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    Summary
    EudraCT Number:2011-001288-32
    Sponsor's Protocol Code Number:I3CPh1-FSM-01.11
    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: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 number2011-001288-32
    A.3Full title of the trial
    A Pilot Study to Evaluate the Safety and Tolerability of the combination ot Trabectidin and Indole-3-Carbinol in refractory ER-positive metastatic breast cancer
    Studio pilota per valutare la sicurezza e la tollerabilita' della combinazione Trabectidina e Indolo-3-Carbinolo nel tumore metastatico della mammella,refrattario ER-positivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Preliminary Study to Evaluate the Safety and Tolerability of the combination ot Trabectidin and Indole-3-Carbinol in advanced breast cancer hormonal receptor positive who failed previous chemioterapy treatment
    Studio iniziale per valutare la sicurezza e la tollerabilita' della combinazione Trabectidina e Indolo-3-Carbinolo nel tumore della mammella con recettori ormonali positivi in fase avanzata,gia' trattato senza beneficio con terapie precedenti
    A.4.1Sponsor's protocol code numberI3CPh1-FSM-01.11
    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 SponsorFONDAZIONE SALVATORE MAUGERI - CLINICA DEL LAVORO E DELLA RIABILITAZIONE
    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 supportPharmamar
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Salvatore Maugeri, IRCCS
    B.5.2Functional name of contact pointUo Oncologia Medica I
    B.5.3 Address:
    B.5.3.1Street Addressvia Salvatore Maugeri, 10
    B.5.3.2Town/ cityPavia
    B.5.3.3Post code27100
    B.5.3.4CountryItaly
    B.5.4Telephone number0039-382-592676
    B.5.5Fax number0039-382-592650
    B.5.6E-mailalberto.zambelli@fsm.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 YONDELIS*EV 1FL POLV 1MG
    D.2.1.1.2Name of the Marketing Authorisation holderPHARMA MAR S.A.
    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 Concentrate for 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.3.8INN - Proposed INNTRABECTEDIN
    D.3.9.1CAS number 114899-77-3
    D.3.10 Strength
    D.3.10.1Concentration unit µg/m2 microgram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1300
    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 typeAntineoplastico di natura chimica
    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
    Refractory ER-positive metastatic breast cancer
    Carcinoma mammario metastatico e refrattario ER-positivo
    E.1.1.1Medical condition in easily understood language
    Hormonal receptor positive advanced brast cancer brast cancer who failed previous treatment
    Tumore mammario con recettori ormonali positivi in fase avanzata che non ha beneficiato di terapie precedenti
    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 10055113
    E.1.2Term Breast cancer metastatic
    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 determine the safety and tolerability of I3C when administered orally to patients receiving T for refractory ER-positive metastatic breast cancers, focusing on the potential modulation of T-induced hepatotoxicity
    Determinare la sicurezza e la tollerabilità di I3C quando somministrato per via orale a pazienti che ricevono T per un carcinoma mammario metastatico refrattario ER-positivo, concentrandosi sulla potenziale modulazione dell’epatotossicità indotta da T
    E.2.2Secondary objectives of the trial
    To compare pharmacokinetic parameters of T when given in combination with I3C at different doses. To perform a preliminary assessment of the anti-tumour activity of T and I3C combination in ER-positive metastatic breast cancer.
    Confrontare i parametri di farmacocinetica della T quando somministrata in associazione con I3C a diverse dosi
    Eseguire una valutazione preliminare dell’attività anti-tumorale della combinazione T e I3C nelle pazienti con carcinoma mammario metastatico ER-positivo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed, informed consent 2.Histologically or cytologically confirmed ER positive breast cancer refractory to standard therapy or for which no standard therapy exists 3.Recovered from all acute adverse effects of prior therapies (excluding alopecia and grade 1 neuropathy) 4.Adequate bone marrow, hepatic and renal function including the following a.Hb ≥ 9.0 g/dL, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥100 x 109/L b.Total bilirubin ≤ 1.5 x upper normal limit, excluding cases where elevated bilirubin can be attributed to Gilberts Syndrome c.AST (SGOT), ALT (SGPT) ≤ 2.5 x upper normal limit (or 5x UNL in the presence of liver metastases) d.Creatinine ≤ 1.5 x upper normal limit 5.Age ≥ 18 years 6.Performance status (PS) ≤ 2 (ECOG scale) 7.Estimated life expectancy greater than 3 months 8.Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to start of trial. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment. Acceptable methods of contraception include IUD, oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge)
    1.Consenso informato scritto firmato
    2.Carcinoma mammario ER positivo confermato citologicamente o istologicamente, refrettario ad una terapia standard o per cui non esiste una terapia
    3.Recupero da tutti gli eventi avversi clinicamente significativi correlati alle terapie pregresse (con l’esclusione di alopecia o neuropatia di I grado)
    4.Valori degli esami di laboratorio eseguiti allo screening che rientrano nei seguenti parametri:
    a.Hb ≥ 9.0 g/dL, conta assoluta dei neutrofili ≥ 1.5 x 109/L, conta delle piastrine ≥100 x 109/L
    b.Bilirubina totale ≤ 1.5 x limite superiore di normalità (ULN), esclusi i casi in cui un incremento della bilirubina può essere attribuita alla Sindrome di Gilbert
    c.AST (SGOT), ALT (SGPT) ≤ 2.5 x limite superiore di normalità (or 5x UNL in presenza di metastasi epatiche)
    d.Creatinina ≤ 1.5 x limite superiore di normalità (ULN)
    5.Età ≥ 18 anni
    6.Performance status (PS) ≤ 2 (scala ECOG)
    7.Aspettativa di vita superiore a 3 mesi
    8.Pazienti di sesso femminile potenzialmente fertili devono avere un test di gravidanza sierico negativo effettuato entro i 7 giorni precedenti all’inizio dello studio. Sia gli uomini che le donne devono accettare di utilizzare un metodo di contraccezione affidabile durante il periodo di trattamento e per 3 mesi dopo la sua interruzione. Metodi accettabili di contraccezione sono rappresentati dallo IUD, dai contraccettivi orali, dall’impianto sottocutaneo e dalla doppia barriera (preservativo con una spugna contraccettiva)
    E.4Principal exclusion criteria
    1.Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used e.g. 6 weeks for mitomycin or nitrosourea, 3 months for antibodies). In patients with progressive disease, bisphosphonates for bone disease and corticosteroids are permitted provided the dose does not change during the trial 2.Patients with a prior allogeneic haematopoietic stem cell transplant 3.Co-existing active infection or serious concurrent illness 4.Patients with significant cardiovascular disease as defined by: a.LVEF below the normal range at the study centre b.Uncontrolled hypertension c.A history of QTc abnormalities or with a mean QTc interval >450 msec at screening 5.Any medical or other condition that in the Investigator’s opinion renders the patient unsuitable for this study due to unacceptable risk 6.Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies 7.Gastrointestinal disorders that may interfere with absorption of the study drug. 8.Patients with known brain tumours or metastases should be excluded from this clinical trial because of their poor prognosis 9.More than 6 prior chemotherapy regimens 10.Patients requiring palliative radiotherapy within the last 4 weeks prior to study entry 11.Uncontrolled hypercalcaemia (>CTCAE v3 grade I) 12.Pregnant or breast-feeding women
    1.Terapia sistemica antineoplastica pregressa, comprendente chemioterapia, radioterapia, terapia endocrina, immunoterapia o altre terapie antineoplastiche in fase sperimentale entro 4 settimane precedenti l’ingresso nello studio (o un periodo più lungo dipendente dalle caratteristiche dei farmaci impiegati es. 6 settimane per la mitomicina e la nitrosurea, 3 mesi per gli anticorpi). Nei pazienti con progressione di malattia , i bifosfonati per le metastasi scheletriche e i corticosteroidi sono consentiti purché non si modifichi il dosaggio durante il periodo di studi
    2.Pazienti sottoposti a precedente di trapianto allogenico di cellule staminali
    3.Infezione attiva co-esistente o grave malattia concomitante
    4.Pazienti con disturbi cardiovascolari significativi come definito da:
    a.LVEF al di sotto del normale range proprio del Centro in cui si svolge lo studio
    b.Ipertensione non controllata
    c.Storia di anomalie del QTc o con un intervallo medio del QTc&gt;450msec allo screening
    5.Qualsiasi condizione medica o altre condizioni che secondo il parere dell’Investigatore rendono il paziente non idoneo a questo studio a causa di un inaccettabile rischio
    6.Disturbi psichiatrici o alterazioni dello stato mentale che precludono la comprensione del consenso informato e/o il completamento degli esami
    7.Patologia gastrointestinale che possa interferire con l’assorbimento del farmaco in studio.
    8.Pazienti con tumore cerebrale o con metastasi note a tale livello dovrebbero essere esclusi da questo protocollo a causa della loro cattiva prognosi
    9.Più di 6 precedenti regimi di chemioterapia
    10.Pazienti che necessitano di radioterapia nelle ultime 4 settimane precedenti all’ingresso nello studio
    11.Ipercalcemia non controllata (&gt;CTCAE v3 grade I)
    12.Donne in gravidanza o in allattamento
    E.5 End points
    E.5.1Primary end point(s)
    1. Hepatotoxicity through liver function control 2. Evaluation of hematologic and nonhematologic toxicities according to CTCAE version 3.0 criteria
    1. Misura dell'epatotossicità attraverso controllo di funzionalità epatica 2. Valutazione delle altre tossicità ematologiche e non ematologiche secondo i criteri CTCAE versione 3.0
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 28 days during treatment and every 3 months after treatment
    Ogni 28 giorni durante la terapia e ogni 3 mesi al termine del trattamento
    E.5.2Secondary end point(s)
    1. Measurement of T plasma concentration according to measures of pharmacokinetics during the first 2 cycles of treatment 2. Antitumor efficacy evaluation according to RECIST criteria after 3 and 6 cycles of treatment or whenever in the case of clinical progression
    1. Misura della concentrazione plasmatica di T secondo misure di farmacocinetica durante i primi 2 cicli di trattamento 2. Valutazione efficacia antitumorale secondo i criteri RECIST dopo il 3 e 6 ciclo di trattamento ovvero ogni volta in caso di progressione clinica
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 T0 2 1 min before the end of the 3 hours infusion 3 0.5 h after the end of infusion 4 1 h after the end of infusion 5 2 h after the end of infusion 6 6 h after the end of infusion “ “ 7 10-12 h after the end of infusion 8 24 h after the end of infusion 9 48 h after the end of infusion 10 72 h after the end of infusion ______________________________________ Antitumor efficacy evaluation according to RECIST criteria after the 3rd and 6th course of treatment or whenever in case of clinical progression
    1 T0, 2 1 min prima della fine della infusione di 3 ore, 3 0,5 h dopo la fine della infusione, 4 1 h dopo la fine dell'infusione, 5 2 ore dopo il termine dell'infusione, 6 6 ore dopo la fine dell'infusione "", 10-12 ore ore dopo il termine dell'infusione, 8 24 ore dopo il termine dell'infusione, 9 48 ore dopo la fine dell'infusione, 10 72 h dopo la fine dell'infusione
    ______________________________________
    Valutazione efficacia antitumorale secondo i criteri RECIST DOPO il 3o e 6o ciclo di Trattamento ovvero ogni volta in caso di progressione clinica
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    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
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial3
    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
    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 months24
    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: 13
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 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 state15
    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)
    According to the investigator advice the patients would recive standard treatment
    A giudizio dell'investigatore i pazienti riceveranno i trattamenti convenzionali
    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 Decision2011-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-18
    P. End of Trial
    P.End of Trial StatusOngoing
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