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    Summary
    EudraCT Number:2015-005153-12
    Sponsor's Protocol Code Number:MITO26
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-15
    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 number2015-005153-12
    A.3Full title of the trial
    Phase II trial on trabectedin in the treatment of advanced uterine and ovarian carcinosarcoma (Cs) – MITO 26
    Studio di Fase II con Trabectedina nel trattamento del carcinosarcoma ovarico o uterino in stadio avanzato – MITO 26
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II trial on trabectedin in the treatment of advanced uterine and ovarian carcinosarcoma (Cs)
    Studio di Fase II con Trabectedina nel trattamento del
    carcinosarcoma ovarico o uterino in stadio avanzato
    A.3.2Name or abbreviated title of the trial where available
    MITO 26
    MITO 26
    A.4.1Sponsor's protocol code numberMITO26
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    A.5.4Other Identifiers
    Name:MITO 26Number:MITO 26
    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 supportPharma Mar Srl Italy
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDirezione Scientifica IRCCS Policlinico A. Gemelli
    B.5.2Functional name of contact pointScientifica IRCCS Policlinico A. Ge
    B.5.3 Address:
    B.5.3.1Street AddressLargo Agostino Gemelli 8
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0630155701
    B.5.6E-maildirezione.scientifica@policlinicogemelli.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.3.2Product code [YONDELIS]
    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 codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    advanced ovarian and uterine carcinosarcoma
    carcinosarcoma ovarico o uterino in stadio avanzato
    E.1.1.1Medical condition in easily understood language
    advanced ovarian and uterine carcinosarcoma
    carcinosarcoma ovarico o uterino in stadio avanzato
    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 10052204
    E.1.2Term Ovarian carcinosarcoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10007508
    E.1.2Term Carcinosarcoma uterus
    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
    To determine the activity in terms of objective response rate by RECIST version 1.1 (Complete and Partial Response [CR + PR]) with trabectedin in patients advanced uterine and ovarian carcinosarcoma
    Valutare l’attività della Trabectedina in termini di risposta secondo RECIST versione 1.1 (Risposta Completa e parziale [CR + PR]) nelle pazienti con carcinosarcoma ovarico o uterino in stadio avanzato.
    E.2.2Secondary objectives of the trial
    •Progression-free survival [the diagnosis of progression will be assessed by radiological criteria; CA 125 increases alone (GCIG criteria of progression) will not be considered as progression of disease without a radiological confirmation of progression].
    •Overall survival
    •Duration of response
    •Toxicity profile of trabectedin in this patient population
    •Sopravvivenza libera da progressione [la diagnosi di progressione sarà valutata secondo criteri radiologici; un solo aumento di CA-125 (secondo i criteri di progressione GCIG) non sarà considerata come progressione di malattia, senza una conferma radiologica di progressione]
    •Sopravvivenza Globale
    •Durata della risposta
    •Profilo di tossicità del farmaco nella popolazione di pazienti
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Histologically documented Stage I-IV or recurrent uterine or ovarian carcinosarcoma not amenable to surgery or radiotherapy
    -No more than 2 previous chemotherapy lines
    -PS 0-2 (ECOG)
    -Age> 18
    -Measurable disease
    -Life expectancy of at least 3 months
    -Adequate organ functions:
    a) Hematopoietic; Absolute neutrophil count = 1,500/mm^3; Platelet count = 100,000/mm^3; Hemoglobin = 9 g/dL
    b) Hepatic; AST and ALT = 1.5 times upper limit of normal (ULN)* ; Alkaline phosphatase = 2.5 times ULN* ; Bilirubin = 1.5 times ULN NOTE: * = 3 times ULN if liver metastases are present
    c) Renal; Creatinine Clearance = 45 mL/min or Serum Creatinine =1.5 x ULN
    d) Serum Albumin >3.0 g/dL
    -Previous Brachytherapy treatment for uterine carcinosarcoma is allowed
    -No other invasive malignancy within the past 3 years except non-melanoma skin cancer
    -Written Informed Consent
    -Recidiva di carcinosarcoma ovarico o uterino stadio I-IV, non suscettibili di intervento chirurgico o radioterapia, istologicamente documentato.
    -Non più di due precedenti linee di chemioterapia
    -Performance status 0-2 (ECOG)
    -Pazienti con età = 18 anni
    -Malattia misurabile
    -Aspettativa di vita di almeno 3 mesi
    -Adeguate funzionalità d’organo, definite come di seguito:
    a) Emopoietica; Neutrofili in valore assoluto = 1,500/mm3; Piastrine = 100,000/mm3; Emoglobina = 9 g/dl
    b) Epatica; AST e ALT = 1.5 x ULN (upper limit normal)*; Fosfatasi Alcalina = 2.5 x ULN* ; Bilirubina = 1.5 x ULN N.B.: * = 3 x ULN se presenza di metastasi epatiche
    c) Renale; Creatinine Clearance = 45 ml/min o Creatinina sierica =1.5 x ULN
    d) Albumina >3.0 g/dL
    -È consentito un precedente trattamento di radioterapia per carcinosarcoma uterino
    -Nessuna altra malignità di rilevanza prognostica negli ultimi 3 anni, fatta eccezione per melanoma in situ
    -Firma del consenso informato
    E.4Principal exclusion criteria
    -More than 2 previous chemotherapy lines
    -Single tumor lesion inside a previous irradiated filed
    -Pregnant (potentially fertile patients must be not in pregnancy during and for at least 3 months after study participation and must have a negative serum pregnancy test)
    -Active infection requiring antibiotics
    -Symptomatic peripheral neuropathy > grade 2 according to the NCI Common Toxicity Criteria.
    -Congestive heart failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia.
    -Unstable or severe intercurrent medical condition that, in the opinion of the investigator, might interfere with achievement of study objectives
    -Psychological or sociological conditions, addictive disorders, or family problems, which would preclude compliance with the protocol
    -Più di due precedenti linee di chemioterapia
    -Lesioni tumorali singole e precedentemente irradiate
    -Gravidanza ( le pazienti potenzialmente fertili devono evitare una gravidanza durante tutta la durata dello studio e per almeno 3 mesi successivi alla fine del trattamento ed effettuare un test di gravidanza su siero negativo)
    -Infezioni attive che richiedono antibiotici
    -Neuropatia periferica sintomatica > grado 2 in accordo ai criteric NCI (Common Toxicity Criteria)
    -Insufficienza cardiaca congestizia o angina pectoris anche se medicalmente controllate. Precedente storia di infarto miocardico nell’anno precedente l’ingresso in studio, ipertensione non controllata ad alto rischio o aritmia.
    -Instabile o grave condizione medica, che a giudizio dello sperimentatore, potrebbe interferire con il raggiungimento degli obiettivi dello studio
    -Condizioni psicologiche o sociologiche, disturbi da dipendenza o problemi familiari, che ostacolano la compliance al protocollo
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is to evaluate the activity of trabectedin in terms of the objective response rate (ORR) in patients with advanced uterine and ovarian carcinosarcoma.
    L’endpoint primario dello studio è valutare l’attività della trabectedina in termini di tasso di risposta obiettiva nei pazienti con carcinosarcoma uterino ed ovarico avanzato.
    E.5.1.1Timepoint(s) of evaluation of this end point
    three years
    tre anni
    E.5.2Secondary end point(s)
    Safety profile of trabectedin
    Profilo di sicurezza della Trabectedina
    E.5.2.1Timepoint(s) of evaluation of this end point
    Three years
    Tre anni
    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 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 Yes
    E.8.2.3.1Comparator description
    NA
    NA
    E.8.2.4Number of treatment arms in the trial1
    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 concerned20
    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 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: 18
    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 state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 43
    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)
    Follow up
    Follow up
    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 Decision2019-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-25
    P. End of Trial
    P.End of Trial StatusCompleted
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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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