Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-001578-31
    Sponsor's Protocol Code Number:CINC280A2301
    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:2020-08-06
    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 number2020-001578-31
    A.3Full title of the trial
    A phase III, randomized, controlled, open-label, multicenter, global study of capmatinib versus SoC docetaxel chemotherapy in previously treated patients with EGFR wt, ALK negative, locally advanced or metastatic (stage IIIB/IIIC or IV) NSCLC harboring MET exon 14 skipping mutation (METΔex14)
    Etude internationale de phase III, multicentrique, randomisée, en ouvert, évaluant capmatinib versus docétaxel chez des patients atteints de cancer bronchique non à petites cellules, localement avancé ou métastatique, avec mutations responsables d’un saut de l’exon 14 de MET (METΔex14) et préalablement traités
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy of capmatinib in comparison with standard of care docetaxel as a second or third line therapy in participants with non-small cell lung cancers harboring MET exon 14 skipping mutation.
    A.4.1Sponsor's protocol code numberCINC280A2301
    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 SponsorNovartis Pharma AG
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma S.A.S
    B.5.2Functional name of contact pointInformation&Communication Médicales
    B.5.3 Address:
    B.5.3.1Street Address8/10 rue Henry Sainte Claire Deville, CS 40150
    B.5.3.2Town/ cityRueil-Malmaison
    B.5.3.3Post code92563
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 1 5547 6600
    B.5.5Fax number+33 1 5547 6100
    B.5.6E-mailicm.phfr@novartis.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 namecapmatinib
    D.3.2Product code INC280
    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 INNcapmatinib
    D.3.9.1CAS number 1197376-85-4
    D.3.9.2Current sponsor codeINC280
    D.3.9.3Other descriptive nameINC280
    D.3.9.4EV Substance CodeSUB31645
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 Yes
    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 nameDocetaxel
    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 INNDOCETAXEL
    D.3.9.1CAS number 114977-28-5
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namecapmatinib
    D.3.2Product code INC280
    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 INNcapmatinib
    D.3.9.1CAS number 1197376-85-4
    D.3.9.2Current sponsor codeINC280
    D.3.9.3Other descriptive nameINC280
    D.3.9.4EV Substance CodeSUB31645
    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) 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
    cMET mutated NSCLC
    E.1.1.1Medical condition in easily understood language
    Type of lung cancer, called non-small cell lung cancer (NSCLC) with certain genetic alterations (called mutations) of a gene called the MET gene
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    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
    To compare the efficacy of capmatinib versus docetaxel
    Comparer l’efficacité du capmatinib par rapport au docétaxel
    E.2.2Secondary objectives of the trial
    To assess the antitumor activity of capmatinib versus docetaxel

    To evaluate Overall Survival (OS) in participants treated with capmatinib versus docetaxel

    To evaluate the safety profile of capmatinib versus docetaxel

    To characterize the pharmacokinetics of capmatinib in this study population

    To assess the effect of capmatinib versus docetaxel on patient-reported disease-related symptoms, functioning, and health-related quality of life (HRQoL)

    To assess intracranial anti-tumor activity of capmatinib and docetaxel in participants with Central Nervous System (CNS) lesions at baseline by BIRC
    Evaluer l’activité antitumorale du capmatinib par rapport au docétaxel
    Evaluer la survie globale (SG) des patients traités par le capmatinib par rapport au docétaxel
    Evaluer le profil d’innocuité du capmatinib par rapport au docétaxel
    Caractériser la pharmacocinétique (PK) du capmatinib dans la population à l’étude
    Evaluer l’effet rapporté par le patient du capmatinib par rapport au docétaxel sur les symptômes liés à la maladie, les activités et la qualité de vie liée à la santé
    Evaluer l’activité antitumorale intracrânienne du capmatinib par rapport au docétaxel chez les patients présentant des lésions du système nerveux central (SNC) à la baseline
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent must be obtained prior to participation in the study.

    2. Adult ≥ 18 years old at the time of informed consent.

    3. Stage IIIB/IIIC (not amenable to surgery, radiation or multi modality therapy) or IV NSCLC at the time of study entry.

    4. Histologically or cytologically confirmed diagnosis of NSCLC that is:
    • EGFR wt. This should have been assessed as part of the participant’s standard of care by a validated test for EGFR mutations as per local guidelines.
    • AND ALK rearrangement negative. This should have been assessed as part of the participant’s standard of care by a validated test.
    • AND has MET∆ex14 mutation per Novartis-designated central laboratory.

    5. Mandatory provision of a formalin-fixed, paraffin embedded tumor tissue sample (archival tumor block or slides, or a newly obtained tumor sample) in a quantity sufficient to allow the confirmation of MET mutation status for all participants and potential companion diagnostics development. Tumor samples must contain at least 10% tumor content.

    6. Participants must have progressed on one or two prior lines of systemic therapy for advanced/metastatic disease (stage IIIB/IIIC [not candidates for surgery, radiation or multi modality therapy] or IV NSCLC) and must be candidates for single agent chemotherapy (docetaxel).

    7. ECOG performance status (PS) of 0 or 1.
    1. Le consentement éclairé doit être obtenu avant toute participation à l’étude.
    2. Adultes ≥ 18 ans lors de la signature du consentement.
    3. CBNPC de stades IIIB/IIIC (non éligibles à un traitement par chirurgie, radiothérapie ou traitement multimodal) ou IV lors de l’entrée dans l’étude.
    4. Diagnostic de CBNPC histologiquement ou cytologiquement confirmé, qui en outre :
    • Ne présente pas de mutation d’EGFR. L’évaluation doit avoir eu lieu dans le cadre de la prise en charge standard du patient par une analyse des mutations d’EGFR selon les recommandations locales.
    • ET ne présente pas de réarrangement du gène ALK (ALK-négatif) : l’évaluation doit avoir eu lieu dans le cadre de la prise en charge standard du patient par un test validé.
    • ET présente des mutations METΔex14 déterminées par le laboratoire central désigné par Novartis.

    5. Pour tous les patients, un échantillon tumoral fixé au formol et conservé en paraffine (bloc ou lames d’échantillon archivé ou nouvelle biopsie tumorale) doit obligatoirement être disponible en quantité suffisante pour permettre la confirmation du statut mutationnel de MET et le développement potentiel d’un test diagnostique compagnon. Ces échantillons doivent inclure au moins 10 % de contenu tumoral.

    6. Les patients doivent avoir progressé sous une ou deux lignes de traitement systémique antérieures pour la maladie au stade avancé/métastatique (CBNPC de stades IIIB/IIIC [non éligibles à un traitement par chirurgie, radiothérapie ou traitement multimodal] ou IV) et être éligibles à une chimiothérapie en monothérapie (docétaxel).

    7. Indice de performance ECOG (pour Eastern Cooperative Oncology Group) de 0 ou 1.
    E.4Principal exclusion criteria
    1. Prior treatment with any MET inhibitor or HGF-targeting therapy.

    2. Participants with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms. If participants are on corticosteroids for endocrine deficiencies or tumor-associated symptoms other than CNS related, dose must have been stabilized (or decreasing) for at least 5 days before Cycle 1 Day 1.

    3. Participants with known druggable molecular alterations (such as ROS1 translocation or BRAF mutation, etc.) which might be a candidate for alternative targeted therapies as applicable per local regulations and treatment guidelines.
    1. Traitement antérieur par un inhibiteur de MET ou d’HGF.

    2. Patients ayant des métastases du système nerveux central (SNC) symptomatiques, neurologiquement instables, ou ayant nécessité des doses croissantes de stéroïdes au cours des 2 semaines précédant l’inclusion dans l’étude. Pour les patients traités par corticoïdes pour des déficits endocriniens ou des symptômes associés à la tumeur autres que ceux liés au SNC, la dose devra être la même (ou avoir diminué) depuis au moins 5 jours avant le Jour 1 du Cycle 1.

    3. Les patients présentant des mutations oncogéniques (par exemple translocation de ROS1 ou mutation de BRAF, etc.), pouvant être traitées par voie médicamenteuse, qui peuvent être éligibles à des thérapies ciblées alternatives, tel qu’applicable selon les réglementations et les recommandations locales de traitement.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) by BIRC as per RECIST 1.1
    La SSP sera déterminée par le BIRC selon les critères RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis and safety analyses will be performed after observing approximately 62 PFS events as assessed by BIRC. A final analysis will be performed at the end of the study.
    L’analyse principale sera effectuée lorsque 62 événements de SPP, évaluée par le BIRC, seront documentés. Une analyse finale sera réalisée à la fin de l’étude.
     
    E.5.2Secondary end point(s)
    All calculated per RECIST 1.1, both by BIRC and investigator:
    • Overall response rate (ORR)
    • Duration of response (DOR)
    • Time to response (TTR)
    • Disease control rate (DCR)

    All calculated per RECIST 1.1, by investigator:
    • PFS

    Overall Survival

    Incidence of adverse events and serious adverse events, change in vital signs, laboratory results and ECG

    Plasma concentrations and plasma PK parameters based on population PK model as appropriate.

    Change from baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-LC13, QLQ-C30, EuroQoL-5 Dimension-5 Level/EQ-5D-5L) questionnaires

    Overall intracranial response rate (OIRR), duration of intracranial response (DOIR), time to intracranial response (TTIR), intracranial disease control rate (IDCR) by BIRC as per RANO-BM criteria
    Critères évalués selon les critères RECIST v1.1 par le BIRC et par le médecin-investigateur :
    • Taux de réponse globale (TRG)
    • Durée de réponse globale (DRG)
    • Temps de réponse (TR)
    • Taux de contrôle de la maladie (TCM)
    Critère évalué selon les critères RECIST v1.1 par le médecin-investigateur :
    • SSP

    La survie globale

    Incidence des effets indésirables et des effets indésirables graves, des modifications des signes vitaux, des paramètres biologiques et des électrocardiogrammes (ECG)
    Concentration plasmatique et paramètres PK plasmatiques selon un modèle de population PK

    Changement par rapport à la baseline dans les réponses aux questionnaires EORTC (pour European Organization for Research and Treatment of Cancer) QLQ-LC13, QLQ-C30 et EQ-5D-5L (pour EuroQoL 5 Dimension-5 Level)

    TRG intracrânienne, DRG intracrânienne, TR intracrânienne, TCM intracrânienne évalués par le BIRC selon les critères RANO-BM (pour Response Assessment in Neuro-Oncology Brain Metastases)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The primary analysis and safety analyses will be performed after observing approximately 62 PFS events as assessed by BIRC. A final analysis will be performed at the end of the study.
    L’analyse principale sera effectuée lorsque 62 événements de SPP, évaluée par le BIRC, seront documentés. Une analyse finale sera réalisée à la 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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 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) 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 Yes
    E.8.1.7Other No
    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 trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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
    Belgium
    Brazil
    France
    Germany
    Hungary
    India
    Israel
    Italy
    Korea, Republic of
    Lithuania
    Netherlands
    Portugal
    Russian Federation
    South Africa
    Spain
    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
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 75
    F.4.2.2In the whole clinical trial 90
    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)
    There are currently no specific plans.
    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 Decision2020-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-10-31
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 05 17:11:27 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA