puede interferir con la capacidad del pacientes para firmar el consentimiento informado o colaborar y participar en el estudio, o interferir en la interpretación de los resultados del estudio.
    -Pacientes con antecedentes patológicos y/o enfermedades sistémicas que en opinión del investigador
    impidan el tratamiento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS) is the primary efficacy endpoint.
    Supervivencia libre de progresión (SLP) es el objetivo principal de eficacia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS is defined as the number of months from the date of randomization to the date of death or progression, whichever occurred earlier.
    La SLP se define como el número de meses entre la fecha de aleatorización y la fecha de la muerte o la progresión, lo que ocurra antes.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints that will be used to evaluate target and non-target lesion antitumor response of each treatment regimen using RECIST v1.1 criteria include:
    - Overall Survival (OS)
    - Time to treatment failure (TTF)
    - Objective response rate
    - Duration of Response (DOR)
    - Safety profiles will also be analyzed
    - Health-Related Quality of Life (HRQOL) scores

    The following will be assessed in treatment arm regimens that include MM-111:
    - Pharmacokinetic (PK) concentrations and pharmacodynamic activity of MM-111 in distal esophageal, GE junction, and gastric carcinoma Immunogenicity of MM-111 when administered in combination with paclitaxel
    with/without trastuzumab.
    Comparar las siguientes medidas entre los dos grupos de tratamiento dentro de cada grupo:
    -Supervivencia global (SG)
    -Tiempo hasta el fracaso terapéutico (TFT)
    -Tasa de respuesta objetiva
    -Duración de la respuesta (DR).
    -Perfiles de seguridad
    -Puntuaciones de la calidad de vida relacionada con la salud (CVRS)
    Evaluar lo siguiente en los regímenes del grupo de tratamiento que incluyen MM-111:
    -Perfil farmacocinético (FC) y perfil de la actividad farmacodinámica de MM-111 en el carcinoma de esófago distal, unión GE y estómago
    -Inmunogenicidad de MM-111 cuando se administra en combinación con paclitaxel con/sin trastuzumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    Death (i.e. overall survival)
    Muerte (por ejemplo supervivencia global)
    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 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) 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 Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Denmark
    France
    Korea, Republic of
    South Africa
    Spain
    Taiwan
    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
    Date when all subjects are deceased.
    Fecha cuando todos los pacientes han fallecido.
    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 months9
    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 months9
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 180
    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)
    Physicians choice, there are no restrictions. Note: there is no 3rd line options for these patients
    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 Sarah Cannon Research Institute
    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 Decision2013-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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