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    Summary
    EudraCT Number:2019-003706-27
    Sponsor's Protocol Code Number:D8530C00002
    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:2020-02-21
    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 number2019-003706-27
    A.3Full title of the trial
    SERENA-2: A Randomised, Open-Label, Parallel-Group, Multicentre Phase 2 Study Comparing the Efficacy and Safety of Oral AZD9833 versus Fulvestrant in Women with Advanced ER-Positive HER2-Negative Breast Cancer
    SERENA-2 : Étude de phase 2 multicentrique, randomisée, ouverte, à groupes parallèles comparant l'efficacité et l'innocuité de l'AZD9833 administré par voie orale par rapport au fulvestrant chez des femmes atteintes de cancer du sein avancé ER positif et HER2 négatif
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SERENA-2: A Randomised Comparative Phase 2 Study of AZD9833 versus Fulvestrant in Women with Advanced ER-Positive HER2-Negative Breast Cancer
    SERENA-2 : Etude de phase 2 comparant AZD9833 et fulvestrant chez des femmes atteintes de cancer du sein avancé ER positif et HER2 négatif
    A.3.2Name or abbreviated title of the trial where available
    SERENA-2
    A.4.1Sponsor's protocol code numberD8530C00002
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street AddressNot Applicable
    B.5.3.2Town/ cityNot Applicable
    B.5.3.3Post code19803
    B.5.3.4CountryUnited States
    B.5.4Telephone number+13028851180
    B.5.6E-mailinformation.center@astrazeneca.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.2.1.1.1Trade name Not answered
    D.2.1.1.2Name of the Marketing Authorisation holderNot answered
    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 nameAZD9833
    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 INNN/A
    D.3.9.2Current sponsor codeAZD9833
    D.3.9.3Other descriptive nameN/A
    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 No
    D.2.1.1.1Trade name Not answered
    D.2.1.1.2Name of the Marketing Authorisation holderNot answered
    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 nameAZD9833
    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 INNN/A
    D.3.9.2Current sponsor codeAZD9833
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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.2.1.1.1Trade name Faslodex 250 mg solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB, SE-151 85 Södertälje, Sweden
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFulvestrant
    D.3.9.1CAS number 129453-61-8
    D.3.9.3Other descriptive nameFULVESTRANT
    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 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
    Estrogen Receptor Positive HER2 Negative Advanced Breast Cancer
    Cancer du sein avancé ER positif et HER2 négatif
    E.1.1.1Medical condition in easily understood language
    Advanced Breast Cancer
    Cancer du sein avancé
    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 LLT
    E.1.2Classification code 10072737
    E.1.2Term Advanced breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the clinical efficacy (as assessed by PFS) of AZD9833 when compared to fulvestrant in
    women with advanced ER-positive HER2-negative breast cancer.
    Déterminer l'efficacité clinique (évaluée par la SSP) de l'AZD9833 par rapport au fulvestrant chez des femmes atteintes de cancer du sein avancé ER positif et HER2 négatif
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of AZD9833 when compared to fulvestrant in women with advanced ER positive HER2 negative breast cancer.

    To determine anti-tumour effect of AZD9833 when compared to fulvestrant in women with advanced ER positive HER2 negative breast cancer.

    To determine the effect of AZD9833 on survival and clinical benefit when compared to fulvestrant in women with advanced ER positive HER2 negative breast cancer

    To evaluate the PK of AZD9833 in this patient population at steady state.

    To evaluate the pharmacodynamics of AZD9833 and fulvestrant in a subgroup of patients with advanced ER positive HER2-negative breast cancer.

    To evaluate the effect of AZD9833 and fulvestrant on the patients’ HRQoL, as assessed by patient completed HRQoL questionnaires.
    Evaluer l’innocuité et la tolérance de l'AZD9833 par rapport au fulvestrant chez des femmes atteintes de cancer du sein avancé ER positif et HER2 négatif

    Déterminer l'effet anti-tumoral de l'AZD9833 par rapport au fulvestrant chez des femmes atteintes de cancer du sein avancé ER positif et HER2 négatif

    Déterminer l'effet de l'AZD9833 sur la survie et l’effet bénéfique clinique par rapport au fulvestrant chez des femmes atteintes de cancer du sein avancé ER positif et HER2 négatif

    Évaluer la PK de l'AZD9833 dans cette population de patientes à l'état d'équilibre

    Évaluer la pharmacodynamique de l'AZD9833 et du fulvestrant dans un sous-groupe de patientes atteintes de cancer du sein avancé ER positif et HER2 négatif

    Évaluer l'effet de l'AZD9833 et du fulvestrant sur la qualité de vie liée à la santé (HRQoL) des patientes évaluée à l’aide des questionnaires HRQoL complétés par les patientes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Provision of signed and dated, written informed consent prior to any mandatory study specific procedures, sampling, and analyses. Patients are also required to consent to the provision of archival tumour biopsies.
    • For patients who consent, provision of signed and dated written genetic informed consent prior to collection of sample for genetic analysis.
    • Female patients aged at least 18 years.
    • Post-menopausal as per the defined criteria.
    • Histologically or cytological confirmation of adenocarcinoma of the breast.
    • ER-positive status of primary or metastatic tumour tissue.
    • HER2-negative.
    • Metastatic disease or loco-regionally recurrent disease suitable for treatment with fulvestrant.
    • Radiological or other objective evidence of progression on or after the last systemic therapy prior to starting study treatment.
    • Patients must have at least 1 lesion, not previously irradiated, that can be measured accurately at baseline as ≥10 mm in the longest diameter or in absence of measurable disease as defined above, at least 1 lytic or mixed (lytic+sclerotic) bone lesion.
    • Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) performance status 0 to 1.
    Inclusion criteriion for the paired tumour biopsy research subgroup:
    • Washout from prior tamoxifen: 4 months to elapse from last tamoxifen dose to pre-dose on-study biopsy.
    • Avoir fourni un consentement éclairé écrit signé et daté avant la réalisation de toute procédure spécifique à l’étude, prélèvement ou analyse obligatoire. Les patientes devront également consentir à fournir des biopsies tumorales d'archive.
    • Pour les patientes qui y consentent, fournir un consentement éclairé pour l’analyse génétique par écrit signé et daté avant le prélèvement de l'échantillon destiné à l'analyse génétique.
    • Patientes âgées d’au moins 18 ans.
    • Patientes en ménopause selon les critères établis.
    • Confirmation histologique ou cytologique de l'adénocarcinome du sein.
    • Statut ER positif du tissu tumoral primaire ou métastatique.
    • Statut HER2 négatif
    • Maladie métastatique ou maladie locorégionale récidivante adaptée au traitement par fulvestrant.
    • Radiologie ou autre preuve objective de progression pendant ou après le dernier traitement systémique avant de commencer le traitement à l'étude.
    • Les patientes doivent présenter au moins 1 lésion, n’ayant jamais été irradiée, dont le diamètre le plus long peut être mesuré avec précision à l’inclusion comme ≥ 10 mm ou, en l'absence d’une maladie mesurable telle que définie ci-dessus, au moins 1 lésion osseuse lytique ou mixte (lytique + sclérotique).
    • Indice de performance de l’Eastern Cooperative Oncology Group (ECOG)/Organisation mondiale de la santé (OMS) compris entre 0 à 1
    Critère d'inclusion pour le sous-groupe de patientes incluses dans la recherche sur les biopsies tumorales appariées :
    • Sevrage d’un traitement antérieur par tamoxifène : 4 mois doivent s’être écoulés entre la dernière dose de tamoxifène et la biopsie prélevée dans le cadre de l’étude avant l’administration.
    E.4Principal exclusion criteria
    • Intervention with any of the following:
    o Any cytotoxic chemotherapy, investigational agents or other anti-cancer drugs for the treatment of breast cancer from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
    o Use of systemic oestrogen-containing hormone replacement therapy within 6 months prior to the first dose of study treatment.
    o Medications or herbal supplements known to be strong inhibitors/inducers of cytochrome P450 (CYP) 3A4/5 and sensitive CYP2B6 substrates.
    o Drugs that are known to prolong QT and have a known risk of torsades de pointes.
    o The following cardiovascular criteria: QTcF >470 ms, resting heart rate <45 bpm, clinically significant abnormalities of resting ECG, uncontrolled hypertension, symptomatic hypotension, factors that increase the risk for QTc prolongation, LVEF <40%
    o Radiotherapy with a limited field of radiation for palliation.
    o Major surgical procedure or significant traumatic injury.
    • Presence of life-threatening metastatic visceral disease or uncontrolled central nervous system (CNS) metastatic disease.
    • Inadequate bone marrow reserve or organ function.
    • Refractory nausea and vomiting, uncontrolled chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9833.
    • History of hypersensitivity to active or inactive excipients of AZD9833 or fulvestrant.
    • Previous randomisation in the present study.
    • Women of childbearing potential.
    • Avoir reçu l’un des traitements suivants :
    o Toute chimiothérapie cytotoxique, agent expérimental ou autre médicament anticancéreux pour le traitement du cancer du sein d'un schéma thérapeutique antérieur ou d'une étude clinique dans les 14 jours précédant la première administration du traitement à l'étude.
    o Utilisation d'une hormonothérapie substitutive contenant des œstrogènes systémiques dans les 6 mois précédant la première administration du traitement à l'étude.
    o Médicaments ou suppléments à base de plantes connus pour être de puissants inhibiteurs/inducteurs du cytochrome P450 (CYP) 3A4/5 et des substrats sensibles du CYP2B6.
    o Médicaments connus pour allonger l'intervalle QT et associés à un risque connu de torsades de pointes.
    o Critères cardiovasculaires suivants : intervalle QTcF moyen au repos > 470 msec, fréquence cardiaque au repos < 45 bpm, anomalie importante sur le plan clinique de l'ECG au repos, hypertension non contrôlée, hypotension symptomatique, tout facteur qui augmente le risque d’allongement de l'intervalle QTc, fraction d'éjection ventriculaire gauche < 40 %
    o Radiothérapie avec un champ de rayonnement limité pour des soins palliatifs.
    o Intervention chirurgicale lourde ou blessure traumatique importante.
    • Présence d'une maladie viscérale métastatique menaçant le pronostic vital ou d'une
    maladie métastatique du SNC non contrôlée.
    • Réserve de moelle osseuse ou fonction organique inadéquate.
    • Nausées et vomissements réfractaires, maladies gastro-intestinales chroniques non contrôlées, incapacité à avaler le produit formulé, ou résection intestinale importante antérieure qui empêcheraient l’absorption adéquate de l'AZD9833.
    • Antécédents d'hypersensibilité aux excipients actifs ou inactifs de l'AZD9833 ou du fulvestrant.
    • Randomisation antérieure dans la présente étude.
    • Femmes pouvant avoir des enfants.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival
    Survie sans progression de la maladie
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary analysis will be conducted when sufficient events have accrued for the treatment comparison at approximately 60% maturity.
    L'analyse du critère d'évaluation principal aura lieu lorsqu’un nombre suffisant d’évènements aura eu lieu pour la comparaison par paires soit environ 60% de maturité.
    E.5.2Secondary end point(s)
    - Objective response rate
    - Duration of response
    - Percentage change in tumour size at 16 weeks
    - Overall survival
    - Clinical benefit rate at 24 weeks
    - Plasma concentrations of AZD9833 and, if appropriate, metabolite(s)
    - Percent change from baseline in ER and progesterone receptor (PgR) expression assessed by the manual H-score method
    - Percent change from baseline in Ki67 labelling index
    - Changes from baseline in total/subscale scores of the HrQoL questionnaires
    - Taux de réponse objective
    - Durée de la réponse
    - Variation en pourcentage de la taille de la tumeur à 16 semaines
    - Survie globale
    - Taux d’effets bénéfiques cliniques à 24 semaines
    - Concentrations plasmatiques d'AZD9833 et, le cas échéant, du/des métabolite(s)
    - Variation en pourcentage par rapport à l’inclusion de l'expression des ER et des PgR évaluée par la méthode manuelle basée sur le score H
    - Variation en pourcentage par rapport à l’inclusion de l’indice de marquage par le Ki67
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be evaluated at the end of the trial.
    Survival analyses may be conducted at 50% and 75% overall survival maturity.
    Les critères d'évaluation secondaires seront évalués à la fin de l’étude. Les analyses de la survie pourront être réalisées après le décès de 50 % et 75 % des patientes
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA85
    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
    Canada
    France
    Georgia
    Germany
    Hungary
    Israel
    Italy
    Mexico
    Peru
    Poland
    Portugal
    Russian Federation
    Spain
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the last expected visit/contact of the last patient undergoing the study.
    La fin de l’étude est définie comme étant la dernière visite ou le dernier contact prévu du dernier patient participant à l’étude.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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: 183
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 183
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 No
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 189
    F.4.2.2In the whole clinical trial 366
    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)
    Subsequent anti-cancer treatment (after study treatment discontinuation) will be at the discretion of the patient's treating physician and should be recorded in the CRF.
    Le traitement anti-cancéreux ultérieur (après l’arrêt du traitement de l’étude) sera à la discrétion du médecin traitant du patient et devra être enregistré dans le CRF.
    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 Decision2020-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-30
    P. End of Trial
    P.End of Trial StatusOngoing
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