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    Summary
    EudraCT Number:2013-003398-91
    Sponsor's Protocol Code Number:ABI-007-PANC-003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-03-06
    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 number2013-003398-91
    A.3Full title of the trial
    A Phase 3, Multicenter, Open-label, Randomized Study of nab-Paclitaxel Plus Gemcitabine versus Gemcitabine Alone as Adjuvant Therapy in Subjects with Surgically Resected Pancreatic Adenocarcinoma
    Estudio de fase 3, multicéntrico, abierto y aleatorizado de nab-paclitaxel más gemcitabina en
    comparación con gemcitabina en monoterapia como tratamiento adyuvante en sujetos con
    adenocarcinoma pancreático extirpado quirúrgicamente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A large clinical study, for patients who have recently undergone surgery to remove some cancerous tissue from the pancreas, to compare post surgery treatment using nab-Paclitaxel and Gemcitibine or Gemcitibine alone.
    Un estudio clínico a gran escala, para pacientes que se han sometido recientemente a cirugía para extirpar parte del tejido canceroso en el páncreas, para comparar el tratamiento después de la cirugía utilizando nab-paclitaxel y gemcitabina o solo gemcitabina
    A.4.1Sponsor's protocol code numberABI-007-PANC-003
    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 SponsorCelgene Corporation
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9225 Indian Creek Parkway, Suite 900, Overland Park
    B.5.3.2Town/ cityKansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34 91 422 00 00
    B.5.5Fax number+1 913-266-0394
    B.5.6E-mailClinicalTrialDisclosure@celgene.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 Abraxane
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/809-withdrawn by Sponsor 07Feb2013
    D.3 Description of the IMP
    D.3.2Product code nab-paclitaxel, ABI-007
    D.3.4Pharmaceutical form Powder 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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Yes
    D.3.11.13.1Other medicinal product typeIMP contiene un excipiente de origen biológico,albúmina,agente estabilizador no activo.Derivado de sangre humana de sujeto para selección de donantes aprobados y procesos de fabricación de productos
    D.IMP: 2
    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 Gemcitabine for Injection 1g
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited, Middlesex (UK)
    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 nameGemcitabina
    D.3.4Pharmaceutical form Powder 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 INNGEMCITABINA
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects With Surgically Resected Pancreatic Adenocarcinoma
    Sujetos con adenocarcinoma pancreático que ha sido objeto de una resección quirúrgica
    E.1.1.1Medical condition in easily understood language
    Subjects with pancreatic cancer who have recently undergone surgery to remove some of the infected tissue
    Sujetos con cáncer de páncreas que se han sometido recientemente a cirugía para extirpar parte del tejido infectado
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10033602
    E.1.2Term Pancreatic adenocarcinoma resectable
    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 compare disease-free survival (DFS) between subjects randomized to nabpaclitaxel in combination with gemcitabine and subjects randomized to gemcitabine alone
    Comparar la supervivencia sin enfermedad (SSE) entre los sujetos aleatorizados a
    recibir nab-paclitaxel en combinación con gemcitabina y los aleatorizados a recibir
    gemcitabina en monoterapia
    E.2.2Secondary objectives of the trial
    -To assess overall survival (OS) between subjects randomized to nab-paclitaxel in combination with gemcitabine and subjects randomized to gemcitabine alone

    - To assess safety and tolerability of the 2 treatment regimens
    - Evaluar la supervivencia global (SG) entre los sujetos aleatorizados a recibir nabpaclitaxel
    en combinación con gemcitabina y los aleatorizados a recibir gemcitabina
    en monoterapia.
    - Evaluar la seguridad y la tolerabilidad de los dos regímenes de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded.
    2. Pancreatic cancer surgical staging: T 1-3, N0-1, M0.
    3. Subject should be able to start treatment no later than 12 weeks postsurgery.
    4. >= 18 years of age at the time of signing the informed consent form (ICF).
    5. ECOG performance status of 0 or 1.
    6. Acceptable hematology parameters:
    - Absolute neutrophil count >=1500 cell/mm3
    - Platelet count >=100,000/mm3
    - Hemoglobin (Hgb) >=9 g/dL
    7. Acceptable blood chemistry levels:
    - AST/ SGOT and ALT/ SGPT <=2.5 × upper limit of normal range (ULN)
    - Total bilirubin <= ULN (subjects with Gilbert?s syndrome can have bilirubin of up to 1.5 x ULN)
    - Alkaline phosphatase <= 2.5 x ULN
    - Serum creatinine within upper limits of normal or calculated clearance >=50 mL/min/1.73 m2. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For subjects with a Body Mass Index (BMI) >30 kg/m2, lean body weight should be used instead
    8. CA19-9 <100 U/mL assessed within 14 days of randomization
    9. Acceptable coagulation studies as demonstrated by PT and PTT within normal limits
    (+-15%)
    10. Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [ie, has had menses at any time during the preceding 24 consecutive months]) must:
    - Agree to the use of two physician-approved contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study IP; and for 3 months following the last dose of IP; and
    - Has negative serum pregnancy test (? -hCG) result at screening
    11. Male subjects:
    a. Must practice true abstinence* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following IP discontinuation, even if he has undergone a successful vasectomy.
    12. Understand and voluntarily sign an ICF prior to any study related assessments or procedures being conducted.
    13. Be able to adhere to the study visit schedule and other protocol requirements.
    * True abstinence is acceptable 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).
    1. Adenocarcinoma pancreático canalicular, confirmado histológicamente, extirpado con resección macroscópica completa (R0 y R1). Se excluirá a los sujetos con tumores neuroendocrinos (y de tipo mixto).
    2. Estadificación quirúrgica del cáncer de páncreas: T 1-3, N0-1, M0.
    3. Posibilidad de comenzar el tratamiento del estudio, a lo sumo, 12 semanas después de la intervención quirúrgica.
    4. Edad mínima de 18 años en el momento de firmar el documento de consentimiento informado (DCI).
    5. Estado funcional del ECOG de 0 o 1.
    6. Parámetros hematológicos aceptables:
    -Recuento absoluto de neutrófilos >= 1500 cel/mm3.
    -Recuento de plaquetas >= 100.000/mm3.
    -Hemoglobina (Hb) >= 9 g/dl.
    7. Parámetros de bioquímica sanguínea aceptables:
    -AST/SGOT y ALT/SGPT <= 2,5 veces el límite superior de la normalidad (LSN).
    -Bilirrubina total <= LSN (los sujetos con síndrome de Gilbert podrán tener una bilirrubina de hasta 1,5 veces el LSN).
    -Fosfatasa alcalina <= 2,5 veces el LSN.
    -Creatinina sérica dentro del LSN o aclaramiento calculado >= 50 ml/min/1,73 m2. Si se utiliza el aclaramiento de creatinina, se empleará el peso corporal real para calcular el aclaramiento de creatinina (por ejemplo, con la fórmula de Cockcroft-Gault). En los sujetos con un índice de masa corporal (IMC) > 30 kg/m2, deberá utilizarse en su lugar el peso corporal magro.
    8. CA19.9 < 100 U/ml evaluado en los 14 días previos a la aleatorización.
    9. Estudios de coagulación aceptables, según lo indicado por un TP y un TTP dentro de los límites normales (+- 15%).
    10. Las mujeres en edad fértil [definidas como las sexualmente maduras que: 1) no se hayan sometido a una histerectomía (resección quirúrgica del útero) ni una ovariectomía bilateral (resección quirúrgica de ambos ovarios) o 2) no hayan presentado un estado posmenopáusico natural durante al menos 24 meses consecutivos (es decir, han tenido la menstruación en algún momento durante los 24 meses previos consecutivos)] deberán:
    -Comprometerse a utilizar dos métodos anticonceptivos aprobados por un médico (anticonceptivos hormonales orales, inyectables o implantables, ligadura de trompas, dispositivo intrauterino, anticonceptivo de barrera con espermicida o vasectomía de la pareja) mientras reciban el PEI del estudio y durante los 3 meses siguientes a la última dosis del PEI.
    -Tener un resultado negativo en la prueba de embarazo (?-hCG) de selección.
    11. Los varones:
    a. Deberán mantener abstinencia sexual real* o comprometerse a utilizar preservativo durante las relaciones sexuales con mujeres embarazadas o en edad fértil mientras participen en el estudio, durante las interrupciones del tratamiento y durante al menos 6 meses después de la suspensión del PEI, incluso si se han sometido a una vasectomía con éxito.
    12. Comprensión y firma voluntaria de un DCI antes de realizar las evaluaciones y procedimientos relacionados con el estudio.
    13. Capacidad de cumplir el calendario de visitas del estudio y los demás requisitos del protocolo.
    *La abstinencia real es aceptable cuando está en consonancia con el estilo de vida preferido y habitual del sujeto. (Abstinencia periódica [por ejemplo, por calendario, ovulación, sintotérmico, métodos postovulation] y la retirada no son métodos anticonceptivos aceptables)
    E.4Principal exclusion criteria
    The presence of any of the following will exclude a subject from enrollment:
    1. Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma

    2. Presence of or history of metastatic pancreatic adenocarcinoma

    3. Any other malignancy within 5 years prior to randomization, with the exception of
    adequately treated in-situ carcinoma of the cervix, uteri, or nonmelanomatous skin cancer
    (all treatment of which should have been completed 6 months prior to randomization)

    4. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy,
    defined as ongoing signs/symptoms related to the infection without improvement despite
    appropriate antibiotics, antiviral therapy, and/or other treatment

    5. Known infection with hepatitis B or C, or history of human immunodeficiency virus
    (HIV) infection, or subject receiving immunosuppressive or myelosuppressive
    medications that would in the opinion of the investigator, increase the risk of serious
    neutropenic complications

    6. History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their
    excipients

    7. Serious medical risk factors involving any of the major organ systems, or serious
    psychiatric disorders, which could compromise the subject's safety or the study data
    integrity. These include, but are not limited to:
    a. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
    b. History of interstitial lung disease, slowly progressive dyspnea and unproductive
    cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary
    hypersensitivity pneumonitis or multiple allergies
    c. History of the following within 6 months prior to Cycle 1 Day 1: a myocardial
    infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft,
    New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled
    hypertension, clinically significant cardiac dysrhythmia or ECG abnormality,
    cerebrovascular accident, transient ischemic attack, or seizure disorder

    8. Enrollment in any other clinical protocol or investigational study with an interventional
    agent or assessments that may interfere with study procedures

    9. Any significant medical condition, laboratory abnormality, or psychiatric illness that
    would prevent the subject from participating in the study

    10. Any condition including the presence of laboratory abnormalities, which places the
    subject at unacceptable risk if he/she were to participate in the study

    11. Any condition that confounds the ability to interpret data from the study

    12. Unwillingness or inability to comply with study procedures
    1. Tratamiento neoadyuvante o radioterapia anterior por adenocarcinoma pancreático.
    2. Presencia o antecedentes de adenocarcinoma pancreático metastásico.
    3. Cualquier otra neoplasia maligna en los 5 años previos a la aleatorización, a excepción de carcinoma in situ de cuello uterino o cáncer de piel no melanomatoso debidamente tratado (todo el tratamiento tendrá que haberse completado 6 meses antes de la aleatorización).
    4. Infección bacteriana, micótica o viral, no controlada, activa, con necesidad de tratamiento sistémico, definida como la presencia de signos y síntomas persistentes relacionados con la infección sin mejoría a pesar del tratamiento apropiado con antibióticos, antivirales o cualquier otro tratamiento.
    5. Infección conocida por el virus de la hepatitis B o C o antecedentes de infección por el virus de la inmunodeficiencia humana (VIH) o tratamiento con inmunodepresores o mielodepresores que, en opinión del investigador, podrían aumentar el riesgo de presentar complicaciones neutropénicas graves.
    6. Antecedentes de alergia o hipersensibilidad a nab-paclitaxel o gemcitabina o a cualquiera de sus excipientes.
    7. Factores de riesgo médicos graves relacionados con cualquiera de los órganos principales o trastornos psiquiátricos graves que podrían poner en peligro la seguridad del sujeto o la integridad de los datos del estudio. Entre otros, los siguientes:
    a. Antecedentes de trastornos del tejido conjuntivo (por ejemplo, lupus, esclerodermia o arteritis nudosa).
    b. Antecedentes de neumopatía intersticial, disnea lentamente progresiva y tos no productiva, sarcoidosis, silicosis, fibrosis pulmonar idiopática, neumonitis por hipersensibilidad pulmonar o alergias múltiples.
    c. Antecedentes de los procesos siguientes en los 6 meses previos al día 1 del ciclo 1: infarto de miocardio, angina de pecho grave o inestable, injerto de derivación de arterias coronarias o periféricas, insuficiencia cardíaca en clase III-IV de la New York Heart Association (NYHA), hipertensión no controlada, arritmia cardíaca o anomalía del ECG clínicamente significativa, accidente cerebrovascular, accidente isquémico transitorio o trastorno convulsivo.
    8. Participación en otro protocolo clínico o estudio de investigación con fármacos o evaluaciones que puedan interferir en los procedimientos del estudio.
    9. Cualquier enfermedad, anomalía analítica o trastorno psiquiátrico importante que impida participar en el estudio al sujeto.
    10. Cualquier situación, incluida la presencia de anomalías analíticas, que entrañe un riesgo inaceptable para el sujeto en caso de participar en el estudio.
    11. Cualquier situación que altere la capacidad de interpretar los datos del estudio.
    12. Falta de disposición o incapacidad de cumplir los procedimientos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be DFS which is defined as the time from the date of randomization to the date of disease recurrence or death, whichever is earlier.
    El criterio de valoración principal de la eficacia será la SSE, que se define como el tiempo
    transcurrido entre la fecha de aleatorización y la fecha de recidiva de la enfermedad o muerte, lo que ocurra antes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease recurrence will be determined by the independent radiological review of CT or MRI scans. Subjects who have two or more missing consecutive scheduled tumor assessments prior to disease recurrence will be censored on the previous tumor assessment date. Subjects who do not develop disease recurrence or die will be censored on the date of last tumor assessment.
    The survival distribution of DFS will be estimated using the Kaplan-Meier method
    La recidiva de la enfermedad se determinará mediante una revisión radiológica independiente de las TC o RM. A los sujetos con dos o más evaluaciones tumorales programadas consecutivas omitidas antes de la recidiva de la enfermedad se les censurará en la fecha de la evaluación tumoral previa. A los sujetos que no presenten recidiva de la enfermedad ni fallezcan se les censurará en la fecha de la última evaluación tumoral.
    La distribución de la SSE se calculará con el método de Kaplan-Meier
    E.5.2Secondary end point(s)
    The secondary efficacy endpoint will be OS which is defined as the time from the date of randomization to the date of death.
    El criterio de valoración secundario de la eficacia será la SG, que se define como el tiempo
    transcurrido entre la fecha de aleatorización hasta la fecha de muerte
    E.5.2.1Timepoint(s) of evaluation of this end point
    Subjects who are alive will be censored on the last-known-to be- alive date.
    The survival distribution of OS will be estimated using the Kaplan-Meier method
    Se censurará a los sujetos que sigan vivos en la última fecha con certeza de que estaban vivos. La distribución de la SG se calculará con el método de Kaplan-Meier
    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 No
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    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
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hong Kong
    Hungary
    Ireland
    Italy
    Korea, Republic of
    Mexico
    New Zealand
    Portugal
    Singapore
    Spain
    Sweden
    Taiwan
    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
    The End of Trial is defined as the date of receipt of the required data point from all subjects for primary, secondary and/or exploratory analysis, as prespecified in the protocol
    El final del estudio se define como la fecha de recepción de los datos necesarios de todos los
    sujetos para los análisis principal, secundarios o exploratorios, tal como aparece especificado en el protocolo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 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: 480
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 320
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 800
    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)
    Post treatment procedures and data collection will follow sponsor procedures for subject safety. Following treatment discontinuation, other treatment options should be discussed with the subject's physician. Patients will be followed for survival. Subjects who discontinue for reasons other than disease progression will continue to undergo CT scans every 8 weeks for the first 24 wks, every 12 wks for the first 3 yrs, every 24 wks thereafter until disease recurrence up to 5 yrs from last treatment
    Procedimientos post-tto y recopilación de datos seguirán PNT del promotor para la seguridad del sujeto.Tras la interrupción del tto, otras opciones se deben discutir con el médico.Se monitorizará la supervivencia. Los que abandonen por razones distintas a progresión de enfermedad se evaluarán mediante TC cada 8sem durante las 24 primeras sems,cada 12sem durante los 3 primeros años y,a partir de entonces,cada 24sem hasta que se produzca recidiva durante un máximo de 5años después del último tto
    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 Decision2014-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-09
    P. End of Trial
    P.End of Trial StatusOngoing
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