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    EudraCT Number:2014-003773-42
    Sponsor's Protocol Code Number:PM1183-B-005-14
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-06-09
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-003773-42
    A.3Full title of the trial
    A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors.
    Étude clinique multicentrique de phase II du lurbinectedin (PM01183) chez des patients atteints de tumeurs solides avancées sélectionnées

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors.
    Étude clinique du lurbinectedin (PM01183) chez des patients atteints de tumeurs solides avancées sélectionnées
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberPM1183-B-005-14
    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 SponsorPharma Mar S.A.
    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 supportPharma Mar, S.A.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharma Mar, S.A.
    B.5.2Functional name of contact pointClinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressAvd. De Los Reyes nº 1, Pol. Ind. La Mina
    B.5.3.2Town/ cityColmenar Viejo (Madrid)
    B.5.3.3Post code28770
    B.5.4Telephone number3491846 60 87
    B.5.5Fax number3491846 60 03
    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 nameLurbinectedin
    D.3.2Product code PM01183
    D.3.4Pharmaceutical form Powder for 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 INNlurbinectedin
    D.3.9.1CAS number 497871-47-3
    D.3.9.2Current sponsor codePM01183
    D.3.9.4EV Substance CodeSUB31196
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Selected Advanced Solid Tumors.
    Tumeurs solides avancées sélectionnées
    E.1.1.1Medical condition in easily understood language
    Selected Advanced Solid Tumors.
    Tumeurs solides avancées sélectionnées
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10048683
    E.1.2Term Advanced 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 assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), according to RECIST v 1.1 in the following advanced solid tumors: small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs) and Ewing´s family of tumors (EFTs).
    Pour évaluer l’activité antitumorale du lurbinectedine (PM01183) en termes de taux de réponse globale (TRG), selon les critères d'évaluation de réponse dans les tumeurs solides (RECIST) v.1.1, dans les tumeurs solides avancées suivantes : cancer du poumon à petites cellules (CPPC ), cancer de la tête et du cou (CTC), tumeurs neuroendocrines (TNE), carcinome des voies biliaires, cancer de l'endomètre, cancer du sein métastatique avec mutation BRCA 1/2, carcinome de site primitif inconnu, tumeurs des cellules
    germinales (TCG) et les tumeurs de la famille du sarcome d’Ewing (ESFT)
    E.2.2Secondary objectives of the trial
    *Characterize the antitumor activity of PM01183 in terms of duration of response (DR), clinical benefit (ORR or stable disease (SD) lasting over four months (SD>=4 months)), progression-free survival (PFS) and one-year overall survival (1y-OS) in each cohort of advanced solid tumors (overall survival (OS) instead of 1y-OS in the cohort of SCLC patients).
    *Characterize the plasma pharmacokinetics (PK) of PM01183.
    *Conduct an exploratory pharmacogenomic (PGx) and pharmacogenetic analysis.
    *Evaluate the safety profile of PM01183 in this patient population.
    *Pour caractériser davantage l’activité antitumorale de PM01183 en termes de durée de réponse (DR), de bénéfice clinique [TRG ou maladie stable (MS) durant plus de quatre mois (MS ≥ 4 mois)], de survie sans progression (SSP), et de survie globale à un an (SG-1 an) dans chaque cohorte de tumeurs solides avancées (survie globale (SG) au lieu de SG-1 an dans la cohorte de patients atteints du CPPC).
    * Pour caractériser les paramètres pharmacocinétiques (PK) plasmatiques de PM01183.
    * Pour mener des tests pharmacogénomiques (PGx) et pharmacogénétiques exploratoires.
    * Pour évaluer le profil d’innocuité de PM01183 dans cette population de patients.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    An exploratory pharmacogenomic (PGx) and pharmacogenetic sub-study.
    E.3Principal inclusion criteria
    1) Age ≥ 18 years.
    2) Voluntary signed informed consent (IC) of the patient
    before any study-specific procedure.
    3) Pathologically proven diagnosis of any of the following
    a) Small cell lung cancer (SCLC).
    b) Head and neck carcinoma (H&N). Salivary glands
    tumors are excluded.
    c) Neuroendocrine tumors (NETs), grade 2 and grade 3
    according to World Health Organization (WHO)
    d) Biliary tract carcinoma.
    e) Endometrial carcinoma.
    f) BRCA 1/2- associated metastatic breast carcinoma
    g) Carcinoma of unknown primary site.
    h) Germ cell tumor (GCTs), excluding immature teratoma,
    or teratoma with malignant transformation.
    i) Ewing’s family of tumors (EFTs).
    4) Prior treatment. Patients must have received:
    a) SCLC: one prior chemotherapy-containing line.
    b) H&N: one or two prior chemotherapy-containing lines.
    c) NETs: one or two prior chemotherapy-containing lines.
    No more than three prior hormone or biological therapy
    d) Biliary tract carcinoma: one or two prior chemotherapy containing lines.
    e) Endometrial carcinoma: one prior chemotherapycontaining line.
    f) BRCA 1/2-associated metastatic breast carcinoma: at east one but no more than three prior chemotherapy -containing lines.
    g) Carcinoma of unknown primary site: one or two prior
    chemotherapy-containing lines.
    h) GCTs: no limit of prior therapy (patients with no other
    clinical therapeutic options).
    i) EFTs: no more than two prior chemotherapy-containing
    lines in the metastatic/recurrent setting.
    5) Measurable disease as defined by RECIST v.1.1, and
    documented progression before study entry.
    6) Eastern Cooperative Oncology Group (ECOG)
    performance status (PS) ≤ 2.
    7) Adequate major organ function:
    a) Hemoglobin ≥ 9 g/dl, prior red blood cell (RBC)
    transfusions are allowed if clinically indicated; absolute
    neutrophil count (ANC) ≥ 2.0 x 109/l; and platelet count
    ≥ 100 x 109/l.
    b) Alanine aminotransferase (ALT), and aspartate
    aminotransferase (AST) ≤ 3.0 x upper limit of normal
    c) Total bilirubin ≤ 1.5 x ULN, or direct bilirubin ≤ ULN.
    d) Albumin ≥ 3 g/dl.
    e) Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥
    30 ml/min.
    f) Creatine phosphokinase (CPK) ≤ 2.5 x ULN.
    8) Washout periods prior to Day 1 of Cycle 1:
    a) At least three weeks since the last chemotherapy (six
    weeks if therapy contained nitrosureas or systemic
    mitomycin C).
    b) At least four weeks since the last monoclonal antibody
    (MAb)-containing therapy, or radiotherapy (RT) > 30
    gray (Gy).
    c) At least two weeks since the last
    biological/investigational therapy (excluding MAbs) or
    palliative RT (≤ 10 fractions or ≤ 30 Gy total dose).
    9) Grade ≤ 1 toxicity due to any previous cancer therapy
    according to the National Cancer Institute Common
    Terminology Criteria for Adverse Events (NCI-CTCAE,
    v.4). Grade 2 is allowed in case of alopecia and/or
    peripheral sensory neuropathy.
    10) Women of childbearing potential must have pregnancy
    excluded by appropriate testing before study entry. Fertile
    women must agree to use a medically acceptable method of contraception throughout the treatment period and for at
    least three months after treatment discontinuation. Fertile
    men must agree to refrain from fathering a child or
    donating sperm during the trial and for four months after
    the last infusion.
    1) Âge ≥ 18 ans.
    2) Signature volontaire du formulaire de consentement éclairé (FCE) du patient avant toute procédure spécifique à l’étude.
    3) Diagnostic confirmé par analyses pathologiques de l’une des tumeurs malignes suivantes :
    a) Cancer du poumon à petites cellules (CPPC).
    b) Cancer de la tête et du cou (CTC). Les tumeurs des glandes salivaires sont exclus.
    c) Tumeurs Neuroendocrines (TNE), grades 2 et 3 selon la classification l’organisation mondiale de la santé.
    d) Carcinome des voies biliaires.
    e) Cancer de l’endomètre.
    f) Cancer du sein métastatique avec mutation BRCA 1/2
    g) Carcinome de site primitif inconnu.
    h) Tumeurs des cellules germinales (TCG), excluant le tératome immature ou le tératome avec transformation maligne.
    i) Les tumeurs de la famille du sarcome d’Ewing (ESFT).
    4) Traitements antérieurs : les patients doivent avoir reçu :
    a) CPPC : une ligne de chimiothérapie antérieure.
    b) CTC : une ou deux lignes de chimiothérapie antérieures.
    c) TNE : une ou deux lignes de chimiothérapie antérieure. Pas plus de trois lignes antérieures d’hormonothérapie ou de biothérapie.
    d) Carcinome des voies biliaires : une ou deux lignes de chimiothérapie antérieure.
    e) Cancer de l’endomètre : une ligne de chimiothérapie antérieure.
    f) Cancer du sein métastatique avec mutation BRCA 1/2 : entre une et trois lignes de chimiothérapie antérieures.
    g) Carcinome de site primitif inconnu : une ou deux lignes de chimiothérapie antérieures.
    H) TCG : pas de limite de traitement antérieur (patients qui n’ont pas d’autres options thérapeutiques cliniques).
    i) ESFT : pas plus de deux lignes de chimiothérapie antérieures dans le cadre de cancer métastatique/récurent.
    5) Maladie mesurable telle que définie selon RECIST v.1.1, et progression documentée avant l’entrée dans l’étude.
    6) Un indice de performance (IP) de l’Eastern Cooperative Oncology Group (ECOG) ≤ 2.
    7) Fonction adéquate des organes majeurs :
    a) Hémoglobine ≥ 9 g/dl ; les transfusions de globules rouges (GR) sont autorisées si cliniquement indiqué ; nombre absolu de polynucléaires neutrophiles (NAPN) ≥ 2,0 x 109/l ; et taux de plaquettes ≥ 100 x 109/l.
    b) Alanine aminotransférase (ALT) et aspartate aminotransférase (AST) ≤ 3,0 x la limite supérieure de la normale (LSN).
    c) Bilirubine totale ≤ 1,5 x LSN, ou bilirubine directe ≤ LSN.
    d) Albumine ≥ 3 g/dl.
    e) Créatinine sérique ≤ 1,5 x LSN ou clairance de la créatinine ≥30 ml/min..
    f) Créatine phosphokinase (CPK) ≤ 2,5 x LSN.
    8) Périodes de sevrage (washout) avant le jour 1 du cycle 1 :
    a) Au moins trois semaines depuis la dernière chimiothérapie (six semaines en cas de thérapie par nitrosourées ou par mitomycine C).
    b) Au moins quatre semaines depuis la dernière thérapie par anticorps monoclonaux (ACM), ou radiothérapie (RT) > 30 gray (Gy).
    c) Au moins deux semaines depuis la dernière thérapie biologique/expérimentale (excluant ACM) ou RT palliative (≤ 10 fractions ou dose totale ≤ 30 Gy).
    9) Toxicité de grade ≤ 1 due à toute thérapie antérieure d’après les critères communs de toxicité (CTC) de l’institut national du cancer (INC-CTCAE, v.4). Une toxicité de grade 2 est acceptée en cas d’alopécie et/ou de neuropathie sensorielle périphérique.
    10) Les femmes susceptibles de procréer doivent subir des tests de grossesse appropriés pour exclure toute grossesse éventuelle avant l’entrée dans l’étude. Les femmes fertiles doivent utiliser une méthode de contraception médicalement approuvée tout au long de la période de traitement et pendant au moins trois mois après l’arrêt du traitement. Les hommes fertiles doivent accepter de ne pas engendrer un enfant ou un don de sperme pendant le procès et pendant quatre mois après la dernière perfusion.
    E.4Principal exclusion criteria
    1) Prior treatment with PM01183 or trabectedin.
    2) Prior or concurrent malignant disease unless in complete
    remission for more than five years, except treated in situ
    carcinoma of the cervix, basal or squamous cell skin
    carcinoma, and in situ transitional cell bladder carcinoma.
    3) Known central nervous system (CNS) involvement. In
    patients with SCLC, brain computed tomography (CT)-scan
    or magnetic resonance imaging (MRI) results must be
    provided at baseline.
    4) Relevant diseases or clinical situations which may increase
    the patient’s risk:
    a) History within the last year or presence of unstable
    angina, myocardial infarction, congestive heart failure,
    or clinically relevant valvular heart disease or
    symptomatic arrhythmia or any asymptomatic
    ventricular arrhythmia requiring ongoing treatment.
    b) Grade ≥ 3 dyspnea or daily intermittent oxygen
    requirement within two weeks prior to the study
    treatment onset.
    c) Active infection.
    d) Unhealed wounds or presence of any external drainage.
    e) Known chronic active hepatitis or cirrhosis.
    f) Immunocompromised patients, including known
    infection by human immunodeficiency virus (HIV).
    5) Women who are pregnant or breast-feeding, and fertile
    patients (men and women) who are not using an effective
    method of contraception. *
    6) Impending need for RT (e.g., painful bone metastasis
    and/or risk of spinal cord compression).
    7) Limitation of the patient’s ability to comply with the
    treatment or to follow-up the protocol.
    * Women of childbearing potential (WOCBP) must agree to
    use an effective contraception method to avoid pregnancy
    during the course of the trial (and for at least three months after
    the last infusion). Valid methods to determine the childbearing
    potential, adequate contraception and requirements for WOCBP
    partners are described in APPENDIX 2. Fertile men must agree
    to refrain from fathering a child or donating sperm during the
    trial and for four months after the last infusion.
    1) Traitement antérieur par PM01183 ou trabectédine.
    2) Présence ou antécédents de maladie maligne, à moins d’une rémission complète pour plus de cinq ans, à l’exception des pathologies suivantes si traitées : du carcinome in situ du col utérin, de carcinomes basocellulaires ou squameux, et du carcinome à cellules transitionnelles in situ de la vessie.
    3) Atteinte du système nerveux central (SNC). Les patients avec CPPC doivent fournir les résultats d’une tomodensitométrie (TDM) – scanner ou l’imagerie par résonance magnétique (IRM) à l’inclusion.
    4) Maladies ou circonstances cliniques qui peuvent augmenter le risque pour le patient :
    a) Antécédents durant la dernière année ou présence d’angor instable, infarctus du myocarde, insuffisance cardiaque congestive, cardiopathie valvulaire cliniquement significative ou antécédents de troubles du rythme symptomatiques ou autres arythmies ventriculaires asymptomatiques nécessitant un traitement régulier.
    b) Dyspnée de grade ≥ 3 ou nécessité d’une oxygénothérapie quotidienne intermittente dans les deux semaines précédant le début du traitement de l’étude.
    c) Infection active.
    d) Blessures non cicatrisées ou présence d’un dispositif de drainage externe.
    e) Hépatite active chronique ou cirrhose déclarés.
    f) Patients immunodéprimés, y compris une infection par le virus de l’immunodéficience humaine (VIH) déclarée.
    5) Femmes enceintes ou qui allaitent et patients fertiles (hommes et femmes) n’employant pas de contraception efficace.*
    6) Nécessité urgente d’une RT (par exemple, métastases osseuses douloureuses et/ou risque de compression de la moelle épinière).
    7) Limitation de la capacité du patient à se conformer au traitement ou au déroulement du protocole.

    * Les femmes fertiles doivent accepter d’employer une méthode contraceptive efficace afin d’éviter toute grossesse au cours de l’étude (et pendant encore trois mois au moins après la dernière perfusion). Les méthodes acceptées pour déterminer la fertilité, la contraception adaptée et les exigences pour les partenaires des femmes fertiles sont décrites dans l’annexe 2. Les hommes fertiles doivent accepter de ne pas engendrer et de ne pas donner leur sperme pendant l’étude et quatre mois après la dernière perfusion.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Rate (ORR) in each tumor type. ORR is defined as the percentage of patients with a confirmed response, either complete (CR) or partial (PR), according to the RECIST (v. 1.1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Along the study.
    E.5.2Secondary end point(s)
    Efficacy: Duration of Response (DR), defined as the time between the date when the response criteria (PR or CR, whichever one is first reached) are fulfilled to the first date when PD, recurrence or death is documented. Clinical Benefit, defined as ORR or stable disease lasting over four months (SD >/= 4 months). Progression-free Survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (of any cause), or last tumor evaluation. PFS4/PFS6, defined as the Kaplan-Meier estimates of the probability of being free from progression and death after the first infusion at these time points (4 and 6 months). OS6/OS12, defined as the Kaplan-Meier estimates of the probability of being alive after the first infusion at these time points (6 and 12 months) (overall survival in the cohort of SCLC patients). Plasma Pharmacokinetics (PK) of PM01183 Non-compartmental (NCA) PK parameters: area under the curve (AUC), maximum plasma concentration (Cmax), clearance (CL) and half-life (t1/2).
    Population PK parameters of the compartment model to be developed (initially based on Volumes and Clearance), and PK/PD correlation parameters, if applicable. Pharmacogenetics This analysis will be performed in those patients who signed the IC for the pharmacogenetic sub-study. The presence or absence of
    known polymorphisms from a single sample collected just before the PM01183 treatment start will be assessed to explain the individual variability in the main PK parameters. Pharmacogenomics (PGx): This exploratory analysis will be performed in those patients treated in any arm who signed the IC for the PGx sub-study. mRNA or protein expression levels of factors involved in DNA repair mechanisms, or related to the mechanism of action of lurbinectedin, will be evaluated from prior available tumor tissue samples obtained at diagnosis or relapse. Their mutational status might be also analyzed. Their correlation with the clinical response and outcome after treatment will be assessed. Safety Profile: Clinical examinations. Clinical assessment of AEs and serious adverse events (SAEs). Changes in laboratory parameters (hematological and biochemical, including liver function tests). Reasons for treatment discontinuations. Reasons for dose reduction and treatment delays.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Along the study.
    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 No
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    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
    When all evaluable patients have at least 12 months of follow-up, and all patients in the SCLC cohort have been followed up until death.
    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 months0
    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 months0
    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: 137
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 188
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 235
    F.4.2.2In the whole clinical trial 325
    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)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-01
    P. End of Trial
    P.End of Trial StatusOngoing
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