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    Summary
    EudraCT Number:2013-004600-19
    Sponsor's Protocol Code Number:PAINTER01
    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:2013-12-09
    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 number2013-004600-19
    A.3Full title of the trial
    Multicenter, interventional, single-arm, phase IV study evaluating tolerability of Eribulin and its relationship with a set of polymorphisms in an unselected population of female patients with metastatic breast cancer
    Studio di fase IV, multicentrico, interventistico, a singolo braccio per la valutazione della tollerabilità dell’Eribulina e della sua associazione con alcuni polimorfismi in una popolazione non selezionata di donne con tumore mammario metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter, interventional, single-arm, phase IV study evaluating tolerability of Eribulin and its relationship with a set of polymorphisms in an unselected population of female patients with metastatic breast cancer
    Studio di fase IV, multicentrico, interventistico, a singolo braccio per la valutazione della tollerabilità dell’Eribulina e della sua associazione con alcuni polimorfismi in una popolazione non selezionata di donne con tumore mammario metastatico
    A.3.2Name or abbreviated title of the trial where available
    PAINTER: Polymorphism And INcidence of Toxicity in ERibulin treatment
    A.4.1Sponsor's protocol code numberPAINTER01
    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 SponsorAzienda Ospedaliera Fatebenefratelli e Oftalmico - Milano, Italy
    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 supportEISAI S.r.l.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera Fatebenefratelli e Oftalmico - Milano, Italy
    B.5.2Functional name of contact pointNicla La Verde
    B.5.3 Address:
    B.5.3.1Street AddressCorso di Porta Nuova, 23
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20121
    B.5.3.4CountryItaly
    B.5.4Telephone number+390263632223
    B.5.5Fax number+390263632216
    B.5.6E-mailnicla.laverde@fbf.milano.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.2.5The 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 nameEribulin mesylate
    D.3.4Pharmaceutical form Solution for injection/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 INNERIBULIN MESYLATE
    D.3.9.1CAS number 441045-17-6
    D.3.9.3Other descriptive nameERIBULIN MESYLATE
    D.3.9.4EV Substance CodeSUB31126
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.44
    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 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 with metastatic breast cancer
    Pazienti con carcinoma della mammella metastatico
    E.1.1.1Medical condition in easily understood language
    Patients with metastatic breast cancer
    Pazienti con tumore della mammella in fase metastatica
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study is primarily aimed at surveying the tolerability profile of Eribulin in an unselected population of patients with MBC in relation to toxicities already described in clinical trials, and neurotoxicity in particular.
    Questo studio ha come obiettivo primario la valutazione della tollerabilità di Eribulina nelle pazienti non selezionate con tumore mammario metastatico.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial include:
    •To study the relationship between specific genetic polymorphism and incidence and severity of peripheral neuropathy
    •To describe treatment efficacy in terms of duration of treatment and impact on survival.
    Obiettivi secondari sono la valutazione della compliance al trattamento e l’efficacia dello stesso.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
    1.Female patients ≥18 years
    2.Diagnosis of metastatic breast cancer
    3.Previous treatment with anthracyclines and taxanes
    4.Patients who will start Eribulin or who have already received only the first dose (cycle 1, day 1) of Eribulin according to the approved indication
    5.Ability to comply with sample collection
    6.Patient has signed the study Informed Consent Form (ICF) and the specific Pharmacogenetic ICF.
    7.Absence of any contraindication to treatment as in sections “Contraindication” “Special warning” and “Interaction with other medicinal product” of the Summary of product characteristics (SPC).
    −Donne con età > 18.
    −Diagnosi di neoplasia mammaria metastatica
    −Precedente trattamento con antracicline e taxani
    −Pazienti che inizieranno un trattamento con Eribulina o che hanno ricevuto la prima dose (ciclo 1, giorno 1) di Eribulina, secondo le indicazioni da scheda tecnica e la schedula approvate in Italia.
    −Volontà e capacità di ottenere i campioni previsti dallo studio.
    −Firma dei moduli di consenso informato dello studio e di consenso specifico alle analisi farmacogenetiche.
    −Assenza di controindicazioni al trattamento come indicato nelle sezioni “Controindicazioni”, “Avvertenze speciali” e “Interazioni con altri medicinali ed altre forme di interazione” riportati nel “Riassunto delle caratteristiche del prodotto”.
    E.4Principal exclusion criteria
    The presence of any of the following will exclude a subject from study enrollment:
    1.Previous treatment with Eribulin in a previous line of treatment
    2.Previous treatment with Eribulin off label
    −Pazienti pretrattate con Eribulina in precedenti linee di terapia.
    −Pazienti in trattamento con Eribulina off-label.
    E.5 End points
    E.5.1Primary end point(s)
    1.Incidence, time of onset, severity and duration of all Adverse Events (AEs) experienced during treatment with Eribulin (any grade), especially the most common AEs reported in previous clinical studies (asthenia/fatigue, neutropoenia, alopecia, nausea, peripheral neuropathy and constipation) but also other possible unexpected toxicities.
    1.Valutazione dell’incidenza, della severità e della durata di tutti gli eventi avversi (ogni grado) comparsi durante il trattamento con Eribulina, con particolare attenzione agli eventi più comuni riportati in studi clinici precedenti (astenia/fatigue, neutropenia, alopecia, nausea, neuropatia periferica e costipazione).
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the treatment untill 30 days after treatment discontinuation
    Durante il trattamento fino a 30 giorni dopo l'ultima somministrazione
    E.5.2Secondary end point(s)
    -Association between a set of selected polymorphisms and the onset of any grade peripheral neuropathy
    -Evaluation of quality of life during treatment using EORTC QLQ-C30 and QLQ-BR23 questionnaires.
    -Assessment of dose intensity and dose schedule maintenance.
    -DOT (Duration Of Treatment) and OS (Overall Survival).
    -Valutazione dell’associazione tra una serie di polimorfismi selezionati e la neuropatia periferica di qualsiasi grado, nelle pazienti che svilupperanno neurotossicità.
    -Valutazione della qualità di vita del paziente durante il trattamento, mediante la compilazione da parte delle pazienti dei questionari EORTC QLQ-C30 e QLQ-BR23.
    -Valutazione dell’intensità della dose e mantenimento della stessa.
    -Valutazione del tempo di durata del trattamento (DOT) e della sopravvivenza globale (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the treatment, untill 30 days after treatment discontinuation and untill death
    Durante il trattamento fino a 30 giorni dopo l'ultima somministrazione e fino al decesso
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial0
    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 concerned22
    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
    Last patient enrolled: approximately December 2015. Cycles with Eribulin mesylate will be repeted until progression of disease, unacceptable toxicity, patient refusal or medical decision.
    L'ultimo paziente verrà arruolato all'incirca a dicembre 2015. Il trattamento con Eribulina mesilatocontinuerà fino a progressione di malattia, tossicità inaccettabile, rifiuto del paziente o per decisione clinica.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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.1.1.1In 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: 200
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state200
    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)
    NONE
    NULLA
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-10
    P. End of Trial
    P.End of Trial StatusOngoing
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