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    Summary
    EudraCT Number:2011-006350-87
    Sponsor's Protocol Code Number:HORUS
    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:2012-03-19
    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 number2011-006350-87
    A.3Full title of the trial
    HydrOxychloRoqUine and Sorafenib in locally advanced or Metastatic Hepatocellular Carcinoma as First line therapy: a multi-center phase II trial
    Idrossiclorochina e Sorafenib nel carcinoma epatocellulare localmente avanzato o metastatico, come terapia di prima linea: uno studio multicentrico di fase II.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    clinical trial designed to demonstrate the efficacy of hydroxychloroquine and sorafenib as therapy in advanced hepatocellular carcinoma
    studio clinico volto a dimostrare efficacia dell'associazione idrossiclorochina e sorafenib come terapia dell'epatocarcinoma in fase avanzata
    A.3.2Name or abbreviated title of the trial where available
    HORUS
    A.4.1Sponsor's protocol code numberHORUS
    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 supportuniversita' campus bio-medico di roma
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNIVERSITA' CAMPUS BIOMEDICO 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 number06225411160
    B.5.5Fax number06225411933
    B.5.6E-mails.intagliata@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 Yes
    D.2.1.1.1Trade name PLAQUENIL*100CONF 200MG
    D.2.1.1.2Name of the Marketing Authorisation holderMAGGIONI 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 INNNA
    D.3.9.1CAS number 118-42-3
    D.3.9.2Current sponsor codeNA
    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 number155
    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
    ADVANCED HEPATOCELLULAR CARCINOMA
    EPATOCARCINOMA FASE AVANZATA
    E.1.1.1Medical condition in easily understood language
    ADVANCED HEPATOCELLULAR CARCINOMA
    TUMORE DEL FEGATO AVANZATO
    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 SOC
    E.1.2Classification code 10019805
    E.1.2Term Hepatobiliary disorders
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    efficacy
    EFFICACIA
    E.2.2Secondary objectives of the trial
    safety
    sicurezza
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients must have histologically confirmed metastatic or unresectable Hepatocellular carcinoma.
    • Patients must have at least one measurable site of disease according to RECIST criteria that has not been previously irradiated.
    • If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since radiation.
    • Male or female patients ≥18 years old.
    • Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
    • Child-Pugh A
    • Baseline MUGA or ECHO must demonstrate LVEF ≥ the lower limit of the institutional normal.
    • ECOG Performance Status of ≤2
    I pazienti devono avere CONFERMA ISTOLOGICA DI carcinoma epatocellulare non resecabile o metastatico.
    • I pazienti devono avere almeno un sito misurabile di malattia secondo i criteri RECIST che non sia stato precedentemente irradiato.
    • Se il paziente ha avuto una lesione precedentemente irradiata, è necessario un segno di progressione di malattia prima di iniziare trattamento.
    • pazienti maschi o femmine ≥ 18 anni.
    • Capacità di fornire il consenso informato scritto ottenuto prima di partecipare allo studio e le eventuali procedure previste.
    • Child-Pugh A
    • Baseline MUGA o ECHO deve dimostrare FEVS ≥ il limite inferiore del normale istituzionali.
    • ECOG performance status ≤ 2
    E.4Principal exclusion criteria
    • Prior treatment with a multi-kinase inhibitor or chemotherapy or antibody therapy.
    • Patients who have had major surgery or significant traumatic injury within 4 weeks of start of study drug patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
    • Prior treatment with any investigational drug within the preceding 4 weeks
    • Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed
    • Female patients who are pregnant or breast feeding or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days of the first administration of oral hydroxychloroquine and Sorafenib)
    • Un precedente trattamento con un inibitore multi-chinasi o la chemioterapia o la terapia con l'anticorpo.
    • I pazienti che hanno subito un intervento chirurgico maggiore o trauma significativo entro 4 settimane dalla partenza del farmaco in studio pazienti che non hanno recuperato dagli effetti collaterali di qualsiasi intervento di chirurgia maggiore (definito come richiede l'anestesia generale) o nei pazienti che possono richiedere interventi di chirurgia maggiore nel corso del lo studio
    • Un precedente trattamento con qualsiasi farmaco sperimentale nei precedenti 4 settimane
    • I pazienti in trattamento cronico, il trattamento sistemico con corticosteroidi o un altro farmaco immunosoppressivo. I corticosteroidi topici o per via inalatoria sono ammessi
    • Le pazienti che sono in gravidanza o allattamento o adulti di età fertile che non utilizzano efficaci metodi di controllo delle nascite. Se contraccettivi barriera sono utilizzati, questi devono essere continuato durante il processo da entrambi i sessi. Contraccettivi ormonali non sono accettabili come unico metodo di contraccezione. (Donne in età fertile deve avere un urine negative o test di gravidanza siero entro 7 giorni dalla prima somministrazione orale di idrossiclorochina e Sorafenib)
    E.5 End points
    E.5.1Primary end point(s)
    • Evaluation of clinical benefit
    Valutazione del beneficio clinico
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 months
    2 mesi
    E.5.2Secondary end point(s)
    • Evaluation of shrinkage rate
    • Evaluation of Progression Free Survival
    • Evaluation of Tumor Response Rate according to RECIST criteria
    • Determine the toxicity of adding hydroxychloroquine to standard first line therapy for stage IV Hepatocellular carcinoma
    • Valutazione del tasso di regressione
    • Valutazione del tasso di sopravvivenza libera da malattia
    • Valutazione del tasso di risposta tumorale in base ai criteri RECIST
    • Determinare la tossicità di idrossiclorochina aggiunta alla terapia standard di prima linea del carcinoma epatocellulare stadio IV
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 months
    2 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 Yes
    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 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 concerned2
    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 months36
    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: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 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)
    BEST SUPPORTIVE CARE
    MIGLIORE TERAPIA DI SUPPORTO
    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 Decision2012-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-06
    P. End of Trial
    P.End of Trial StatusOngoing
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