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    Summary
    EudraCT Number:2013-003579-36
    Sponsor's Protocol Code Number:BAY73-4506/15906
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-19
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-003579-36
    A.3Full title of the trial
    A multi-center, open-label, non-randomized, phase I dose escalation study of
    regorafenib (BAY 73-4506) in pediatric subjects with solid malignant tumors that are recurrent or refractory to standard therapy.
    Studio multicentrico, in aperto, non-randomizzato, di Fase I, su regorafenib (BAY 73-4506) in soggetti pediatrici affetti da tumori maligni solidi ricorrenti o refrattari alla terapia standard
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, tolerability and pharmacokinetics of regorafenib in pediatric subjects.
    Sicurezza, tollerabilità e farmacocinetica di regorafenib in soggetti pediatrici
    A.4.1Sponsor's protocol code numberBAY73-4506/15906
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/258/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCPT Team / Ref: "EU CTR" Bayer Pharma AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 nameRegorafenib 20 mg coated tablet
    D.3.2Product code BAY 73-4506 TABL 20MG 122 COAT
    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 INNRegorafenib
    D.3.9.1CAS number 755037-03-7
    D.3.9.2Current sponsor codeBAY 73-4506
    D.3.9.3Other descriptive nameREGORAFENIB
    D.3.9.4EV Substance CodeSUB73090
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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
    Pediatric patients with solid malignant tumors that are recurrent or refractory to standard therapy.
    Tumori maligni solidi ricorrenti o refrattari alla terapia standard
    E.1.1.1Medical condition in easily understood language
    Pediatric patients with cancer.
    Tumori maligni in pediatria
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To define the safety profile, maximum tolerated dose (MTD) and
    recommended phase II dose (RP2D) of regorafenib administered orally as a single agent in a 3-weeks-on / 1- week-off schedule in repeating cycles of 28 days in pediatric subjects with solid malignant tumors recurrent or refractory to standard therapy.
    - To characterize the pharmacokinetics (PK) of regorafenib.
    Definire il profilo di sicurezza, la dose massima tollerata (MTD) e la dose raccomandata di Fase II (RP2D) di regorafenib somministrato per via orale in monoterapia secondo uno schema di trattamento per 3 settimane con 1 settimana di sospensione a cicli ripetuti di 28 giorni in soggetti pediatrici affetti da tumori maligni solidi ricorrenti o refrattari alla terapia standard • Caratterizzare la farmacocinetica (PK) di regorafenib
    E.2.2Secondary objectives of the trial
    - To evaluate preliminarily anti-tumor activity of regorafenib
    - To evaluate pharmacodynamic parameters of regorafenib
    - Acceptability and palatability of the formulations - tablets and granulates (when available per amendment)
    Valutare preliminarmente l’attività antitumorale di regorafenib • Valutare i parametri farmacodinamici di regorafenib • L’accettabilità e la palatabilità delle formulazioni in compresse e granulato (se disponibili per emendamento)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed Informed Consent Form by subjects and/or subjects’ parents/legal guardians and age appropriate Assent Form by the subjects obtained before any study specific procedure
    - Age: from 5 years to less than 18 years old
    - Pediatric subjects who are able to swallow tablets
    - Diagnosis: subjects must have had histologic verification of solid malignancy at original diagnosis. Subjects with recurrent or refractory solid tumors are eligible, including primary CNS tumors or subjects with known CNS metastases
    - Subject’s current disease state must be one for which there is no known effective therapy or therapy proven to prolong survival with an acceptable quality of life. Effective therapy may include surgery, radiation therapy, chemotherapy or any combination of these modalities.
    - Sexually active females of childbearing potential and sexually active males must agree to use adequate contraception before entering the program until at least 8 weeks after the last study drug administration. Abstinence is considered an adequate contraception method. For sexually active females, 2 forms of highly effective contraception are mandatory. The investigator or a designated associate is requested to advise the subject on how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically
    recommended method (or combination of methods) as per standard of care.
    - Female subjects of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of study treatment, and a negative result must be documented before start of study treatment.
    - Subjects must have at least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. For neuroblastoma subjects with osteomedullary disease, the SIOPEN (International Society of Pediatric Oncology Europe Neuroblastoma Group) score will be used.
    - Life expectancy of at least 12 weeks from the time of signing informed
    consent/assent
    - Performance level: Karnofsky ≥ 70% for subjects > 10 years of age and Lansky ≥ 70% for subjects ≤ 10 years of age, except children with motor paresis due to disease. Neurological deficits in subjects must have been stable for a minimum of 1 week prior to first dose of study treatment.
    - Subjects with brain tumors or brain metastases must be on stable dose of corticosteroids for at least 1 week prior to first dose of study treatment.
    - Adequate hematological function assessed by the following laboratory
    requirements conducted within 7 days before starting study treatment:
    o Peripheral absolute neutrophil count (ANC): ≥ 1.0 x 10 9/L
    o Platelet count : ≥ 100 x 109/L (transfusion independent)
    o Hemoglobin : ≥ 8.0 g/ dL
    - Adequate renal function defined as creatinine clearance based on Schwartz Estimate ≥ 70 ml/min/1.73 m2 (1)
    - International normalized ratio (INR) ≤ 1.5 x upper limit of normal (ULN) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
    - Lipase ≤ 1.5 x ULN
    - Adequate hepatic function defined as:
    o Aspartate aminotransferase/alanine aminotransferase (AST/ALT)
    ≤3.0 x ULN
    o Bilirubin (sum of conjugated and unconjugated) ≤ 1.5 ULN
    o Alkaline phosphatase limit ≤ 2.5 x ULN for age (≤ 5 x ULN for
    subjects with bone tumors)
    • Modulo di Consenso Informato firmato dai soggetti e/o dai genitori/tutori legali dei soggetti e Modulo di Assenso adatto all’età da parte dei soggetti, rilasciato prima di qualsiasi procedura specifica dello studio • Età compresa fra 5 anni e meno di 18 anni • Soggetti pediatrici che siano in grado di inghiottire le compresse • Diagnosi: i soggetti devono aver avuto una verifica istologica di tumore maligno solido alla diagnosi iniziale. I soggetti con tumori solidi ricorrenti o refrattari sono eleggibili compresi i tumori primari a carico del SNC o soggetti con note metastasi al SNC • Lo stato attuale di malattia del soggetto deve essere tale per cui non esista una terapia efficace nota o una terapia che sia stata dimostrata in grado di prolungare la sopravvivenza con una qualità della vita accettabile. Una terapia efficace può comprendere un intervento chirurgico, la radioterapia, la chemioterapia o un insieme di queste modalità. • Le femmine sessualmente attive in età fertile ed i maschi sessualmente attivi devono accettare di utilizzare una contraccezione adeguata prima di entrare nel programma fino ad almeno 8 settimane dopo l’ultima somministrazione del farmaco in studio. L’astinenza è considerata un metodo di contraccezione adeguata. Per femmine sessualmente attive, sono indispensabili 2 forme di contraccezione altamente efficaci. Allo sperimentatore o ad un assistente incaricato viene chiesto di consigliare il soggetto sul modo in cui sia possibile ottenere un adeguato controllo delle nascite. Una contraccezione adeguata è definita nello studio come qualsiasi metodo raccomandato dal punto di vista medico (o un insieme di metodi) come da trattamento standard.. • I soggetti di sesso femminile in età fertile devono sottoporsi ad un test di gravidanza eseguito al massimo 7 giorni prima dell’inizio del trattamento dello studio e un risultato negativo deve essere documentato prima dell’inizio del trattamento dello studio. • I soggetti devono avere almeno una lesione misurabile o valutabile secondo i criteri RECIST (Response Evaluation Criteria in Solid Tumors), versione 1.1. Per i soggetti affetti da neuroblastoma con malattia osteomidollare, verrà utilizzato il punteggio del SIOPEN (International Society of Pediatric Oncology Europe Neuroblastoma Group). • Aspettativa di vita di almeno 12 settimane dal momento della firma del consenso/assenso informato • Livello di performance: Karnofsky >70% per soggetti > 10 anni e Lansky >70% per soggetti <10 anni, tranne i bambini con paresi motoria dovuta alla malattia. I deficit neurologici nei soggetti devono essere rimasti stabili per un minimo di 1 settimana prima della prima dose del trattamento dello studio. • I soggetti con tumori cerebrali o metastasi al cervello devono ricevere una dose stabile di corticosteroidi per almeno 1 settimana prima della prima dose del trattamento dello studio. • Adeguata funzione ematologica valutata mediante i seguenti requisiti di laboratorio eseguiti entro 7 giorni prima dell’inizio del trattamento dello studio: o Conta assoluta dei neutrofili periferici (ANC): >1,0 x 10 9/L o Conta piastrinica : >100 x 109/L (indipendente dalla trasfusione) o Emoglobina : >8,0 g/ dL • Adeguata funzione renale definita come clearance della creatinina in base alla “Schwartz Estimate” (Stima di Schwartz) >70 ml/min/1.73 m2 (1) • “International Normalized Ratio” (INR) (Rapporto Internazionale Normalizzato) < 1,5 volte il limite superiore della norma (ULN) e tempo di tromboplastina parziale (PTT) o tempo di tromboplastina parziale attivata (aPTT) <1,5 volte il limite superiore della norma (ULN) • Lipasi <1,5 volte l’ULN • Adeguata funzione epatica definita come: o Aspartato-aminotransferasi/alanin-aminotransferasi (AST/ALT) <3,0 volte l’ULN o Bilirubina (somma di bilirubina coniugata e non-coniugata) <1,5 volte l’ULN • Limite della fosfatasi alcalina < 2,5 volte l’ULN per l’età (<5 volte l’ULN per soggetti affetti da tumori ossei)
    E.4Principal exclusion criteria
    - Prior treatment with regorafenib. Subjects permanently withdrawn from study participation will not be allowed to re-enter the study.
    - Active or uncontrolled infection (> National Cancer Institute Common
    Terminology Criteria for Adverse Events [NCI-CTCAE] Grade 2 at screening).
    - Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy
    - Known history of human immunodeficiency virus (HIV) infection
    - Major surgical procedure or significant traumatic injury within 28 days before start of study medication. Bone marrow biopsy and central lines will not be considered as a major surgical procedure.
    - Non-healing wound, ulcer, or bone fracture
    - Seizure disorder requiring medication with: carbamazepine, phenobarbital, phenytoin, ethosuximide, valproic acid, tiagabine, felbamate, tiagabine, zomisamide and lamotrigine. Subjects with history of seizures controlled with levetiracetam or gabapentin and subjects with brain tumors receiving prophylactic levetiracetam or gabapentin are allowed to enter the study.
    - Subjects with uncontrolled baseline hypertension higher than Grade 1 NCICTCAE v.4.0 (recurrent or persistent [≥24 hours] blood pressure [BP] >ULN: BP > the 95th percentile for age, height, and gender measured as described in Appendix 14.5). Additional information about hypertension is provided in Appendix 14.6.
    - Clinically significant bleeding (NCI-CTCAE v. 4.0 Grade 3 or higher) within 30 days before start of study medication
    - Arterial or venous thrombotic or embolic events such as deep vein thrombosis or pulmonary embolism within 6 months before start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than 1 month before the start of study medication)
    - Subjects with evidence or history of disorders of coagulation or thrombosis
    - Cardiac abnormalities such as congestive heart failure (Modified Ross Heart Failure Classification for Children ≥ class 2) and cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
    - History of organ allograft (including allogeneic bone marrow transplant)
    - Unresolved toxicity higher than NCI-CTCAE v. 4.0 Grade 1 attributed to any prior therapy/procedure (excluding alopecia, chemotherapy-induced ototoxicity, Grade 2 chemotherapy-induced neuropathy and, as per above eligibility criteria, anemia with hemoglobin ≥ 8 mg/dL and ANC ≥ 1.0 x 10 9/L )
    - Pleural effusion or ascites that causes respiratory compromise (NCI-CTCAE v. 4.0 Grade 2 dyspnea)
    - Known hypersensitivity to any of the study drugs, study drug classes, or
    excipients in the formulation
    - Pregnancy or breast feeding
    - Significant gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn’s disease or any malabsorption condition
    - Interstitial lung disease with ongoing signs and symptoms at the time of screening
    - Any other serious or unstable illness, or medical, psychological or social
    condition, that could jeopardize the safety of the subject and/or his/her
    compliance with study procedures, or may interfere with the subject’s
    participation in the study or evaluation of the study results
    - Close affiliation with the investigational site, e.g. a close relative of the
    investigator or a dependent person (e.g. employee or student of the
    investigational site)
    • Precedente trattamento con regorafenib. Ai soggetti ritirati definitivamente dalla partecipazione allo studio non sarà consentito rientrare nello studio. • Infezione in atto o non controllata (> grado 2 allo screening secondo i National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE]) • Epatite B o C in atto o epatite B o C cronica che richieda un trattamento con una terapia antivirale • Nota anamnesi di infezione da parte del virus dell’immunodeficienza umana (HIV) • Intervento di chirurgia maggiore o significativa lesione traumatica entro 28 giorni prima dell’inizio dell’assunzione del farmaco in studio. Una biopsia del midollo osseo e l’inserimento di linee venose centrali non saranno considerate un intervento di grande chirurgia. • Ferita che non guarisca, ulcera o frattura ossea. • Disturbo convulsivo che richieda un trattamento con: carbamazepina, fenobarbitale, fenitoina, etosuccimide, acido valproico, tiagabina, felbamato, tiagabina zomisamide e lamotrigina. Ai soggetti con anamnesi di convulsioni controllate con levetiracetam o gabapentin e soggetti affetti da tumori cerebrali che ricevano levetiracetam o gabapentin come profilassi è consentito di entrare nello studio. • I soggetti affetti da ipertensione non controllata al basale superiore al Grado 1 del NCI-CTCAE v.4.0 (pressione arteriosa ricorrente o persistente [>24 ore] [BP] >ULN: BP > al 95° percentile per l’età, l’altezza ed il sesso misurata come descritto nell’Appendice). Ulteriori informazioni sull’ipertensione sono fornite nell’Appendice. • Emorragia clinicamente significativa (NCI-CTCAE v. 4.0 di Grado 3 o superiore) entro 30 giorni prima dell’inizio del farmaco in studio • Eventi trombotici od embolici arteriosi o venosi come trombosi venosa profonda od embolia polmonare entro 6 mesi prima dell’inizio del farmaco in studio (ad eccezione della trombosi venosa correlata al catetere adeguatamente trattata che si sia verificata più di un mese prima dell’inizio del farmaco in studio) • Soggetti con evidenza od anamnesi di disturbi della coagulazione o trombosi • Anormalità cardiache, come l’insufficienza cardiaca congestizia (Classificazione dell’Insufficienza Cardiaca di Ross modificata per bambini di classe > 2) e le aritmie cardiache che richiedano una terapia anti-aritmica (sono permessi i beta-bloccanti o la digossina) • Anamnesi di eterotrapianto d’organo (compreso il trapianto di midollo osseo eterologo) • Tossicità irrisolta superiore a NCI-CTCAE v. 4.0 di Grado 1 attribuita ad una terapia o ad un procedimento precedente (escludendo l’alopecia, l’oto-tossicità indotta dalla chemioterapia. la neuropatia di Grado 2 indotta dalla chemioterapia e, come per i criteri di eleggibilità suddetti, l’anemia con valori di emoglobina >8 mg/dL e ANC >1.0 x 10 9/L ) • Versamento pleurico od ascite che causi una compromissione respiratoria (NCI-CTCAE v. 4.0 dispnea di Grado 2) • Nota ipersensibilità ad uno dei farmaci in studio, a classi di farmaci in studio o ad eccipienti nella formulazione • Gravidanza o allattamento al seno • Significativi disturbi gastrointestinali con diarrea come sintomo principale ad esempio morbo di Crohn od un’eventuale malattia da malassorbimento • Pneumopatia interstiziale con segni e sintomi in corso al momento dello screening • Qualsiasi altra malattia seria o instabile od affezione medica, psicologica o sociale che possa mettere in pericolo la sicurezza del soggetto e/o la sua conformità con i procedimenti dello studio o che possa interferire con la partecipazione del soggetto allo studio o con la valutazione dei risultati dello studio • Affiliazione con la sede della sperimentazione, ad esempio un parente stretto dello sperimentatore o un dipendente (ad esempio dipendente o studente della sede della sperimentazione) Terapia precedente vietata • Altro trattamento antitumorale, comprendente eventuali nuovi farmaci in sperimentazione entro 28 giorni o 5 emivite del farmaco (se si conosce l’emivita del farmaco nei soggetti), quale delle due sia più breve (oppure entro 6 settimane per la mitomicina C), prima dell’inizio del trattamento dello studio • Fattori di crescita emopoietici: entro gli ultimi 21 giorni prima dell’inizio del trattamento dello studio • Radioterapia: <4 settimane prima dell’inizio del trattamento dello studio (< 2 settimane se la radioterapia è a campo limitato); devono essere passati >6 mesi >50% di radiazione sul bacino. • Trapianto di cellule staminali autologhe
    E.5 End points
    E.5.1Primary end point(s)
    - To define the safety profile, maximum tolerated dose (MTD) and
    recommended phase II dose (RP2D) of regorafenib administered orally as a single agent in a 3-weeks-on / 1- week-off schedule in repeating cycles of 28 days in pediatric subjects with solid malignant tumors recurrent or refractory to standard therapy
    - To characterize the pharmacokinetics (PK) of regorafenib
    • Definire il profilo di sicurezza, la dose massima tollerata (MTD) e la dose raccomandata di Fase II (RP2D) di regorafenib somministrato per via orale in monoterapia secondo uno schema di trattamento per 3 settimane con 1 settimana di sospensione a cicli ripetuti di 28 giorni in soggetti pediatrici affetti da tumori maligni solidi ricorrenti o refrattari alla terapia standard • Caratterizzare la farmacocinetica (PK) di regorafenib
    E.5.1.1Timepoint(s) of evaluation of this end point
    During cycle 1.
    durante ciclo 1
    E.5.2Secondary end point(s)
    - To evaluate preliminarily anti-tumor activity of regorafenib
    - To evaluate pharmacodynamic parameters of regorafenib
    - Acceptability and palatability of the formulations - tablets and granulates (when available per amendment)
    • Valutare preliminarmente l’attività antitumorale di regorafenib • Valutare i parametri farmacodinamici di regorafenib • L’accettabilità e la palatabilità delle formulazioni in compresse e granulato (se disponibili per emendamento)
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Tumor evaluation is conducted every 8 weeks.
    - Pharmacodynamic parameters evaluated during screening phase and end of treatment.
    -Taste and texture questionnaire is collected during cycle 1.
    Valutazione del tumore ogni 8 settimane Valutazione parametri farmacodinamici durante la fase di screening e alla fine del Trattamento Questionario “taste and texture” raccolto durante il ciclo 1
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    tollerabilià
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I dose escalation in pediatric subjects
    E.7.2Therapeutic exploratory (Phase II) No
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 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 subject last visit.
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 50
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 5
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 35
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Consent obtained from subject's parents/legal guardians, if the subject is unable to give consent personally. Age appropriate assent form obtained from the subjects.
    il consenso verrà fornito dal genitore/tutore legale del minore se necessario
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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.
    NA
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation ITCC
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-25
    P. End of Trial
    P.End of Trial StatusCompleted
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