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    Summary
    EudraCT Number:2006-001949-34
    Sponsor's Protocol Code Number:E7389-G000-305
    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:2007-06-04
    Trial results View 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 number2006-001949-34
    A.3Full title of the trial
    A Phase III Open Label, Randomized Parallel Two-Arm Multi Center Study of E7389 versus ‘Treatment of Physician's Choice' in Patients with Locally Recurrent or Metastatic Breast Cancer, Previously Treated with At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane.
    A phase III Open Label, Randomised Parallel Two-Arm Multi Center Study of E7389 versus ``Treatment of Physician Choice`` in Patients with Locally Recurrent or Metastatic Breast Cancer, Previously Treated with at least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane.
    A.4.1Sponsor's protocol code numberE7389-G000-305
    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 SponsorEISAI LIMITED
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameBOLD
    D.3.2Product code E7389
    D.3.4Pharmaceutical form 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 INNBOLD
    D.3.9.1CAS number 441045-17-6
    D.3.9.2Current sponsor codeE7389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number1
    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 typeNon Applicabile
    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 with locally recurrent or metastatic breast cancer
    Pazienti con carcinoma mammario recidivato localmente o metastatico
    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 10021977
    E.1.2Term Inflammatory carcinoma of breast recurrent
    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
    The primary objective of this study is to compare Overall Survival (OS) in patients treated with E7389 versus the Treatment of Physician's Choice (TPC, see ‘Treatments' section for definition) in patients with locally recurrent or metastatic breast cancer.
    L'obiettivo principale di questo studio e' mettere a confronto la sopravvivenza globale (OS) nelle pazienti trattate con E7389 rispetto al trattamento di scelta del medico (TSM, vedere la sezione ‘Trattamenti' per la definizione) in pazienti con carcinoma mammario recidivato localmente o metastatico.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to assess:
    • Progression Free Survival (PFS)
    • Objective Tumor Response Rate as measured using RECIST
    criteria
    • Duration of Response
    • Safety Parameters (adverse events, laboratory parameters,
    concomitant medication, and study drug exposure)
    Gli obiettivi secondari consistono nella valutazione:
    • della sopravvivenza libera da progressione (PFS)
    • del tasso di risposta tumorale obiettiva misurata in base ai Criteri RECIST
    • della durata della risposta
    • dei parametri di sicurezza (eventi avversi,parametri di laboratorio,trattamenti concomitanti ed esposizione al farmaco in studio).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Female patients with locally recurrent or metastatic breast cancer
    who have received two to five prior chemotherapy regimens, which
    must have contained an anthracycline and a taxane component, at
    least 2 of which must have been given for locally recurrent or
    metastatic disease. Patients must have proved refractory to the most
    recent chemotherapy, documented by progression on or within six
    (6) months of therapy
    Patients with a known HER-2/neu over-expressing status may also
    have been treated with trastuzumab. Patients with estrogen receptor
    positive tumors may have been treated with anti-hormonals.
    Previous chemotherapy, radiation, trastuzumab or hormonal therapy
    must be discontinued three weeks before administration of E7389 or
    TPC.
    Pazienti di sesso femminile con carcinoma mammario recidivato localmente o metastatico che siano state sottoposte ad almeno due ma a non piu' di cinque regimi chemioterapici, comprensivi di un'antraciclina e di un taxano, almeno 2 dei quali somministrati per la malattia recidivata localmente o metastatica. Deve essere stata dimostrata la refrattarieta' delle pazienti alle piu' recenti chemioterapie, documentata dalla progressione durante o entro sei (6) mesi dalla terapia
    Le pazienti con una condizione accertata di iperespressione dell'HER-2/neu possono essere state trattate anche con trastuzumab. Le pazienti con positivita' del tumore per i recettori per gli estrogeni possono essere state trattate con farmaci antiormonali.
    La chemioterapia, la radioterapia, il trastuzumab o l'ormonoterapia somministrati in precedenza devono essere sospesi tre settimane prima della somministrazione dell'E7389 o del TSM.
    E.4Principal exclusion criteria
    1. Patients who have received any of the following treatments within the specified period
    before E7389 or TPC treatment start:
    -chemotherapy, radiation, trastuzumab or hormonal therapy within three weeks
    - any investigational drug within four weeks
    2. Radiation therapy encompassing > 30% of marrow (Appendix 6)
    3. Prior treatment with mitomycin C or nitrosourea
    4. Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring
    active treatment, including the use of oxygen
    5. Patients with brain or subdural metastases are not eligible, unless they have completed
    local therapy and have discontinued the use of corticosteroids for this indication for at
    least 4 weeks before starting treatment in this study. Any signs (e.g. radiologic) and/or
    symptoms of brain metastases must be stable for at least 4 weeks.
    6. Patients with meningeal carcinomatosis7. Patients who are receiving anti-coagulant therapy with warfarin or related compounds,
    other than for line patency, and cannot be changed to heparin-based therapy, are not
    eligible. If a patient is to continue on mini-dose warfarin, then the prothrombin time (PT)
    or international normalized ratio (INR) must be closely monitored.
    8. Women who are pregnant or breast-feeding; women of childbearing potential with either
    a positive pregnancy test at screening or no pregnancy test; women of childbearing
    potential unless (1) surgically sterile or (2) using adequate measures of contraception in
    the opinion of the Investigator. Perimenopausal women must be amenorrheic for at least
    12 months to be considered of non-childbearing potential.
    9. Severe/uncontrolled intercurrent illness/infection
    10. Significant cardiovascular impairment (history of congestive heart failure > NYHA
    grade II, unstable angina or myocardial infarction within the past six months, or serious
    cardiac arrhythmia) (Appendix 7)
    11. Patients with organ allografts requiring immunosuppression
    12. Patients with known positive HIV status
    13. Patients who have had a prior malignancy, other than carcinoma in situ of the cervix, or
    non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively
    treated &#8805; 5 years previously with no subsequent evidence of recurrence
    14. Patients with pre-existing neuropathy > Grade 2
    15. Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical
    derivative
    16. Patients who participated in a prior E7389 clinical trial
    17. Patients with other significant diseaseor disorders that, in the Investigator's opinion,
    would exclude the patient from the study
    1. Pazienti che, prima del periodo specificato di somministrazione di E7389 o TPC, abbiano ricevuto uno dei seguenti trattamenti:
    - chemioterapia, trattamento radiante, trastuzumeb od ormonoterapia tre settimane prima dell'arruolamento;
    - farmaci sperimentali nelle quattro settimane precedenrti l'arruolamento.

    2. Radioterapia midollare &gt;30%.

    3. Precedente terapia con mitomicina C o nitrosurea.

    4. Linfangite polmonare che comporti non adeguata funzionalita' polmonare e richieda trattamento farmacologico, compresa la somministrazione di ossigeno.

    5. Pazienti con metastasi cerebrali o subdurali, ad esclusione dei soggetti che abbiano completato la terapia locale o interrotto l'uso di corticosteroidi per questa indicazione per almeno 4 settimane prima dell'inizio dello studio. Qualsiasi evidenza (e.g. radiologica) e/o sintomi di metastasi cerebrali stabile per almeno 4 settimane.

    6. Pazienti con carcinomatosi meningea.

    7. Pazienti in terapia anticoagulante con warfarina o composti analoghi e che non possano passare a trattamento con eparina. Nel caso di soggetti che debbano proseguire warfarina a basso dosaggio e' necessario il monitoraggio stretto del tempo di protrombina (TP) e di INR.

    8. Donne in gravidanza o allattamento; donne in eta' fertile con positivita' al test di gravidanza o in assenza di test; donne in eta' fertile non sterilizzate chirurgicamente o che non usino adeguati metodi contraccettivi a giudizio dell'Investigatore.

    9. Grave/non controllata malattia/infezione ricorrente.

    10. Significativa patologia cardiovascolare (storia di scompenso cardiaco congestizio &gt; grado II NYHA, angina insatbile o infarto del miocardio nei 6 mesi precedenti l'arruolamento, o severa aritmia cardiaca) (Appendice 7).

    11. Pazienti con trapioanto d'organo che necessitino di terapia immunosoppressiva.

    12. Pazienti HIV positivi.

    13. Pazienti con precedente diagnosi di neoplasia, diversa da carcinoma della cervice in situ, o carcinoma della pelle non-melanoma, esclusa una precedente neoplasia diagnosticata e trattata in via defin itiva &gt;5 anni prima dell'arruolamento.

    14. Pazienti con pregressa neuropatia &gt; grado 2.

    15. Pazienti con ipersensitivita' ad alicondrina B e/o a derivati di alicondrina B.

    16. Pazienti che hanno precedentemente preso parte ad uno studio con E7389.

    17. Pazienti con altre patologie significative che, a giudizio dell'Investigatore, ne rendano necessaria l'esclusione.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival is the primary endpoint. The study will be declared
    positive, if at the final analysis, overall survival in the E7389 arm is
    statistically significantly better compared to the TPC arm (p<0.05).
    The p-value will be based on a two-sided, stratified log-rank test for
    the ITT population.
    La sopravvivenza globale e' l'endpoint principale. Lo studio sara' dichiarato positivo se all'analisi conclusiva la sopravvivenza globale nel braccio dell'E7389 sara' migliore in modo statisticamente significativo rispetto al braccio del TSM (p<0,05). Il valore p sara' riferito a un test log-rank stratificato, a due code, per la popolazione ITT.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    trattamento di scelta del medico
    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 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 Information not present in EudraCT
    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
    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 months39
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months39
    E.8.9.2In all countries concerned by the trial 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.1.3Elderly (>=65 years) Yes
    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 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 630
    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 Decision2007-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-31
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