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    Summary
    EudraCT Number:2015-002411-14
    Sponsor's Protocol Code Number:12576/15
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-04
    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 number2015-002411-14
    A.3Full title of the trial
    TRABECTEDIN SINGLE AGENT IN PARTIALLY PLATINUM SENSITIVE (PPS) RECURRENT OVARIAN CANCER (ROC) PATIENTS: A PROSPECTIVE, PHASE II STUDY
    Trabectedina in monoterapia in pazienti affette da recidiva di carcinoma ovarico parzialmente platino-sensibili: studio prospettico di fase II.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    nd
    nd
    A.3.2Name or abbreviated title of the trial where available
    nd
    nd
    A.4.1Sponsor's protocol code number12576/15
    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 POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    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 SA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPOLICLINICO GEMELLI
    B.5.2Functional name of contact pointUOC GINECOLOGIA ONCOLOGICA
    B.5.3 Address:
    B.5.3.1Street AddressL.GO A GEMELLI 8
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0630158545
    B.5.5Fax number0630157241
    B.5.6E-mailclinicaltrials@rm.unicatt.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 - 1 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 1 FLACONCINO
    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.3.1Product nameYondelis
    D.3.4Pharmaceutical form Powder for 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 INNTRABECTEDINA
    D.3.9.2Current sponsor codend
    D.3.9.3Other descriptive namend
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ovarian cancer
    carcinoma ovarico
    E.1.1.1Medical condition in easily understood language
    n
    nd
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051938
    E.1.2Term Ovarian adenocarcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of efficacy of single agent trabectedin in first line treatment in partially platinum-senstive recurrent ovarian cancer.
    valutazione dell'efficacia della trabectedina in monoterapia nel trattamento di prima linea nel trattamento del carcinoma ovarico parzialmente platino sensibile.
    E.2.2Secondary objectives of the trial
    Duration of response
    ¿ Progression-free survival
    ¿ Safety profile of trabectedin and Quality of Life (QoL) evaluation by EORTC-OV-28 questionnaire.
    Durata della risposta
    ¿ Progression-free survival
    ¿ Profilo di sicurezza di trabectedina e valutazione della qualit¿ di vita and (QoL) con il questionario EORTC-OV-28.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: MECHANISMS OF ACTION OF TRABECTEDIN IN OVARIAN CANCER

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Meccanismo di azione della trabectedina in tumori ovarici
    E.3Principal inclusion criteria
    1. Patients with partially platinum sensitive ovarian cancer (platinum-free interval 6-12 months) who have not received first line treatment.
    2. 18 years of age of older
    3. Patient’s written informed consent before any clinical trial specific procedures
    4. Measurable disease according to RECIST criteria
    5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
    6. Hematologic variables:
    • Hemoglobin = 9 g/dL
    • Absolute Neutrophils count (ANC) =1,500/µL
    • Platelets count =100,000/µL
    • Serum Creatinine = 1.5 mg/dL or Creatinine Clearance = 30 mL/min
    • Creatinine Phosphokinase (CPK) = 2.5 ULN
    • Hepatic function variables
    • Total Bilirubin = ULN.
    • Total Alkaline Phosphatase = 2.5 ULN
    • AST (serum aspartate transaminase [SGOT]) must be = 2.5 x ULN
    • ALT (serum alanine transaminase [SGPT]) must be = 2.5 x ULN
    • Albumin = 25 g/l.
    7. Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or lower
    1. Pazienti affette da prima recidiva di carcinoma ovarico parzialmente platino-sensibili (intervallo libero da platino 6-12 mesi).
    2. Età = 18 anni
    3. Consenso informato scritto della paziente prima di qualsiasi procedura specifica dello studio
    4. Malattia misurabile secondo criteri RECIST.
    5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) pari a 0-1
    6. Variabili ematologiche:
    • Emoglobina = 9 g/dL
    • Conta assoluta dei neutrofii (ANC) =1,500/µL
    • Conta piastrinica =100,000/µL
    • Creatinina = 1.5 mg/dL or Creatinina Clearance = 30 mL/min
    • Creatinin Fosfochinasi (CPK) = 2.5 ULN
    7. Variabili di funzionalità epatica:
    • Bilirubina totale = ULN.
    • Fosfatasi alcalina = 2.5 ULN
    • AST (SGOT) = 2.5 x ULN
    • ALT (SGPT) = 2.5 x ULN
    • Albumina = 25 g/l.
    8. Recupero da tossicità di precedent trattamenti al Grado 1 o normalità in accordo al NCI CTCAE.
    E.4Principal exclusion criteria
    1. Prior exposure to trabectedin
    2. Known hypersensitivity to any of the components of the trabectedin i.v. formulation or dexamethasone
    3. Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy
    4. History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 3 years or longer
    5. Known clinically relevant CNS metastases
    6. Other serious illnesses, such as: congestive heart failure or angina pectoris; myocardial infarction within 1 year before enrollment; uncontrolled arterial hypertension or arrhythmias.
    7. Psychiatric disorder that prevents compliance with protocol.
    8. Active viral hepatitis; or chronic liver disease.
    9. Active infection.
    10. Any other unstable medical conditions.
    1. Precedente trattamento con trabectedina
    2. Accertata ipersensibilità a qualsiasi componente della formulazione endovena di trabectedina o desametasone.
    3. Meno di 4 settimane dall’ultima dose di terapia con qualsiasi altro farmaco in studio o chemioterapico.
    4. Storia di alter malattie neoplastiche negli ultimi tre anni (eccetto carcinoma cutaneo basocellulare o carcinoma della cervice uterine in sede adeguatamente trattato)
    5. Presenza accertata di metastasi cerebrali.
    6. Altre malattie serie: scompenso cardiaco o angina pectoris; infarto del miocardio nell’anno precedente l’arruolamento nello studio; ipertensione arteriosa non controllata farmacologicamente o aritmie.
    7. Malattie psichiatriche che possano pregiudicare la compliance al trattamento in studio.
    8. Epatiti virali attive o malattie epatiche croniche.
    9. Infezioni attive.
    10. Qualsiasi altra instabile condizione medica.
    E.5 End points
    E.5.1Primary end point(s)
    evaluation of objective response rate to trabectedin by Response Evaluation Criteria in Solid Tumor (RECIST) (version 1.1) in recurrent partially platinum sensitive ovarian cancer patients
    valutazione del tasso di risposte obiettive secondo criteri RECIST (Response Evaluation Criteria in Solid Tumor (versione 1.1) in paziente affette da recidive di carcinoma ovarico parzialmente platino-sensibili.
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 months
    36 mesi
    E.5.2Secondary end point(s)
    Duration of response
    ¿ Progression-free survival
    ¿ Safety profile of trabectedin and Quality of Life (QoL) evaluation by EORTC-OV-28 questionnaire.
    Durata della risposta
    ¿ Progression-free survival
    ¿ Profilo di sicurezza di trabectedina e valutazione della qualit¿ di vita and (QoL) con il questionario EORTC-OV-28.
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 mesi
    36 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 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 No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state39
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 39
    F.4.2.2In the whole clinical trial 39
    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)
    clinical practice
    routine 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 Decision2015-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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