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    Summary
    EudraCT Number:2019-001494-88
    Sponsor's Protocol Code Number:ET19-073
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-05-29
    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 number2019-001494-88
    A.3Full title of the trial
    MegaMOST - A multicenter, open-label, biology driven, Phase II study evaluating the activity of anti-cancer treatments targeting tumor molecular alterations/characteristics in advanced / metastatic tumors.
    MegaMOST - Etude multicentrique de phase II, menée en ouvert, guidée par la biologie, évaluant l’activité de thérapies ciblant les altérations/caractéristiques moléculaires de tumeurs de stade avancé ou métastatique.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial evaluating the value of treatment with therapy specifically targeting the molecular alterations identified in the tumor of patients with advanced or metastatic cancer.
    Essai clinique évaluant l'intérêt d'un traitement par une thérapie ciblant spécifiquement les altérations moléculaires identifiées dans la tumeur de patient atteints d'un cancer à un stade avancé ou métastatique.
    A.3.2Name or abbreviated title of the trial where available
    MegaMOST (My Own Specific Therapy)
    MegaMOST (Mon traitement spécifique et personnalisé)
    A.4.1Sponsor's protocol code numberET19-073
    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 SponsorCentre Léon Bérard
    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 supportCentre Léon Bérard
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Léon Bérard
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address28 rue Laennec
    B.5.3.2Town/ cityLYON
    B.5.3.3Post code69737 Cedex 08
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)478 78 27 96
    B.5.5Fax number+33(0)469 85 61 82
    B.5.6E-mailSophie.BIDAUX@lyon.unicancer.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 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 nameHDM201
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Kisqali
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    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 nameRibociclib
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Yes
    D.2.1.1.1Trade name Cabometyx
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen
    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 nameCabozantinib
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    all histological types of advanced / metastatic tumors with alterations molecular identified
    Tout type histologique de tumeur à un stade avancé ou métastatique avec une altération moléculaire identifiée
    E.1.1.1Medical condition in easily understood language
    Advanced / metastatic cancers
    cancers à un stade avancé ou métastatique
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the activity of selected study drugs for each cohort based on molecular alterations /characteristics of patient’s tumor
    Evaluer l’activité clinique des thérapies ciblées pour chaque cohorte de traitement
    E.2.2Secondary objectives of the trial
    - To further document the clinical activity of study drugs for each cohort (Objective response rate after 3 months of treatment (3M-ORR); Duration of Response (DoR); Progression Free Survival (PFS); Overall survival (OS); Percentage of long-term responders (> 6 months))
    - To assess the safety profile of the study drugs for each cohort.
    - Exploratory objective: follow the evolution of the mutations identified in ctDNA and to evaluate the correlation with efficacy endpoints.
    - Documenter l’activité clinique des thérapies ciblées pour chaque cohorte de traitement.
    - Evaluer le profil de tolérance des thérapies ciblées pour chaque cohorte de traitement.
    - Objective exploratoire: Evaluer les mutations avant et après traitement sur l’ADN tumoral circulant, et corréler les mutations identifiées aux données cliniques.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General criteria:
    - Male or female patients aged of at least 18 years on day of signing informed consent.
    - Patients with histologically confirmed diagnosis of metastatic or locally advanced solids tumors.
    - A multidisciplinary molecular board must have recommended the specific MTT based on the following documented actionable alterations:
    Cohorte Ribociclib + HDM201 = amplification of CDK6 and/or CDK4, and/or CDKN2A homozygous deletion, and/or amplification of CCND1 and/or CCND3 with no deletion/losses more than single copy of RB1 by copy number and P53 wild-type.
    Cohorte Cabozantinib = AXL, MET, VEGFR, VEGF, KIT, RET, ROS1, MER, TRKB, FLT3, TIE-2 and/or Tyro3 activating mutations and/or amplification, and/or NTRK translocation.
    - Previously treated by at least one prior line of treatment in the advanced/metastatic setting.
    - Documented radiological disease progression as per RECIST v1.1 and presence of at least one measurable lesion according to RECIST 1.1 criteria based on screening tumor assessment.
    - Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
    - Adequate organ function, as per laboratory tests performed within 7 days prior to C1D1 (see specific criteria in protocole for each cohort)
    - Specific toxicities related to any prior anti-cancer therapy must have resolved to grade ≤1 (according to NCI CTCAE v5.0), except for alopecia (all grades), grade 2 neuropathy or anemia.
    - Women of child-bearing potential must have a negative serum pregnancy test within 7 days of first dose of study drugs and agree to use effective contraception from the date of negative pregnancy test and after the last dose of study drugs (see each specific cohort for the duration)
    - Fertile men must agree to use effective contraception from C1D1 and after the last dose of study drugs (see each specific cohort for the duration).
    - Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study procedures as per protocol.
    - Patient must be covered by a medical insurance.
    Critères généraux:
    - Homme ou femme âgé(e) d’au moins 18 ans à la date de signature du consentement.
    - Diagnostic confirmé par un examen histologique de tumeur solide à un stade avancé ou métastatique.
    - Recommandation d’une thérapie ciblée par une RCP moléculaire basée sur des altérations génétiques actionnables :
    Cohorte Ribociclib + HDM201 = Amplification de CDK4 et/ou 6, et/ou délétion homozygote de CDKN2A, et/ou amplification de CCND 1 et/ou 3 sans délétion/perte de RB1 et P53 sauvage
    cohorte Cabozantinib = Mutations activatrices et/ou amplification de AXL, MET, VEGFR, VEGF, KIT, RET, ROS1, MER, TRKB, FLT3, TIE-2 et/ou Tyro3, et/ou translocation de NTRK.
    - Patient précédemment traité par au moins une ligne de traitement en phase métastatique ou avancée.
    - Progression de la maladie documentée par un examen radiologique à l’inclusion avec au moins une lésion mesurable selon les critères RECIST v1.1.
    - Statut de performance (PS) de 0 ou 1 selon l’échelle ECOG.
    - Fonction normale des principaux organes selon un bilan biologique effectué dans les 7 jours précédant le C1J1 : voir critères spécifiques dans le protocole pour chaque cohorte de traitement.
    - Résolution à un Grade ≤ 1 (selon NCI-CTCAE v5.0) de toute toxicité relative à un précédant traitement, à l’exception de l’alopécie (tout grade), de neuropathie de grade 2 et les valeurs biologiques définies dans les critères d’inclusion de chaque cohorte de traitement.
    - Les femmes en âge de procréer doivent justifier d’un test de grossesse sérique négatif dans les 7 jours précédant le C1J1 et doivent accepter d’utiliser des méthodes de contraception efficaces à compter du jour du test de grossesse négatif et après la dernière prise des traitements de l’étude (se référer à chaque cohorte spécifique pour la durée).
    - Les hommes fertiles doivent accepter d'utiliser une contraception efficace à partir du C1J1 et après la dernière prise des traitements de l’étude (se référer à chaque cohorte spécifique pour la durée).
    - Patient capable de comprendre, de signer et de dater le consentement éclairé avant le début de toute procédure du protocole de l’étude. Patient acceptant de se conformer aux visites de suivi et procédures imposées par le protocole.
    - Patient affilié ou bénéficiaire d’un régime de sécurité sociale.
    E.4Principal exclusion criteria
    General criteria:
    - Patients amenable to therapy with curative intent.
    - Patients participating to another clinical trial with a medicinal product.
    - Patients previously treated with similar MTT meaning any agent targeting the same signaling pathways components.
    - Patients with known hypersensitivity to excipients of products
    - Patients with symptomatic central nervous system (CNS) metastasis who are neurologically unstable or require increasing doses of corticosteroids or local CNS-directed therapy to control their CNS disease.
    - Patients with secondary malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints and is approved by the sponsor. Examples of the latter include: basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer, prior malignancy and no evidence of recurrence for ≥ 2 years.
    - Known Human Immunodeficiency Virus (HIV) infection and/or active Hepatitis B (HBV) or Hepatitis C (HCV) infection.
    - Any clinically significant and/or uncontrolled medical disease that could compromise the patient's ability to tolerate study drug or would likely interfere with study procedures or results.
    - Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    - Patients who are pregnant or breastfeeding women
    Critères généraux:
    - Patients éligibles à un traitement à visée curative.
    - Patients participant à un autre essai clinique portant sur un médicament.
    - Patients précédemment traités par une thérapie ciblée comparable de même classe thérapeutique.
    - Patients présentant une hypersensibilité ou des risques allergiques aux traitements expérimentaux proposés ou à l’un de ses excipients.
    - Patient présentant des métastases du SNC symptomatiques ou actives, nécessitant des doses croissantes de corticostéroïdes ou d'un traitement local.
    - Patient présentant un autre type de cancer, sauf si, après accord du Promoteur, il est avéré que ce cancer n’est pas susceptible d’avoir un impact sur l’évaluation des critères de jugements de l’étude. Par exemple, les patients présentant les cancers listés ci-après peuvent être inclus après accord du Promoteur : carcinome cutané baso-cellulaire ou épidermoïde de la peau, carcinome in situ du col de l'utérus, cancer de la prostate localisé, autre cancer sans évidence de récidive depuis ≥ 2 ans.
    - Infection connue pour le virus de l'immunodéficience humaine (VIH) et/ou infection active par le virus de l'hépatite B (VHB) ou l'hépatite C (VHC).
    - Patients présentant des antécédents ou toute maladie cliniquement significative et/ou non contrôlée qui pourrait compromettre la capacité du patient à tolérer le médicament à l'étude ou qui pourrait interférer avec les procédures / résultats de l'étude.
    - Patients présentant des antécédents psychiatriques ou troubles liés à l'abus de drogues qui pourraient compromettre la coopération du patient durant l’étude
    - Patiente enceinte ou allaitante
    E.5 End points
    E.5.1Primary end point(s)
    Progression free rate after 3 months of treatment (3M-PFR).
    le taux de non progression après 3 mois de traitement
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 3 months of treatment (3M-PFR).
    après 3 mois de traitement
    E.5.2Secondary end point(s)
    - Objective response rate after 3 months of treatment (3M-ORR)
    - Duration of Response (DoR)
    - Progression Free Survival (PFS)
    - Overall survival (OS)
    - Percentage of long-term responders (> 6 months)

    - Nature, frequency and severity of Adverse Events (AEs), Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) graded using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.

    - Compare the type of mutations identified before and after study drug initiation and to evaluate the correlation with efficacy endpoints.
    - Taux de réponse objective après 3 mois de traitement
    - Durée de la réponse
    - Survie sans progression
    - Survie globale
    - Proportion de patients répondeurs (> 6 mois)

    - Nature, fréquence et grade des EI, EIG, EIGI, gradés selon CTCAE v5.0

    - Evaluer les mutations avant et après traitement sur l’ADN tumoral circulant, et corréler les mutations identifiées aux données cliniques.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Objective response rate : after 3 month of treatment
    Others points : up to 1 year of follow-up
    Le taux de réponse objective : après 3 mois de traitement
    Les autres points : 1 an de suivi
    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 Yes
    E.8.1.7.1Other trial design description
    Design Bayésien
    Bayesien design
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    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
    LVLS
    dernière visite du dernier patient
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 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 state100
    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)
    Treatment administered as long as the patients experience clinical benefit, in the opinion of the investigator or
    until unacceptable toxicity or until symptomatic deterioration attributed to disease progression or until withdrawal of consent.

    A short-term visit must be scheduled 30 days after the last dose of study treatment to determine if any new AEs have occurred.
    Les patients recevront les traitements expérimentaux tant que le bénéfice clinique sera jugé favorable par l'investigateur, jusqu'à détérioration symptomatique due à la progression de la maladie ou jusqu'au retrait du consentement du patient.

    Une visite à court terme sera programmée 30 jours après la dernière prise des traitements pour déterminer si apparition de nouveau évènements indésirables.
    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 Decision2019-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-03
    P. End of Trial
    P.End of Trial StatusOngoing
    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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