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    Summary
    EudraCT Number:2017-004618-24
    Sponsor's Protocol Code Number:012018CONTROL
    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:2018-09-14
    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 number2017-004618-24
    A.3Full title of the trial
    Evaluation of CardioprOtection by the use of betablocker Nebivolol in paTients with bReast cancer Or diffuse Large B cell lymphoma undergoing chemotherapy with anthracyclines: a randomized controlled trial.
    Valutazione della cardioprotezione con il betabloccante nebivololo in pazienti con tumore della mammella o linfoma diffuso a cellule B sottoposti a chemioterapia con antracicline: studio randomizzato controllato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the protective effect on the heart of a betablocker drug, nebivolol, in patients with breast cancer or diffuse B-cell lymphoma for which anthracyclinic chemotherapy has been planned
    Valutazione dell'effetto di protezione sul cuore di un farmaco betabloccante, nebivololo, in pazienti con tumore della mammella o linfoma diffuso a cellule B per i quali è stata pianificata chemioterapia con antracicline
    A.3.2Name or abbreviated title of the trial where available
    Evaluation of CardioprOtection by the use of betablocker Nebivolol in paTients with bReast cancer Or
    Valutazione della cardioprotezione con il betabloccante nebivololo in pazienti con tumore della mamm
    A.4.1Sponsor's protocol code number012018CONTROL
    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 SponsorIRCCS ISTITUTO CLINICO HUMANITAS
    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 support
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCD Pharma Group S.r.l.
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressPiazza De Angeli 7
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20146
    B.5.3.4CountryItaly
    B.5.4Telephone number0289051076
    B.5.5Fax number0289051088
    B.5.6E-mailsimona.manzi@cdpharma.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 NEBIVOLOLO DOC GENERICI - 5 MG COMPRESSE "" 28 COMPRESSE IN BLISTER PVDC/PVC/AL
    D.2.1.1.2Name of the Marketing Authorisation holderDOC GENERICI SRL
    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.3.1Product nameNEBIVOLOLO
    D.3.2Product code NEBIVOLOLO
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNEBIVOLOLO
    D.3.9.1CAS number 99200-09-6
    D.3.9.2Current sponsor codeNEBIVOLOLO
    D.3.9.3Other descriptive nameNEBIVOLOLO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    To prevent cardiotoxicity of chemotherapeutic agents (anthracyclines)
    Prevenzione della cardiotossicità da chemioterapia (antracicline)
    E.1.1.1Medical condition in easily understood language
    To prevent cardiotoxicity of chemotherapeutic agents (anthracyclines)
    Prevenire la cardiotossicità da chemioterapia (antracicline)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10008444
    E.1.2Term Chemotherapy cardiotoxicity attenuation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of betablocker nebivolol on heart function in patients treated with anthracyclines.
    Valutare l’efficacia cardioprotettiva del betabloccante nebivololo nei pazienti sottoposti a chemioterapia con antracicline.
    E.2.2Secondary objectives of the trial
    Imaging endpoints:
    LVEF, Left ventricular diastolic function, myocardial fibrosis, right ventricular systolic function, left ventricular end-diastolic volume, left ventricular end-systolic volume, left ventricular mass.
    Biomarker endpoints:
    Serum troponin levels, serum BNP levels.
    Clinical endpoints:
    All-cause mortality, cardiovascular mortality, myocardial infarction, cerebrovascular events, and hospitalization for heart failure
    Endpoint di imaging:
    FEVS, funzione diastolica ventricolare sinistra, fibrosi miocardica, funzione sistolica ventricolare destra, volume telediastolico ventricolare sinistro, volume telesistolico ventricolare sinistro, massa ventricolare sinistra.
    Biomarcatori circolanti:
    Troponina, BNP.
    Endpoint clinici:
    Mortalità, mortalità per cause cardiovascolari, infarto miocardico, eventi cerebrovascolari, ospedalizzazioni per insufficienza cardiaca.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years
    2. Established histological diagnosis of BC or DLBCL
    3. Planned first-line chemotherapy with anthracyclines
    4. LVEF ≥55% (assessed by echocardiography)
    5. Ability to provide informed consent
    6. For women of childbearing potential a negative serum pregnancy is required before the inclusion in the study
    1. Età ≥18 anni
    2. Nota diagnosi di tumore della mammella o linfoma diffuso a cellule B
    3. In programma chemioterapia di prima linea con antracicline
    4. Funzione sistolica ventricolare sinistra nella norma (≥55% valutata con ecocardiografia)
    5. Firma del consenso informato
    6. Per donne in età fertile è necessario un test di gravidanza negativo prima dell’inclusione nello studio
    E.4Principal exclusion criteria
    1. Known intolerance/contraindications to betablocker therapy
    2. Known hypersensitivity to nebivolol or any of the excipients
    3. History of coronary artery disease
    4. History of cardiomyopathy
    5. History of heart failure
    6. Ongoing treatment with betablockers for other indications
    7. Heart rate <60 beats per minute
    8. Arterial blood pressure <100/60 mmHg
    9. Contraindications to undergo MRI (e.g., non compatible pacemakers or metallic prosthesis)
    10. Pregnancy or lactation
    11. Currently participating in another trial

    1. Nota intolleranza/controindicazione alla terapia betabloccante
    2. Ipersensibilità nota a nebivololo o ad uno qualsiasi degli eccipienti
    3. Cardiopatia ischemica nota
    4. Cardiomiopatia nota
    5. Storia di insufficienza cardiaca
    6. Terapia con farmaci betabloccanti già in corso
    7. Frequenza cardiaca <60 battiti per minuto
    8. Pressione arteriosa <100/60 mmHg
    9. Controindicazione alla risonanza magnetica (e.g., protesi metalliche, pacemaker non-compatibile)
    10. Gravidanza o allattamento
    11. Partecipazione ad altra sperimentazione clinica
    E.5 End points
    E.5.1Primary end point(s)
    Left ventricular ejection fraction (LVEF) reduction assessed by cardiac MRI at 12 months of follow-up. LVEF reduction is defined as the difference between LVEF at baseline and LVEF at 12 months follow-up.
    Riduzione della funzione sistolica ventricolare sinistra (FEVS) misurata con la risonanza magnetica cardiaca a 12 mesi di follow-up. La riduzione della FEVS è definita come la differenza tra la FEVS basale e la FEVS a 12 mesi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months follow-up
    12 mesi follow-up
    E.5.2Secondary end point(s)
    Imaging endpoints:
    LVEF, Left ventricular diastolic function, myocardial fibrosis, right ventricular systolic function, left ventricular end-diastolic volume, left ventricular end-systolic volume, left ventricular mass.
    Biomarker endpoints:
    Serum troponin levels, serum BNP levels.
    Clinical endpoints:
    All-cause mortality, cardiovascular mortality, myocardial infarction, cerebrovascular events, and hospitalization for heart failure
    Endpoint di imaging:
    FEVS, funzione diastolica ventricolare sinistra, fibrosi miocardica, funzione sistolica ventricolare destra, volume telediastolico ventricolare sinistro, volume telesistolico ventricolare sinistro, massa ventricolare sinistra.
    Biomarcatori circolanti:
    Troponina, BNP.
    Endpoint clinici:
    Mortalità, mortalità per cause cardiovascolari, infarto miocardico, eventi cerebrovascolari, ospedalizzazioni per insufficienza cardiaca.
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days, 6 months, 12 months
    30 giorni, 6 mesi, 12 mesi
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 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.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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 months36
    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 months36
    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: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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: 30
    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 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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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 subjects, at the end of the participation in the trial, will be followed according to the normal clinical practice
    I pazienti al termine della sperimentazione saranno seguiti in accordo alla normale pratica clinica.
    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 Decision2018-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-23
    P. End of Trial
    P.End of Trial StatusOngoing
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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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