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    Summary
    EudraCT Number:2018-002931-35
    Sponsor's Protocol Code Number:D9108C00001
    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:2019-04-23
    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 number2018-002931-35
    A.3Full title of the trial
    A Phase 2, Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab Alone or in Combination with Novel Agents in Subjects with Locally Advanced, Unresectable, Stage III Non-small Cell Lung Cancer (COAST)
    Étude de plateforme de phase 2, multicentrique, randomisée, en ouvert, utilisant plusieurs médicaments, visant à évaluer le durvalumab en monothérapie ou en association avec de nouveaux agents chez des sujets atteints de cancer du poumon non à petites cellules de stade III, localement avancé et non résécable (COAST)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of durvalumab alone or in combination with other agents in subjects with non-small cell lung cancer that is not removable by surgery
    Étude visant à évaluer le durvalumab en monothérapie ou en association avec de nouveaux agents chez des patients atteints de cancer du poumon non à petites cellules, non retirable par une intervention chirurgicale.
    A.3.2Name or abbreviated title of the trial where available
    COAST
    A.4.1Sponsor's protocol code numberD9108C00001
    A.5.4Other Identifiers
    Name:IND numberNumber:140603
    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 SponsorMedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
    B.1.3.4CountryUnited States
    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 supportMedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
    B.5.2Functional name of contact pointClinical Trial Enquiries
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg, Maryland
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1301398 0000
    B.5.6E-mailclinicaltrialenquiries@medimmune.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 namedurvalumab
    D.3.2Product code MEDI4736
    D.3.4Pharmaceutical form Concentrate 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 INNdurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    D.3.9.3Other descriptive nameImmunoglobulin G1, anti-human CD antigen
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 nameoleclumab
    D.3.2Product code MEDI9447
    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 INNoleclumab
    D.3.9.2Current sponsor codeMEDI9447
    D.3.9.3Other descriptive namehuman IgG1λ monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 namemonalizumab
    D.3.2Product code IPH2201
    D.3.4Pharmaceutical form Lyophilisate 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 INNmonalizumab
    D.3.9.2Current sponsor codeIPH2201
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Stage III non-small cell lung cancer
    E.1.1.1Medical condition in easily understood language
    Non-small cell lung cancer
    Cancer du poumon non à petites cellules
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029519
    E.1.2Term Non-small cell lung cancer stage III
    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
    Clinical activity
    - To compare the antitumor activity of durvalumab alone vs durvalumab in combination with novel agents.
    Activité Clinique
    - Comparer l’activité antitumorale du durvalumab en monothérapie contre le durvalumab en association avec de nouveaux agents.
    E.2.2Secondary objectives of the trial
    Safety
    - To evaluate the safety and tolerability of durvalumab alone and durvalumab in combination with novel agents.

    Clinical activity
    - To further compare the efficacy of durvalumab alone vs durvalumab in combination with novel agents.

    Pharmacokinetics
    (a) To describe the pharmacokinetics (PK) of durvalumab alone and durvalumab in combination with novel agents.
    (b) To describe the PK of novel agents in combination with durvalumab.

    Immunogenicity
    (a) To assess the immunogenicity of durvalumab alone or in combination with novel agents
    (b) To assess the immunogenicity of novel biologic agents in combination with durvalumab
    Sécurité d’emploi
    - Évaluer la sécurité d’emploi et la tolérance du durvalumab en monothérapie et du durvalumab en association avec de nouveaux agents.

    Activité Clinique
    - Comparer de façon approfondie l’efficacité du durvalumab en monothérapie contre le durvalumab en association avec de nouveaux agents.

    Pharmacocinétique
    (a) Décrire la pharmacocinétique (PK) du durvalumab en monothérapie et du durvalumab en association avec de nouveaux agents.
    (b) Décrire la PK des nouveaux agents en association avec le durvalumab.

    Immunogénicité
    (a) Évaluer l’immunogénicité du durvalumab en monothérapie ou en association avec de nouveaux agents.
    (b) Évaluer l’immunogénicité des nouveaux agents biologiques en association avec le durvalumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluation
    2. Age 18 years or older
    3. Body weight ≥ 35 kg
    4. Subjects must have histologically or cytologically documented NSCLC who present with locally advanced, unresectable, Stage III disease
    5. Subjects must have completed, without progressing, definitive cCRT within 28 days prior to being randomized into the study.
    6. Subjects must have at least one previously irradiated tumor lesion that can be measured by RECIST v1.1
    7. Provision of tumor tissue sample, when available, from original diagnosis obtained before initiation of chemoradiotherapy
    8. Life expectancy ≥ 12 weeks
    9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
    1. Ils doivent fournir un consentement éclairé écrit et toute autorisation locale nécessaire avant qu’une procédure du protocole soit effectuée, y compris l’évaluation lors de la sélection.
    2. Ils doivent être âgés de 18 ans ou plus.
    3. Leur poids corporel doit être ≥ 35 kg.
    4. Ils doivent être atteints d’un CPNPC histologiquement ou cytologiquement documentés, présentant une maladie de stade III localement avancée et non résécable.
    5. Ils doivent avoir effectué, sans progression, une RCTc définitive dans les 28 jours précédant la randomisation dans l’étude.
    6. Les sujets doivent présenter au moins une lésion tumorale irradiée antérieurement, mesurable selon les critères RECIST v1.1
    7. La fourniture d’un échantillon de tissus tumoraux, le cas échéant, issu du diagnostic initial obtenu avant le début de la chimioradiothérapie.
    8. Espérance de vie ≥ 12 semaines.
    9. Indice de performance ECOG de 0 ou 1.
    E.4Principal exclusion criteria
    1. Mixed small cell and non-small cell lung cancer histology
    2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug.
    3. Subjects with history of ≥ Grade 2 pneumonitis from prior chemoradiation therapy
    4. Subjects with a history of venous thrombosis within the past 3 months
    5. Subjects with history of myocardial infarction, transient ischemic attack, or stroke in the past 6 months
    6. Congestive heart failure
    7. Active or prior documented autoimmune or inflammatory disorders
    8. History of active primary immunodeficiency
    9. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
    10. History of allogenic organ transplantation
    11. QTcF interval ≥ 470 ms
    12. History of another primary malignancy
    13. Concurrent enrollment in another therapeutic clinical study or during the follow-up period of an interventional study. Enrollment in observational studies will be allowed
    14. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study
    1. Histologie mixte du cancer du poumon à petites cellules et du cancer du poumon non à petites cellules.
    2. Utilisation actuelle ou antérieure d’un immunosuppresseur dans les 14 jours précédant la première dose du médicament à l’étude.
    3. Sujets présentant des antécédents de pneumopathie inflammatoire de grade ≥ 2 après un traitement radiochimiothérapeutique antérieur.
    4. Sujets présentant des antécédents de thrombose veineuse au cours des 3 derniers mois.
    5. Sujets présentant des antécédents d’infarctus du myocarde, d’accident ischémique transitoire ou d’accident vasculaire cérébral au cours des 6 derniers mois.
    6. Insuffisance cardiaque congestive.
    7. Maladies auto-immunes ou inflammatoires actuelles ou antérieures documentées.
    8. Antécédents d’immunodéficience primaire active.
    9. Infection active, dont tuberculose, hépatite B, hépatite C ou virus de l’immunodéficience humaine (VIH).
    10. Antécédents d’allogreffe d’organe.
    11. Intervalle QTcF ≥ 470 ms
    12. Antécédents d’une autre tumeur maligne primaire
    13. Inclusion concomitante dans une autre étude clinique, sauf s’il s’agit d’une étude clinique observationnelle (non interventionnelle) ou pendant la période de suivi d’une étude interventionnelle
    14. Femmes enceintes, allaitantes ou ayant l’intention de commencer une grossesse pendant leur participation à l’étude
    E.5 End points
    E.5.1Primary end point(s)
    Clinical activity
    - Objective response (OR) per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)
    Activité Clinique
    - Réponse objective (RO) selon les critères d’évaluation de réponse tumorale pour les tumeurs solides version 1.1 (RECIST v1.1)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomization until documention of disease progression, or the last evaluable disease assessment in the absence of PD prior to the initiation of subsequent anticancer therapy or discontinuation from the study, whichever occurs first.
    E.5.2Secondary end point(s)
    Safety
    - Presence of adverse events (AEs), serious adverse events (SAEs), and abnormal laboratory parameters and vital signs.

    Clinical activity
    - Duration of response (DoR), disease control (DC), progression-free survival (PFS) at 12 months, and PFS per RECIST v1.1 and overall survival (OS).

    Pharmacokinetics
    - Concentration of durvalumab or novel agents in serum.

    Immunogenicity
    - Antidrug antibody (ADA) incidence of durvalumab or novel biologic agents
    Sécurité d’emploi
    - Présence d’événements indésirables (EI), d’événements indésirables graves (EIG), de paramètres biologiques et de signes vitaux anormaux.

    Activité Clinique
    - Durée de réponse (DR), contrôle de la maladie (CM), survie sans progression (SSP) à 12 mois et SSP selon les critères RECIST v1.1 et survie globale (SG) .

    Pharmacocinétique
    Concentration sérique du durvalumab ou des nouveaux agents.

    Immunogénicité
    - Incidence des anticorps anti-médicaments (AAM) du durvalumab ou des nouveaux agents biologiques.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety - From time of informed consent through treatment period (12 months) or up to 3 months post last dose of study treatment.

    DoR - From randomization until documention of disease progression.

    DC - From randomization until progression, or the last evaluable disease assessment in the absence of PD prior to the initiation of subsequent anticancer therapy or discontinuation from the study, whichever occurs first.

    PFS and OS - From start of treatment until study completion or death, whichever comes first.

    Pharmacokinetics and immunogenicity - During the treatment period and follow-up.
    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 No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Platform study
    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.8.2.4Number of treatment arms in the trial3
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Canada
    France
    Germany
    Hong Kong
    Italy
    Poland
    Portugal
    Spain
    Taiwan
    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
    The end of the study (“study completion”) is defined as the date of the last protocol-specified visit/assessment (including telephone contact) for the last subject in the study. This date will be 5 years after the final subject is entered into the study or when the sponsor stops the study, whichever occurs first.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 225
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 300
    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)
    None
    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 Decision2019-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-16
    P. End of Trial
    P.End of Trial StatusOngoing
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