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    Summary
    EudraCT Number:2011-002029-24
    Sponsor's Protocol Code Number:AX11
    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:2012-09-27
    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 number2011-002029-24
    A.3Full title of the trial
    MULTICENTER SECOND LINE STUDY OF AXITINIB IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA (HCC) PROGRESSED WITH SORAFENIB
    STUDIO CLINICO MULTICENTRICO DI SECONDA LINEA DI AXITINIB IN PAZIENTI CON CARCINOMA EPATOCELLULARE (HCC) IN PROGRESSIONE DOPO TERAPIA CON SORAFENIB
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EVALUATION OF THE EFFECTIVENESS OF AXITINIB IN PATIENT WITH HEPATOCELLULAR CARCINOMA PROGRESSED WITH SORAFENIB
    VALUTAZIONE DELL'EFFICACIA DI AXITINIB IN PAZIENTI CON CARCINOMA EPATOCELLULARE GIA' TRATTATI CON SORAFENIB
    A.4.1Sponsor's protocol code numberAX11
    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 SponsorUNIVERSITA' CAMPUS BIOMEDICO
    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 supportPFIZER ITALIA S.R.L.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNIVERSITA' CAMPUS BIO-MEDICO DI ROMA
    B.5.2Functional name of contact pointONCOLOGIA MEDICA
    B.5.3 Address:
    B.5.3.1Street AddressVIA ALVARO DEL PORTILLO, 200
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00128
    B.5.3.4CountryItaly
    B.5.4Telephone number06225411206
    B.5.5Fax number06225411456
    B.5.6E-maild.santini@unicampus.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 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 nameAXITINIB
    D.3.2Product code NA
    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 INNAXITINIB
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeAG-013736
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Hepatocellular carcinoma (HCC)
    carcinoma epatocellulare (HCC)
    E.1.1.1Medical condition in easily understood language
    Hepatocellular carcinoma (HCC)
    Carcinoma epatocellulare
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    explore the clinical activity of Axitinib in patients affected by locally advanced, unresectable, metastatic hepatocellular carcinoma progressed under treatment or intolerant to sorafenib.
    esplorare l’attività clinica di Axitinib in pazienti affetti da HCC localmente avanzato, non resecabile, metastatico in progressione in corso di trattamento con sorafenib o intolleranti al sorafenib
    E.2.2Secondary objectives of the trial
    To assess the duration of response (first administration of study drug until PD in patients with objective responses)
    Valutare la durata della risposta(dalla I somministrazione di farmaco fino a progressione di malattia in pazienti con risposta obiettiva)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Histologically or cytologically proven HCC or alpha-fetoprotein level > 400 ng/ml together with hypervascular tumor and cirrhosis documented by CT scan or MRI. BCLC criteria 2000  HCC not amenable to curative treatment (resection, transplantation, percutaneous ablation)  prior systemic treatment for HCC with sorafenib  Presence of at least one dimensionally measurable target lesion with largest diameter >= 2 cm.  World Health Organization (WHO) performance status <= 2  Life expectancy >= 12 weeks.  Age >= 18 years.  Child Pugh score A  Adequate hematologic functions (neutrophil count ≥ 1500 per cubic millimeter; platelet count ≥ 75,000 per cubic millimetre; Hemoglobin ≥ 9 g/dl)  Adequate liver function (bilirubin ≤ 1.5 the upper limit of normal; AST and ALT ≤ 2.5 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT ≤ 5.0 x ULN)  Adequate renal function (serum creatinine 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min)  Urinary protein <2+ by urine dipstick. If dipstick is ≥ 2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is <2 g per 24 hours.  Adequate coagulation function  No evidence of pre-existing uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be 140 mm Hg, and the baseline diastolic blood pressure readings must be 90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible  Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment  Written informed consent  Minimum of 4 weeks since any local procedures (chemoembolizzation or termoablation) or completion of radiation  Minimum of 4 weeks since completion of all prior systemic anticancer therapy  written informed consent approval by the institutional review board at each institution
     Conferma istologica/radiologica di epatocarcinoma. (Criteri BCLC 2000)  HCC non sottoponibile a trattamento locale(resezione, trapianto, ablazione percutanea)  Precedente trattamento sistemico con sorafenib per HCC  Presenza di almeno 1 lesione misurabile con il diametro maggiore superiore a 2 cm  WHO performance status &lt;= 2  Attesa di vita &gt;= 12 settimane  età &gt;= 18 anni  Child Pugh score A  Valori ematologici adeguati(neutrofili ≥ 1500 x millimetro cubico; piastrine ≥ 75,000 x millimetro cubico; emoglobina ≥ 9 g/dl)  Funzionalità epatica adeguata (bilirubina ≤ 1.5 upper limit; AST e ALT ≤ 2.5 x upper limit normale (ULN), se metastasi epatiche AST e ALT ≤ 5.0 x ULN)  Funzionalità renale adeguata (creatinina sierica1.5 x ULN o clearance creatinina calcolata ≥ 60 mL/min)  Proteine Urinarie &lt;2+ (dipstick). Se dipstick ≥ 2+ deve essere fatta la raccolta delle urine nelle 24-ore. Il paziente è includibile solo se le proteine urinarie sono &lt;2 g nelle 24 ore.  Coagulazione adeguata  Assenza di ipertensione non controllata (documentata da valori della pressione basale misurata almeno ad 1 ora di distanza). La sistolica dovrà essere 140 mm Hg, e la diastolica 90 mm Hg. Possono essere reclutati pazienti che assumono anti-ipertensivi.  Donne in età fertile devono avere un test di gravidanza sierico o urinario negative fino a 3 giorni prima dell’inizio del trattamento.  Firma del consenso informato  Almeno 4 settimane da una procedeura locale (chemioembolizzazione or termoablazione) o completamento della RT  Almeno 4 settimane dall’assunzione di terapie antitumorali sistemiche
    E.4Principal exclusion criteria
     Decompensated cirrhosis (Child-Pugh score > 7)  Variceal bleeding during the previous 3 months  Gastrointestinal abnormalities including: History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment, inability to take oral medication, requirement for intravenous alimentation, prior surgical procedures affecting absorption including total gastric resection, treatment for active peptic ulcer disease in the past 6 months, active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy, malabsorption syndromes.  Thromboembolic event during the previous 6 months, except for portal vein neoplastic thrombosis  Current or anticipated use of drugs known to be potent CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine).  Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John’s wort).  Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.  Abnormal cardiac function with history of ischemic heart disease in the previous 6 months, uncontrolled hypertension, unstable angina, severe cardiac arrhythmia  Any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry.  Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.  Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.  Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis.  Previous or current malignancies at other sites  Concomitant antitumor treatment including tamoxifen or somatostatin analogs.  Unstable systemic diseases or active uncontrolled infections.  Female patients who are pregnant or lactating, or men and women of reproductive potential not willing or not able to employ an effective method of birth control/contraception to prevent pregnancy during treatment and for 6 months after discontinuing study treatment The definition of effective contraception should be in agreement with local regulation and based on the judgment of the principal investigator or a designated associate.  Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug.  Serious or non-healing wound, ulcer, or bone fracture.  Uncontrolled Hypertension  Class III or IV heart failure as defined by the NYHA functional classification system.  Patients with thyroid abnormality not in cure.  Any condition which, in the judgement of the Investigator, would place the patient at undue risk or interfere with the results of the study.  Other concurrent chemotherapy, immunotherapy, radiotherapy or investigational agents.  History of other malignancies except for adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma of cervix, unless the patient has been disease-free for at least 5 years.
     Cirrosi scompensata(Child-Pugh score &gt; 7)  Sanguinamento da varici esogagee nei 3 mesi precedenti  Patologie del tratto gastro-intestinale: storia di fistola addominale, perforazione, ascesso (ultimi 28 giorni, impossibilità ad assumere farmaci orali, alimentazione parenterale, procedure chirurgiche con alterazione dell’assorbimento, trattamento per ulcera peptica attiva negli ultimi 6 mesi, sanguinamento gastrointestinale, non correlato al tumore, negli ultimi 3 mesi, senza evidenza di risoluzione.  Evento tromboembolico durante i 6 mesi precedenti, eccetto trombosi neoplastica della vena porta  Uso corrente o recente di farmaci o sostanze potenti inibitori di CYP3A4 (ad esempio succo di pompelmo, verapamil, ketoconazolo, miconazolo, itraconazolo, eritromicina, clarithromicina, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir e delavirdine).  Uso corrente o recente di farmaci induttori diCYP3A4 o CYP1A2 (ad esempio carbamazepina, desametasone, felbamate, omeprazolo, fenobarbital, fenitoina, amobarbital, nevirapine, primidone, rifabutin, rifampin, e Erba di San Giovanni).  Necessità di terapia anticoagulante con antagonisti della vitamina K. E’ permesso l’uso di anticoagulanti a basse dosi e l’uso terapeutico di eparina a basso peso molecolare.  Patologia cardiaca: storia di malattia ischemica cardiaca nei 6 mesi precedenti,ipertensione non controllata, angina instabile, severa aritmia cardiaca.  Storia di accidente cerebrovascolare o TIA nei 12 mesi precedenti  HIV o syndrome da immunodeficienza acquisita (AIDS)  Demenza o stato mentale significativamente alterato.  Crisi epilettiche o evidenza di metastasi cerebrali, compressione spinale, o meningite carcinomatosa  Anamnesi di tumore o tumore sincrono eccetto carcinoma basocellulare o spinale della cute adeguatamente trattato.  Trattamenti concomitanti antitumorali includendo terapie ormonali, analoghi della somatostatina, altri agenti sperimentali o trattamento radioterapico.  Malattie sistemiche non stabili o infezioni attive  Donne in gravidanza  Chirurgia maggiore meno di 4 settimane o terapia radiante meno di 2 settimane prima  Ferite, ulcere, o fratture ossee attive.  Ipertensione non controllata  Scompenso cardiaco Classe III or IV secondo la classificazione funzionale NYHA.  Anomalie tiroidee non in trattamento.  Condizioni che a giudizio dell’investigatore possano , esporre il paziente a rischi o interferire con i risultati dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    To assess rate of patients without progression
    Valutare quanti pazienti non avranno progressione
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 month
    4 mesi
    E.5.2Secondary end point(s)
    1) To estimate disease control rate (proportion of patients with best response of CR+PR+SD) 2) to estimate overall survival (first day of receiving study medication to death) 3) To define safety/toxicity profile
    1) Valutare il tasso di controllo di malattia (proporzione dei pazienti con la migliore risposta come CR (risposta completa)+PR (risposta parziale)+SD (stabilità di malattia)) 2) Valutare la sopravvivenza globale 3) Definire profilo di sicurezza e tossicità
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 months
    4 mesi
    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 No
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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
    LVLS
    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 months24
    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.1.2.1Number of subjects for this age range: 29
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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 state46
    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)
    After disease progression,patients will receive subsequent therapy or supportive care at the investigator’s discretion.Subsequent treatment will be registered in the CRF.For patients who withdraw from the study treatment without documented progression,disease assessment will be performed every 2-3 months for 12 month until progression,new treatment and survival updates,unless the patient withdraws the consent.In the event of withdrawal of consent,no further information will be collect
    Dopo la progressione della malattia,i pazienti riceveranno una terapia o terapia di supporto a discrezione dello sperimentatore.Il trattamento sarà registrata nella CRF.Per i pazienti che finiscono il trattamento in studio senza progressione documentata,la valutazione della malattia verrà eseguita ogni 2-3 mesi per 12 mesi fino a progressione,a meno che il paziente ritiri il consnenso.In caso di revoca del consenso,nessuna informazione sarà raccolta
    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 Decision2011-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-19
    P. End of Trial
    P.End of Trial StatusOngoing
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