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    Summary
    EudraCT Number:2010-021590-37
    Sponsor's Protocol Code Number:A4061058
    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:2012-03-01
    Trial results View 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 number2010-021590-37
    A.3Full title of the trial
    A MULTICENTER, GLOBAL, RANDOMIZED, DOUBLE-BLIND STUDY OF AXITINIB PLUS BEST SUPPORTIVE CARE VERSUS PLACEBO PLUS BEST SUPPORTIVE CARE IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA FOLLOWING FAILURE OF ONE PRIOR ANTIANGIOGENIC THERAPY.
    Studio globale, multicentrico, randomizzato, in doppio cieco, su axitinib piu' la miglior terapia di supporto (BSC) in confronto a placebo piu' la miglior terapia di supporto (BSC) in pazienti affetti da carcionoma epatocellulare in stadio avanzato la cui patologia ha progredito dopo una precedente terapia antiangiogenica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A MULTICENTER, GLOBAL, RANDOMIZED, DOUBLE-BLIND STUDY OF AXITINIB PLUS BEST SUPPORTIVE CARE VERSUS PLACEBO PLUS BEST SUPPORTIVE CARE IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA FOLLOWING FAILURE OF ONE PRIOR ANTIANGIOGENIC THERAPY.
    Studio globale, multicentrico, randomizzato, in doppio cieco, su axitinib piu' la miglior terapia di supporto (BSC) in confronto a placebo piu' la miglior terapia di supporto (BSC) in pazienti affetti da carcionoma epatocellulare in stadio avanzato la cui patologia ha progredito dopo una precedente terapia antiangiogenica.
    A.4.1Sponsor's protocol code numberA4061058
    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 SponsorPFIZER 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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 800 7181021
    B.5.5Fax number001 303 7391119
    B.5.6E-mailClinicalTrials.govCallCentrere@pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameaxitinib
    D.3.2Product code AG-013736
    D.3.4Pharmaceutical form Film-coated 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 319460-85-0
    D.3.9.2Current sponsor codeAG-013736
    D.3.9.3Other descriptive nameN-Methyl-2-[3-((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl]-benzamide
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 nameaxitinib
    D.3.2Product code AG-013736
    D.3.4Pharmaceutical form Film-coated 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 319460-85-0
    D.3.9.2Current sponsor codeAG-013736
    D.3.9.3Other descriptive nameN-Methyl-2-[3-((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl]-benzamide
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    hepatocellular carcinoma
    carcinoma epatocellulare
    E.1.1.1Medical condition in easily understood language
    liver cancer
    carcinoma epatico
    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 LLT
    E.1.2Classification code 10019829
    E.1.2Term Hepatocellular carcinoma 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 compare the OS of patients with advanced HCC receiving axtitinib + best supportive care (BSC) versus (vs) placebo + BSC following failure of one prior antiangiogenic therapy.
    Confrontare l’OS dei pazienti con HCC avanzato che ricevono axitinib + miglior terapia di supporto (BSC) rispetto a placebo + BSC dopo mancata risposta ad una precedente terapia antiangiogenica.
    E.2.2Secondary objectives of the trial
    •To compare PFS between both arms •To compare TTP between both arms •To compare overall response rate (ORR) between both arms •To evaluate DR within each treatment arm •To compare CBR between both arms •To evaluate the safety and tolerability of axitinib in this patient population •To evaluate the pharmacokinetics of axitinib in this patient population. •To compare patients' health-related quality of life (HRQoL) and health status between both arms. •To evaluate baseline blood VEGF-C level as a potential predictive biomarker of axitinib efficacy. •To evaluate blood soluble protein concentrations and RNA transcripts associated with angiogenesis or tumor growth.
    •Confrontare PFS tra i due bracci •Confrontare TTP tra i due bracci •Confrontare il tasso di risposta complessiva (ORR) tra i due bracci •Valutare la durata della risposta (DR) in ciascun braccio di trattamento •Confrontare la risposta di beneficio clinico (CBR) tra i due bracci •Valutare la sicurezza e la tollerabilità di axitinib in questa popolazione di pazienti •Valutare la farmacocinetica di axitinib in questa popolazione di pazienti •Confrontare la qualità della vita relativa alla salute (HRQoL) dei pazienti e lo stato di salute tra i due bracci •Valutare il livello ematico di VEGF-C basale come potenziale biomarcatore predittivo dell’efficacia di axitinib •Valutare le concentrazioni di proteine solubili nel sangue e trascritti di RNA associati all’angiogenesi o alla crescita del tumore.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Locally advanced or metastatic HCC confirmed by histology or cytology (diagnosis of HCC obtained from a prior tumor biopsy specimen is acceptable) or liver mass confirmed as HCC by one or more imaging modalities, including triphasic contrastenhanced helical CT, triphasic dynamic contrast-enhanced MRI and contrast-enhanced ultrasonography, and not amenable to local therapy. 2. Failure of one prior antiangiogenic therapy (patients must have received at least 4 weeks of prior therapy). Antiangiogenic agents include sorafenib, bevacizumab and brivanib. Failure is defined as either a) documented progressive disease (per RECIST version 1.1) while receiving prior therapy or after the last dose of prior therapy; or b) intolerance to the prior antiangiogenic therapy. Intolerance to prior antiangiogenic therapy (at any dose and/or duration) is defined as documented treatment-related grade 3 or 4 adverse events that led to treatment discontinuation. 3. Presence of either measurable or non-measurable disease according to RECIST (version 1.1).
    1. HCC avanzato o localmente metastatico confermato da esame istologico o citologico (la diagnosi di HCC ottenuta da una precedente biopsia tumorale è accettabile) o massa a livello epatico confermata come HCC da una o più immagini, tra cui trifasico CT contrasto enhanced elicoidale trifasico, MRI con contrasto enhanced dinamico e ultrasonografia con contrasto enhanced e non suscettibili di terapia locale. 2. Fallimento di una precedente terapia antiangiogenica (i pazienti devono avere ricevuto almeno 4 settimane di terapia preventiva). Agenti antiangiogenici comprendono sorafenib, bevacizumab e brivanib. Il fallimento è definito come a) malattia documentata (a seconda dei RECIST versione 1.1) durante la terapia prima o dopo l'ultima dose della terapia precedente, oppure b) intolleranza alla precedente terapia antiangiogenica. Intolleranza a precedente terapia antiangiogenica (a qualsiasi dosaggio, e/o durata) è definito come eventi avversi di grado 3 e 4 documentati e correlati al trattamento che hanno portato alla sospensione del trattamento. 3. Presenza di una malattia misurabile o non misurabile secondo RECIST (versione 1.1).
    E.4Principal exclusion criteria
    1. Prior treatment of advanced HCC with more than one prior first-line systemic therapy. 2. Any prior local therapy (such as surgery, radiation therapy, hepatic arterial embolization, TACE, hepatic arterial infusion, radiofrequency ablation, percutaneous ethanol injection or cryoablation) within 2 weeks of study screening. 3. Prior history of liver transplant.
    1. precedente trattamento di carcinoma epatico avanzato con più di una precedente terapia sistemica di prima linea. 2. Qualsiasi precedente terapia locale (come la chirurgia, la radioterapia, embolizzazione arteriosa epatica, TACE, infusione arteriosa epatica, ablazione con radiofrequenza, l'iniezione percutanea di etanolo o crioablazione) entro 2 settimane dallo screening. 3. 3. precedente storia di trapianto di fegato.
    E.5 End points
    E.5.1Primary end point(s)
    overall survival.
    sopravvivenza generale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Randomized Portion: Overall Survival evaluated for 3 years after the last subject is randomized. Non-randomized Portion • Plasma PK (Cmax, AUCinf, AUClast, Tmax, t1/2, CL/F, Vz/F) and tolerability of single-agent axitinib following continuous dosing. Assessed Cycle 1 Day 15 • First-cycle DLT (Child-Pugh Class B, Score 7 population only). • Type, incidence, severity, timing, seriousness, and relatedness of adverse events, laboratory abnormalities based upon the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. will be assessed throughout the study.
    Porzione randomizzata: sopravvivenza complessiva valutata per 3 anni dopo la randomizzazione dell'ultimo soggetto. Porzione non randomizzata: • PK plasmatica (Cmax, AUCinf, AUClast, Tmax, t1/2, CL/F, Vz/F) e tollerabilità di axitinib come agente singolo a seguito di somministrazione continua. Valutazione del giorno 15 del ciclo 1 • Primo ciclo DLT (Child-Pugh B, popolazione con punteggio 7 solamente)• Tipo, incidenza, gravità, tempi, serietà, e relazione degli eventi avversi, anomalie di laboratorio in base al National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 saranno valutati durante lo studio.
    E.5.2Secondary end point(s)
    - PFS - TTP - ORR - DR - CBR - Type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 3.0), timing, seriousness, and relatedness of adverse events and laboratory abnormalities - Axitinib population PK analysis - Patient Reported Outcome (PRO) of health-related quality of life and disease-related symptoms as measured by the Functional Assessment of Cancer Therapy – Hepatobiliary questionnaire (FACT-Hep) and health status measured by the EuroQol EQ-5D Self-Report Questionnaire (EQ-5D). - Plasma soluble proteins [including but not limited to AFP, VEGF-A, VEGF-C, sVEGFR, HGF, sHGFR] - Plasma RNA transcripts associated with angiogenesis and tumor growth.
    - PFS - TTP - ORR - DR - CBR - Tipo,incidenza, gravità (classificata secondo il National Cancer Institute [NSC] Criteri per la Terminologia comune degli eventi avversi[CTCAE], versione 3.0),tempi,serietà, relazione degli eventi avversi e anomalie di laboratorio - analisi PK della popolazione con Axitinib - risultati (PRO) sulla qualità della vita e sintomi correlati alla malattia misurati scondo la Functional Assessment of Cancer Therapy - questionario epatobiliare (FACT-Hep) e stato di salute misurato con EuroQol EQ-5D Self-Report Questionnaire (EQ-5D). - proteine ​​plasmatiche solubili [compreso ma non limitato ad AFP, VEGF-A,VEGF-C,sVEGFR, HGF, sHGFR] - trascrizione di RNA plasmatico associato ad angiogenesi e crescita tumorale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Tumor assessment including CT/MRI will be required at baseline and every 8 weeks. Response (CR/PR) requires confirmation at least 4 weeks after the response is noted. • Safety assessment (for adverse events) will be carried out throughout the study and at the 28 day follow-up visit. • Axitinib Population PK analysis - assessed Day 1 of Cycle 1, 2 and 3 • Patient Reported Outcome (PRO) of health-related quality of life and disease-related symptoms as well as Health status will be assessed every 4 weeks during the study, end of treatment and at the 28 day follow-up visit. • Plasma soluble proteins will be assessed, at baseline, Cycle 2 Day 1 and end of treatment. • Plasma RNA transcripts will be assessed, at baseline, Cycle 2 Day 1 and end of treatment.
    •valutazione del tumore inclusa TC/RM sarà richiesta al basale e ogni 8 settimane. La risposta (CR/PR) richiede la conferma almeno 4 settimane dopo che la risposta è nota. -valutazione della sicurezza (per eventi avversi) sarà effettuata durante tutto lo studio e il giorno 28 alla visita di follow-up. - Analisi della popolazione PK con Axitinib, valutata al giorno 1 del ciclo 1, 2 e 3 -PRO di qualità di salute e di vita e i sintomi correlati alla malattia, nonché lo stato di salute verranno valutati ogni 4 settimane durante lo studio, alla fine del trattamento e al giorno 28 della visita di follow-up. -Le proteine plasmatiche solubili verranno valutate al basale, Giorno 1 del Ciclo 2 e alla fine del trattamento. -La trascrizione dell’RNA plasmatico sarà valutata al basale
    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 Yes
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    China
    Hong Kong
    Japan
    Korea, Democratic People's Republic of
    Korea, Republic of
    Singapore
    Taiwan
    Turkey
    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
    - Enrolment is completed according to protocol planned sample size, and assessments and requirements are completed as per protocol. - The stated objectives of the trial are achieved. - Recommendation by DMC.
    - Arruolamento completato in base alle dimensioni del campione previste dal protocollo, valutazioni e requisiti completati in accordo al protocollo. - sono raggiunti gli obiettivi dello studio indicati. - raccomandazioni dal DMC.
    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 months19
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months19
    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.1.1Number 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: 152
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 222
    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)
    n/a
    n/a
    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 Decision2011-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-20
    The status of studies in GB is no longer updated from 1.1.2021
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