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    Summary
    EudraCT Number:2019-001623-12
    Sponsor's Protocol Code Number:MITO32
    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:2021-06-17
    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 number2019-001623-12
    A.3Full title of the trial
    RANDOMIZED PHASE III MULTICENTRE STUDY INVESTIGATING THE ROLE OF LETROZOLE IN HEAVILY PRETREATED RECURRENT OVARIAN CANCER
    Studio randomizzato di fase 3 sulla somministrazione del letrozolo in pazienti affette da recidiva di carcinoma ovarico pluritrattate (MITO 32)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RANDOMIZED PHASE III MULTICENTRE STUDY INVESTIGATING THE ROLE OF LETROZOLE IN HEAVILY PRETREATED RECURRENT OVARIAN CANCER
    Studio randomizzato di fase 3 sulla somministrazione del letrozolo in pazienti affette da recidiva di carcinoma ovarico pluritrattate (MITO 32)
    A.3.2Name or abbreviated title of the trial where available
    MITO 32
    MITO 32
    A.4.1Sponsor's protocol code numberMITO32
    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 supportEpionpharma S.r.l.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMargherita Zona
    B.5.2Functional name of contact pointDirezione Scientifica IRCCS
    B.5.3 Address:
    B.5.3.1Street AddressL.go A. gemelli 1
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number+390630155701
    B.5.6E-mailmargherita.zona@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.2.1.2Country 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 nameLetrozolo
    D.3.2Product code [L02BG04]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLetrozolo
    D.3.9.1CAS number 112809-51-5
    D.3.9.2Current sponsor codeCGS 20267
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2500
    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 CANCER
    CARCINOMA OVARICO IN FASE AVANZATA
    E.1.1.1Medical condition in easily understood language
    ADVANCED OVARIAN CANCER
    CARCINOMA OVARICO IN FASE AVANZATA
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10054913
    E.1.2Term Serous cystadenocarcinoma ovary
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Proportion of patient alive at 12 months
    Proporzione delle pazienti vive a 12 mesi
    E.2.2Secondary objectives of the trial
    PFS
    OS
    ORR (according to RECIST criteria version 1.1)
    TPST
    TSST
    Toxicity profile (evaluated according to NCI-CTCAE version 4.0)
    Quality of Life (QoL) (evaluated by EORTC QLQ-C30/ QLQ-OV28 questionnaire, FACT Ovarian Symptom Index (FOSI), FACT-ES and Activity daily living (ADL) and instrumental ADL (IADL) scales)
    Sopravvivenza globale
    Tasso di sopravvivenza
    Sopravvivenza libera da progressione
    TPST
    TSST
    Profilo di tossicità (valutato in accordo al CTCAE v4.0)
    QoL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Female of 18 years of age or older
    • Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
    • Platinum resistant or refractory disease (patients who did not respond to last platinum-based therapy or with last relapse occurred < 6 months from the last dose of platinum) or patients not amenable of platinum treatment
    • >3 previous chemotherapy lines
    • ECOG performance status 0 -2
    • Measurable and evaluable disease according to RECIST criteria confirmed by radiological imaging: at least one lesion of = 1.0 cm for non-lymph nodes or = 1.5 cm in short-axis diameter for lymph nodes at CT scan (Subjects with isolated rising CA-125 without radiologically visible disease are excluded)
    • Left Ventricular Ejection Fraction (LVEF) = institutional lower limit normal
    • Estimated life expectancy = 16 weeks
    • Adequate functions evidenced by:
    ¬ Hemoglobin 10.0 g/dl
    ¬ Absolute neutrophil count 1.5 x 109/L
    ¬ White blood cells >3x109/L
    ¬ Platelet >100 x109/L
    ¬ AST and ALT 2.5 x Upper limit of normal, unless liver metastasis
    ¬ Bilirubin = 1.5 times the upper limit of normal (ULN)
    Estimated glomerular filtration 60mL/min
    • Patient able to comply with the treatment
    • Evidence of not pregnancy status as documented by a negative beta-human chorionic gonadotropin (ß-hCG) test
    • Not breastfeeding women
    Patients with child-bearing potential using (or willing to use) effective contraception during treatment and 3 months ahead unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically
    Comprehension and signature of the informed consent
    • Donne con età superiore ai 18 anni
    • Istologia o citologia che documenta un carcinoma epiteliale invasivo ovarico, primitivo peritoneale o delle tube di falloppio.
    • Platino resistenza o platino refrattarie o pazienti che non possono essere sottoposte al platino.
    • >3 precedenti line di chemioterapie
    • ECOG performance status 0 -2
    • Malattia misurabile per I criteri RECIST 1.1(donne con rialzo isolato del CA-125 senza evidenza radiologica di patologia sono state escluse)
    • Left Ventricular Ejection Fraction (LVEF) = al valore inferior limite.
    Funzione d’organo adeguata
    E.4Principal exclusion criteria
    • Subjects with borderline ovarian cancer
    • Subject with low malignant potential tumors
    • Less than 3 lines of previous therapies
    • Platinum sensitive disease (last relapse occurred > 6 months from the last dose of platinum)
    • Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy
    • History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 3 years or longer
    • Breastfeeding women
    • Pregnant women
    • Prior therapy with letrozole
    • Severe osteoporosis documented by Bone Mineral Density(BMD) T-score = -2.5 with existing fragility fracture(s)
    • Patients with a known hypersensitivity to Paclitaxel , PLD, Topotecan, Gemcitabine or Letrozole or any case of severe toxicity related to them.
    • Prior resistance to Paclitaxel , PLD, Topotecan, Gemcitabine
    • Patients with active hepatic disease (HCV or HBV infections), hepatic severe impairment or cirrhosis
    • Bowel obstruction, sub-occlusive disease, prior gastrectomy, symptomatic brain metastases
    • Myocardial infarct within six months before enrolment , NYHA Class II or worse heart failure, unstable angina, serious cardiac arrhythmia or cardiac arrhythmia requiring treatment
    • Any serious concomitant illness requiring treatment
    • Pre-existing peripheral neuropathy > CTCAE Grade 2
    • Concomitant use of strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, and telithromycin) or strong CYP2A6 inhibitors (e.g. methoxsalen) because they may increase exposure to letrozole
    • Concomitant use of inducers of CYP3A4 (e.g. phenytoin, rifampicin, carbamazepine, phenobarbital, and St. John’s Wort) which may reduce exposure to letrozole
    Concomitant use of medicinal products with a narrow therapeutic index that are substrates for CYP2C19 (e.g. phenytoin, clopidrogel) that may have their systemic serum concentrations altered by letrozole
    • Donne con tumore ovarico borderline. Donne con patologia a basso grado di malignitià sono escluse.
    • Meno di 3 linee precedent di chemioterapia
    • Malattia platino senibile
    • Meno di 4 settimane dall’ultima dose di chemioterapia.
    • Storia di altra patologia neoplastica ( eccetto basalioma o carcinoma della cervice in situ adeguatamente trattato) History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) a meno che non sia stata accertata la remissione da più di 3 anni
    Osteoporosi severa
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patient alive at 12 months
    Proporzione delle pazienti vive a 12 mesi
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 months
    30 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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned32
    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 years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-06-17. Yes
    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 state236
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 236
    F.4.2.2In the whole clinical trial 236
    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)
    general clinical practice
    Normale pratica 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 Decision2020-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2024-11-04
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