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    Summary
    EudraCT Number:2011-000561-12
    Sponsor's Protocol Code Number:S.E.R.I.O.
    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:2012-01-05
    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 number2011-000561-12
    A.3Full title of the trial
    A phase II, open label, non-randomized study of second or third line treatment with the combination of sorafenib and everolimus in patients affected by relapsed and non-resectable high-grade osteosarcoma.
    Studio di fase II, non-randomizzato, su sorafenib ed everolimus come trattamento di seconda/terza linea in pazienti affetti da osteosarcoma ad alto grado di malignita' in ricaduta non operabile.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    study of the combination with sorafenib and everolimus in patients affected by non-resectable high-grade osteosarcoma.
    Studio sull'associazione di sorafenib ed everolimus in pazienti affetti da osteosarcoma ad alto grado di malignita' non operabile
    A.3.2Name or abbreviated title of the trial where available
    S.E.R.I.O. (Sorafenib+Everolimus in Relapsed Inoperable Osteosarcoma)
    SERIO Sorafenib+Everolimus in Relapsed Inop.Osteos
    A.4.1Sponsor's protocol code numberS.E.R.I.O.
    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 SponsorITALIAN SARCOMA GROUP
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione del Piemonte per l'Oncologia IRCC Candiolo
    B.5.2Functional name of contact pointD.O. Oncologia Medica a Dir.Univ.
    B.5.3 Address:
    B.5.3.1Street AddressStrada Provinciale 142
    B.5.3.2Town/ cityCandiolo
    B.5.3.3Post code10060
    B.5.3.4CountryItaly
    B.5.4Telephone number011.9933278
    B.5.5Fax number011.9933299
    B.5.6E-mailmassimo.aglietta@ircc.it
    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 Yes
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical 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 INNEVEROLIMUS
    D.3.9.1CAS number 159351-69-6
    D.3.9.2Current sponsor codeRAD001
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number5
    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 Yes
    D.2.1.1.1Trade name NEXAVAR
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical 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 INNsorafenib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Patients with high-grade Osteosarcoma, not resectable/metastatic, failing at least 2 different lines of standard tr4eatment for relapsed/metastatic disease
    Pazienti affetti da Osteosarcoma ad alto grado di malignita' non resecabile/metastatico dopo fallimento di una o due linee terapeutiche standard per la malattia recidivata/metastatica
    E.1.1.1Medical condition in easily understood language
    Patients with high-grade Osteosarcoma, not resectable/metastatic, failing at least 2 different lines of standard tr4eatment for relapsed/metastatic disease
    Pazienti affetti da Osteosarcoma ad alto grado di malignita' non resecabile/metastatica dopo fallimento di una o due linee terapeutiche standard per la malattia recidivata/metastatica
    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 10031294
    E.1.2Term Osteosarcoma 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective of the study will be to assess the antitumor activity of sorafenib 400 mg twice a day in combination with everolimus 5mg/die as second or third line treatment of relapsed unresectable/metastatic high-grade osteosarcoma
    L'obiettivo principale dello studio sara' la valutazione dell'attvita' antitumorale di sorafenib 400 mg bid in combinazione con everolimus 5 mg/die come seconda o terza linea di trattamento nell'osteosarcoma ad alto grado di malignita' non resecabile/metastatico
    E.2.2Secondary objectives of the trial
    Secondary objectives of the study will be to explore the activity of the combination sorafenib and everolimus in this unfavorable Osteosarcoma subset. This will be accomplished by both recording overall survival, progression-free survival, duration of response, RECIST response rate (dimensional reduction), non-dimensional response rate (metabolic or functional responses), safety and oncogene activation and correlation with outcomes parameters. Any improvement in patients’ quality of life will be captured by the Pain and Analgesic scale and recorded as clinical benefit. Finally, a specific effort will be conducted to evaluate the pattern of response, if any, given the peculiar patterns of response observed in solid tumors with molecular-targeted therapy.
    Gli obiettivi secondari dello studio saranno volti alla valutazione dell'attivita' della combinazione sorafenib ed everolimus in questo subset sfavorevole di pazienti affetti da osteosarcoma. Tale obiettivo sara' conseguito sia attraverso la valutazione della sopravvivenza globale, della sopravvivenza libera da progressione di malattia, la durata della risposta, il tasso di risposta secondo i criteri RECIST (riduzione dimensionale), tasso di risposta non dimensionale, tollerabilita' e valutazione della attivazione di oncogeni e la loro correlazione con i parametri di outcome. Qualsiasi miglioramento della qualita' di vita dei pazienti sara' registrato dalla Pain and Analgesic Scale e sara' interpretato come beneficio clinico. Infine, uno sforzo specifico sara' rivolto alla valutazione del peculiare pattern di risposta osservato nei tumori solidi con le terapie a bersaglio molecolare
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with histologically documented and not surgically resectable or metastatic high-grade osteosarcoma which progressed after first or second line treatments for relapsing disease. 2. Measurable disease as defined by having at least one uni-dimensional (RECIST v1.1 / bone lesions are allowed) measurable lesion that can be accurately measured by means of CT or MRI. Baseline evaluations must be completed within 28 days prior to enrollment. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0/ 1 and an estimated life expectancy of at least 3 months. Patients with an ECOG PS 2 are eligible if the PS 2 depends solely on orthopedic problems. 4. Estimated life expectancy of at least 3 months. 5. age ≥18 years. 6. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of treatment: - Hemoglobin > 9.0 g/dl - Absolute neutrophil count (ANC) >1,500/mm3 - Platelet count  100,000/μl - Total bilirubin < 1.5 times the upper limit of normal - ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer) - PT-INR/PTT < 1.5 x upper limit of normal (Patients who are being therapeutically anticoagulated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists) - Serum creatinine < 2 x upper limit of normal. 7. Written informed consent.
    1. Pazienti con osteosarcoma confermato istologicamente e non suscettibile di trattamento chirurgico o metastatico che siano andati in progressione dopo la prima o la seconda linea di trattamento per la malattia recidivata. 2. Malattia misurabile definita come la presenza di almeno una lesione uni-dimensionale (RECIST v1.1 / sono permesse le lesioni osee) misurabile accuratamente dalla TC o dalla RM. La valutazione iniziale deve essere completata entro i 28 giorni precedenti l’arruolamento. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status di 0/1 e un’attesa di vita stimata di almeno 3 mesi. I pazienti con PS di 2 sono eleggibili se il PS 2 e' dovuto unicamente a problemi ortopedici. 4. Eta' ≥18 anni. 5. Adeguata funzionalita' midollare epatica e renale cosi' come indicato dai seguenti requisiti laboratoristici che devono essere effettuati entro i 7 giorni precedenti l’avvio del trattamento: - Emoglobina &gt; 9.0 g/dl - Neutrofili (ANC) &gt;1,500/mm3 - Conta piastrinica  100,000/μl - Bilirubina totale &lt; 1.5 volte il valore superiore di norma - ALT e AST &lt; 2.5 volte il valore superiore di norma (&lt; 5 volte il valore superiore di norma per I pazienti con coinvolgimento epatico da parte della neoplasia) - PT-INR/PTT &lt; 1.5 volte il limite superiore di norma (Pazienti in trattamento anticoagulante con un farmaco come warfarin o eparina possono essere arruolati previa documentazione di precedente assenza di alterazione di questi parametri). - Creatinina sierica &lt; 2 volte il limite superiore di normalita' 6. Consenso informato scritto.
    E.4Principal exclusion criteria
    1. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. 2. Patients with any severe and/or uncontrolled medical conditions such as unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 6 months, serious uncontrolled cardiac arrhythmia, uncontrolled hyperlipidemia, active or uncontrolled severe infection, cirrhosis, chronic or persistent active hepatitis or severely impaired lung function. In particular for history of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension. 3. History of HIV infection and active clinically serious infections (> grade 2 NCI-CTC version 4.03). 4. Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry). 5. Patients with seizure disorders requiring medication (such as steroids or anti-epileptics). 6. Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 8 weeks after last dose of study drug. 7. Patients with evidence or history of bleeding diathesis. 8. Patients undergoing renal dialysis. 9. Patients unable to swallow oral medications. 10. Uncontrolled diabetes (fasting glucose > 2 x ULN). 11. Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent (except corticosteroids with a daily dosage equivalent to prednisone ≤ 20 mg for adrenal insufficiency). Patients receiving corticosteroids must be on a stable dose for ≥ 4 weeks prior to the first dose of RAD001. Topical or inhaled corticosteroids are permitted. 12. Patients with a history of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or in-situ cervical cancer skin or other solid tumors curatively treated with no evidence of disease for ≥3 years. Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drugs). 13. Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry. 14. Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed). Major surgery within 4 weeks of start of study. 15. Investigational drug therapy outside of this trial during or within 4 weeks of study entry. 16. Prior exposure to the study drugs or their analogues. 17. Patients with known hypersensitivity to sorafenib, RAD001 or other rapamycin analogs (sirolimus, temsirolimus), or to its excipients. 18. Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results. 19. A history of noncompliance to medical regimens or inability or unwillingness to return for scheduled visits.
    1. Demenza o significativa alterazione dello stato mentale, che possa impedire la comprensione o l’esecuzione del consenso informato e la compliance ai requisiti del protocollo. 2. Pazienti con una condizione medica severa/incontrollata come una angina pectoris instabile, scompenso cardiac congestizio, infarto ≤ 6 mesi, aritmia cardiaca severa non controllata, iperlipidemia non controllata, infezione severa attiva o non controllata, cirrosi, epatite cronica o persistentemente attiva, o compromissione severa della funzionalita' polmonare. In paricolare storia di patologia cardiaca: scompenso cardiaco congestizio &gt; classe NYHA 2; CAD attiva (e' consentito un infarto miocardico avvenuto piu' di 6 mesi prima dell’ingresso nello studio); aritmia cardiaca richiedente terapia anti-aritmica (e' permesso l’uso di beta-bloccanti e digossina) o ipertensione non controllata. 3. Storia di infezione da HIV e di infezione seria clinicamente attiva (&gt; grado 2 sec NCI-CTC versione 4.03) 4. Metastasi cerebrali o meningee (a meno che il paziente non sia a &gt; 6 mesi da una terapia definitive, abbia un imaging negative entro le 4 settimane precedent l’ingresso nello studio e sia clinicamente stabile a livello encefalico al momento dell’ingresso nello studio). 5. Pazienti con epilessia necessitante trattamento anti-epilettico. 6. Stato di gravidanza o di allattamento. Le donne in eta' fertile devono avere un test di gravidanza negativo entro i 7 giorni precedenti l’inizio del trattamento. Sia gli uomini che le donne arruolati devono usare adeguate barriere per il controllo delle nascite per tutta la durata del trial e per le 8 settimane successive al completamento del trial. 7. Pazienti con storia o evidenza di diatesi emorragica 8. Pazienti in trattamento dialitico. 9. Pazienti non in grado di assumere farmaci per via orale 10. Diabete non controllato (Fasting glucose&gt; 2 x ULN) 11. Pazienti in trattamento cronico con corticosteroidi o altri agenti immunosoppressivi (fatta eccezione per i corticosteroidi con un dosaggio giornaliero equivalente a ≤ 20 mg di prednisone per insufficienza surrenalica). Pazienti che ricevono corticosteroidi devono essere in trattamento conuna dose stabile da ≥ 4 settimane. Corticosteroidi topici o inalatori sono permessi. 12. Pazienti con una storia di alter neoplasie maligne entro i 5 anni precedenti l’ingresso nello studio, fatta eccezione per i tumori della pelle non-melanoma trattati con intento curativo o cancro della cervice in situ o altri tumori solidi trattati con intento curativo e senza evidenza di malattia per ≥ 3 anni. Pazienti con patologie severe e/o non controllate dalla terapia medica che ad opinione dell’investigator possano determinare un rischio di eventi avversi non accettabile o compromessa compliance con il protocollo (ad es, alterazione della funzionalita' gastrointestinale (GI) o po'atologia GI che possa alterare in maniera significativa l’assorbimento dei farmaci in studio.) 13. Chemioterapia antiblastica o immunoterapia durante lo studio o nelle 4 settimane precedent l’ingresso nello studio. 14. Radioterapia durante lo studio o nei 3 mesi precendenti l’avvio del farmaco I studio. (sara' permessa la radioterapia palliativa). Intervento di chirurgia maggiore nelle 4 settimane precedent l’inizio del farmaco in studio. 15. Terapia in fase sperimentale al di fuori di questo trial durante o entro 4 settimane prima dell’ingresso nello studio. 16. Precedente assunzione dei farmaci in studio o loro analoghi. 17. Pazienti con nota ipersensibilita' a sorafenib, RAD001 o altri analoghi della rapamicina (sirolimus, temisirolimus) o ai loro eccipienti. 18. Abuso di sostante, condizioni mediche, psicologiche o sociali che possano interferire con la partecipazione del paziente allo studio o con la valutaizone dei risultati dello studio stesso. 19. Storia di non compliance
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival at 6 months
    Sopravvivenza libera da progressione di malattia a 6 mesi
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease status will be assessed every 2 months interval by TC/MR depending on disease site/s. Patients free from progression of the disease (RECIST 1.1) at 6 month assessment will be considered as success.
    Verranno effettuate rivalutazioni di malattia ogni 2 mesi tramite TC/RM a seconda della sede di malattia. I pz che saranno liberi da progressione di malattia (RECIST 1.1) alla rivalutazione a 6 mesi saranno considerati come successi.
    E.5.2Secondary end point(s)
    Overall survival (OS), Progression-free survival (PFS), Overall response rate (ORR), Duration of response, Non-dimensional pattern of response (i.e. metabolic or functional), Clincal benefit, Safety (according to CTC version 4.03)
    sopravvivenza globale, tasso di risposta globale,
    sopravvivenza libera da progressione di malattia, durata della risposta, pattern di
    risposata non dimensionale, beneficio clinico, tossicità (in accordo con CTC)
    E.5.2.1Timepoint(s) of evaluation of this end point
    October 2013
    ottobre 2013
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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.7.1.3.1Other trial type description
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned5
    E.8.5The trial involves multiple Member States No
    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
    LVLS , intolerable toxicity or clinical evidence for the interruption
    LVLS, tossicita' intollerabile o evidenze cliniche che suggeriscano l'interruzione
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-01-05. Yes
    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 state37
    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)
    Each patient will be followed-up regularly and physician will record any further line treatment and date of death
    I pazienti saranno seguiti in follow-up regolarmente con registrazione da parte del medico di ogni eventuale successiva linea di trattamento e data del decesso
    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 Decision2011-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-19
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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