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    Summary
    EudraCT Number:2011-006234-16
    Sponsor's Protocol Code Number:INT003
    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:2012-03-05
    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 number2011-006234-16
    A.3Full title of the trial
    Evaluation of the efficacy of the tandem treatment [90Y-DOTA, TYR(3)]OCTREOTATE and [177Lu-DOTA, TYR(3)]OCTREOTATE in patients with neuroendocrine tumour expressing somatostatin receptors and refractory to conventional therapies
    VALUTAZIONE DELL'EFFICACIA DEL TRATTAMENTO ASSOCIATO [90Y-DOTA, TYR(3)]OCTREOTATE E [177Lu-DOTA, TYR(3)]OCTREOTATE, IN PAZIENTI CON NEOPLASIE NEUROENDOCRINE ESPRIMENTI RECETTORI PER LA SOMATOSTATINA REFRATTARIE AI TRATTAMENTI CONVENZIONALI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of neuroendocrine tumours with radiolabelled somatostatin analogues
    Trattamento dei tumori neuroendocrini con analoghi della somatostatina radiomarcati
    A.4.1Sponsor's protocol code numberINT003
    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 Istituto 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 pointTerapia Medico Nucleare
    B.5.3 Address:
    B.5.3.1Street AddressVia Venezian 1
    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 name177Lu-DOTA, TYR(3)OCTREOTATE
    D.3.2Product code 177Lu-DOTATATE
    D.3.4Pharmaceutical form Radiopharmaceutical precursor
    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 INNother therapeutic radiopharmaceuticals
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor code177Lu-DOTATATE
    D.3.9.3Other descriptive name177Lu-DOTA-Tyr-3-Octreotate
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number0
    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.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 name90Y-DOTA,TYR3-OCTREOTATE
    D.3.2Product code 90Y-DOTATATE
    D.3.4Pharmaceutical form Radiopharmaceutical precursor
    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 INNother therapeutic radiopharmaceuticals
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor code90Y-DOTATATE
    D.3.9.3Other descriptive name90Y-DOTA-Tyr-3-Octreotate
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number0
    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 neuroendocrine tumour expressing somatostatin receptors refractory to conventional therapies
    Pazienti portatori di neoplasia neuroendocrina esprimente recettori per la somatostatina refrattaria ai trattamenti convenzionali
    E.1.1.1Medical condition in easily understood language
    Neuroendocrine tumour in progression after conventional therapy
    Tumore neuroendocrino in progressione dopo terapia convenzionale
    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 10052399
    E.1.2Term Neuroendocrine tumour
    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 clinical efficacy and toxicity of the tandem treatment with 177Lu-DOTA-TATE and 90Y-DOTA-TATE
    Valutazione dell'efficacia clinica e della tossicità del trattamento con 177Lu-DOTA-TATE in associazione con 90Y-DOTA-TATE
    E.2.2Secondary objectives of the trial
    Evaluation of Time to Progression (TTP)
    Valutazione del tempo alla progressione (TTP)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histopathologic diagnosis of neuroendocrine tumour; TC or MRI scan within 3 months from enrollment; Nuclear medicine imaging showing an high expression of somatostatin receptors; ECOG performance status equal or lower than 2; Age over 18 years old; Measurableor evaluable disease; Adequate medullar reserve and renal functionality; Signed informed consent.
    Diagnosi istopatologica di tumore neuroendocrino (esclusi i microcitomi); Disponibilità in formato elettronico di una CT o MRI effettuata entro 3 mesi dal reclutamento; Scintigrafia con 111In-pentetreotide (OctreoScan) o PET con analoghi della somatostatina marcati con 68Ga, dimostranti una elevata espressione dei recettori per la somatostatina; ECOG performance status inferiore a 2; Età superiore ai 18 anni; Malattia misurabile o valutabile; Adeguata riserva midollare e funzionalità renale; Consenso informato firmato dal paziente.
    E.4Principal exclusion criteria
    Concomitant non neoplastc serious diseases not adequately controlled; Pregnancy or lactation; Surgery or radiotherapy within two weeks from beginning of treatment
    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; Chirurgia e radioterapia mirata entro due settimane dall'inizio dello studio;
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of the clinical efficacy of the treatment
    Valutazione dell'efficacia clinica del trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    One year from beginning treatment
    12 mesi dall'inizio del trattamento
    E.5.2Secondary end point(s)
    Evaluation of the time to progression
    Valutazione del tempo alla progressione
    E.5.2.1Timepoint(s) of evaluation of this end point
    There isn't a definided timepoint: TTP is calculated at the progression of the disease or at the death of the patient.
    Non vi è un tempo definito. Il TTP viene valutato al momento della progressione della malattia o della morte del paziente.
    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 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 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
    Efficacy will be defined after 6 months from intermediate evaluation and aafter 1 year from entering the study. cronic toxicity and TTP will be evaluated at the progression of the disease
    L'efficacia verrà definita in corrispondenza della rivalutazione a 6 mesi dalla valutazione intermedia e ad 1 anno dall'inizio del trattamento. I pazienti continueranno il monitoraggio per la tossicità a lungo termine e il TTP fino alla progressione
    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 months42
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state110
    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 will continue follow-up every 6 months till progression of disease
    I pazienti continueranno il follow up ogni 6 mesi fino a progressione della malattia
    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 Decision2012-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-31
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