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    Summary
    EudraCT Number:2011-000954-46
    Sponsor's Protocol Code Number:MO25743
    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:2011-06-21
    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 number2011-000954-46
    A.3Full title of the trial
    An open-label, single-arm, phase II, multicenter study to evaluate
    the efficacy of vemurafenib in metastatic melanoma patients with brain
    metastases
    Estudio de fase II multicéntrico, abierto, con un solo grupo de tratamiento, para evaluar la eficacia de vemurafenib en pacientes con melanoma metastásico con metástasis cerebrales.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Este estudio abierto evaluará la eficacia y seguridad de vemurafenib (RO5185426) en pacientes con melanoma metastásico con metástasis cerebrales tratadas o no tratadas. Los pacientes recibirán vemurafenib (RO5185426) oralmente a una dosis de 960 mg dos veces al día hasta progresión de la enfermedad o toxicidad inaceptable.
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    A.4.1Sponsor's protocol code numberMO25743
    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 SponsorF. Hoffmann-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post codeCH-4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameRO5185426
    D.3.2Product code RO5185426/F17
    D.3.4Pharmaceutical form Film-coated 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 INNVemurafenib
    D.3.9.1CAS number 918504-65-1
    D.3.9.2Current sponsor codeRO5185426-006
    D.3.9.3Other descriptive nameRG7204, PLX4032
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    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
    Metastatic Melanoma with Brain Metastases
    Melanoma metastásico con metástasis cerebrales.
    E.1.1.1Medical condition in easily understood language
    Metastatic Melanoma with Brain Metastases
    Melanoma metastásico con metástasis cerebrales.
    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 LLT
    E.1.2Classification code 10027481
    E.1.2Term Metastatic melanoma
    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
    Evaluar la eficacia de vemurafenib basándose en el mejor índice de respuesta global (MIRG) determinado por un Comité de Revisión Independiente (CRI) utilizando los Criterios de Evaluación de la Respuesta en Tumores Sólidos, Versión 1.1 (RECIST, v1.1), en el cerebro de pacientes con melanoma metastásico con metástasis cerebrales no tratadas previamente.
    E.2.2Secondary objectives of the trial
    Evaluar la eficacia de vemurafenib basándose en el MIRG determinado por el CRI utilizando los criterios RECIST v1.1, en el cerebro de pacientes con metástasis cerebrales tratadas o no previamente. Evaluar la eficacia de vemurafenib basándose en el MIRG determinado por el CRI utilizando los criterios RECIST v1.1, en el cerebro de pacientes con metástasis cerebrales tratadas previamente. Evaluar la seguridad y la tolerancia de vemurafenib en pacientes con melanoma con metástasis cerebrales, de acuerdo con los Criterios de Terminología Común para Acontecimientos Adversos del National Cancer Institute, Versión 4.0. Evaluar el MIRG en localizaciones fuera del cerebro, basándose en la evaluación del CRI, la duración de la respuesta en el cerebro y en otras localizaciones, la SLP, el tiempo transcurrido hasta el desarrollo de metástasis cerebrales nuevas en los pacientes que alcanzan una respuesta y la SG en pacientes con melanoma con metástasis cerebrales. Evaluar la eficacia de vemurafenib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes adultos 18 años de edad
    2. Pacientes con melanoma metastásico en estadio IV (American Joint Committee on Cancer, 7th Edition) con mutación BRAF V600 (test Cobas 4800 para mutaciones BRAF V600).
    3. Metástasis cerebrales medibles tratadas o no tratadas.
    4. Pueden haber recibido o no tratamiento sistémico previo para el melanoma metastásico y pueden a) no haber recibido tratamiento previamente para metástasis cerebrales o b) haber recibido tratamiento previamente para metástasis cerebrales y haber manifestado progresión de la enfermedad.
    5. Pueden presentar o no síntomas relacionados con las metástasis cerebrales.
    6. Estado funcional ECOG 0 o 1
    7. Los pacientes se deben haber recuperado de todos los efectos secundarios del tratamiento sistémico o local más reciente para el melanoma metastásico
    E.4Principal exclusion criteria
    1. Pacientes tratados con dosis crecientes de corticosteroides durante los 7 días previos a la administración de la primera dosis de vemurafenib
    2. Afectación leptomeníngea
    3. Se excluyen los pacientes con neoplasias malignas previas que hayan requerido tratamiento activo en los 2 últimos años, excepto los pacientes con carcinoma basocelular o escamocelular de piel o carcinoma in situ de cervix
    4. Administración concomitante de otros tratamientos anticancerosos que no sean los utilizados en este estudio
    5. Tratamiento con cualquier fármaco citotóxico comercializado y/o en investigación o con terapia dirigida 4 semanas antes de la administración de la primera dosis de vemurafenib y con radioterapia en las 2 semanas previas
    6. Tratamiento previo con inhibidores de BRAF o MEK
    7. Enfermedad cardiovascular clínicamente significativa o evento en los 6 meses previos a la administración de la primera dosis de vemurafenib
    8. Antecedentes o existencia de arritmias ventriculares o auriculares clínicamente significativas
    9. Intervalo QT corregido (QTc) 450 mseg o antecedentes de síndrome de QT prolongado congénito
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal es el MIRG en metástasis cerebrales no tratadas previamente (evaluado por un CRI utilizando los criterios RECIST).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Junio 2012
    E.5.2Secondary end point(s)
    MIRG en metástasis cerebrales tratadas o no tratadas previamente (evaluado por un CRI).
    MIRG en metástasis cerebrales tratadas previamente (evaluado por un CRI).
    MIRG fuera del cerebro (evaluado por un CRI).
    MIRG en metástasis cerebrales y fuera del cerebro (evaluado por el investigador).
    Duración de la respuesta, Supervivencia libre de progresión, tiempo hasta el desarrollo de nuevas metástasis cerebrales, Supervivencia global
    Seguridad (evaluado por el NCI CTCAE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Junio 2014
    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 Yes
    E.6.13.1Other scope of the trial description
    Calidad de vida y sintomatolgía física
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned0
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Australia
    Canada
    France
    Germany
    Italy
    Netherlands
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    El estudio terminará cuando se haya realizado un seguimiento de la supervivencia en todos los pacientes durante un máximo de 24 meses o cuando los pacientes hayan fallecido, retirado su consentimiento o se haya perdido su seguimiento, dependiendo de lo que ocurra antes.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 106
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 61
    F.4.2.2In the whole clinical trial 132
    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)
    Not applicable
    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 Decision2011-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-22
    P. End of Trial
    P.End of Trial StatusCompleted
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