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    Summary
    EudraCT Number:2016-005068-33
    Sponsor's Protocol Code Number:D4191C00068
    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:2017-10-20
    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 number2016-005068-33
    A.3Full title of the trial
    An Open-Label, Multi-Centre, Safety Study of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies
    Étude d’innocuité, multicentrique, ouverte comparant, à dose fixe, l’association durvalumab-trémélimumab à la monothérapie par durvalumab dans les tumeurs solides à stade avancé (Etude STRONG)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is an open-label, multi-center, study to determine the short and long term safety of fixed doses of durvalumab 1500 mg + tremelimumab 75 mg combination therapy or durvalumab 1500 mg monotherapy in patients with advanced solid malignancies
    Il s’agit d’une étude ouverte, multicentrique, destinée à déterminer la tolérance à court et long termes de doses fixes de l’association durvalumab 1 500 mg + trémélimumab 75 mg ou du durvalumab 1500 mg en monothérapie chez des patients ayant des tumeurs solides à stade avancé.
    A.3.2Name or abbreviated title of the trial where available
    STRONG
    A.4.1Sponsor's protocol code numberD4191C00068
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03084471
    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 pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressForskargatan 18
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post code15185
    B.5.3.4CountrySweden
    B.5.6E-mailClinicalTrialTransparency@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.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDurvalumab
    D.3.2Product code MEDI4736
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDURVALUMAB
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    D.3.9.4EV Substance CodeSUB176342
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTremelimumab
    D.3.2Product code MEDI1123
    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 INNTremelimumab
    D.3.9.1CAS number 745013-59-6
    D.3.9.2Current sponsor codeMEDI1123
    D.3.9.3Other descriptive nameTREMELIMUMAB
    D.3.9.4EV Substance CodeSUB37101
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The target patient population of the protocol includes patients with advanced solid tumors who meet the overall and tumor specific inclusion and exclusion criteria as outlined in each protocol Module.
    Please refer to the protocol version and the tumor specific protocol Modules for the full list of medical conditions to be investigated.
    La population de patients ciblés par le protocole inclut des patients présentant des tumeurs solides avancées répondant aux critères d’inclusion globaux et spécifiques à une tumeur et ne présentant pas de critères de non inclusion, conformément à ce qui est décrit dans chaque module.
    E.1.1.1Medical condition in easily understood language
    Different type of tumors
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061272
    E.1.2Term Malignant urinary tract neoplasm
    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 collect additional data and assess the incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality, including immune-relatedness, of adverse events of special interest (AESIs) in patients with advanced solid malignancies treated with fixed doses of durvalumab and tremelimumab combination therapy or durvalumab monotherapy.
    Recueillir des données supplémentaires et d’évaluer l’incidence, la sévérité, la nature, la gravité, les interventions/traitements, les résultats et la causalité, y compris la relation avec le système immunitaire, des événements indésirables d’intérêt particulier (EIIP) chez les patients présentant des cancers solides avancés et recevant un
    traitement à dose fixe par association de durvalumab et de trémélimumab ou par durvalumab en monothérapie.
    E.2.2Secondary objectives of the trial
    1. To collect additional data and assess the incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality of AEs (including SAEs).
    2. To collect additional data and assess the incidence and frequency of durvalumab and tremelimumab (as applicable to each tumor Module) interruption and discontinuation due to treatment-emergent AEs (including SAEs).
    3. To assess overall survival (OS). Patients will be followed for survival for up to 5 years following date of first patient treatment initiation. Patients will be followed to a minimum of 6 months following enrollment of the last patient to the study.

    Exploratory objective:
    To assess overall response rate (ORR) and disease control rate (DCR) based on investigator assessed response to treatment (RECIST 1.1).
    1. Recueillir des données supplémentaires et évaluer l’incidence, la sévérité, la nature, la gravité, les interventions/traitements, les résultats et la causalité des EI (y compris EIG).
    2. Recueillir des données supplémentaires et évaluer l’incidence et la fréquence de la suspension ou de l’arrêt du traitement par durvalumab et trémélimumab (selon ce qui est applicable dans chaque module spécifique à une tumeur) en raison d’EI apparaissant sous traitement (y compris EIG).
    3. Évaluer la survie globale (SG). Les patients seront suivis pour évaluer la survie jusqu’à 5 ans après la date de début de traitement du premier patient. Les patients seront suivis pendant un minimum de 6 mois après le recrutement du dernier patient dans l’étude.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Genetic Research (Appendix C of study protocol, dated 19 Apr 2017)

    Rationale and Objectives
    AstraZeneca intends to collect and store DNA for genetic research to explore how genetic variations may affect clinical parameters, risk and prognosis of diseases, and the response to medications. Genetic research may lead to better understanding of diseases, better diagnosis of diseases or other improvements in health care and to the discovery of new diagnostics, treatments or medications.
    In addition, collection of DNA samples from populations with well described clinical characteristics may lead to improvements in the design and interpretation of clinical trials and,possibly, to genetically guided treatment strategies.

    All patients will be asked to participate in this genetic research. Participation is voluntary and
    if a patient declines to participate there will be no penalty or loss of benefit. The patient will
    not be excluded from any aspect of the main study.
    E.3Principal inclusion criteria
    - Disease not amendable to curative surgery
    - ECOG performance status as defined in the specific module.
    - Body weight >30 kg.
    - No prior exposure to anti-PD-1or anti-PD-L1, including on another AstraZeneca study. Exposure to other investigational agents may be permitted after discussion with the Sponsor.
    - Adequate organ and marrow function as defined in the protocol
    - Maladie ne pouvant bénéficier d’une intervention chirurgicale à visée curative
    - Bilan de performances ECOG tel que défini dans le module spécifique.
    - Poids corporel > 30 kg.
    - Aucun antécédent d’exposition à un anti-PD-1 ou anti-PD-L1, y compris dans une autre étude d’AstraZeneca. L’exposition à d’autres agents expérimentaux pourra être autorisée après discussion avec le promoteur
    - Fonction organique et médullaire appropriée, définie selon les critères dans le protocole
    E.4Principal exclusion criteria
    - Any concurrent chemotherapy, investigational agent, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
    - Local treatment of isolated lesions for palliative intent is acceptable (e.g., local surgery or radiotherapy).
    - Receipt of any investigational anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment.
    - Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug. Note: Local treatment of isolated lesions, excluding target lesions, for palliative intent is acceptable.
    - Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
    - History of allogenic organ transplantation.
    - Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent

    - History of another primary malignancy except for
    -- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of investigational product (durvalumab + tremelimumab) and of low potential risk for recurrence
    -- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
    -- Adequately treated carcinoma in situ without evidence of disease

    - History of leptomeningeal carcinomatosis
    - Has untreated central nervous system (CNS) metastases and/or carcinomatous meningitis identified either on baseline brain imaging (please refer to RECIST for details on the imaging modality) obtained during the screening period or identified prior to signing the ICF. Patients whose brain metastases have been treated may participate provided they show radiographic stability (defined as 2 brain images, both of which are obtained after treatment to the brain metastases. These imaging scans should both be obtained at least four weeks apart and show no evidence of intracranial progression). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either, without the use of steroids, or are stable on a steroid dose of ≤10mg/day of prednisone or its equivalent and anti-convulsants for at least 14 days prior to the start of treatment.Active or recent history of diverticulitis. Note: Patients with known diverticulosis are permitted to enroll.
    - History of active primary immunodeficiency.
    - Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
    - Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab. The following are exceptions to this criterion:Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) // Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
    - Active or prior documented autoimmune or inflammatory disorders
    - Tout traitement concomitant (chimiothérapie, agent expérimental, agent biologique ou hormonothérapie) pour le traitement du cancer. L’utilisation concomitante d’une hormonothérapie pour des pathologies non liées au cancer (par exemple, hormonothérapie de substitution) est acceptable.
    - Le traitement local de lésions isolées à visée palliative est acceptable (par exemple, chirurgie ou radiothérapie locale).
    -Administration d’un traitement anticancéreux expérimental dans les 28 jours précédant ou les 5 demivies précédant, selon la durée la plus courte, la première dose du traitement à l’étude.
    -Traitement par radiothérapie sur plus de 30 % de la moelle osseuse ou à champ large, dans les 4 semaines précédant la première dose du traitement à l’étude. Remarque : Le traitement local à des fins palliatives est acceptable pour des lésions isolées, hormis les lésions ciblées.
    - Intervention chirurgicale majeure (telle que définie par l’investigateur) dans les 28 jours précédant la première dose de Médicament à l’Etude (ME). Remarque : Une intervention chirurgicale locale à des fins palliatives pour des lésions isolées est acceptable.
    - Antécédents de greffe d’organe allogénique.
    - Maladie intercurrente non contrôlée, y compris notamment, infection en cours ou active, insuffisance cardiaque congestive symptomatique, hypertension artérielle non contrôlée, angor instable, arythmie cardiaque, pneumopathie interstitielle, pathologies gastro-intestinales chroniques graves associées à une diarrhée, situations sociales/de maladie psychiatrique susceptibles de limiter l’observance des exigences de l’étude, d’augmenter de façon importante le risque de survenue d’EI ou de compromettre la capacité du patient de fournir son consentement éclairé écrit.

    Antécédents d’autres cancers primitifs sauf :
    • Cancer traité à titre curatif et absence de maladie active connue depuis ≥ 5 ans avant la première dose de médicament à l’étude (durvalumab + trémélimumab) et à faible risque potentiel de récidive
    • Cancer cutané non mélanomateux ou lentigo malin traité de façon appropriée, sans signe de présence de la maladie
    • Carcinome in situ traité de façon appropriée, sans signe de présence de la maladie

    - Antécédents de carcinomatose leptoméningée
    - Présence de métastases non traitées du système nerveux central (SNC) et/ou méningite carcinomateuse identifiée(s) soit sur l’imagerie cérébrale initiale (se reporter aux critères RECIST pour plus de détails sur les modalités d’imagerie) obtenue pendant la période de sélection soit identifiée(s) avant la signature du FCE. Les patients dont les métastases cérébrales ont été traitées pourront participer à condition qu’ils présentent une stabilité radiographique (définie comme 2 images cérébrales obtenues après traitement des métastases cérébrales. Ces examens d’imagerie doivent être effectués à au moins quatre semaines d’intervalle et ne présenter aucune progression intracrânienne). En outre, tout symptôme neurologique apparu en raison des métastases cérébrales ou de leur traitement doit avoir disparu ou être stable, sans l’utilisation de corticoïdes, ou être stable sous dose de corticoïdes ≤ 10 mg/jour de prednisone ou de son équivalent et d’anticonvulsivants depuis au moins 14 jours avant le début du traitement. Diverticulite active ou d’apparition récente. Remarque : Les patients ayant une diverticulose connue pourront être recrutés.
    - Antécédents d’immunodéficience primitive active.
    - Infection active, y compris tuberculose (évaluation clinique incluant les antécédents médicaux, un examen clinique et des radiographies, avec test de dépistage de la TB respectant la pratique locale), hépatite B (résultat positif à la recherche d’antigène de surface du VHB [AgHbs]), hépatite C ou infection par le virus de l’immunodéficience humaine (séropositivité aux anticorps anti-VIH 1/2).
    Les patients ayant des antécédents d’infection à VHB résolue (définie comme la présence d’anticorps anti-noyau central du virus de l’hépatite B [anti-HBc] et l’absence d’AgHbs) sont éligibles. Les patients ayant des résultats positifs pour la présence d’anticorps anti-virus de l’hépatite C (VHC) sont éligibles uniquement si l’amplification par PCR ne met pas en évidence d’ARN du VHC.
    - Utilisation en cours ou antérieure d’un médicament immunosuppresseur dans les 14 jours précédant la première dose de durvalumab ou trémélimumab. Les situations suivantes constituent des
    exceptions à ce critère :
    • Corticoïdes par voie intra-nasale, inhalation ou topique, ou injections locales de corticoïdes (par exemple, injection intra-articulaire).
    • Corticoïdes systémiques à doses physiologiques ne dépassant pas 10 mg/jour de prednisone ou son équivalent
    - Présence ou antécédents de pathologies auto-immunes ou inflammatoires documentées
    E.5 End points
    E.5.1Primary end point(s)
    AESI outcome measures will be assessed, in order to further characterize safety objectives related to AESIs.
    EIIP seront évalués, afin de caractériser davantage les objectifs de sécurité liés aux EIIPs
    E.5.1.1Timepoint(s) of evaluation of this end point
    - at each visit (every 4 weeks) + safety-follow up visit (90 days after last dose)
    - À chaque visite ( tous les 4 semaines) + Visite de suivi de la tolérance (90 jours après la dernière dose)
    E.5.2Secondary end point(s)
    SAE: Number and proportion of patients with SAEs in total and by causality and severity AEs leading to death: Number and proportion of patients with AEs leading to death
    AEs leading to treatment interruption or discontinuation: Number and proportion of patients with AEs leading to treatment interruption and/or discontinuation
    Overall Survival: defined as the time from the first date of treatment until death due to any cause. OS (days) = Death date or Censor date – treatment start date + 1. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
    Objective Response Rate (ORR) and Disease Control Rate (DCR): based on investigator assessed response to treatment of CR and PR or CR, PR and SD respectively based on RECIST 1.1.
    EI conduisant à un décès : Nombre et proportion de patients présentant un EI conduisant à un décès
    EI conduisant à une suspension ou un arrêt de traitement : Nombre et proportion de patients présentant un EI
    conduisant à une suspension ou un arrêt de traitement
    Survie globale (SG): définie comme le temps écoulé depuis la première date de traitement jusqu’au décès, de
    quelque cause que ce soit.
    SG (jours) = Date de décès ou Date de censure – date du début du traitement + 1.
    Tout patient non connu pour être décédé au moment de l’analyse sera censuré sur la base de la date de la
    dernière observation stipulant que le patient est vivant.
    Taux de réponse objective (TRO) et taux de contrôle de la maladie (TCM) : sur la base de la réponse au
    traitement évaluée par l’investigateur, de type respectivement RC et RP ou RC, RP et MS reposant sur les
    critères RECIST 1.1
    E.5.2.1Timepoint(s) of evaluation of this end point
    - at each visit (every 4 weeks) + safety-follow up visit (90 days after last dose)
    - survival follow up (every 3 month for up to 5 years)
    - À chaque visite ( tous les 4 semaines) + Visite de suivi de la tolérance (90 jours après la dernière dose)
    - de suivi de la survie (tous les 3 mois pour 5 ans)
    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 Yes
    E.6.13.1Other scope of the trial description
    Biomarker
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA78
    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
    Austria
    Canada
    China
    Denmark
    Finland
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Norway
    Spain
    Sweden
    Switzerland
    United Kingdom
    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
    Last visit (i.e. 3 month phone or email contact follow up contact) of last patient: After safety follow-up visit, patients will be contacted by phone or email every 3 months up to 5 years from date of first patient treatment initiation to check survival status until death, whichever occurs first.
    dernière visite du dernier patient : Les patients seront ensuite contactés par téléphone ou courriel tous les 3 mois pour évaluer la survie, jusqu’à 5 ans après la date de début de traitement du premier patient.
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 720
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 480
    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 state421
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 650
    F.4.2.2In the whole clinical trial 1200
    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)
    If patients are still benefiting from treatment at the time of study closure, they will be provided continued access to treatment, which may include the possibility to transition to requirement long-term extension trial or a named patient supply program. For details please refer to section "Post Study Access to Study Treatment" of the protocol.
    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 Decision2017-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-20
    P. End of Trial
    P.End of Trial StatusOngoing
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