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    Summary
    EudraCT Number:2017-000987-14
    Sponsor's Protocol Code Number:TRAMANT-01
    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:2021-09-06
    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 number2017-000987-14
    A.3Full title of the trial
    Phase II Study: Maintenance therapy with Trabectedin after combination therapy Liposomal Doxorubicin plus Trabectedin vs Liposomal Doxorubicin plus Trabectedin in patients affected by relapsed ovarian cancer recurring between 6 and 12 months after platinum based chemotherapy.
    Studio di fase II:
    Terapia di mantenimento con Trabectedina dopo terapia di combinazione con Doxorubicina Liposomiale e Trabectedina verso terapia di combinazione con Doxorubicina Liposomiale e Trabectedina in pazienti affetti da carcinoma ovarico recidivato tra 6 e 12 mesi dopo chemioterapia a base di platino.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Maintenance therapy with Trabectedin after combination therapy Liposomal Doxorubicin plus Trabectedin vs Liposomal Doxorubicin plus Trabectedin in patients affected by relapsed ovarian cancer.
    Studio di fase II:
    Terapia di mantenimento con Trabectedina dopo terapia di combinazione con Doxorubicina Liposomiale e Trabectedina in pazienti affetti da carcinoma ovarico.
    A.3.2Name or abbreviated title of the trial where available
    TRAMANT-01
    TRAMANT-01
    A.4.1Sponsor's protocol code numberTRAMANT-01
    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 PER L'EMERGENZA CANNIZZARO
    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 supportPharma Mar SA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGB PHARMA SERVICES & CONSULTING SRL-SOCIETA' UNIPERSONALE
    B.5.2Functional name of contact pointRicerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Ferreri 11
    B.5.3.2Town/ cityPavia
    B.5.3.3Post code27100
    B.5.3.4CountryItaly
    B.5.4Telephone number0382530676
    B.5.5Fax number0382302619
    B.5.6E-mailinfo@gbpharmaservices.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 nameTrabectedina
    D.3.2Product code [Trabectedina]
    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.3.9.1CAS number 114899-77-3
    D.3.9.2Current sponsor codeTrabectedina
    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 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
    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
    Ovarian tumour
    Tumore ovarico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10033160
    E.1.2Term Ovarian epithelial cancer 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
    Progression free survival.
    To demonstrate non inferiority (PFS) of Trabectedin maintenance therapy vs combination arm with liposomal doxorubicin (PLD) and Trabectedin after a common treatment with 6 cycles of (PLD) and Trabectedin.
    Intervallo libero da progressione (PFS);
    Dimostrare la non inferiorità della terapia di mantenimento con Trabectidina vs il braccio di terapia combinata con Doxorubicina liposomiale pegilata (PLD) e Trabectdina dopo un trattamento comune di 6 cicli di PLD e Trabectidina
    E.2.2Secondary objectives of the trial
    OS;
    Safety;
    Role of CA 125 as a predictor of response;
    Role of PET/CT as a detector of early response;
    To compare Quality of life (QoL) in each arm using the European Organization for Reserch and Treatment of Cancer (EORTC) Quality of Life Questionaire C30 and Quality of life.
    Sopravvivenza generale (OS);
    Sicurezza;
    Ruolo del CA 125 come predittore della risposta;
    Ruolo della PET/CT come rilevatore delle risposte precoci;
    Comparare la qualità della vita (QoL) in ogni braccio sperimentale utilizzando il questionario sulla qualità della vita C30 dell’ Organizzazione Europea per la Ricerca e il Trattamento dei Tumori (EORTC) e il Questionario della Qualità della vita 0V28
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically and/or cytologically proven epithelial ovarian, epithelial fallopian tube cancer or primary peritoneal cancer
    - Female, Age = 18 years
    - Indication for chemotherapy
    - No more of 3 previous lines of chemotherapy
    - Life expectancy of more of 3 months
    - Presense of CVC
    - Completion of n 6 cycles of combined therapy of Liposomal Doxorubincin plus Trabectidine
    - Stable disease, partial response, complete response confirmed by radiological imaging, such as magnetic resonance imaging (MR1), computed tomography (CT) scan, or PET/CT scan, after n. 6 cycles of combined therapy of Liposomal Doxorubincin plus Trabectidine
    - Relapsed ovarian cancer with a progression free interval of six and twelve (6-12) months (calculated from the first day of the last cycle of the last platinum-based chemotherapy until the date of progression confirmation through radiologic imaging). Patients may have received up to three platinum-based chemotherapy lines, of which at least one must have contained a taxane
    - Measurable or evaluable disease confirmed by radiological imaging, such as magnetic resonance imaging (MR1), computed tomography (CT) scan, or PET/CT scan at study entry (CA -125 rise not supported by radiological evidence of disease is not accepted as criteria for defining progression) or histological proven recurrent ovarian cancer even in the absence of postoperatively measurable or evaluable lesions
    - Eastern Cooperative Oncology Group (ECOG) performance status (PS)=2
    - Patients must be accessible for treatment and follow-up
    - Adequate organ Function within 14 days prior to first cycle as evidenced by:
    A. Peripheral blood counts and serum chemistry values:
    • Hemoglobin=9 g/dl
    • Absolute neutrophil count (ANC) =1,500
    • Platelet count = 100,000
    • Estimated glomerular filtration rate = 60 ml/min according to the Cockroft-Gault formula
    • Creatine phosphokinase (CPK) = 2.5 x ULN
    B. Hepatic function variables:
    • Total bilirubin = ULN
    • Total alkaline phosphatase = 2.5 ULN (consider hepatic isoenzymes of 5-nucleotidase or GGT if the elevation could be osseous in origin)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be = 2.5 x ULN
    - All randomized patients must be able to receive dexamethasone or its equivalent,
    - Informed consent of the patient obtained within the 6th chemo-cycle and before any study-specific procedure
    - Determination of BRCA 1 and BRCA 2 mutation within the screening visit
    - Conferma citologica e / o istologica di carcinoma epiteliale ovarico, carcinoma epiteliale alla tube di falloppio o carcinoma peritoneale primario
    - Donna, età = 18 anni
    - Indicazione per chemioterapia
    - Non più di 3 precedenti linee di chemioterapia
    - Aspettativa di vita maggiore di 3 mesi
    - Presenza di CVC
    - Completamento di n 6 cicli di terapia combinata di Doxorubicina Liposomiale più Trabectedina
    - Malattia stabile, risposta parziale, risposta completa confermata da immagini radiologiche, come la risonanza magnetica (MRI), tomografia computerizzata (TC), o PET / TAC, dopo n. 6 cicli di terapia combinata di Doxorubincin liposomiale più Trabectedina
    - carcinoma ovarico recidivante con un intervallo libero progressione di sei e dodici (6-12) mesi (calcolato a partire dal primo giorno dell'ultimo ciclo dell'ultima chemioterapia a base di platino fino alla data di conferma progressione attraverso l'immagine radiologica). I pazienti possono aver ricevuto fino a tre linee di chemioterapia a base di platino, di cui almeno uno doveva contenere un taxano
    - Lesione misurabile o valutabile, confermata da immagini radiologiche come la risonanza magnetica (MR1), tomografia computerizzata (TC), o PET / TC all'inizio dello studio (innalamento di CA -125 non supportata da evidenza radiologica di malattia non è accettato come criteri per la definizione progressione) o carcinoma ovarico recidivante comprovato istologicamente anche in assenza di lesioni misurabili o valutabili dopo l'intervento.
    - Eastern Cooperative Oncology Group (ECOG) performance status (PS)=2
    - I pazienti devono essere accessibili per il trattamento e il follow-up
    - Adeguata funzionalità d’organo nei 14 giorni prec edenti il primo ciclo come indicato da:
    o A. sangue periferico e valori di chimica del siero:
    ¿ Hemoglobina =9 g / dl
    ¿ Conta assoluta dei neutrofili (ANC) =1,500
    ¿ Conta piastrinica = 100.000
    ¿ Velocità di filtrazione glomerulare stimata = 60 ml / min secondo la formula di Cockroft-Gault
    ¿ Creatina (CPK) = 2,5 x ULN
    o Variabili della funzione epatica: B.
    o Bilirubina Totale = ULN
    o Fosfatasi alcalina totale = 2,5 ULN (considerare gli isoenzimi epatici su 5-nucleotidasi o GGT se l'innalzamento possa essere di origine ossea)
    o Aspartato aminotransferasi (AST) e alanina aminotransferasi (ALT) devono essere = 2,5 x ULN
    - Tutti i pazienti randomizzati devono essere in grado di ricevere desametasone o equivalente
    - Consenso informato del paziente ottenuto entro il 6 ° chemio-ciclo e prima di qualsiasi procedura specifica per lo studio
    - Determinazione delle mutazioni BRCA 1 e BRCA 2 entro la visita di screening
    E.4Principal exclusion criteria
    - Non epithelial ovarian or mixed epithelial/non epithelial tumors (e.g., Mullerian tumors)
    - Previous or concomitant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix)
    - ECOG Performance status =3
    - Heart disease (congestive heart failure, myocardic infarction, atrioventricular block of any grade, severe arrhythmias)
    - Prior exposure to trabectedin
    - Prior resistance to anthracyclines or PLD defined as a progression: during anthracycline-based chemotherapy or a recurrence within 6 months from its ending
    - Prior severe PLD related toxicity
    - Prior exposure to cumulative doses of doxorubicin >400mg/m² or epirubicin >720mg/m²
    - Treatment with any investigational product within 30 days prior to inclusion in the study
    - Patients who did not respond to last platinum-based therapy or in whom last relapse occurred < 6 months or > 12 months from the last dose of platinum
    - Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain metastases
    - Pre-existing grade > 1 motor or sensory neuropathy according to the National Cancer Institute Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 4.0
    - History of liver disease
    - Concurrent severe medical problems or any unstable medical condition unrelated to malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
    - Breastfeeding or pregnant women. Women of child bearing potential must use effective contraception during treatment and 3 months thereafter, which may include prescription contraceptives (oral, injection, or patch), intrauterine device, double-barrier method or male partner sterilization (not applicable to patients that are surgically sterile)
    - Tumori non epiteliale ovarico o misto epiteliale / non epiteliali (ad esempio, i tumori Mulleriani)
    - Malignità precedente o concomitante (escluso carcinoma baso o squamocellulare carcinoma della pelle adeguatamente trattato e carcinoma in situ della cervice)
    - Performance stato ECOG =3
    - Malattie cardiache (insufficienza cardiaca congestizia, infarto miocardico, blocco atrioventricolare di qualunque grado, gravi aritmie)
    - Precedente esposizione alla trabectedina
    - Precedente resistenza alle antracicline o PLD definita come progressione durante chemioterapia a base di antracicline o recidiva entro 6 mesi dalla sua fine
    - Precedente tossicità grave relativa a PLD
    - Precedente esposizione a dosi cumulative di doxorubicina > 400mg / m² o epirubicina > 720mg / m²
    - Trattamento con qualsiasi prodotto sperimentale nei 30 giorni precedenti l'inclusione nello studio
    - Pazienti che non hanno risposto all’ultima terapia a base di platino o in cui l’ultima ricaduta si è verificata < 6 mesi o > 12 mesi dall'ultima dose di platino
    - Occlusione intestinale, malattia sub-occlusiva o la presenza di metastasi cerebrali sintomatiche
    - Pre-esistente neuropatia motoria o sensoriale di grado> 1 secondo il National Cancer Institute Common Toxicity Criteria Adverse Event (NCI-CTCAE) versione 4.0
    - Storia di malattia epatica
    - Gravi problemi di salute concomitanti o qualsiasi condizione medica instabile non correlata alla malignità, che potrebbero limitare in modo significativo la piena conformità con lo studio o esporre il paziente a un rischio estremo o diminuzione dell’aspettativa di vita
    - Donne in gravidanza o allattamento. Donne in età fertile devono utilizzare un metodo contraccettivo efficace durante il trattamento e nei 3 mesi successivi, che possono includere metodi contraccettivi (orale, iniezione, o patch), dispositivo intrauterino, metodo a doppia barriera o la sterilizzazione del partner maschile (non applicabile ai pazienti che sono chirurgicamente sterili)
    E.5 End points
    E.5.1Primary end point(s)
    To demonstrate non inferiority of Trabectedin maintenance therapy vs combination arm with liposomal doxorubicin (PDL) and Trabectedin after a common treatment with 6 or 8 cycles of PDL and Trabectedin .
    Dimostrare la non inferiorità della terapia di mantenimento con Trabectedina vs braccio di combinazione con Doxorubicina Liposomiale (PDL) e Trabectedina dopo un comune trattamento con 6 o 8 cicli di PDL e Trabectedina.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Progression Free Survival (PFS) will be measured from the date of 1th cycle to the date of documented PD or death (regardless of cause of death).
    La Progression Free Survival (PFS) sarà calcolata dalla data del primo ciclo alla data di progressione documentata o morte (indipendentemente dalla causa di morte).
    E.5.2Secondary end point(s)
    Objective RR will be the best response obtained in any evaluation according to RECIST 1.1
    CA-125 serological response will be the best response obtained in each arm according to Rustin criteria.
    Investigate the role of PET/CT as a detector of early response.
    Overall survival will be evaluated in both arms.
    RR obiettivo sarà la migliore risposta ottenuta in ciascuna valutazione secondo i criteri RECIST 1.1
    Risposta CA-125 sierologico sarà la migliore risposta ottenuta in ciascun braccio in accordo con i criteri Rustin.
    Indagare il ruolo di PET / CT come rivelatore di risposta precoce.
    La sopravvivenza generale sarà valutata in entrambi i bracci.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From the date of 1th cycle to the date of documented PD or death (regardless of cause of death).
    Dalla data del primo ciclo alla data di progressione documentata o morte (indipendentemente dalla causa di morte)
    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) 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 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
    Standard terapeutico: stesso farmaco (Trabectedina) in combinazione con Doxorubicina Liposomiale
    therapeutic standard: same drug (Trabectedin) in combination with Liposomal Doxorubicin.
    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 concerned25
    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 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 years5
    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 years5
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 130
    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)
    At the end of treatment, the patients will be followed by the physician and treated as clinical practice for the disease
    Al termine del trattamento in studio i pazienti verranno seguiti dal medico curante e trattati come da pratica clinica per la patologia in essere
    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 Decision2017-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-11
    P. End of Trial
    P.End of Trial StatusOngoing
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