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    Summary
    EudraCT Number:2011-000634-11
    Sponsor's Protocol Code Number:MEK114653
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2011-07-08
    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 number2011-000634-11
    A.3Full title of the trial
    A Phase II, Open-label, Multicenter, Randomized Study to Assess the Efficacy and Safety of GSK1120212 Compared with Docetaxel in 2nd Line Subjects with Targeted Mutations (KRAS, NRAS, BRAF, MEK1) in Locally Advanced or Metastatic Nonsmall Cell Lung Cancer (NSCLC Stage IIIBwet-IV).
    Estudio Fase II, aleatorizado, multicéntrico, abierto para evaluar la eficacia y seguridad de GSK1120212 en comparación con docetaxel en el tratamiento de 2ª línea de sujetos con mutaciones dirigidas (KRAS, NRAS, BRAF, MEK1) en el cáncer de pulmón no microcítico localmente avanzado o metastásico (NSCLC estadio IIIBhúmedo-IV).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Test a New Drug (GSK1120212) to Treat Lung Cancer
    Estudio para analizar un nuevo farmaco para tratar el cáncer de pulmón (GSK1120212)
    A.4.1Sponsor's protocol code numberMEK114653
    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 SponsorGlaxoSmithKline, S.A.
    B.1.3.4CountrySpain
    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 supportGlaxoSmithKline
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44208990 44 66
    B.5.5Fax number+44208990 12 34
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameGSK1120212
    D.3.2Product code GSK1120212
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGSK1120212
    D.3.9.2Current sponsor codeGSK1120212
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The 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 nameDocetaxel
    D.3.4Pharmaceutical form Concentrate and solvent 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 INNDOCETAXEL
    D.3.9.1CAS number 114977-28-5
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    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 nameGSK1120212
    D.3.2Product code GSK1120212
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGSK1120212
    D.3.9.2Current sponsor codeGSK1120212
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    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 nameGSK1120212
    D.3.2Product code GSK1120212
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGSK1120212
    D.3.9.2Current sponsor codeGSK1120212
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    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
    In 2nd Line Subjects with Targeted Mutations (KRAS, NRAS, BRAF, MEK1) in Locally Advanced or Metastatic Nonsmall Cell Lung Cancer (NSCLC Stage IIIBwet-IV).
    En 2ª línea de sujetos con mutaciones dirigidas (KRAS, NRAS, BRAF, MEK1) en el cáncer de pulmón no microcítico localmente avanzado o metastásico (NSCLC estadio IIIBhúmedo-IV). In 2nd Line Subjects with Targeted Mutations (KRAS, NRAS, BRAF, MEK1) in Locally Advanced or Metastatic Nonsmall Cell Lung Cancer (NSCLC Stage IIIBwet-IV).
    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 14.0
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare Progression-Free Survival (PFS) in KRAS mutated NSCLC subjects who are receiving GSK1120212 with those receiving docetaxel.
    Comparar la supervivencia libre de progresión (SLP) en sujetos con NSCLC con mutación KRAS tratados con GSK1120212, con la de los sujetos tratados con docetaxel. To compare Progression-Free
    Survival (PFS) in KRAS mutated NSCLC subjects who are receiving GSK1120212 with those receiving docetaxel.
    E.2.2Secondary objectives of the trial
    - To assess the safety and tolerability of GSK1120212 in NSCLC.
    - To compare the response rate of subjects receiving GSK1120212 to those treated with docetaxel.
    - To compare the duration of response of subjects receiving GSK1120212 to those treated with docetaxel.
    -To estimate overall survival (OS).
    -To assess the steady state exposure and characterise the population pharmacokinetics of GSK1120212.
    -Evaluar la seguridad y tolerabilidad de GSK1120212 en el NSCLC.
    -Comparar la tasa de respuesta de los sujetos tratados con GSK1120212 con la de los tratados con docetaxel. Comparar la duración de la respuesta de los sujetos tratados con GSK1120212 con la de los tratados con docetaxel.
    -Calcular la supervivencia global (SG).
    -Evaluar la exposición en el estado de equilibrio y caracterizar la
    farmacocinética de población de GSK1120212.
    - To assess the safety and tolerability of GSK1120212
    in NSCLC.
    - To compare the response rate of subjects receiving GSK1120212 to those treated with docetaxel.
    - To compare the duration of response of subjects receiving GSK1120212 to those treated with docetaxel.
    -To estimate overall survival (OS).
    -To assess the steady state exposure and characterise the population pharmacokinetics of GSK1120212.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent.
    2. 18 years old or older.
    3. Histologically- or cytologically-confirmed diagnosis of adenocarcinoma Stage
    IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC with a
    positive mutational status for the KRAS, NRAS, BRAF, or MEK1 gene (performed
    in a CLIA-certified laboratory or equivalent). View page page 27 of the protocol for further information.
    4. Documented tumor progression (based on radiological imaging) after receiving at least one, but not more than one, prior approved platinum-containing chemotherapy regimen for advanced stage/metastatic NSCLC.
    a. Erlotinib maintenance therapy following first-line treatment with any approved
    platinum-containing chemotherapy for advanced stage/metastatic NSCLC is allowed.
    b. Pemetrexed maintenance therapy is only allowed following a first-line treatment
    with cisplatin or carboplatin and pemetrexed for advanced stage/metastatic
    NSCLC.
    c. Patients who have received any treatment (e.g., erlotinib, chemotherapy, or
    Investigational Agents) in a second-line setting are not allowed.
    5. Measurable disease, i.e., presenting with at least one measurable tumor lesion per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
    6. Performance status score of 0 or 1 according to the Eastern Cooperative Oncology
    Group (ECOG) scale.
    7. Able to swallow and retain orally administered medication and does not have any
    clinically significant gastrointestinal abnormalities that may alter absorption such as expectancy of at least three months in the opinion of the investigator.
    8. Women of childbearing potential must have a negative serum pregnancy test within 14 days of randomization to study treatment and agree to use effective contraception, as defined in the protocol, during the study and for at least four weeks following the last dose of study medication. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception as described in the protocol from the time of randomization to study medication until at least four weeks after the last dose of study treatment. However, the Sponsor advises that contraception be used for a total of 16 weeks following the last dose (based on the lifecycle of sperm). Investigators should reference the product label for docetaxel for additional clarification.
    9. Adequate baseline organ function as defined in Table 2.
    10. French subjects: In France, a subject will be eligible for inclusion in this study only
    if either affiliated to or a beneficiary of a social security category.
    1. Haber firmado el consentimiento informado por escrito.
    2. Edad igual o superior a 18 años.
    3. Diagnóstico histológicamente o citológicamente confirmado de adenocarcinoma de estadio IIIB húmedo (con derrame pleural maligno confirmado) o NSCLC de estadio IV con mutación positiva de los genes
    KRAS, NRAS, BRAF o MEK1 (análisis realizado en un laboratorio con certificación CLIA o equivalente) (véase la págtina 28 del protocolo para más información).
    4. Progresión documentada del tumor (basada en una prueba radiológica) tras recibir al menos un régimen, pero no más de uno, de
    quimioterapia con platino aprobado para el NSCLC de estadio avanzado/metastásico.
    a. La terapia de mantenimiento con erlotinib tras el tratamiento de primera línea con un régimen de quimioterapia con platino para el NSCLC de estadio avanzado/metastásico está permitida.
    b. La terapia de mantenimiento con pemetrexed sólo está permitida después del tratamiento de primera línea con cisplatino o
    carboplatino y pemetrexed para el NSCLC de estadio avanzado/metastásico.
    c. Los pacientes que hayan recibido cualquier tratamiento de segunda línea (por ejemplo, erlotinib, quimioterapia o fármacos en
    investigación) no están permitidos.
    5. Enfermedad medible, es decir presentando al menos una lesión
    tumoral medible según los criterios de evaluación de la respuesta en tumores sólidos (RECIST) v1.1 [Eisenhauer, 2009].
    6. Puntuación de 0 o 1 en la escala de estado funcional del Eastern Cooperative Oncology Group (ECOG) [Oken, 1982].
    7. Sujetos capaces de tragar o retener la medicación administrada por vía oral y que no tengan anomalías gastrointestinales clínicamente significativas que puedan alterar la absorción, como síndrome de malabsorción o resección mayor del estómago o intestino. Esperanza de vida de al menos 3 meses a juicio del investigador.
    8. Las mujeres potencialmente fértiles deben tener una prueba de embarazo en suero negativa en los 14 días anteriores
    a la aleatorización al tratamiento del estudio y estar de acuerdo en utilizar los métodos anticonceptivos efectivos que se definen en el protocolo, durante el estudio y al menos durante 4 semanas después de la última dosis de medicación del estudio. Los hombres con una mujer potencialmente fértil deben estar vasectomizados o estar de acuerdo en utilizar los métodos anticonceptivos efectivos que se definen en el protocolo desde el momento de la aleatorización a la medicación del estudio hasta al menos 4 semanas después de la última dosis de tratamiento del estudio. No obstante, el promotor aconseja utilizar métodos anticonceptivos durante un total de 16 semanas tras la última dosis (basándose en el ciclo vital del esperma). Para más aclaración, los investigadores deben consultar la ficha técnica de docetaxel [Prospecto de Taxotere, 2010]. 9. Función orgánica basal adecuada como se define en la Tabla 2 10.
    Sujetos franceses: En Francia, un sujeto sólo será elegible para participar en este estudio si está afiliado o es beneficiario alguna categoría de la seguridad social.
    E.4Principal exclusion criteria
    1. History of another malignancy. Exception: (a) history of curatively treated malignancy different from NSCLC with a disease-free period of ? 3 years, (b) history of completely resected non-melanoma skin cancer, (c) successfully treated in situ carcinoma, (d) CLL in stable remission (Rai Stage 0) with no therapy required, (e) indolent prostate cancer requiring no or only anti-hormonal therapy with histologically confirmed tumor lesions that can be clearly differentiated from NSCLC target and non-target lesions.
    2. Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject?s safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.
    3. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drugs, excipients, dimethyl sulfoxide (DMSO), or to polysorbate 80.
    4. Treatment with a BRAF or MEK inhibitor or docetaxel as monotherapy or as part of a combination regimen.
    5. Anti-cancer therapy (including chemotherapy and radiation therapy) within the last three weeks.
    6. Current use of a prohibited medication (see Section 6.2 titled Prohibited Medications and Non-Drug Therapies). Use of anticoagulants such as warfarin is permitted (see Section 6.1 title Permitted Mediations of the protocol), however INR must be monitored in accordance with local institutional practice.
    7. History or current evidence / risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR):
    - History of RVO or CSR, or predisposing factors to RVO or CSR (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes).
    - Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as: Evidence of new optic disc cupping; Evidence of new visual field defects; Intraocular pressure > 21 mm Hg as measured by tonography.
    8. Any tumor manifestation in the CNS.
    9. History or evidence of cardiovascular risk including any of the following:
    a. QTcB ? 480 msec.
    b. History or evidence of current clinically significant uncontrolled arrhythmias.
    Exception: Subjects with controlled atrial fibrillation for >30 days prior to
    randomization are eligible.
    c. History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization.
    d. History or evidence of current ? Class II congestive heart failure as defined by New York Heart Association (Appendix 4).
    10. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection which will be allowed).
    11. French subjects: the French subject has participated in any study using an investigational drug during the previous 30 days.
    1. Historia de otra neoplasia. Excepción: (a) historia de otra neoplasia tratada con fines curativos diferente de NSCLC con un periodo libre de enfermedad 3 años, (b) historia de cáncer cutáneo distinto
    del melanoma extirpado por completo, (c) carcinoma in situ tratado con éxito, (d) LLC en remision estable (Estadio Rai 0) que no necesita tratamiento, (e) cáncer de próstata indolente que no requiere
    tratamiento o sólo necesita tratamiento anti-hormonal con lesiones tumorales histológicamente confirmadas que pueden diferenciarse claramente de las lesiones diana y no diana de NSCLC.
    2. Cualquier enfermedad grave y/o inestable preexistente (además de las excepciones de neoplasias anteriores), trastorno psiquiátrico u otra condición que, a juicio del investigador, pueda interferir con la
    seguridad del sujeto, la obtención del consentimiento informado o el cumplimiento de los procedimientos del estudio.
    3. Reacción de hipersensibilidad inmediata o tardía o idiosincrasia conocida a fármacos químicamente relacionados con los fármacos del estudio, excipientes, dimetil sulfóxido (DMSO) o polisorbato 80.
    4. Tratamiento con un inhibidor de BRAF o MEK o docetaxel como
    monoterapia o como parte de un régimen de combinación.
    5. Terapia antineoplásica (incluida la quimioterapia y la radioterapia) en las 3 últimas semanas.
    6. Utilización actual de medicación prohibida (ver la Sección 6.2 Medicaciones y terapias no farmacológicas prohibidas del protocolo). El empleo de anticoagulantes como la warfarina está permitido (ver la Sección 6.1 Medicaciones permitidas del protocolo); sin embargo, se debe monitorizar el INR de acuerdo con la práctica habitual del centro. 7. Historia o evidencia/riesgo actual de oclusión de la vena retiniana (OVR) o retinopatía serosa central (RSC): - Historia de OVR o RSC, o factores predisponentes de OVR o RSC (por ejemplo, glaucoma o
    hipertensión ocular no controlada, enfermedad sistémica no controlada como hipertensión, diabetes mellitus o síndromes de hiperviscosidad o hipercoagulabilidad). - Patología retiniana visible evaluada mediante examen oftalmológico que se considere un factor de riesgo de OVR o RSC como: evidencia de nueva excavación del disco óptico; evidencia de nuevos defectos del campo visual; presión
    intraocular >21 mmHg medida mediante tonografía.
    8. Cualquier manifestación tumoral en el SNC.
    9. Historia o evidencia de riesgo cardiovascular, incluidos cualquiera de los siguientes:
    a. QTcB 480 mseg.
    b. Historia o evidencia actual de arritmias no controladas clínicamente significativas. Excepción: Los sujetos con fibrilación auricular controlada durante >30 días antes de la aleatorización son elegibles. c.
    Historia de síndromes coronarios agudos (incluidos el infarto de miocardio y la angina inestable), angioplastia coronaria o colocación de un stent en los 6 meses anteriores a la aleatorización. d. Historia
    o evidencia actual de insuficiencia cardiaca congestiva Clase II según la definición de la New York Heart Association (Apéndice 4).
    10. Infección conocida por virus de inmunodeficiencia humana (VIH),
    virus de hepatitis B (VHB) o virus de hepatitis C (VHC) (excepto la infección crónica o aclarada por VHB y VHC que estarán permitidas). 11. Sujetos franceses: Sujeto francés que haya participado en
    cualquier estudio con un fármaco en investigación durante los 30 días previos.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival
    Supervivencia libre de progresión.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 6 weeks.
    Cada 6 semanas.
    E.5.2Secondary end point(s)
    - Clinical laboratory parameters, adverse events, cardiac parameters, and vital signs.
    - Response rate defined as the percentage of subjects with evidence of complete response (CR) or partial response (PR) (RECIST 1.1).
    - Duration of Response, for the subset of subjects with CR or PR, defined as the time from first documented evidence of CR or PR until the earliest date of documented radiological progression or death due to any cause.
    - OS defined as the time from randomization until death.
    - GSK1120212 trough concentrations and population PK parameters.
    - Evaluar la seguridad y tolerabilidad de GSK1120212 en el NSCLC a través de
    parámetros de laboratorio clínico, acontecimientos adversos, parámetros
    cardíacos y constantes vitales.
    - Comparar la tasa de respuesta de los sujetos tratados con GSK1120212 con la de
    los tratados con docetaxel, definida como el porcentaje de sujetos con evidencia
    de respuesta completa (RC) o respuesta parcial (RP) (RECIST 1.1).
    - Comparar la duración de la respuesta de los sujetos tratados con GSK1120212
    con la de los tratados con docetaxel, en el subgrupo de sujetos con RC o RP,
    definida como el tiempo desde la primera evidencia documentada de RC o RP
    hasta la primera fecha de progresión radiológica documentada o muerte por cualquier causa.
    - Calcular la supervivencia global definida como el tiempo desde la aleatorización hasta la muerte por cualquier causa.
    - Evaluar la exposición en el estado de equilibrio y caracterizar la farmacocinética de población de GSK1120212 calculada utilizando concentraciones valle y parámetros FC de población.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 6 weeks
    Cada 6 semanas
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    El cruzamiento entre brazos es opcional.
    Crossover is optional.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Docetaxel
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    France
    Germany
    Greece
    Italy
    Netherlands
    Spain
    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
    Study will be closed when 80% of the randomized KRAS-mutant NSCLC subjects (96 subjects) have died, withdrawn, or are lost to follow-up.
    Cuando el 80% de los sujetos con mutación KRAS reclutados en el estudio hayan fallecido, se hayan retirado o se hayan perdido para el seguimiento.
    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 months0
    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 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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    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: 41
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 141
    F.4.2.2In the whole clinical trial 500
    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)
    If the patient does not enter the crossover phase or the rollover study, the investigator is responsible for ensuring that consideration has been given for the post-study care of the subjects medical condition as GSK is not providing specific post-study treatment.
    Si el paciente no entra en la fase de cruzamiento o en el estudio de continuación, el Investigador responable debe asegurar el tratamiento del paciente despues del estudio ya que GSK no proporciona tratamiento especifico despues del estudio.
    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 Decision2011-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-04
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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