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    Summary
    EudraCT Number:2014-003467-37
    Sponsor's Protocol Code Number:14726103
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-22
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-003467-37
    A.3Full title of the trial
    Evaluation of Ixazomib, Lenalidomide, Dexamethasone Induction and extended Consolidation followed by Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients ≤65 years eligible for High Dose Therapy: a phase II study of the Intergroupe Francophone du Myélome (IFM)
    Evaluation de l’association Ixazomib, Lenalidomide, Dexamethasone en induction et consolidation longue suivie de Lenalidomide en entretien chez des patients d’âge
    ≤65 ans atteints de Myélome Multiple de novo et éligibles pour un traitement
    haute dose : une étude de phase II de l’Intergroupe Francophone du Myélome
    (IFM)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Ixazomib, Lenalidomide, Dexamethasone in Newly Diagnosed Multiple Myeloma Patients eligible for High Dose Therapy
    Evaluation de l’association Ixazomib, Lenalidomide, Dexamethasone chez des patients d’âge ≤65 ans atteints de Myélome Multiple de novo et éligibles pour un traitement haute dose
    A.4.1Sponsor's protocol code number14726103
    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 SponsorCHU de Toulouse
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMILLENNIUM
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportCELGENE
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU TOULOUSE
    B.5.2Functional name of contact pointHuguet
    B.5.3 Address:
    B.5.3.1Street Address2 rue de viguerie
    B.5.3.2Town/ cityTOULOUSE
    B.5.3.3Post code31059
    B.5.3.4CountryFrance
    B.5.4Telephone number33561778490
    B.5.5Fax number33561778490
    B.5.6E-mailhuguet.a@chu-toulouse.fr
    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 Revlimid 25 mg (Lenalidomide)
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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 numberMM:EU/3/03/177
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 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 Revlimid 5 mg (Lenalidomide)
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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 numberMM:EU/3/03/177
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.2.5.1Orphan drug designation numberORPHA275257
    D.3 Description of the IMP
    D.3.1Product nameIxazomib
    D.3.4Pharmaceutical form Capsule
    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 INNIXAZOMIB
    D.3.9.1CAS number 1072833-77-2
    D.3.9.3Other descriptive nameIXAZOMIB
    D.3.9.4EV Substance CodeSUB121332
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Yes
    D.2.1.1.1Trade name Dexamethasone
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire CTRS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameDexamethasone
    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 INNDEXAMETHASONE
    D.3.9.1CAS number 50-02-2
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number40
    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
    Multiple Myeloma newly diagnosed
    Myelome Multiple de novo
    E.1.1.1Medical condition in easily understood language
    Myeloma
    Myelome
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10028566
    E.1.2Term Myeloma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the sCR rate of the combination of Ixazomib, Lenalidomide with and without dexamethasone as induction and extended consolidation therapy in an intensive program in newly diagnosed MM patients, after consolidation and before maintenance therapy.
    Évaluer le taux de RC stringente à la fin du traitement de consolidation.
    E.2.2Secondary objectives of the trial
    Determine the safety and tolerability of the drug combination in this patient population as induction and extensive consolidation therapy.
    Evaluate the sCR, CR, VGPR and PR rates, the overall response rate after induction, high dose Melphalan, early consolidation, late consolidation and maintenance therapy
    Evaluate progression free survival, overall survival, time to progression and duration of response, time to response.
    Evaluate the quality of stem cell harvest after induction therapy
    Determine biological prognostic factors influencing outcome and response rates
    - Déterminer l'innocuité et la tolérance de l’association MLN RD en induction et MLN Rd puis MLN R en traitement de consolidation
    - Évaluer les taux de sRC, RC, TBRP et RP après l'induction, l’intensification, la consolidation précoce, la consolidation tardive, pendant et à la fin de l'entretien
    - Évaluer le taux de réponse globale, la date de réponse, la survie sans progression, la survie globale, le temps jusqu'à progression et la durée de la réponse.
    - Évaluer la faisabilité et la qualité de la collecte de cellules souches périphériques.

    OBJECTIFS EXPLORATOIRES:
    - Déterminer les facteurs pronostiques biologiques qui influent sur les taux de réponse et la survie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male or female patients ≥ 18 years and ≤ 65 years at the time of signing informed consent form
    - Patients diagnosed with multiple myeloma based on the new International Myeloma Working Group Diagnostic Criteria for plasma cells disorders (leukemia 2009)
    -Subjects must have symptomatic myeloma with CRAB criteria
    - Subjects must have measurable disease requiring systemic therapy defined by serum M-component ≥ 5g/l or urine M-component ≥ 200 mg/24h or serum FLC ≥ 100 mg/l.
    -Subjects must not have been treated previously with any systemic therapy for multiple myeloma. Prior treatment with corticosteroids or radiation therapy does not disqualify the subject (the maximum dose of corticosteroids should not exceed the equivalent of 160 mg of dexamethasone in a 2-week period before initiation therapy). Two weeks must have elapsed since the date of the last radiotherapy treatment
    -Subjects must be eligible for high dose therapy.
    -Life expectancy ≥ 3 months
    - Un âge ≥ 18 ans et ≤ 65 ans au moment de la signature du formulaire de consentement éclairé
    - Un diagnostic de Myélome Multiple de novo selon les Critères diagnostiques du Groupe de travail international des dyscrasies plasmocytaires (Leukemia 2009)
    - Un Myélome Multiple symptomatique de novo avec atteinte organique liée au Myélome ou critères CRAB
    - Une maladie mesurable définie par un composant monoclonal
    sérique ≥ 5 g / l, ou un composant monoclonal urinaire ≥ 200 mg/24 h
    ou des chaines légères libres sériques ≥ 100 mg / l.
    - Les sujets ne doivent pas avoir été traités antérieurement par un traitement systémique pour le myélome multiple. Un traitement antérieur avec des corticostéroïdes ou de la radiothérapie ne disqualifie pas le sujet. La dose maximale de corticostéroïdes ne doit pas dépasser l'équivalent de 160 mg de dexaméthasone dans une période de 2 semaines avant le début du traitement. L’inclusion des sujets qui nécessitent une radiothérapie concomitante (qui doit être localisée) doit être reportée jusqu'à ce que la radiothérapie soit terminée et que 2 semaines se soient écoulées depuis la dernière dose délivrée.
    - Etre éligible pour un traitement à haute dose avec autogreffe de cellules souches.
    - Une espérance de vie ≥ 3 mois
    - Un indice de performance ECOG 0-2
    E.4Principal exclusion criteria
    -Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test
    -Evidence of mucosal or internal bleeding and/or platelet refractory.
    -Prior myeloma systemic therapy
    -Central nervous system involvement
    -Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to first dose of study drug=
    -Infection requiring systemic antibiotic therapy or other serious infection within 14 days before first dose of study drug.
    -Evidence of current uncontrolled cardiovascular conditions...
    -Systemic treatment, within 14 days before first dose of study drug, with strong inhibitors of CYP1A2, strong inhibitors of CYP3A or strong CYP3A inducers or use of Ginkgo biloba or St. John’s wort
    -Ongoing or active systemic infection, known human immunodeficiency virus (HIV) positive, known active hepatitis B virus hepatitis, or known active hepatitis C virus hepatitis and history of hepatitis B or C virus hepatitis.
    -Diagnosed or treated for another malignancy within 5 years before study enrollment
    -Patient has significant neuropathy
    - Les femmes enceintes ou qui allaitent
    - un syndrome hémorragique cutanéo-muqueux ou interne et/ou état
    réfractaire aux transfusions plaquettaires
    - Un traitement systémique antérieur du myélome
    une hypertension non contrôlée ou un diabète non contrôlé dans les 14 jours précédant la 1ère dose de traitement à l’étude.
    - une fonction cardiovasculaire instable non contrôlée
    - Un traitement systémique, dans les 14 jours avant la première dose
    de médicament à l'étude, avec des inhibiteurs puissants du CYP1A2 du CYP3A ou inducteurs puissants du CYP3A ou l'utilisation de Ginkgo biloba ou le millepertuis.
    - Une infection connue par le virus d'immunodéficience humaine
    - Une hépatite virale active ou des antécédents d'hépatite B ou C
    - Patients diagnostiqués ou traités pour une autre tumeur maligne dans les 5 ans avant l’inclusion
    - une Neuropathie significative de Grade 3-4 ou grade 2 avec douleurs dans les 14 jours précédant l'enregistrement
    E.5 End points
    E.5.1Primary end point(s)
    The sCR rate
    Le taux de réponse complète stringente
    E.5.1.1Timepoint(s) of evaluation of this end point
    After consolidation and before maintenance therapy
    Après la consolidation et avant la phase de mainteanance
    E.5.2Secondary end point(s)
    1-the safety and tolerability
    2-the sCR, CR, VGPR and PR rates, the overall response rate
    3-évaluate progression free survival, overall survival, time to progression and duration of response, time to response
    4-the quality of stem cell harvest
    5-biological prognostic factors influencing outcome and response rates
    1- Innocuité et la tolérance
    2- les taux de sRC, RC, TBRP et RP
    3-le taux de réponse globale, la date de réponse, la survie sans progression, la survie globale, le temps jusqu'à progression et la durée de la réponse.
    4- la faisabilité et la qualité de la collecte de cellules souches périphériques.
    5-les facteurs pronostiques biologiques qui influent sur les taux de réponse et la survie.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-induction and consolidation
    2-after induction, high dose Melphalan, early consolidation, late consolidation and maintenance therapy
    3-end of study
    4-after stem celsl harvest
    5-end of study
    1-induction et consolidation
    2-après induction, aute dose de Melphalan, consolidation précoce, consolidation tardive et maintenance
    3-fin de l'étude
    4-après la collecte de cellules souches
    5-fin de l'étude
    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 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) 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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    66th month to complete secondary objectives
    66ème mois pour répondre au objectif secondaires de l'étude
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    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 state46
    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)
    it is not different from the expected in progressive disease. It's will be decided as per usual center practice.
    il n'est pas différent de celui en cas de pogression soit Il est sera décidée conformément à la pratique habituelle ducentre.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-09-24
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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