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    Summary
    EudraCT Number:2013-001432-22
    Sponsor's Protocol Code Number:IC2013-05
    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:2015-06-17
    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 number2013-001432-22
    A.3Full title of the trial
    A Multicenter Open label Phase II study of Pomalidomide and Cyclophosphamide and Dexamethasone in relapse/refractory Multiple Myeloma patients who were first treated within the IFM/DFCI 2009 trial
    Etude multicentrique, ouverte, de phase II, évaluant l’association pomalidomide, cyclophosphamide et dexaméthasone chez des patients atteints d’un myélome multiple en rechute ou réfractaire après un premier traitement selon le protocole IFM/DFCI 2009
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Myeloma
    Myelome
    A.3.2Name or abbreviated title of the trial where available
    PCD
    A.4.1Sponsor's protocol code numberIC2013-05
    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 SponsorINSTITUT CURIE
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInstitut Curie
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportCelgene Internationnal
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut Curie
    B.5.2Functional name of contact pointChrystelle GASTRIN
    B.5.3 Address:
    B.5.3.1Street Address26 rue d'Ulm
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75005
    B.5.3.4CountryFrance
    B.5.4Telephone number33156245630
    B.5.5Fax number33153104029
    B.5.6E-mailchrystelle.gastrin@curie.net
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/672
    D.3 Description of the IMP
    D.3.1Product namePomalidomide
    D.3.4Pharmaceutical form Capsule, hard
    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 INNPOMALIDOMIDE
    D.3.9.1CAS number 19171-19-8
    D.3.9.2Current sponsor codeCC-4047
    D.3.9.3Other descriptive namePOMALIDOMIDE
    D.3.9.4EV Substance CodeSUB33379
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Dexamethasone
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form 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 INNDEXAMETHASONE
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Endoxan
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form 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 INNEndoxan
    D.3.9.1CAS number 6055-19-2
    D.3.9.3Other descriptive nameCYCLOPHOSPHAMIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB16414MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    Progressive/Refractory multiple myeloma.
    Myélome multiple en rechute après une ligne de traitement.
    E.1.1.1Medical condition in easily understood language
    Progressive/refractory Multiple Myéloma
    Myélome multiple en rechute après une ligne de traitement.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level HLT
    E.1.2Classification code 10028229
    E.1.2Term Multiple myelomas
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine Response rate to the triple combination of pomalidomide and cyclophosphamide and dexamethasone in MM patients who are progressive after having received a first line of therapy according to the IFM/DFCI 2009 trial.
    Déterminer le taux de réponse de la triple association pomalidomide et cyclophosphamide et dexaméthasone chez des patients atteints de Myélome Multiple (MM) qui ont progressé après avoir reçu une 1ère ligne de traitement dans le cadre de l’essai IFM/DFCI 2009.
    E.2.2Secondary objectives of the trial
    -To determine safety of pomalidomide associated to cyclophosphamide and dexamethasone.
    -To determine time to response and response duration of pomalidomide associated to cyclophosphamide and dexamethasone.
    -To determine time to disease progression to pomalidomide associated to cyclophosphamide and dexamethasone.
    -Overall Survival (OS) of pomalidomide associated to cyclophosphamide and dexamethasone.
    -To determine response with regards to previous IFM/DFCI 2009 trial treatment arm (Arm A vs arm B) as well as cytogenetic of the bone marrow tumor plasma cells.
    - Déterminer la tolérance du pomalidomide associé au cyclophosphamide et à la dexaméthasone.
    - Déterminer le temps de réponse et la durée de la réponse au pomalidomide associé au cyclophosphamide et à la dexaméthasone.
    - Déterminer le temps jusqu’à progression sous pomalidomide associé au cyclophosphamide et à la dexaméthasone.
    - Survie globale sous pomalidomide associé au cyclophosphamide et à la dexaméthasone.
    - Déterminer la réponse en fonction du bras de traitement de l’essai précédent IFM/DFCI 2009 (Bras A versus Bras B) ainsi que la cytogénétique des plasmocytes tumoraux de la moelle osseuse.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients must have been treated in first line within the IFM/DFCI 2009 trial
    2.Must be able to understand and voluntarily sign an informed consent form
    3.Must be able to adhere to the study visit schedule and other protocol requirements
    4.Age ≥ 18 years
    5.Life expectancy > 6 months
    6.Patients must have symptomatic and progressive Myeloma as defined by the IMWG criteria
    7.Patients must have a clearly detectable and quantifiable monoclonal M-component value
    8.Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
    9.Adequate bone marrow function, documented within 96 hours prior to treatment without transfusion or growth factor support
    10.Adequate organ function, documented within 96 hours prior to treatment.
    11.Wash out period of at least 2 weeks from previous antitumor therapy or any investigational treatment.
    12.Able to take antithrombotic medicines such as low molecular weight heparin or aspirin.
    13.Subjects affiliated with an appropriate social security system
    14.Agree to abstain from donating blood while taking study drug therapy and for at least 28 days following discontinuation of study drug therapy
    15.Agree not to share study medication with another person and to return all unused study drug to the investigator
    16.Female subjects of childbearing potential must:
    - Understand the potential teratogenic risk to the unborn child
    - Understand the need and agree to use, and be able to comply with, two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study:
    1) for at least 28 days before starting study drug;
    2) while participating in the study;
    3) dose interruptions; and
    4) for at least 28 days after study treatment discontinuation.
    The two methods of reliable contraception must include one highly effective method and one additional effective (barrier) method. Females of childbearing potential must be referred to a qualified provider of contraceptive methods if needed.
    17.Male subjects must:
    - Practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.
    - Agree not to donate semen or sperm during study drug therapy and for at least 28 days following discontinuation of study drug.
    1.Les patients doivent avoir été traités en 1ère ligne dans le cadre de l’essai IFM/DFCI 2009
    2.Etre apte à comprendre et signer volontairement un formulaire de consentement éclairé
    3.Etre capable d’adhérer au schéma des visites de l’étude et aux autres requis du protocole
    4.Age ≥ 18 ans
    5.Espérance de vie > 6 mois
    6.Les patients doivent présenter un myélome symptomatique et progressif comme défini par les critères IMWG.
    7.Les patients doivent présenter une valeur de l’immunoglobuline monoclonale clairement détectable et quantifiable
    8.Statut de performance (ECOG) de 0, 1 ou 2
    9.Fonction hématologique adéquate, documentée dans les 96 heures avant le traitement sans transfusion ou facteur de croissance.
    10.Fonction hépatique adéquate, documentée dans les 96 heures avant le traitement.
    11.Période de wash out d’au moins 2 semaines depuis la précédente thérapie anti-tumorale ou tout autre traitement expérimental
    12.Etre apte à recevoir des médicaments anti thrombotiques tels que l’héparine de bas poids moléculaire ou l’aspirine
    13.Patients affiliés à un régime de Sécurité Sociale
    14.Accepter de ne pas donner son sang pendant la prise du traitement à l’étude et au moins 28 jours après la dernière prise du traitement à l’étude
    15.Accepter de ne pas partager le traitement à l’étude avec qui que ce soit et retourner tous les produits de l’essai non utilisés à l’investigateur
    16.Les patientes en âge de procréer doivent :
    - Comprendre le risque potentiel tératogène pour l’enfant à naître
    - Comprendre la nécessité, accepter d’utiliser et être capable de se soumettre simultanément à deux formes complémentaires de contraception ou de pratiquer une abstinence totale de rapports hétérosexuels durant les périodes suivantes :
    1) au moins 28 jours avant la première prise du traitement à l’étude
    2) durant toute la durée de l’étude
    3) durant les interruptions de dose
    4) au moins 28 jours après l’arrêt du traitement à l’étude.

    17.Les patients masculins doivent:
    - Pratiquer l’abstinence totale ou accepter d’utiliser des préservatifs durant tout contact sexuel avec une femme enceinte ou une femme en âge de procréer tout au long du traitement à l’étude, durant toute interruption de dose et au moins 28 jours après l’arrêt du traitement à l’étude même s’il a subi une vasectomie confirmée.
    - Accepter de ne pas donner de sperme ou de spermatozoïdes pendant le traitement à l’étude et au moins 28 jours après l’arrêt du traitement à l’étude.
    E.4Principal exclusion criteria
    1.Any other uncontrolled medical condition or comorbidity that might interfere with subject’s participation
    2.Primary amyloidosis or myeloma complicated by amyloidosis
    3.Pregnant or breast feeding females
    4.Use of any other experimental drug or therapy within 2 weeks before study treatment initiation(except local radiotherapy and/or corticosteroid until dose of dexamethasone 160mg)
    5.Known positive for HIV or Active infectious hepatitis, type B or C
    6.Patients with non-secretory MM
    7.Prior history of malignancies within 10 years
    8.Evidence of Central Nervous System (CNS) involvement
    9.Any > grade 2 toxicity unresolved
    10.Peripheral neuropathy > grade 2
    11.Known hypersensitivity to thalidomide, lenalidomide, cyclophosphamide or dexamethasone
    12.Ongoing active infection, especially ongoing pneumonytis
    13.Participant with clinical signs of heart or coronary failure, or evidence of Left Ventricular Ejection Fraction (LVEF) inferior to 40%.
    Participant with myocardial infarction within 6 months prior to enrolment or have New York Heart Association (NYHA) Class III or IV heart failure, and controlled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
    14.Inability or unwillingness to comply with birth control requirements
    15.Unable to take antithrombotic medicines at study entry
    16.Unable to take corticotherapy at study entry
    17.Individually deprived of liberty or placed under the authority of a tutor
    1.Toute autre maladie non contrôlée ou comorbidité qui pourrait interférer avec la participation du patient
    2.Amyloïdose primaire ou myélome compliqué d’une amyloïdose
    3.Femmes enceintes ou allaitantes
    4.Utilisation de tout autre médicament ou thérapie expérimentale dans les 2 semaines avant l’initiation du traitement à l’étude (excepté la radiothérapie locale et/ou les corticostéroïdes à une dose maximale de 160 mg de dexaméthasone)
    5.HIV positif connu ou hépatite active de type B ou C
    6.Patients avec un MM non sécrétant
    7.Antécédents de cancer(s) dans les 10 ans
    8.Preuve d’une atteinte du système nerveux central (SNC)
    9.Toute toxicité non résolue > grade 2
    10.Neuropathie périphérique > grade 2
    11.Hypersensibilité connue au thalidomide, lénalidomide, cyclophosphamide ou à la dexaméthasone
    12.Infection active en cours, particulièrement pneumopathie en cours
    13.Patient avec des signes cliniques d’insuffisance cardiaque ou coronaire, ou preuve d’une Fraction d’Ejection Ventriculaire Gauche (FEVG) inférieure à 40%.
    Patient ayant eu un infarctus du myocarde dans les 6 mois précédant l’inclusion ou qui présente une insuffisance cardiaque de classe III ou IV de la New York Heart Association (NYHA), et une angine contrôlée, des arythmies ventriculaires sévères non contrôlées, ou une preuve électrocardiographique d’ischémie aigüe ou des anomalies actives du système de conduction
    14.Incapacité ou réticence à se soumettre aux exigences contraceptives
    15.Impossibilité de recevoir des médicaments anti thrombotiques à l’entrée dans l’étude
    16.Impossibilité de recevoir une corticothérapie à l’entrée dans l’étude
    17.Personne privée de liberté ou sous tutelle
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the response rate (Partial Response (PR) or better) after 4 cycles of the triple combination pomalidomide and cyclophosphamide and dexamethasone (PCD) in the studied population using International Myeloma Working Group (IMWG) response criteria [Rajkumar, 2011].
    Le critère de jugement principal est le taux de réponse (Réponse Partielle (RP) ou meilleure réponse) après 4 cycles de la triple association pomalidomide et cyclophosphamide et dexaméthasone (PCD) dans la population étudiée en utilisant les critères de réponse de l’IMWG (International Myeloma Working Group) [Rajkumar, 2011].
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint is the response rate (Partial Response (PR) or better) after 4 cycles of the triple combination pomalidomide and cyclophosphamide and dexamethasone (PCD)
    Après 4 cycles de triple combinaison de pomalidomide + cyclophosphamide + dexamethasone (PCD)
    E.5.2Secondary end point(s)
    - Safety (type, frequency, severity, and relationship of Adverse Events (AE) to study treatment). Incidence of AE, Serious Adverse Event (SAE) and laboratory abnormalities using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTC AE) V4.03.
    - Time to response (from the date of inclusion to the date of the first observation of response) and response duration (time between first documentation of response and disease progression).
    - Time to disease progression (from the date of the first dose to the date of the first observation of disease progression).
    - Overall Survival (OS) (from the date of inclusion to the date of the last news).
    - To determine response with regards to previous IFM/DFCI 2009 trial treatment arm (Arm A vs arm B) as well as cytogenetic of the bone marrow tumor plasma cells. Analysis of cytogenetic study of bone marrow plasma cells is a key test in myeloma. The following cytogenetic FISH studies (Deletion 13q, Deletion 17p, translocation 4;14) will be performed (by Pr H. Avet Loiseau, Toulouse, France) at study entry.

    - Tolérance (type, fréquence, sévérité et relation des Evénements Indésirables (EI) au traitement à l’étude). Incidence des EI, Evénements Indésirables Graves (EIG) et anomalies biologiques en utilisant le National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTC-AE) v4.03.
    - Temps de réponse (depuis la date d’inclusion jusqu’à la date de la première observation d’une réponse) et délai de réponse (temps entre la première documentation d’une réponse et la progression de la maladie).
    - Temps jusqu’à progression (depuis la date de la première dose jusqu’à la date de la première observation de la progression de la maladie).
    - Survie globale (depuis la date d’inclusion jusqu’à la date des dernières nouvelles).
    - Déterminer la réponse en fonction des bras de traitement de l’étude IFM/DFCI 2009 (Bras A vs Bras B) ainsi que la cytogénétique des plasmocytes tumoraux de la moelle osseuse. Cette analyse est un test clé dans le myélome. Les études cytogénétiques en FISH suivantes (Délétion 13q, Délétion 17p, translocation 4;14) seront effectuées (par le Pr H. Avet Loiseau, Toulouse, France) à l’entrée dans l’étude
    E.5.2.1Timepoint(s) of evaluation of this end point
    - At end of treatment with pomalidomide
    - Until disease progression
    - Until disease progression
    - Until death lost of follow-up
    - After 4 cycles of the triple combination pomalidomide and cyclophosphamide and dexamethasone (PCD)
    - Après la dernière prise de pomalidomide.
    - Jusqu'a progression de la maladie
    - Jusqu'a progression de la maladie
    - Jusqu'au décès / perdu de vue
    - Après 4 cycles de triple combinaison de pomalidomide + cyclophosphamide + dexamethasone (PCD)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other 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.8.3 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 concerned34
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee 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
    Five years after LVLS (for disease reccurence free and overall survival, secondary primary malignacies)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    NONE
    Aucun
    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 Decision2013-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-25
    P. End of Trial
    P.End of Trial StatusCompleted
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