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    Summary
    EudraCT Number:2011-005248-81
    Sponsor's Protocol Code Number:INT0111
    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:2011-12-28
    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 number2011-005248-81
    A.3Full title of the trial
    Differentiated thyroid cancer: metabolic radiotherapy with high activity of radioiodine calculated by individual pre-therapy dosimetry
    Carcinoma tiroideo differenziato: radioterapia metabolica con radioiodio ad attivita' massimizzata sulla base di dosimetria previsionale individuale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Therapy with high activity of radioiodine in patients bearing differentiated thyroid cancer
    Terapia con elevate attivita' di radioiodio in pazienti portatori di carcinoma tiroideo differenziato
    A.3.2Name or abbreviated title of the trial where available
    High activity of radioiodine
    Radioiodio ad elevate attivita'
    A.4.1Sponsor's protocol code numberINT0111
    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 SponsorISTITUTO NAZIONALE PER LA CURA TUMORI
    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 supportFondazione IRCCS Isttituto Nazionale dei Tumori
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Istituto Nazionale dei Tumori
    B.5.2Functional name of contact pointMedicina Nucleare
    B.5.3 Address:
    B.5.3.1Street AddressVia Venezian a
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number02 23902688
    B.5.5Fax number02 2367874
    B.5.6E-mailettore.seregni@istitutotumori.mi.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 nameiodine-131
    D.3.4Pharmaceutical form Capsule
    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 INNIODINE (131I) SODIUM
    D.3.9.1CAS number 7790-26-3
    D.3.9.4EV Substance CodeSUB12294MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mCi millicurie(s)
    D.3.10.2Concentration typenot less then
    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 Yes
    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 bearing differentiated thyroid carcinoma with distant metastases, candidated to metabolic radiotherapy after surgery or repetition of same therapy
    La popolazione in studio è costituita da pazienti con diagnosi di carcinoma tiroideo differenziato con metastasi a distanza, candidati a prima radioterapia metabolica con radioiodio dopo tiroidectomia o a ripetizione della stessa terapia.
    E.1.1.1Medical condition in easily understood language
    Patients having differentiated thyroid carcinoma metastatic candidated to therapy with radioiodine
    Pazienti portatori di carcinoma della tiroide differenziato metastatico candidati a terapia con radioiodio
    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 10055107
    E.1.2Term Thyroid cancer 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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    main objective of the study is the feasibility, the toxicity and the therapeutic efficacy of the treatment with elevated activities of radioiodine respect the scheme with fixed activities.
    Il presente progetto di ricerca si propone di valutare la fattibilità, la tossicità e l'efficacia terapeutica della radioterapia metabolica con attività massimizzata di radioiodio (131I) rispetto allo schema ad attività fisse.
    E.2.2Secondary objectives of the trial
    There aren't secondary objectives
    Non ci sono obbiettivi secondari
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - diagnosis of differentiated thyroid carcinoma - ECOG performance status of grade 0 or 1 - Age between 18 and 80 years old - Life expectancy of 3 months at least - Fertile women compliance to adopt contraceptive methods for at least 6 months after treatment -Adequate medullar reserve and renal functionality - Eventual second tumor in complete remission for 5 years at least - Signed informed consent
    •Diagnosi istopatologica di carcinoma differenziato della tiroide. •ECOG performance status di grado 0 o 1. •Età compresa tra 18 e 80 anni. •Aspettativa di vita di almeno 3 mesi. •Disponibilità delle donne in età fertile ad effettuare efficaci metodi contraccettivi per almeno 6 mesi dopo l'ultimo ciclo. •Adeguata riserva midollare e funzionalità renale •Eventuale secondo tumore in remissione completa da almeno 5 anni. •Consenso informato firmato dal paziente.
    E.4Principal exclusion criteria
    - Presence of serious concomitant non neoplastic diseases, not adequately controlled - Pregnancy or breast feeding - Impossibility to follow-up - Concomitant use of nephrotoxic drugs - Surgery or radiotherapy within 2 weeks from beginning of treatment - Pulmonary diffused micrometastases - Extensive skeletal metastases
    •Presenza di gravi malattie concomitanti non neoplastiche (cardiache, renali, epatiche, metaboliche), non adeguatamente controllate o controllabili. •Gravidanza od allattamento in atto. •Impossibilità ad effettuare il follow up. •Uso concomitante di farmaci nefrotossici. •Chirurgia e radioterapia mirata entro due settimane dall'inizio dello studio. •Micrometastasi polmonari diffuse (il polmone diviene l’organo critico) •Esteso interessamento metastatico allo scheletro.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of the therapeutic efficacy of the treatment with elevated activities
    Valutazione dell'efficacia terapeutica del trattamento con attività massimizzata
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical response is evaluated 6 months after treatment
    La valutazione della risposta viene effettuata dopo 6 mesi dal trattamento
    E.5.2Secondary end point(s)
    Evaluation of the feasibility of the pre-therapy dosimetry for the calculation of the administrable activity
    Valutazione della fattibilità della dosimetria pre-terapia per il calcolo dell'attività da somministrare
    E.5.2.1Timepoint(s) of evaluation of this end point
    During protocol
    Durante il protocollo
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 months54
    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: 10
    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 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 state20
    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)
    Patients that have ended theri participation in the trial continue follow-up with visits every three months.
    I pazienti al termine della loro partecipazione allo studio continueranno il follow-up con visite trimestrali
    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 Decision2012-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-30
    P. End of Trial
    P.End of Trial StatusOngoing
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