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    Summary
    EudraCT Number:2011-003202-24
    Sponsor's Protocol Code Number:mirta
    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:2012-03-08
    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 number2011-003202-24
    A.3Full title of the trial
    MULTICENTER ITALIAN STUDY ON THE CEUS ASSESSMENT OF RESPONSE OF COLORECTAL CANCER METASTASIS TREATED WITH AVASTIN.
    STUDIO MULTICENTRICO ITALIANO PER VALUTARE LA RISPOSTA ALLA TERAPIA CON AVASTIN DELLE METASTASI EPATICHE DA COLON RETTO CON ECOGRAFIA CON MEZZO DI CONTRASTO.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    evaluation of response of treatment by contrast enhanced ultrasound
    valutazione della risposta alla terapia con ecografia con mezzo di contrasto
    A.3.2Name or abbreviated title of the trial where available
    mirta
    mirta
    A.4.1Sponsor's protocol code numbermirta
    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 SponsorAZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
    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 supportBRACCO
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationA.O. Spedali Civili di Brescia
    B.5.2Functional name of contact pointCoordinamento Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressP.zza Spedali Civili 1
    B.5.3.2Town/ cityBrescia
    B.5.3.3Post code25123
    B.5.3.4CountryItaly
    B.5.4Telephone number0303996851
    B.5.5Fax number0303996125
    B.5.6E-mailcarmen.terraroli@spedalicivili.brescia.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 SONOVUE*1FL 8MCG+1SIR 5ML C/BI
    D.2.1.1.2Name of the Marketing Authorisation holderBRACCO SpA DIV.FARMACEUTICA
    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 Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNesafluoruro di zolfo
    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 µl/ml microlitre(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number8
    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
    hepatic colorectal metastasis treated with Folfiri+Avastin
    METASTASI EPATICHE DA COLON RETTO in trattamento chemioterapico con Folfiri+Avastin
    E.1.1.1Medical condition in easily understood language
    hepatic colorectal metastasis treated with Folfiri+Avastin
    METASTASI EPATICHE DA COLON RETTO in trattamento chemioterapico con Folfiri+Avastin
    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 HLT
    E.1.2Classification code 10027467
    E.1.2Term Metastases to specified sites
    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
    evaluation of early response to FOLFIRI+bevacizumab treatment by quantitative analysis of Contrast Enhanced US
    valutazione di risposta precoce al trattamento con FOLFIRI+bevacizumab per identificare parametri quantitativi all'esame eco-contrastografico
    E.2.2Secondary objectives of the trial
    na
    na
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    – Age  18 years – Diagnosis of histologically proven inoperable adenocarcinoma of the colon or rectum not suitable for curative-intent resection and candidate to receive CHT+BEV as first line treatment for advanced disease. – Eastern Cooperative Oncology Group-performance status (ECOG-PS) 0-1 The scale is attached below * – At least one liver lesion, measurable according to RECIST criteria and evaluable by CEUS. A CEUS evaluable lesion is defined as: 1. With acoustic window sufficient for adequate US examination of the liver 2. Not previously treated 3. With a diameter of 2 cm or more 4. With a necrosis <50% of total volume Written informed consent collected
    • Età≥18 anni • Diagnosi istologica di adenocarcinoma del colon o retto inoperabile • Performance status (scala ECOG) &lt;2 • Almeno una lesione epatica misurabile in accordo ai criteri RECIST e valutabile anche con CEUS. I criteri di valutabilità per la CEUS sono: a) una finestra acustica sufficiente ad un adeguato esame US del fegato; b) metastasi non ancora trattate; c) diametro della lesione ≥ 2 cm; d) volume in necrosi &lt; 50% del volume totale della lesione; • Impegno ad evitare una gravidanza qualora esista il rischio di concepimento • Dimostrazione della conoscenza ed adesione allo studio mediante firma del consenso informato. • Consenso informato firmato
    E.4Principal exclusion criteria
    – Previous chemotherapy for metastatic colorectal cancer (any). Adjuvant therapy is allowed if the chemotherapy treatment free interval is > 6 months – Known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue. – Recent Acute Coronary Syndrome (ACS) or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronarY artery intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders. - Right-to-left shunts, severe pulmonary hypertension (PAP >90 mmHg), uncontrolled systemic hypertension, and adult respiratory distress syndrome. – Pregnancy or lactation – Inadequate contraception (for both sexes) if of childbearing or procreation potential – Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
    • Malattia cardiovascolare in fase attiva (es: accidenti cerebrovascolari nei 6 mesi precedenti, infarto miocardico nell’anno precedente, ipertensione non controllata, reperti ECG significativi, angina instabile, aritmie importanti, malattia congestizia di grado NYHA≥2 • Scompenso respiratorio cronico o anamnesi positiva per ipertensione polmonare • Gravidanza o allattamento • Chemioterapia adjuvante conclusa da meno di 6 mesi dall’inizio del trattamento per la malattia avanzata.
    E.5 End points
    E.5.1Primary end point(s)
    to obtain pefusion parameters of contrast enhnaced US
    Ottenere parametri di perfusione tramite la CEUS
    E.5.1.1Timepoint(s) of evaluation of this end point
    2-4-8-12-16-20-24 weeks
    2-4-8-12-16-20-24 settimane
    E.5.2Secondary end point(s)
    na
    na
    E.5.2.1Timepoint(s) of evaluation of this end point
    na
    na
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned6
    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 months14
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 2012-03-08. 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 state75
    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)
    NOT NECESSARY FOR THE STUDY
    NON NECESSARIO PER LO STUDIO
    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 Decision2011-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-04
    P. End of Trial
    P.End of Trial StatusOngoing
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