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    Summary
    EudraCT Number:2016-003498-16
    Sponsor's Protocol Code Number:LOXO-TRK-15003
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-16
    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 number2016-003498-16
    A.3Full title of the trial
    A Phase 1/2 Study of the Oral TRK Inhibitor LOXO-101 in Pediatric Patients with Advanced Solid or Primary Central Nervous System Tumors
    STUDIO DI FASE 1/2 SULL¿INIBITORE ORALE DI TRK, LOXO-101, IN PAZIENTI PEDIATRICI AFFETTI DA TUMORI SOLIDI AVANZATI O DA TUMORI PRIMARI DEL SISTEMA NERVOSO CENTRALE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2 Clinical Trial of Pediatric Cancer Patients With Solid Tumors Treated with LOXO-101
    Studio di Fase 1/2 in Pazienti Pediatrici Affetti da Tumori Solidi e Trattati con LOXO-101
    A.3.2Name or abbreviated title of the trial where available
    SCOUT
    SCOUT
    A.4.1Sponsor's protocol code numberLOXO-TRK-15003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02637687
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLOXO ONCOLOGY INCORPORATED
    B.1.3.4CountryUnited States
    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 supportLoxo Oncology Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressLe Rhone Alpes, 235 cours Lafayette
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69006
    B.5.3.4CountryFrance
    B.5.4Telephone number00330437530980
    B.5.5Fax number00330972369787
    B.5.6E-mailregsubmissions@medpace.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/15/1606
    D.3 Description of the IMP
    D.3.1Product namelarotrectinib
    D.3.2Product code LOXO-101
    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.3.9.2Current sponsor codelarotrectinib
    D.3.9.4EV Substance CodeSUB179762
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/15/1606
    D.3 Description of the IMP
    D.3.1Product namelarotrectinib
    D.3.2Product code LOXO-101
    D.3.4Pharmaceutical form Oral solution
    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.3.9.2Current sponsor codelarotrectinib
    D.3.9.4EV Substance CodeSUB179762
    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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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/3/15/1606
    D.3 Description of the IMP
    D.3.1Product namelarotrectinib
    D.3.2Product code LOXO-101
    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.3.9.2Current sponsor codelarotrectinib
    D.3.9.4EV Substance CodeSUB179762
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Central Nervous System Neoplasms and advanced solid tumors
    Neoplasie del Sistema Nervoso Centrale e tumori solidi avanzati
    E.1.1.1Medical condition in easily understood language
    Pediatric Cancer
    Tumori Pediatrici
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level HLT
    E.1.2Classification code 10007960
    E.1.2Term Central nervous system neoplasms malignant NEC
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10049516
    E.1.2Term Malignant tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10007959
    E.1.2Term Central nervous system neoplasm NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10007958
    E.1.2Term Central nervous system 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I:
    To determine the safety of oral larotrectinib (LOXO-101), including Dose-Limiting Toxicity (DLT), in pediatric patients with advanced solid or primary Central Nervous System tumors.
    Phase II:
    To determine the overall response rate (ORR) as determined by an independent radiology review committee and measured by the proportion of subjects with best overall confirmed response of complete response (CR) or partial response (PR) by the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), or
    Response Assessment in Neuro-Oncology (RANO) criteria, as appropriate, following treatment with larotrectinib (LOXO-101) in pediatric subjects with an advanced cancer harboring a fusion involving NTRK1, NTRK2, or NTRK3 (collective referred to as NTRK fusions).
    Fase I:
    Stabilire la sicurezza del trattamento con larotrectinib (LOXO-101) orale, inclusa la tossicit¿ dose-limitante (DLT), nei pazienti pediatrici affetti da tumori solidi avanzati o da tumori primitivi del sistema nervoso centrale (SNC).
    Fase II:
    Determinare l'ORR (tasso di risposta globale) misurato sulla base della percentuale di soggetti che hanno ottenuto la migliore risposta globale confermata di CR (risposta completa) o PR (risposta parziale) rispetto ai Criteri di Valutazione della Risposta nei Tumori Solidi, versione 1.1 (RECIST 1.1), oppure ai Criteri di Valutazione della Risposta in Neuro-Oncologia (RANO), a seconda del caso, dopo trattamento con larotrectinib (LOXO-101) nei pazienti pediatrici affetti da carcinoma avanzato con geni di fusione NTRK1, NTRK2 o NTRK3 (nell¿insieme indicati come geni di fusione del recettore tirosin-chinasico per il fattore di crescita neurotrofico [NTRK]).
    E.2.2Secondary objectives of the trial
    To determine the ORR based on the treating investigator's response assessment using RECIST 1.1 or RANO criteria
    To evaluate the duration of response in subjects with best overall response of CR or PR as determined by 1) an independant radilogy review committee and 2) the treating investigator
    To estimate the proportion of subjects that are in tumor regression as a best response
    To evaluate the duration of PPFS following initiation of larotrectinib (LOXO 101)
    To evaluate the duration of OS following initiation of larotrectinib (LOXO 101)
    ¿ Determinare l¿ORR sulla base della valutazione della risposta a discrezione dello Sperimentatore che ha in cura il paziente applicando i criteri RECIST 1.1 o RANO, a seconda del caso per il tipo di tumore
    ¿ Valutare la DRO (durata della risposta) in soggetti con la migliore risposta globale di CR o PR misurata 1) da un comitato di revisione indipendente del reperto radiologico e 2) dallo Sperimentatore che ha in cura il paziente
    ¿ Calcolare la percentuale di soggetti che evidenziano come migliore risposta una qualunque regressione della neoplasia
    ¿ Stabilire la durata della PFS (sopravvivenza libera da progressione) dopo l¿inizio della terapia con larotrectinib (LOXO-101)
    ¿ Stabilire la durata dell'OS (sopravvivenza globale) dopo l¿inizio della terapia con larotrectinib (LOXO 101)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Phase 1: Birth through 21 years of age at C1D1 with a locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was nonresponsive to available therapies for whIch no standard or available systemic curative therapy exists or
    Infants from birth and older with a diagnosis of malignancy and with a documented NTRK fusion that hAs progressed or was nonresponsive to available therapies for which no standard or systemic curative therapy exists or
    patients with locally advanced or metastatic infantile fibrosarcoma who would require in the opinion of the Investigator disfiguring surgery or limb amputation to achieve a complete surgical resection or
    Phase 2: Birth through 21 years of age at C1D1 with a locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was nonresponsive to available therapies for which no standard or available systemic curative therapy with a documented NTRK gene fusion with the exception of patients with IFS (Infantile FibroSarcoma), CMN (Congenital Mesoblastic Nephroma tumors) or SBC (Secretory Breast Cancer), they may enroll into this cohort with documentation of an ETV6 rearrangement by FISH or RT-PCR or a documented NTRK fusion by NGS (Next Generation Sequencing).Patients with NTRK fusion positive benign tumors are also eligible.
    Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy
    Willingness of male and female patients with reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following study completion. Ability to swallow capsules, liquid or gastric access via a naso- or gastric tube
    1 Fase 1: dalla nascita a 21 anni di età il giorno C1D1 ed essere affetto da tumore solido localmente
    avanzato o metastatico oppure da tumore del SNC recidivato, progredito o non responsivo alle terapie
    disponibili e per il quale non vi è terapia curativa sistemica standard o disponibile, oppure:
    infanti dalla nascita e oltre con diagnosi di tumore e documentata presenza di un gene di fusione NTRK
    che è progredito o non ha risposto alle terapie disponibili e per il quale non vi è terapia curativa
    sistemica standard o disponibile; oppure:
    pazienti con IFS localmente avanzato che, secondo lo Sperimentatore, richiederebbe una chirurgia
    mutilante o l’amputazione di un arto per ottenere una resezione chirurgica completa.
    Fase 2: infanti dalla nascita e oltre¿nel giorno C1D1 ed essere affetto da IFS localmente avanzato o
    metastatico; pazienti affetti da IFS localmente che, secondo lo Sperimentatore, richiederebbe una
    chirurgia mutilante o l’amputazione di un arto per ottenere una resezione chirurgica completa oppure:
    dalla nascita a 21 anni di età il giorno C1D1 ed essere affetto da tumore solido localmente avanzato o
    metastatico oppure tumore primitivo del SNC che è recidivato, progredito o non ha risposto alle terapie
    disponibili e per il quale non vi è terapia curativa sistemica standard o disponibile, con documentata
    presenza di un gene di fusione NTRK (o nel caso di IFS, CMN o SBC con riarrangiamento di ETV6
    documentato alla FISH o RT-PCR o fusione del gene NTRK documentata all’NGS).
    Pazienti
    con i tumori benigni positivi alla fusione NTRK sono anche ammissibili.
    I pazienti devono essere completamente guariti dagli effetti tossici acuti di tutte le precedente chemioterapie antitumorali
    Disponibilità di pazienti uomini e donne con potenziale riproduttivo a osservare il controllo delle nascite convenzionale ed efficace per la durata del trattamento e per 3 mesi dopo il completamento dello studio
    Capacità di ingoiare capsule, accesso liquido o gastrico attraverso un tubo nasale o gastrico
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria are to be excluded from study participation:
    1. Major surgery within 14 days (2 weeks) prior to C1D1.
    2. Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to C1D1; ongoing cardiomyopathy; or current prolonged QTc interval > 480 milliseconds.
    3. Active uncontrolled systemic bacterial, viral, or fungal infection.
    4. Malabsorption syndrome or other condition affecting oral absorption.
    5. Current treatment with a strong CYP3A4 inhibitor or inducer other than those allowed per Section 6.3.2 of the study protocol.
    6. Pregnancy or lactation.
    7. Phase 2 only: Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK, including entrectinib, crizotinib and lestaurtanib. Patients who received a TRK inhibitor for less than 28 days of treatment and discontinued because of intolerance remain eligible.
    studio:
    1. chirurgia maggiore entro 14 giorni (2 settimane) prima del giorno C1D1;
    2. patologia cardiovascolare clinicamente significativa in atto o pregresso infarto miocardico nei 6 mesi precedenti C1D1, cardiomiopatia cronica oppure attuale intervallo QT prolungato, corretto per la frequenza cardiaca (QTc) >480 millisecondi;
    3. infezione batterica, virale, micotica sistemica non controllata in atto;
    4. sindrome da malassorbimento o altra patologia che compromette l’assorbimento orale;
    5. attuale trattamento con un forte inibitore o induttore del citocroma P450 3A4 (CYP3A4 ) diverso da quelli consentiti secondo il capitolo 6.3.2;
    6. gravidanza o allattamento;
    7. solo fase 2: pregressa progressione in corso di terapia con inibitori della tirosinchinasi approvati o sperimentali diretti contro il gene TRK, inclusi entrectinib, crizotinib e lestaurtanib. I pazienti trattati con un inibitore delle chinasi correlate alla tropomiosina (TRK) per meno di 28 giorni e che hanno interrotto la terapia per intolleranza sono comunque eleggibili a partecipare.
    E.5 End points
    E.5.1Primary end point(s)
    (repeat as necessary)
    Phase I: Safety of oral larotrectinib (LOXO-101), including dose-limiting toxicity (DLT) until the Maximum Tolerated Dose or suitable dose based on PK exposure or unacceptable DLT are reached. Pase II: Overall response rate (ORR) as determined by an independent radiology review committee and measured by the proportion of subjects with best overall confirmed response of complete response (CR) or partial response (PR) by the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), or Response Assessment in Neuro-Oncology (RANO) criteria, as appropriate.
    (ripetere quando necessario)
    Fase I: sicurezza di larotrectinib (LOXO-101) per via orale, inclusa la DLT (Dose-Limiting Toxicity [tossicità dose-limitante]) finché non è stata raggiunta la Dose massima tollerata o una dose idonea sulla base dell'esposizione PK (Phamacokinetics [Farmacocinetica]) o una DLT inaccettabile. Fase II: ORR (Overall Response Rate [tasso di risposta globale]) determinato da un comitato di revisione radiologica indipendente sulla base della percentuale di soggetti che hanno ottenuto la migliore risposta globale confermata di CR (Complete Response [risposta completa]) o PR (Partial Response [risposta parziale]) rispetto ai RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, version 1.1 [Criteri di Valutazione della Risposta nei Tumori Solidi, versione 1.1]), oppure ai criteri RANO (Response Assessment in Neuro-Oncology [Valutazione della Risposta in Neuro-Oncologia]), ove appropriato.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every cohort from baseline until disease progression, unacceptable toxicity, patient’s withdrawal of consent, or death
    Ogni coorte dal valore basale fino alla progressione della malattia, tossicità inaccettabile, ritiro del consenso da parte del/la paziente o decesso
    E.5.2Secondary end point(s)
    (Repeat as necessary)
    PK analysis: Plasm and CSF concentrations of larotrectinib (LOXO-101) will be determined with a validtaed bioanalytical assay. Pain and Health related QoL: in patients 3 years age or older pain will be assessed by the Wong-Baker Faces scale.
    (Ripetere quando necessario)
    Analisi PK: le concentrazioni plasmatiche e di LCS di larotrectinib (LOXO-101) saranno determinate con un saggio bioanalitico validato. Dolore e QoL (Quality of Life [Qualit¿ della vita]) correlata alla salute: nei/lle pazienti di almeno 3 anni di et¿, il dolore sar¿ valutato sulla base della scala di Wong-Baker (FACES).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The PK parameters will be calculated from the C1D1 and C2D1 (cohorts 1&2)and C4D1 and every 4 cycles thereafter (cohortes 3 and higher) data. Pain and Health related QoL: Mean changes over time will be analyzed descriptively by time-point.
    I parametri PK saranno calcolati dai dati di C1D1 e C2D1 (coorti 1 e 2) e C4D1, dopodich¿ ogni 4 cicli (coorti 3 e superiori). Dolore e QoL correlata alla salute: variazioni medie nel tempo saranno analizzate in maniera descrittiva per punto temporale.
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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
    NA
    NA
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 EEA13
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Denmark
    France
    Germany
    Italy
    Netherlands
    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 Patient Last Visit
    Ultima visita dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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) 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
    Patients newborn to their legal majority age, with a documented NTRK fusion
    Infants from birth with a diagnosis malignancy and for patients with a locally advanced or metastatic infantile fibrosarcoma
    I/le pazienti da neonati fino alla maggiore et¿ con documentata presenza del gene di fusione NTRK
    Neonati con una diagnosi di tumore e per i/le pazienti con fibrosarcoma infantile localmente avanzato o metastatico
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 84
    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
    Nessuno
    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 Decision2017-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-23
    P. End of Trial
    P.End of Trial StatusOngoing
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