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    Summary
    EudraCT Number:2011-006176-39
    Sponsor's Protocol Code Number:GOIM21001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2012-06-12
    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 number2011-006176-39
    A.3Full title of the trial
    Paclitaxel + Bevacizumab versus doxorubicina liposomiale non pegilata (Myocet), cyclophosfamide e Bevacizumab as the first line treatment in HER-2 negative metastatic breast cancer. Multicenter randomized Study of phase II
    PACLITAXEL + BEVACIZUMAB VERSUS DOXORUBICINA LIPOSOMIALE NON PEGILATA (MYOCET®), CICLOFOSFAMIDE E BEVACIZUMAB NEL TRATTAMENTO DI 1a LINEA NEL CARCINOMA MAMMARIO METASTATIZZATO HER-2 NEGATIVO -STUDIO MULTICENTRICO RANDOMIZZATO DI FASE II-
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Paclitaxel + Bevacizumab versus doxorubicina liposomiale non pegilata (Myocet), cyclophosfamide e Bevacizumab as the first line treatment in HER-2 negative metastatic breast cancer. Multicenter randomized Study of phase II
    PACLITAXEL + BEVACIZUMAB VERSUS DOXORUBICINA LIPOSOMIALE NON PEGILATA (MYOCET®), CICLOFOSFAMIDE E BEVACIZUMAB NEL TRATTAMENTO DI 1a LINEA NEL CARCINOMA MAMMARIO METASTATIZZATO HER-2 NEGATIVO -STUDIO MULTICENTRICO RANDOMIZZATO DI FASE II-
    A.3.2Name or abbreviated title of the trial where available
    Protocol GOIM 21001
    Protocollo GOIM 21001
    A.4.1Sponsor's protocol code numberGOIM21001
    A.5.4Other Identifiers
    Name:N° EUDRACTNumber:2011-006176-39
    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 SponsorGOIM GRUPPO ONCOLOGICO MERIDIONALE
    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 supportStudio no-profit
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGruppo Oncologico Italia Meridionale
    B.5.2Functional name of contact pointCentro dati GOIM (Data Manager)
    B.5.3 Address:
    B.5.3.1Street Addressvia delle Forze Armate 16
    B.5.3.2Town/ cityBari
    B.5.3.3Post code70126
    B.5.3.4CountryItaly
    B.5.4Telephone number0805555448
    B.5.5Fax number0805555440
    B.5.6E-mailcolucci@goim.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country 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 Injection
    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.3.9.1CAS number 33069-62-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 Yes
    D.3.11.13.1Other medicinal product typechemioterapico
    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 Yes
    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 Solution for injection
    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.3.9.1CAS number 216974-75-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeanticorpo monoclonale, farmaco a bersaglio molecolare
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country 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 Solution for injection
    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.3.9.1CAS number 50-18-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 Yes
    D.3.11.13.1Other medicinal product typechemioterapico
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country 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 Solution for injection
    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.3.9.2Current sponsor codemyocet
    D.3.9.3Other descriptive nameMyocet
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Yes
    D.3.11.13.1Other medicinal product typechemioterapico
    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
    metastatic breast cancer HER2 negative
    carcinoma mammario metastatizzato HER2 negativo
    E.1.1.1Medical condition in easily understood language
    metastatic breast cancer
    cancro alla mammella avanzato con presenza di metastasi
    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 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 value the activity of chemotherapic combinations in terms of objective response rate
    Obiettivo primario: valutare l’attività delle combinazioni chemioterapiche in termini di percentuale di risposte obiettive
    E.2.2Secondary objectives of the trial
    To value the quality of life, the tossicity of treatment (in particular the cardiotossity), the time to progression and the overall survival
    Obiettivi secondari: valutare la qualità della vita,la tossicità del trattamento (in particolare la cardiotossicità),valutare il tempo alla progressione e la sopravvivenza globale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    breast cancer HEr2 negative istologically confirmed
    • Carcinoma mammario Her2 neg istologicamente accertato
    •
    Età 18-70 anni
    • Stato di validità (WHO)  2
    • Malattia al IV stadio con presenza di almeno una lesione viscerale misurabile unidimensionalmente
    • Consenso Informato scritto
    E.4Principal exclusion criteria
    Bone metastasis as unic site of desease
    Previous chemotherapy for metastatic desease or concomitant therapy with hormonal agents or byotherapy
    Sintomatic cerebral metastasis
    Hipertension non controlled
    Psychic desease

    Cardiac desease, ictus,transient ischemic attack, TIA
    SNC desease
    Ipersensibility to bevacizumab or to agents of protocol
    • Metastasi ossee quale unica sede di malattia
    • Precedente chemioterapia per malattia metastatica o concomitante terapia con agenti ormonali o bioterapie• Metastasi cerebrali sintomatiche1. Ipertensione non adeguatamente controllata (definita come pressione arteriosa sistolica &gt;150 mmHg e/o pressione arteriosa diastolica &gt;100 mmHg) durante la terapia antipertensiva
    • Malattie psichiche precludenti l’ottenimento del consenso informato
    5. Anamnesi positiva per infarto miocardico o angina instabile nei 6 mesi precedenti il giorno 1 del ciclo 1
    6. Anamesi positiva per ictus o attacco ischemico transitorio (transient ischemic attack, TIA) nei 6 mesi precedenti il giorno 1 del ciclo 1
    7. Malattia nota del sistema nervoso centrale (SNC), ad esclusione delle metastasi cerebrali trattate Ipersensibilità nota ad uno qualsiasi dei componenti di bevacizumb o a uno dei farmaci in studio.
    E.5 End points
    E.5.1Primary end point(s)
    to value the activity of chemotherapic combinations in terms of objective response rate
    Obiettivo primario: valutare l’attività delle combinazioni chemioterapiche in termini di percentuale di risposte obiettive
    E.5.1.1Timepoint(s) of evaluation of this end point
    With an accettable tass of response non inferior to 62%, with a level of significativity of 5% and with a potency of 90%, 21 objective responses will be needed in the first 34 patients to consider active the combination of braccio B therapy.
    into second phase 36 patients will be needed.
    Ritenendo accettabile un tasso di risposte non inferiore al 62%, con un livello di significatività del 5% ed una potenza dell’90%, saranno necessarie 21 risposte obiettive nelle prime 34 pazienti arruolate per considerare attiva la combinazione del braccio B. Nel secondo stadio saranno necessarie ulteriori 36 pazienti per un totale quindi di 70 pazienti per braccio di trattamento
    E.5.2Secondary end point(s)
    To value the quality of life, the tossicity of treatment (in particular the cardiotossity), the time to progression and the overall survival
    Obiettivi secondari: valutare la qualità della vita, la tossicità del trattamento (in particolare la cardiotossicità), valutare il tempo alla progressione e la sopravvivenza globale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    the time of response, the time to progression and the overall survival will be calculated with Kaplan-Meier's method
    La durata della risposta, il tempo alla progressione e la sopravvivenza delle pazienti saranno calcolate con il metodo di Kaplan-Meier.
    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 Yes
    E.8.1.1Randomised Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned21
    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
    To value the activity of combination of arm B in terms of objective response, considering the arm A the control arm
    valutare l'attività in termini di risposte obiettive della combinazione del braccio B, considerando il braccio A come campione di calibrazione
    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 months18
    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: 70
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    incapable subjects to comprise the informative text and the informed consens
    soggetti incapaci di comprendere il testo e il significato del foglietto informativo
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    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)
    The partecipation to Study is volontary and the patient could retreat in every momente but the patient will receive the adeguated assistence.
    L'adesione al protocollo di ricerca è volontaria e potrà essere ritirata in qualsiasi momento.Qualora la paziente decidesse di non prendervi parte, questo non influirà sull'assistenza che riceverà.
    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 Decision2012-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-23
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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