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    EudraCT Number:2012-004322-24
    Sponsor's Protocol Code Number:ARN-509-003
    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:2013-07-26
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-004322-24
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer
    Studio di Fase III, multicentrico, randomizzato, in doppio cieco, controllato con placebo su ARN-509 in uomini con carcinoma prostatico resistente a castrazione, non metastatico (M0)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical study to assess the safety and effectiveness of ARN-509 in men with Castration-Resistant Prostate Cancer (prostate cancer not responsive to castration treatment)
    Studio Clinico per valutare la sicurezza e l'efficacia di ARN-509 in uomini con carcinoma prostatico resistente (cancro alla prostata non responsivo al trattamento di castrazione)
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberARN-509-003
    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 SponsorAragon Pharmaceuticals, Inc
    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 supportAragon Pharmaceuticals Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAragon Pharmaceuticals, Inc
    B.5.2Functional name of contact pointVP, Clinical Development
    B.5.3 Address:
    B.5.3.1Street Address12780 El Camino Real, Suite 301
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92130
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1858369 7627
    B.5.5Fax number+1858639 7662
    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.3.2Product code ARN-509
    D.3.4Pharmaceutical form Capsule, soft
    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 INNARN-509
    D.3.9.1CAS number 956104-40-8
    D.3.9.2Current sponsor codeARN-509
    D.3.9.3Other descriptive nameARN-509
    D.3.9.4EV Substance CodeSUB96228
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Castration-Resistant Prostate Cancer
    Carcinoma prostatico resistente a castrazione
    E.1.1.1Medical condition in easily understood language
    Prostate cancer with rapidly rising PSA not responsive to hormonal treatment.
    Carcinoma prostatico con rapido aumento del PSA non responsivo a trattamento ormonale
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    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 demonstrate superiority in the metastasis-free survival (MFS) of men with high risk NM-CRPC treated with ARN-509 versus placebo
    Dimostrare la superiorità nella sopravvivenza senza metastasi (metastasis-free survival, MFS) di uomini con NM-CRPC ad alto rischio trattati con ARN-509 rispetto al placebo.
    E.2.2Secondary objectives of the trial
    To compare the overall survival (OS) of men with high risk NM-CRPC treated with ARN-509 versus placebo and:
    -To compare the time to symptomatic progression in men with high risk NM-CRPC treated with ARN-509 versus placebo
    -To compare the time to initiation of cytotoxic chemotherapy in men with high risk NM-CRPC treated with ARN-509 versus placebo
    -To compare the radiographic progression-free survival (PFS) of men with high risk NM-CRPC treated with ARN-509 versus placebo
    -To compare the time to metastasis (TTM) in men with high risk NM-CRPC treated with ARN-509 versus placebo
    -To compare patient reported outcomes (PROs) of health-related quality of life and prostate cancer-specific symptoms in men with high risk NM-CRPC treated with ARN-509 versus placebo
    -To evaluate the safety and tolerability of ARN-509
    -To evaluate the population pharmacokinetics of ARN-509
    -To evaluate the effect of ARN-509 on ventricular repolarization in a subset of patients from selected clinical sites
    Confrontare sopravvivenza complessiva (OS) di uomini con NM-CRPC ad alto rischio trattati con ARN-509 vs placebo e confrontare:
    - Tempo alla progressione sintomatica in uomini con NM-CRPC ad alto rischio trattati con ARN-509 vs placebo
    - Tempo all’inizio di chemioterapia citotossica in uomini con NM-CRPC ad alto rischio trattati con ARN-509 vs placebo
    - Sopravvivenza senza progressione (PFS) radiografica di uomini con NM-CRPC ad alto rischio trattati con ARN-509 vs placebo
    - Tempo alla metastasi (TTM) in uomini con NM-CRPC ad alto rischio trattati con ARN-509 vs placebo
    - Esiti riferiti dai pazienti (PRO) sulla qualità della vita correlata alla salute e ai sintomi specifici del carcinoma prostatico in uomini con NM-CRPC ad alto rischio trattati con ARN-509 vs placebo
    e valutare:
    - Sicurezza e tollerabilità di ARN-509
    - Farmacocinetica di popolazione di ARN-509
    - Effetto di ARN-509 sul ripolarizzazione ventricolare in sottogruppo di pazienti da centri clinici selezionati
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features, with high risk for development of metastases, defined as PSADT ≤ 10 months
    2. Castration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy (ADT)/post orchiectomy, defined as 3 consecutive rises of PSA, at least 1 week apart, resulting in two 50% increases over the nadir, with the last PSA > 2 ng/mL
    3. Maintain castrate levels of testosterone (< 50 ng/dL [1.72 nmol/L]) within 4 weeks prior to randomization and throughout the study
    4. Patients currently receiving bone loss prevention treatment with bone-sparing agents (e.g., bisphosphonates, denosumab [Prolia®]) must be on stable doses for at least 4 weeks prior to randomization
    5. Patients who received a first generation anti-androgen (e.g., bicalutamide, flutamide, nilutamide) as part of an initial combined androgen blockade therapy or as second-line hormonal therapy must show continuing disease (PSA) progression off the anti-androgen for at least 4 weeks prior to randomization
    6. At least 4 weeks must have elapsed from the use of 5-α reductase inhibitors (e.g., dutasteride, finasteride, aminoglutethamide), estrogens, and any other anti-cancer therapy prior to randomization, including chemotherapy given in the adjuvant/neoadjuvant setting (e.g., clinical trial)
    7. At least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization
    8. Age ≥ 18 years
    9. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
    10. Resolution of all acute toxic effects of prior therapy or surgical procedure to Grade ≤ 1 or baseline prior to randomization
    11. Adequate organ function as defined by the following criteria:
    -Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x upper limit of normal (ULN)
    -Total serum bilirubin ≤ 1.5 x ULN
    -Serum creatinine ≤ 2 x ULN
    -Absolute neutrophil count (ANC) ≥ 1500/μL
    -Platelets ≥ 100,000/μL
    -Hemoglobin ≥ 9.0 g/dL
    -Administration of growth factors or blood transfusions will not be allowed within 4 weeks of the hematology labs required to confirm eligibility
    12. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to randomization
    13. Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, and other study procedures, including ability to swallow large capsules, the completion of patient reported outcomes questionnaires and long-term follow-up visits
    1. Adenocarcinoma della prostata, istologicamente o citologicamente confermato, senza differenziazione neuroendocrina o caratteristiche da piccole cellule, ad alto rischio di sviluppo di metastasi, definito come un PSADT ≤ 10 mesi.
    2. Carcinoma prostatico resistente a castrazione, comprovato nel corso di una terapia continuativa di deprivazione androgenica (androgen deprivation therapy, ADT) o di una postorchiectomia, definito da 3 aumenti consecutivi dei livelli di PSA, a distanza di almeno 1 settimana, risultanti in due aumenti del 50% oltre il nadir, con l’ultimo valore di PSA > 2 ng/ml.
    3. Mantenimento di livelli testosteronici da castrazione (< 50 ng/dl [1,72 nmol/l]) entro le 4 settimane che precedono la randomizzazione e per l’intera durata dello studio.
    4. I pazienti che stanno attualmente ricevendo un trattamento preventivo con agenti di risparmio osseo contro la perdita ossea (ad es., bisfosfonati, denosumab [Prolia®]) devono aver assunto dosi stabili da almeno 4 settimane prima della randomizzazione.
    5. I pazienti che ricevono un antiandrogeno di prima generazione (ad es., bicalutamide, flutamide, nilutamide) come parte di una iniziale terapia combinata di blocco androgenico oppure una terapia ormonale di seconda linea devono mostrare una continua progressione della malattia (PSA) in mancanza dell’antiandrogeno da almeno 4 settimane prima della randomizzazione.
    6. Devono essere trascorse almeno 4 settimane dall’uso di inibitori della 5-α reduttasi (ad es., dutasteride, finasteride, aminoglutetamide), di estrogeni e di qualsiasi altra terapia antitumorale prima della randomizzazione, compresa la chemioterapia somministrata in contesti con adiuvante/neoadiuvante (ad es., una sperimentazione clinica).
    7. Devono essere trascorse almeno 4 settimane da un intervento chirurgico maggiore o da una radioterapia prima della randomizzazione.
    8. Età ≥ 18 anni.
    9. Stato di validità ECOG (Eastern Cooperative Oncology Group) pari a 0 o 1.
    10. Recupero da tutti gli effetti tossici acuti di una precedente terapia o procedura chirurgica al grado ≤ 1 o al basale prima della randomizzazione.
    11. Adeguata funzione d’organo definita dai seguenti criteri:
    - Aspartato transaminasi sierica (AST; transaminasi glutammico-ossalacetica sierica [serum glutamic oxaloacetic transaminase, SGOT]) e alanina transaminasi sierica (ALT; transaminasi glutammico-piruvica sierica [serum glutamic pyruvic transaminase, SGPT]) ≤ 2,5 volte il limite superiore della norma (upper limit of normal, ULN)
    - Bilirubina sierica totale ≤ 1,5 volte l’ULN
    - Creatinina sierica ≤ 2 volte l’ULN
    - Conta assoluta dei neutrofili (absolute neutrophil count, ANC) ≥ 1500/μl
    - Piastrine ≥ 100.000/μl
    - Emoglobina ≥ 9,0 g/dl
    - La somministrazione di fattori di crescita o le trasfusioni ematiche non sarà consentita nelle 4 settimane precedenti le analisi ematologiche in laboratorio necessarie per confermare l’idoneità.
    12. Documento di consenso informato firmato e datato che indichi che il paziente (o il rappresentante legalmente accettabile) sia stato informato di tutti gli aspetti importanti della sperimentazione prima della randomizzazione.
    13. Disponibilità e capacità nell’attenersi alle visite programmate, ai piani terapeutici, alle valutazioni radiografiche e di laboratorio e ad altre procedure dello studio, compresa la capacità di ingerire grandi capsule, di compilare i questionari sugli esiti riferiti dai pazienti e di completare le visite di follow-up a lungo termine.
    E.4Principal exclusion criteria
    1.Presence of distant metastases, confirmed by blinded independent central review (BICR), including CNS and vertebral or meningeal involvement. Exception: pelvic lymph nodes < 2 cm in short axis (N1) located below the iliac bifurcation are allowed
    2. Symptomatic loco-regional disease requiring medical intervention, such as moderate or severe urinary obstruction or hydronephrosis due to primary tumor (e.g., tumor obstruction of bladder trigone)
    3. Prior treatment with second generation anti-androgens (e.g., enzalutamide)
    4. Prior treatment with CYP17 inhibitors (e.g., abiraterone, orteronel, galeterone, ketoconazole)
    5. Prior treatment with radiopharmaceutical agents (e.g., Strontium-89), immunotherapy (e.g., sipuleucel-T), or any other investigational agent for NM-CRPC
    6. Prior chemotherapy for prostate cancer except if administered in the adjuvant/neoadjuvant setting
    7. History of seizure or condition that may pre-dispose to seizure (e.g., stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
    8. Concurrent therapy with any of the following (all must have been discontinued or substituted for at least 4 weeks prior to randomization):
    -Medications known to lower the seizure threshold
    -Herbal and non-herbal products that may decrease PSA levels (i.e., saw palmetto, pomegranate juice)
    -Systemic (oral/IV/IM) corticosteroids. Short term use (≤ 4 weeks) of corticosteroids during the study is allowed if clinically indicated, but it should be tapered off as soon as possible
    -Any other experimental treatment on another clinical trial
    9. History or evidence of any of the following conditions:
    -Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization
    -Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
    -Uncontrolled hypertension (≥ 160 mmHg systolic blood pressure and/or diastolic blood pressure ≥ 100 mmHg)
    -Gastrointestinal disorder affecting absorption
    -Active infection, such as human immunodeficiency virus (HIV)
    -Any other condition that, in the opinion of the Investigator, would impair the patient’s ability to comply with study procedures
    1. Presenza di metastasi distanti confermate mediante revisione indipendente centralizzata in cieco (blinded independent central review, BICR), compreso il coinvolgimento del SNC e di vertebre o meningi. Eccezione: sono ammessi i linfonodi pelvici < 2 cm lungo l’asse corto (N1) situato sotto la biforcazione iliaca.
    2. Malattia loco-regionale sintomatica richiedente intervento medico, come ostruzione urinaria moderata o grave oppure idronefrosi dovuta a tumore primario (ad es., ostruzione tumorale del trigono vescicale).
    3. Trattamento pregresso con antiandrogeni di seconda generazione (ad es., enzalutamide).
    4. Trattamento pregresso con inibitori di CYP17 (ad es., abiraterone, orteronel, galeterone, ketoconazolo).
    5. Trattamento pregresso con agenti radiofarmaceutici (ad es., stronzio-89), immunoterapia (ad es., sipuleucel-T) o qualsiasi altro agente sperimentale per il NM-CRPC.
    6. Pregressa chemioterapia per il carcinoma prostatico, tranne se somministrata nel contesto con adiuvante/neoadiuvante.
    7. Anamnesi di crisi epilettiche o condizioni che possano predisporre a crisi (ad es., ictus entro 1 anno prima della randomizzazione, malformazione artero-venosa cerebrale, schwannoma, meningioma o altre malattie benigne del SNC o meningee che potrebbero richiedere un trattamento di chirurgia o una radioterapia).
    8. Terapia concomitante con uno qualsiasi dei seguenti prodotti (tutti devono essere stati interrotti o sostituiti almeno 4 settimane prima della randomizzazione):
    - Farmaci indicati per ridurre la soglia delle crisi
    - Prodotti erboristici e non che possano ridurre i livelli di PSA (ossia, la palmetta della Florida, il succo di melograno)
    - Corticosteroidi sistemici (orali/EV/IM). Se clinicamente indicato, l’uso temporaneo (≤ 4 settimane) di corticosteroidi nel corso dello studio è ammesso, ma deve essere ridotto fino alla sospensione non appena possibile
    - Qualsiasi altro trattamento sperimentale o altra sperimentazione clinica
    9. Anamnesi o evidenza di una qualunque delle seguenti condizioni:
    - Qualsiasi neoplasia pregressa (diversa dal carcinoma cutaneo basocellulare o squamocellulare adeguatamente trattato, dal carcinoma superficiale della vescica o da qualsiasi altro carcinoma in situ attualmente in remissione completa) nei 5 anni precedenti la randomizzazione
    - Angina grave/instabile, infarto miocardico, insufficienza cardiaca congestizia sintomatica, eventi tromboembolici venosi o arteriosi (ad es., embolia polmonare, accidente cerebrovascolare, compresi gli attacchi ischemici transitori) oppure aritmie ventricolari clinicamente significative nei 6 mesi precedenti la randomizzazione
    - Ipertensione non controllata (pressione sanguigna sistolica ≥ 160 mmHg e/o pressione sanguigna diastolica ≥ 100 mmHg)
    - Disturbo gastrointestinale che comprometta l’assorbimento
    - Infezione attiva, come quella da virus dell’immunodeficienza umana (HIV)
    - Qualsiasi altra condizione che, a giudizio dello Sperimentatore, precluderebbe la capacità del paziente di attenersi alle procedure dello studio
    E.5 End points
    E.5.1Primary end point(s)
    Metastasis-Free Survival (MFS)
    Sopravvivenza senza metastasi (MFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    MFS data for patients without metastasis or death will be censored on the date of the last tumor assessment (or, if no tumor assessment was performed after the baseline visit, at the date of randomization + 1 day).
    Tumor assessments will be performed at baseline and at 16-week intervals from randomization. Imaging studies will include a CT scan of the chest, abdomen, and pelvis, plus a bone scan.
    I dati di MFS dei pazienti senza metastasi e non deceduti verranno raccolti alla data dell'ultima valutazione del tumore (o, se non è stata effettuata valutazione del tumore dopo la visita basale, alla data di randomizzazione + 1 giorno).
    Le valutazioni del tumore verranno eseguite al basale e ad intervalli di 16 settimane dalla randomizzazione. Lo studio delle immagini includerà TAC di petto, addome e pelvi, più una scintigrafia ossea.
    E.5.2Secondary end point(s)
    -Overall Survival (OS)
    -Time to symptomatic progression
    -Time to initiation of cytotoxic chemotherapy
    -Radiographic Progression-Free Survival (PFS)
    -Time to Metastasis (TTM)
    - Sopravvivenza complessiva (OS)
    - Tempo alla progressione sintomatica
    - Tempo all’inizio della chemioterapia citotossica
    - Sopravvivenza senza progressione (PFS) radiografica
    - Tempo alla metastasi (TTM)
    E.5.2.1Timepoint(s) of evaluation of this end point
    OS (every 4 months via clinic visit or telephone contact)
    OS (ogni 4 mesi tramite visita clinica o contatto telefonico)
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA145
    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
    Czech Republic
    Korea, Republic of
    New Zealand
    Russian Federation
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Patients will remain on study until BICR-confirmed disease progression, development of unacceptable toxicity, or withdrawal of consent.
    If the study is not terminated beforehand per the recommendation of the DMC, the end of trial in all participating countries will be defined as the time at which the secondary endpoint of OS has been met.
    I pazienti assumeranno il trattamento in studio fino alla progressione radiografica della malattia confermata mediante revisione indipendente centralizzata in cieco (BICR), allo sviluppo di tossicità inaccettabile oppure al ritiro del consenso.
    Se lo studio non viene concluso anticipatamente a seguito di una raccomandazione del DMC, la fine della sperimentazione in tutti i Paesi partecipanti sarà definita come il tempo in cui verrà soddisfatto l’endpoint secondario della OS.
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months11
    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: 360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 840
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 640
    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)
    Patients will be followed for at least 28 calendar days after the last dose of study drug. All patients discontinuing study treatment will enter the survival follow-up period and will be followed for the development of symptomatic progression and initiation of subsequent anti-cancer therapies every 4 months until death, loss of follow-up, or withdrawal of consent, whichever comes first.
    I pazienti verranno seguiti per almeno 28 giorni di calendario dopo l'ultima dose del farmaco in studio. Tutti i pazienti che interrompono il trattamento entreranno nel periodo di follow-up di sopravvivenza, nel corso del quale saranno seguiti per lo sviluppo della progressione sintomatica e l’inizio di successive terapie antitumorali ogni 4 mesi, fino al decesso, alla perdita al follow-up o al ritiro del consenso, in base a quale si verifichi per prima.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-02
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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