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    Summary
    EudraCT Number:2009-015298-11
    Sponsor's Protocol Code Number:BRF113683
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-12-21
    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 number2009-015298-11
    A.3Full title of the trial
    Estudio en fase III aleatorizado y abierto para comparar GSK2118436 con DTIC en sujetos con melanoma avanzado (estadio III) o metastásico (estadio IV) y mutación de BRAF, no tratados previamente.
    A Phase III randomized, open-label study comparing GSK2118436 to DTIC in previously untreated subjects with BRAF mutation positive advanced (Stage III) or metastatic (Stage IV) melanoma.
    A.4.1Sponsor's protocol code numberBRF113683
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameGSK2118436
    D.3.2Product code GSK2118436
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number unassigned
    D.3.9.2Current sponsor codeGSK2118436
    D.3.9.3Other descriptive nameGSK2118436B
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 nameGSK2118436
    D.3.2Product code GSK2118436
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number unassigned
    D.3.9.2Current sponsor codeGSK2118436
    D.3.9.3Other descriptive nameGSK2118436B
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 nameDacarbazine
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDACARBAZINE
    D.3.9.1CAS number 4342-0-34
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    melanoma metastásico positivo para la mutación de BRAF
    BRAF mutation positive metastatic melanoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10025670
    E.1.2Term Malignant melanoma stage III
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10025671
    E.1.2Term Malignant melanoma stage IV
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal de este estudio es establecer la superioridad de GSK2118436 respecto de DTIC en cuanto a la supervivencia sin progresión en sujetos con melanoma metastásico positivo para la mutación de BRAF.
    The primary objective for this study is to establish the superiority of GSK2118436 over DTIC with respect to progression-free survival for subjects with BRAF mutation positive metastatic melanoma
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios de este estudio son: comparar la supervivencia global entre los grupos de tratamiento y la tasa de mejor respuesta global; evaluar la supervivencia sin progresión de los sujetos del grupo de tratamiento con DTIC tras la progresión inicial y el subsiguiente cambio al tratamiento con GSK2118436; evaluar la duración de la respuesta; evaluar la tasa de lesiones cutáneas no melanomatosas y de tumores malignos secundarios en ambos grupos de tratamiento; validar adicionalmente un análisis de mutaciones de BRAF; evaluar y comparar los dos grupos de tratamiento en relación con la variación en la calidad de vida relacionada con la salud y los síntomas y también durante el tratamiento con DTIC y el tratamiento posterior con GSK2118436; caracterizar mejor la seguridad y la tolerabilidad de GSK2118436 administrado en monoterapia en el melanoma metastásico positivo para la mutación de BRAF y evaluar la toxicidad desde los puntos de vista cualitativo y cuantitativo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Los sujetos deberán cumplir todos los criterios siguientes para poder ser incluidos en el estudio:
    1. Los sujetos han dado su consentimiento informado firmado.
    2. Melanoma confirmado histológicamente avanzado (no resecable en estadio III) o metastásico (estadio IV) y con mutaciones del gen BRAF (V600 E), determinado mediante pruebas centrales con un análisis de mutaciones de BRAF.
    3. Los sujetos no han sido tratados previamente para el melanoma avanzado (no resecable) o metastásico, con la excepción de IL-2, que se permite.
    4. Enfermedad medible según los Criterios de evaluación de la respuesta en tumores sólidos (RECIST 1.1) [Eisenhauer, 2009].
    5. Edad >= 18 años
    6. Capacidad para tragar y retener medicación por vía oral.
    7. Las mujeres y los hombres con capacidad reproductiva deben estar dispuestos a practicar métodos de control de la natalidad aceptables durante el estudio. Además, las mujeres con capacidad reproductiva deberán tener una prueba de embarazo negativa en los 14 días previos a la primera dosis del tratamiento del estudio.
    8. Estado funcional de 0-1 según el Eastern Cooperative Oncology Group (ECOG) [Oken, 1982].
    9. Deberá presentar una función orgánica adecuada según lo definido por los siguientes valores de selección (se permitirá realizar un nuevo análisis de la función orgánica dudoso en la selección. No se permitirá el tratamiento con factores de transfusión ni de crecimiento para cumplir los criterios de participación).
    E.4Principal exclusion criteria
    No se incluirá en el estudio a los sujetos que cumplan alguno de los criterios siguientes.
    1. Tratamiento previo para el melanoma metastásico, incluida la administración de BRAF o de inhibidor del MEK.
    2. Melanoma ocular o primario de la mucosa.
    3. En tratamiento actual para el cáncer (quimioterapia, radioterapia, inmunoterapia, tratamiento biológico o cirugía).
    4. Uso de cualquier fármaco contra el cáncer en investigación u otro fármaco en investigación en los 28 días o en el período correspondiente a 5 semividas (lo que sea más largo) anteriores a la primera dosis de GSK2118436.
    5. Uso actual de un medicamento prohibido o se prevé que requiera cualquiera de estos fármacos durante el tratamiento con GSK2118436.
    6. Intervención quirúrgica importante, radioterapia o inmunoterapia en las 4 últimas semanas.
    7. Presencia de enfermedad digestiva activa o cualquier otro trastorno que interfiera significativamente en la absorción de fármacos. Si se necesita una aclaración respecto a si el trastorno afectará significativamente a la absorción de fármacos, póngase en contacto con el monitor médico de GSK para obtener la autorización para incluir al sujeto.
    8. Antecedentes de infección por el virus de la inmunodeficiencia humana (VIH)
    9. Antecedentes de déficit de glucosa-6-fosfato deshidrogenasa (G6PD).
    10. Antecedentes de otras neoplasias malignas. Podrán participar los sujetos que hayan permanecido sin enfermedad durante 5 años y los que tengan antecedentes de un cáncer de piel no melanomatoso totalmente resecado o de un carcinoma in situ tratado satisfactoriamente.
    11. Signos de enfermedad activa del SNC (radiológicamente inestable, lesiones sintomáticas). Sin embargo el uso previo de la resección estereotáctica con radiocirugía (SRS) o de la resección quirúrgica se permite si el sujeto sigue sin signos de progresión de la enfermedad en el cerebro durante >= 3 meses y no ha recibido corticosteroides durante >= 3 semanas. No se permite la radioterapia cerebral total, excepto en los sujetos sometidos a resección definitiva o a SRS de todas las lesiones del parénquima radiológicamente detectables.
    12. Antecedentes de alcoholismo u otras toxicomanías en los 6 meses previos a la aleatorización.
    13. Trastornos psicológicos o situaciones familiares, sociológicas o geográficas que no permite el cumplimiento del protocolo, o la negativa o la imposibilidad de seguir los procedimientos exigidos en el protocolo.
    14. Las siguientes anomalías cardíacas:
    - Intervalo QT corregido (QTc) >= 480 mseg
    - Antecedentes de síndromes coronarios agudos (incluida la angina de pecho inestable) en las últimas 24 semanas.
    - Angioplastia coronaria o implantación de endoprótesis en las últimas 24 semanas.
    - Insuficiencia cardíaca de clase II, III o IV según el sistema de clasificación funcional de la New York Heart Association (NYHA).
    - Morfología anormal de la válvula cardíaca (>= grado 2) documentada mediante ecocardiograma (los sujetos con anomalías de grado 1 [es decir, insuficiencia/estenosis leve] pueden entrar en el estudio). Los sujetos con engrosamiento valvular moderado no deben participar en el estudio.
    - Antecedentes de arritmias cardíacas conocidas (excepto arritmia sinusal) en las 24 últimas semanas.
    - Metástasis cardíacas conocidas.
    15. Mujeres embarazadas o en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal de la eficacia en este estudio es la supervivencia sin progresión (SSP). En este estudio, la SSP se define como el tiempo transcurrido desde la aleatorización hasta la primera fecha de progresión objetiva de la enfermedad o 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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Grupos paralelos, pero se permite cruce de grupos tras progresión
    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.8.3 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 EEA73
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    El estudio se considerará completado cuando el 70% de los pacientes hayan fallecido.
    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 months0
    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 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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 133
    F.4.2.2In the whole clinical trial 200
    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 Decision2011-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-16
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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