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    Summary
    EudraCT Number:2012-004628-39
    Sponsor's Protocol Code Number:D5160C00001
    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:2014-04-01
    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 number2012-004628-39
    A.3Full title of the trial
    A Phase I/II, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Ascending Doses of AZD9291 in Patients with Advanced Non Small Cell Lung Cancer who have Progressed Following Prior Therapy with an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent (AURA)
    Studio di fase I/II, in Aperto, Multicentrico per valutare Sicurezza,Tollerabilità, Farmacocinetica e Attività Antitumorale di Dosi Ascendenti di AZD9291 in Pazienti con Tumore Polmonare Non a Piccole Cellule Avanzato o Metastatico la cui Malattia è Progredita a seguito di una Precedente Terapia con un Inibitore Tirosinchinasico del Recettore del Fattore di Crescita (AURA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To investigate the safety and tolerability of AZD9291 when given orally to patients with non small cell lung cancer. These patients will be chosen from those who have already been prescribed an EGFR TKI medicine (such as Iressa
    or Tarceva).
    Studiare la sicurezza e tollerabilità di AZD9291 somministrato per via orale in pazienti con Tumore Polmonare Non a Piccole Cellule. I pazienti saranno scelti fra coloro che hanno già effettuato trattamento con EGRf TKI (ad esempio come Iressa o Tarceva)
    A.3.2Name or abbreviated title of the trial where available
    AURA
    AURA
    A.4.1Sponsor's protocol code numberD5160C00001
    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 pointInformation Center
    B.5.3 Address:
    B.5.3.2Town/ city"
    B.5.3.3Post code"
    B.5.6E-mailinformation.centre@astrazeneca.com
    B.Sponsor: 2
    B.1.1Name of SponsorAstraZeneca
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameAZD9291 20mg
    D.3.2Product code AZD9291
    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 INNNot yet assigned
    D.3.9.1CAS number Not assigned
    D.3.9.2Current sponsor codeAZD9291 mesylate
    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.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 nameAZD9291 40mg
    D.3.2Product code AZD9291
    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 INNNot yet assigned
    D.3.9.1CAS number Not assigned
    D.3.9.2Current sponsor codeAZD9291 mesylate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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 nameAZD9291 40 film-coated tablet
    D.3.2Product code AZD9291
    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 INNNot yet assigned
    D.3.9.1CAS number 1421373-66-1
    D.3.9.2Current sponsor codeAZD9291 mesylate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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: 4
    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 nameAZD9291 80 film-coated tablet
    D.3.2Product code AZD9291
    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 INNNot yet assigned
    D.3.9.1CAS number 1421373-66-1
    D.3.9.2Current sponsor codeAZD9291 mesylate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    Non-Small Cell Lung Cancer
    Carcinoma polmonare non a piccole cellule
    E.1.1.1Medical condition in easily understood language
    Non Small Cell Lung Cancer (NSCLC)
    tumore al polmone
    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 PT
    E.1.2Classification code 10029515
    E.1.2Term Non-small cell lung cancer recurrent
    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 investigate the safety, tolerability and efficacy (Objective Response Rate) of AZD9291 when given orally to patients with locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) who have progressed following prior therapy with an Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) agent.
    Valutare la sicurezza, la tollerabilità e l’efficacia (ORR tasso di risposta oggettiva) di AZD9291 quando somministrato per via orale in pazienti con tumore localmente avanzato o metastatico polmonare non a piccole cellule (NSCLC) la cui malattia è progredita a seguito di una precedente terapia con un Inibitore Tirosinchinasico del Recettore del Fattore di Crescita dell’Epidermide (EGFR TKI).
    E.2.2Secondary objectives of the trial
    Define maximum tolerated dose (MTD), a dose/exposure to result in biological activity (incl but not limited to RECIST, tumour & blood borne biomarkers) or max feasible dose
    Investigate safety & tolerability of oral AZD9291 - 1st line therapy to patients (treatment-naive) - locally advanced or metastatic EGFRm+ve NSCLC.
    Characterise PK of AZD9291 & metabolites (AZ5104, AZ7550) - single oral dose, steady state multiple doses.
    Escalation &expansion cohorts: Obtain assessment anti-tumour activity of AZD9291 by evaluation of DoR & PFS by Response Evaluation Criteria in Solid Tumours (RECIST)
    Extension cohort: Additional assessments of anti tumour activity of AZD9291 by evaluation :duration of response, disease control rate, tumour shrinkage, PFS using Response Evaluation Criteria in Solid Tumours (RECIST) assessed by independent central review of radiological information & overall survival.
    Assess relationship of PK & selected efficacy, pharmacodynamic and/or safety endpoints.

    Definire massima dose tollerata (MTD), se possibile, dose/esposizione prevista dal risultato dell’attività biologica o massima dose possibile.Valutare sicurezza e tollerabilità di AZD9291 somministrato per OS come terapia di prima linea in paz naive al tratt per il tumore polmonare EGFRm+ve NSCLC local avanzato o metast. PK di AZD9291 e dei suoi metaboliti (AZ5104 e AZ7550) dopo singola dose per OS e allo stato stazionario dopo dosi multiple.Per le coorti di escalation ed espansione: valutazione preliminare attività antitumorale di AZD9291 dalla valutazione della durata della risposta (DoR) e dalla sopravvivenza libera da progr secondo RECIST 1.1.
    Per la coorte di estensione: valutazioni supplementari dell’attività antitumorale di AZD9291 dalla valutazione della durata della risposta, tasso di controllo della malattia, riduzione del tumore, sopravvivenza libera da progr secondo criteri RECIST 1.1 Valutare la relazione tra PK e endpoints di efficacia, farmacodinamica e/o sicurezza.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses - Aged at least 18 years. Patients from Japan aged at least 20 years. - Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer (NSCLC). -Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI e.g. gefitinib or erlotinib (with the exception of 1st line expansion cohort). In addition other lines of therapy may have been given. - Previous treatment with a single-agent EGFR TKI (e.g. gefitinib or erlotinib). - Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing or evidence of non-child bearing potential. - Male patients should be willing to use barrier contraception. - For 1st Line expansion cohort ONLY, confirmation that the tumour is EGFRm+ve and have had no prior therapy for their advanced disease.
    • Consenso informato datato e firmato prima di qualunque procedura specifica dello studio, campionamento e analisi.
    • Maschi e Femmine, di almeno 18 anni. Pazienti giapponesi di almeno 20 anni.
    • Diagnosi istologica e citologica confermata di NSCLC (Tumore Polmonare Non a Piccole Cellule).
    • Documentazione radiologica della progressione della malattia durante precedente trattamento continuo con EGFR TKI come gefitinib o erlotinib (con l’eccezione dei pazienti di prima linea della coorte di espansione). In aggiunta altre linee di trattamento possono essere state seguite.
    • Precedente trattamento con terapia singola con un EGFR TKI (es. gefitinib or erlotinib).
    • Soggetti di sesso femminile devono utilizzare adeguate misure contraccettive, non devono allattare e il test di gravidanza deve essere negativo prima dell'inizio del trattamento se la donna è in età fertile o deve dimostrare di non essere in età fertile.
    • Soggetti di sesso maschile devono essere disposti a usare contraccettivi, preservativi.
    • SOLO per i pazienti di prima linea nella coorte di espansione: conferma che il tumore è EGFRm+ve e non ha eseguito alcuna terapia precedente per la malattia avanzata (per pazienti di prima linea la biopsia sarà al momento della diagnosi della progressione della malattia)
    • Per i pazienti nella coorte di espansione ed estensione: i pazienti devono avere conferma dello stato della mutazione T790M (positiva o negativa) grazie a un campione di biopsia prelevato dopo la conferma della progressione della malattia con il più recente regime di trattamento (indipendentemente dal fatto che si tratti di EGFR-TKI o chemioterapia).
    E.4Principal exclusion criteria
    Treatment with an EGFR TKI (erlotinib or gefitinib) within 8 days (approximately 5x half-life) of the first dose of study treatment.
    - Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
    - AZD9291 in the present study (ie, dosing with AZD9291 previously initiated in this study).
    - Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection.
    - Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
    • Trattamento con un EGFR-TKI (erlotinib, gefitinib) entro 8 giorni (circa 5x emivite) dalla prima dose del trattamento in studio.
    • Qualsiasi chemioterapia citotossica, farmaci sperimentali o altri farmaci antitumorali di un precedente regime di trattamento o studio clinico entro 14 giorni dalla prima dose del trattamento in studio.
    • Precedente trattamento con AZD9291)
    • Qualsiasi evidenza di malattie sistemiche gravi e incontrollate, inclusa ipertensione non controllata e diatesi emorragica attiva.
    • Precedente storia medica di malattia polmonare interstiziale, malattia polmonare interstiziale indotta da farmaci, polmonite da radiazioni che ha richiesto trattamento con steroidi, o qualsiasi evidenza di malattia polmonare interstiziale clinicamente attiva.
    E.5 End points
    E.5.1Primary end point(s)
    Safety, tolerability and efficacy (ORR) of AZD9291, as assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram and ophthalmic examinations and RECIST1.1
    Sicurezza, tollerabilità ed efficacia (ORR) di AZD9291, valutato come numero e severità degli eventi avversi registrati nelle CRF, segni vitali, variabili di laboratorio, esame fisico, ECG, esami oftalmici e RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    -Adverse events will be collected from baseline until 28 days after the last dose, expected average 6 months
    ORR 6 weekly until progression
    Gli eventi avversi saranno raccolti dal baseline fino a 28 giorni dopo l’ ultima dose, media attesa 6 mesi.
    ORR ogni 6 settimane fino a progressione.
    E.5.2Secondary end point(s)
    -Plasma concentrations of AZD9291 & 2 active metabolites (AZ5104, AZ7550) & pharmacokinetic parameters following single dose (Cmax, tmax, AUC, terminal rate constant, clearance, half life, volume of distribution & mean resistance time)
    -Plasma concentrations of AZD9291 & 2 active metabolites (AZ5104,AZ7550) and pharmacokinetic parameters following dosing with AZD9291 (Cmax, tmax, AUC, terminal rate constant, clearance, half life, volume of distribution and mean resistance time)
    -Plasma concentrations of AZD9291 & 2 active metabolites (AZ5104, AZ7550) and pharmacokinetic parameters following multiple doses (steady state Cmax, tmax, Cmin AUC, clearance, accumulation ratio and time dependency)
    -Pharmacodynamic markers to assess correlations with disease activity, effects of study drug & clinical outcomes
    -Pharmacodynamic markers to assess correlations with disease activity, effects of study drug & clinical outcomes
    -Evaluation of tumour response, duration of response, tumour shrinkage, progression free survival and overall survival as assessed by RECIST 1.1
    -Pharmacodynamic markers in EGFRm+ T790M+ tumours at selective endpoints
    -Patient reported outcomes: EORTC QLQ C-30 and QLQ-LC13
    -Pharmacogenetics
    • Concentrazione plasmatica di AZD9291 e dei 2 metaboliti attivi (AZ5104, AZ7550) e parametri farmacocinetici dopo la dose singola (Cmax, tmax, AUC, terminal rate constant, clearance, half life, volume of distribution & mean resistance time)
    • Concentrazione plasmatica di AZD9291 e dei 2 metaboliti attivi (AZ5104, AZ7550) e parametri farmacocinetici dopo la somministrazione di AZD9291 (Cmax, tmax, AUC, terminal rate constant, clearance, half life, volume of distribution and mean resistance time)
    • Concentrazione plasmatica di AZD9291 e dei 2 metaboliti attivi (AZ5104, AZ7550) e parametri farmacocinetici dopo dosi multipli (steady state Cmax, tmax, Cmin AUC, clearance, accumulation ratio and time dependency)
    • Marcatori farmacodinamici per valutare la correlazione con l’ attività della malattia, effetti del farmaco e outcome clinici
    • Valutazione della rispsota al tumore, durata della risposta, riduzione del tumore, PFS e OS come indicato dai RECIST 1.1
    • Marcatori farmacodinamici in tumori EGFRm+ T790M+ a endpoint selettivi
    • PRO: EORTC QLQ C-30 and QLQ-LC13
    • Farmacogenetica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Single dose PK day 1, PK & metabolites Cycle 1 day 15
    Multiple dose PK & metabolites Cycle 1 (pre-dose day 1,8 & 15) Cycle 2 (pre-dose & 1,1.5,2,4,6,8,10,12,24 hours post dose).
    Pharmacodynamics
    -optional tumour biopsy - screening, day 15, discontinuation
    -plasma for circulating free tumour DNA - screening day 1 (dosing), 6 weekly, discontinuation, 28 days after last dose & disease progression or withdrawal from study
    Pharmacodynamic markers - optional tumour biopsy screening, Cycle 1 Day 15 (Paired biopsy)
    PRO Expansion & Extension screening, Cycle 1 Day 1, every 6 weeks relative to first dose, discontinuation & progression
    Pharmacogenetic optional no greater than 28 days before first dose
    •dose singola PK giorno 1, PK e metaboliti ciclo 1 e 15•dosi multiple PK e metaboliti ciclo 1 (pre-dose giorno 1, 8 e 15) ciclo 2 (pre-dose e 1, 1.5, 2, 4, 6, 8, 10, 12, 24 ore dopo la sommnistrazione)•Farmacodinamica
    obiopsia tumorale opzionale – screening, giorno 15, discontinuazione
    oplasma per DNA tumorale liberamente circolante – screening giorno 1 (dosaggio), ogni 6 settimane, discontinuazione, 28 gg dopo l’ ultima dose e a progressione di malattia o all’ uscita dallo studio
    •Marcatori farmacodinamici – biopsia tumorale opzionale allo screening, ciclo 1 giorno 15
    •PRO espansione ed estensione allo screening, ciclo 1 giorno 1, ogni 6 settimane dalla prima dose, discontinuazione e progressione.
    •Farmacogenetica opzionale non più di 28 giorni prima della prima dose
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    therapeutic exploratory in addition to safety and tolerability
    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 Yes
    E.8.1.7.1Other trial design description
    Stratification factors applied to Expansion & Extension Cohorts of the study
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    France
    Italy
    Japan
    Australia
    Germany
    Korea, Republic of
    Spain
    Taiwan
    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 subject, Last visit.
    LVLS
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 175
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 79
    F.4.2.2In the whole clinical trial 375
    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)
    Standard of care
    Standard of care
    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 Decision2014-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-16
    P. End of Trial
    P.End of Trial StatusCompleted
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