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    Summary
    EudraCT Number:2014-003673-42
    Sponsor's Protocol Code Number:MM-121-01-02-09
    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:2015-10-05
    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 number2014-003673-42
    A.3Full title of the trial
    A Phase 2 Study of MM-121 in Combination with Docetaxel or Pemetrexed versus Docetaxel or Pemetrexed Alone in Patients with Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
    Estudio de fase 2 de MM-121 en combinación con docetaxel o pemetrexed en comparación con docetaxel o pemetrexed en monoterapia en pacientes con cáncer de pulmón no microcítico localmente avanzado o metastásico, positivo para heregulina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study of MM-121 in Combination with Chemotherapy versus Chemotherapy Alone in Patients with Heregulin Positive Non-Small Cell Lung Cancer.
    Estudio de fase 2 de MM-121 en combinación con quimioterapia frente a quimioterapia sola, en pacientes con cáncer de pulmón no microcítico positivo para heregulina
    A.4.1Sponsor's protocol code numberMM-121-01-02-09
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02387216
    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
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerrimack Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointMM121 Clinical Trial Manager
    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 number0034932746085
    B.5.5Fax number0016178127776
    B.5.6E-mailclinical@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.3.1Product nameMM-121
    D.3.4Pharmaceutical form 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 available
    D.3.9.2Current sponsor codeMM-121
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 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
    Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
    Cáncer de Pulmón no Microcítico Localmente Avanzado o Metastásico, Positivo para Heregulina
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    Cáncer de Pulmón
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung 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 this study is to determine whether the combination of MM-121 plus docetaxel or pemetrexed is more effective than docetaxel or pemetrexed alone based on investigator assessed Progression Free Survival (PFS) according to RECIST 1.1 in HRG positive patients.
    El objetivo principal de este estudio es determinar si la combinación de MM-121 más docetaxel o pemetrexed es más eficaz que docetaxel o pemetrexed en monoterapia según la supervivencia sin progresión (SSP) valorada por el investigador, según los criterios RECIST 1.1 en pacientes positivos para HRG.
    E.2.2Secondary objectives of the trial
    • To determine whether the combination of MM-121 plus docetaxel or pemetrexed is more effective than docetaxel or pemetrexed alone based on centrally assessed PFS according to RECIST 1.1 in HRG positive patients
    • To determine whether the combination of MM-121 plus docetaxel or pemetrexed is more effective than docetaxel or pemetrexed alone based on OS in HRG positive patients
    •To compare the efficacy of the combination of MM-121 plus docetaxel or pemetrexed to docetaxel or pemetrexed alone using locally assessed:
    - ORR based on RECIST v 1.1
    - Duration of objective response
    • To compare the efficacy of the combination of MM-121 plus docetaxel or pemetrexed to docetaxel or pemetrexed alone using centrally assessed:
    - ORR based on RECIST v 1.1
    - Duration of objective response
    • To characterize the safety profile of MM-121 in combination with docetaxel or pemetrexed
    • To determine the PK parameters of MM-121 in combination with docetaxel or pemetrexed
    •Determinar si la combinación de MM-121 + docetaxel o pemetrexed es + eficaz que docetaxel o pemetrexed en monoterapia según la SSP evaluada de forma centralizada según los criterios RECIST 1.1 en pacientes positivos para HRG
    •Determinar si la combinación de MM-121 + docetaxel o pemetrexed es + eficaz que docetaxel o pemetrexed en monoterapia en función de la SG en pacientes positivos para HRG
    •Comparar eficacia de la combinación de MM-121 + docetaxel o pemetrexed con docetaxel o pemetrexed solos mediante la valoración local de: -Tasa de respuesta objetiva (TRO) según RECIST v 1.1 -Duración de la respuesta objetiva
    •Comparar eficacia de la combinación de MM-121 + docetaxel o pemetrexed con docetaxel o pemetrexed solos mediante la valoración central de: -TRO según RECIST v 1.1 -Duración de la respuesta objetiva
    •Caracterizar perfil de seguridad de MM-121 en combinación con docetaxel o pemetrexed
    •Determinar los parámetros FC de MM-121 en combinación con docetaxel o pemetrexed
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic and Immunogenicity Testing

    For patients on the experimental arm (Arm A), blood samples will be collected to determine the levels of monoclonal antibodies that comprise MM-121 and to determine the presence of an immunologic reaction to MM-121.
    Análisis Farmacocinético y de Antiinmunogenia

    Para los pacientes del grupo experimental (grupo A), se recogerán muestras de sangre para determinar los niveles de anticuerpos monoclonales que componen MM-121 y para determinar la presencia de una reacción inmunológica a MM-121.

    E.3Principal inclusion criteria
    INCLUSION CRITERIA FOR ALL PATIENTS:
    a) Patients with a diagnosis of cytologically or histologically confirmed NSCLC with either:
    • Metastatic disease (stage IV) or
    • Stage IIIB disease not amenable to surgery with curative intent
    b) Disease progression or evidence of recurrent or persistent disease documented by radiographic assessment following the last systemic therapy
    c) Received one prior platinum-based regimen for management of primary or recurrent disease
    d) Clinically eligible for intended chemotherapy, docetaxel or pemetrexed, once every three weeks per the investigator's judgment
    e) Must have:
    • Available recent tumor specimen collected following completion of most recent therapy OR
    • At least one lesion amenable to either core needle biopsy or fine needle aspiration
    f) ≥ 18 years of age
    g) Able to provide informed consent, or have a legal representative able and willing to do so

    ADDITIONAL INCLUSION CRITERIA FOR THE INTERVENTIONAL GROUP:

    h) A positive in-situ hybridization (ISH) test for heregulin with a score of ≥ 1+, as determined by centralized testing
    i) Measureable disease in accordance with RECIST v1.1
    j) ECOG performance status (PS) of 0 or 1
    k) Screening ECG without clinically significant abnormalities
    l) Adequate bone marrow reserve as evidenced by:
    • ANC > 1,500/µl and
    • Platelet count ≥ 100,000/µl
    • Hemoglobin ≥ 9 g/dL
    m) Adequate renal function as evidenced by a serum/plasma creatinine ≤ 1.5 x ULN for patients receiving docetaxel and a creatinine clearance ≥ 45 mL/min for patients receiving pemetrexed
    n) For patients receiving pemetrexed: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN is acceptable if liver metastases are present).
    o) For patients receiving docetaxel: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT ) ≤ 1.5 x ULN, Alkaline phosphatase (AP) ≤ 2.5 ULN and serum/plasma total bilirubin within normal institutional limits
    p) Women of childbearing potential, as well as fertile men and their partners, must be willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of study drug(s) (an effective form of contraception is an oral contraceptive or a double barrier method) or for 90 days following the last dose of study drug(s), or greater, as in accordance with the label requirements or institutional guidelines for docetaxel/pemetrexed.
    CRITERIOS DE INCLUSIÓN PARA TODOS LOS PACIENTES:
    a) Los pacientes con un diagnóstico de CPNM confirmado citológica o histológicamente con o bien:
    • Enfermedad metastásica (estadio IV), o bien
    • Enfermedad en estadio IIIB no susceptible de cirugía con intención curativa
    b) Progresión de la enfermedad o signos de enfermedad recurrente o persistente documentados por una evaluación radiográfica tras la última terapia sistémica
    c) Recibió una pauta anterior basada en platino para tratar la enfermedad principal o recurrente
    d) Apto clínicamente para la quimioterapia en cuestión, docetaxel o pemetrexed, una vez cada tres semanas según el criterio del investigador
    e) Debe tener:
    • Una muestra tumoral reciente disponible, recogida tras la finalización de la terapia más reciente O
    • Al menos una lesión susceptible de una biopsia con aguja gruesa o una aspiración con aguja fina
    f) ≥ 18 años de edad
    g) Capacidad de proporcionar el consentimiento informado, o tener un representante legal capaz y dispuesto a hacerlo

    CRITERIOS DE INCLUSIÓN ADICIONALES PARA EL GRUPO DE INTERVENCIÓN:

    h) Una prueba de hibridación in situ (HIS) positiva para heregulina con una puntuación de ≥ 1+, determinada por los análisis centralizados
    i) Enfermedad mensurable de acuerdo con RECIST v 1.1
    j) Estado funcional (PS) según el ECOG de 0 o 1
    k) ECG en la selección sin anomalías clínicamente significativas
    l) Una reserva de médula ósea adecuada, demostrada por:
    • RAN > 1500/µl, y
    • Recuento de plaquetas ≥ 100 000/µl
    • Hemoglobina ≥ 9 g/dl
    m) Función renal adecuada demostrada por creatinina en suero/plasma ≤ 1,5 veces el LSN para los pacientes que reciben docetaxel y un aclaramiento de la creatinina ≥ 45 ml/min para los pacientes que reciben pemetrexed
    n) Para los pacientes que reciben pemetrexed: Aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) ≤ 2,5 veces el LSN (≤ 5 veces el LSN si hay metástasis de hígado).
    o) Para pacientes que reciben docetaxel: Aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) ≤ 1,5 veces el LSN, fosfatasa alcalina (FA) ≤ 2,5 LSN y bilirrubina total en suero/plasma dentro de los límites institucionales
    p) Las mujeres en edad fértil, así como los hombres fértiles y sus parejas, deben estar dispuestos a abstenerse de tener relaciones sexuales o a usar un método eficaz de anticoncepción durante el estudio y durante 90 días tras la última dosis del fármaco o fármacos del estudio (un método eficaz de anticoncepción es un anticonceptivo oral o un método de doble barrera) o durante 90 días tras la última dosis del fármaco o fármacos del estudio o más, de acuerdo con los requisitos del prospecto o las directrices institucionales para docetaxel/pemetrexed.
    E.4Principal exclusion criteria
    a) Known Anaplastic Lymphoma Kinase (ALK) gene rearrangement or presence of exon 19 deletion or exon 21 (L858R) substitution of the EGFR gene
    b) Pregnant or lactating
    c) Prior radiation therapy to >25% of bone marrow-bearing areas
    d) Received >2 prior systemic anti-cancer drug regimen for locally advanced disease
    • Maintenance therapy with pemetrexed following first-line treatment for Stage IIIB or Stage IV disease is counted as one line of therapy
    e) Patients who have received prior docetaxel for advanced/ metastatic disease are not eligible for the docetaxel-containing chemotherapy backbone
    f) Patients who have received prior pemetrexed for advanced/ metastatic disease and/or maintenance therapy are not eligible for the pemetrexed-containing chemotherapy backbone
    g) Received other recent antitumor therapy including:
    • Investigational therapy administered within the 28 days or 5 half-lives, whichever is shorter, prior to the first scheduled day of dosing in this study
    • Radiation or other standard systemic therapy within 14 days prior to the first scheduled dose in this study, including, in addition (if necessary), the timeframe for resolution of any actual or anticipated toxicities from such radiation
    h) CTCAE grade 3 or higher peripheral neuropathy
    i) Presence of an unexplained fever > 38.5°C during screening visits that does not resolve prior to the first day of dosing. If the fever and active infection have resolved prior to randomization, the patient will be eligible. At the discretion of the investigator, patients with tumor fever may be enrolled.
    j) Symptomatic CNS metastases or CNS metastases requiring steroids
    k) Use of strong CYP3A4 inhibitors for patients considered for the docetaxel backbone.
    l) Any other active malignancy requiring systemic therapy
    m) Known hypersensitivity to any of the components of MM-121 or previous hypersensitivity reactions to fully human monoclonal antibodies
    n) History of severe allergic reactions to docetaxel or pemetrexed
    o) Known hypersensitivity to polysorbate (Tween) 80 or arginine
    p) Clinically significant cardiac disease, including: symptomatic congestive heart failure, unstable angina, acute myocardial infarction within 1 year months of planned first dose, or unstable cardiac arrhythmia requiring therapy (including torsades de pointes)..
    q) Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active B or C infection.
    r) Patients who are not appropriate candidates for participation in this clinical study for any other reason as deemed by the investigator
    a) Reordenaciones conocidas del gen de la cinasa del linfoma anaplásico (ALK) o presencia de eliminación del exón 19 o sustitución del exón 21 (L858R) del gen del EGFR
    b) Mujeres embarazadas o en período de lactancia
    c) Radioterapia anterior a > 25 % de las áreas que contienen médula ósea
    d) Recibieron > 2 pautas de fármacos anticancerígenos sistémicos anteriores para la enfermedad localmente avanzada
    • El tratamiento de mantenimiento con pemetrexed tras el tratamiento de primera línea para la enfermedad en estadio IIIB o estadio IV se cuenta como una línea de tratamiento
    e) Los pacientes que han recibido previamente docetaxel para la enfermedad avanzada/metastásica no son aptos para la base de quimioterapia con docetaxel
    f) Los pacientes que han recibido previamente pemetrexed para la enfermedad avanzada/metastásica y/o tratamiento de mantenimiento no son aptos para la base de quimioterapia con pemetrexed
    g) Recibieron otras terapias antitumorales recientes, como:
    • Un tratamiento en investigación administrado en el plazo de 28 días o 5 semividas, lo que sea más corto, antes del primer día programado de la administración en este estudio
    • Radioterapia u otra terapia sistémica estándar en el plazo de 14 días antes de la primera dosis programada en este estudio, incluido, si fuera necesario, el marco temporal para la resolución de cualquier toxicidad real o prevista de dicha radiación
    h) Neuropatía periférica de grado 3 o superior de los CTCAE
    i) Presencia de fiebre inexplicada > 38,5 °C durante las visitas de selección que no se resuelva antes del primer día de administración. Si la fiebre y la infección activa se han resuelto antes de la aleatorización, el paciente será apto. A discreción del investigador, podrá incluirse a pacientes con fiebre tumoral.
    j) Metástasis del SNC sintomáticas o metástasis del SNC que necesiten corticoesteroides
    k) Uso de inhibidores fuertes del CYP3A4 para los pacientes considerados para la base de docetaxel.
    l) Cualquier otra neoplasia maligna activa que necesite terapia sistémica
    m) Hipersensibilidad conocida a cualquiera de los componentes de MM-121 o reacciones de hipersensibilidad previa a anticuerpos monoclonales completamente humanos
    n) Antecedentes de reacciones alérgicas severas a docetaxel o pemetrexed
    o) Hipersensibilidad conocida al polisorbato (Tween) 80 o la arginina
    p) Cardiopatía clínicamente significativa, incluidos: insuficiencia cardiaca congestiva sintomática, angina inestable, infarto de miocardio agudo en el plazo de 1 año de la primera dosis planificada, o arritmia cardiaca inestable que necesite tratamiento (incluidas las torsades de pointes).
    q) Infección no controlada que requiera antibióticos i.v., antivíricos, o antifúngicos, infección conocida por el virus de la inmunodeficiencia humana (VIH), o infección activa por hepatitis B o C.
    r) Pacientes que no son candidatos apropiados para participar en este estudio clínico por cualquier otro motivo según el criterio del investigador
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is PFS in the interventional group as determined by investigator assessment.
    El criterio de valoración principal del estudio es la SSP en el grupo de intervención según lo determine la evaluación del investigador.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS is defined as the time from randomization to the first documented radiographical progression of disease using RECIST 1.1, or death from any cause, whichever comes first.
    La SSP se define como el tiempo desde la aleatorización hasta la primera progresión radiográfica de la enfermedad mediante RECIST v1.1 (basada en la valoración del investigador), o la muerte por cualquier causa, lo que suceda primero.
    E.5.2Secondary end point(s)
    • To determine whether the combination of MM-121 plus docetaxel or pemetrexed is more effective than docetaxel or pemetrexed alone based on centrally assessed PFS according to RECIST 1.1 in HRG positive patients
    • To determine whether the combination of MM-121 plus docetaxel or pemetrexed is more effective than docetaxel or pemetrexed alone based on overall survival (OS) in HRG positive patients
    • To compare the efficacy of the combination of MM-121 plus docetaxel or pemetrexed to docetaxel or pemetrexed alone using locally assessed:
    o Objective response rate (ORR) based on RECIST v 1.1
    o Duration of objective response
    • To compare the efficacy of the combination of MM-121 plus docetaxel or pemetrexed to docetaxel or pemetrexed alone using centrally assessed:
    o Objective response rate (ORR) based on RECIST v 1.1
    o Duration of objective response
    • To characterize the safety profile of MM-121 in combination with docetaxel or pemetrexed
    • To determine the pharmacokinetic (PK) parameters of MM-121 in combination with docetaxel or pemetrexed
    • Determinar si la combinación de MM-121 más docetaxel o pemetrexed es más eficaz que docetaxel o pemetrexed en monoterapia según la SSP evaluada de forma centralizada según los criterios RECIST 1.1 en pacientes positivos para HRG
    • Determinar si la combinación de MM-121 más docetaxel o pemetrexed es más eficaz que docetaxel o pemetrexed en monoterapia en función de la supervivencia global (SG) en pacientes positivos para HRG
    • Comparar la eficacia de la combinación de MM-121 más docetaxel o pemetrexed con docetaxel o pemetrexed solos mediante la valoración local de:
    o Tasa de respuesta objetiva (TRO) según RECIST v 1.1
    o Duración de la respuesta objetiva
    • Comparar la eficacia de la combinación de MM-121 más docetaxel o pemetrexed con docetaxel o pemetrexed solos mediante la valoración central de:
    o Tasa de respuesta objetiva (TRO) según RECIST v 1.1
    o Duración de la respuesta objetiva
    • Caracterizar el perfil de seguridad de MM-121 en combinación con docetaxel o pemetrexed
    • Determinar los parámetros farmacocinéticos (FC) de MM-121 en combinación con docetaxel o pemetrexed
    E.5.2.1Timepoint(s) of evaluation of this end point
    The time from the date of randomization to the date of death from any cause.
    El tiempo desde la fecha de la aleatorización hasta la fecha de la muerte por cualquier causa
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker analysis and MM-121 Anti-Immunogenicity
    Biomarcadores exploratorios y Antiinmunogenia de MM-121
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    France
    Germany
    Spain
    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
    The trial will end when 90 deaths have been reported or the trial is terminated by the sponsor.
    El ensayo clínico acabará cuando se hayan comunicado 90 muertes o el ensayo sea cancelado por el promotor.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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: 100
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 120
    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)
    After the final PFS analysis has been completed, ongoing patients that were randomized to the MM-121 containing treatment arm may continue to receive MM-121 at the discretion of the investigator if the patient is deriving benefit. Merrimack Pharmaceuticals will continue to supply MM-121.
    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 Decision2015-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-11-02
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