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    Summary
    EudraCT Number:2018-000693-30
    Sponsor's Protocol Code Number:56UCS2017
    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:2019-10-16
    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 number2018-000693-30
    A.3Full title of the trial
    EXemestane in Progesterone and/or Estrogen receptor positive epithelial ovarian cancer. A Randomized phase III Trial, EXPERT.
    EXemestane in Progesterone and/or Estrogen receptor positive epithelial ovarian cancer. A Randomized phase III Trial, EXPERT.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EXemestane in Progesterone and/or Estrogen receptor positive epithelial ovarian cancer. A Randomized phase III Trial, EXPERT.
    Exemestane in aggiunta alla terapia standard, nel trattamento di prima linea, in donne con cancro ovarico epiteliale positivo ai recettori del Progesterone e/o degli Estrogeni. Studio clinico, randomizzato, multicentrico di fase III, in doppio cieco, controllato con placebo.
    Studio EXPERT
    A.3.2Name or abbreviated title of the trial where available
    EXPERT
    EXPERT
    A.4.1Sponsor's protocol code number56UCS2017
    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 SponsorENTE OSPEDALIERO OSPEDALI GALLIERA
    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 support
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trial Center Spa
    B.5.2Functional name of contact pointna
    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 number06 88805565
    B.5.5Fax number0688805567
    B.5.6E-mailbetty.polikar@clinicaltrialcenter.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 MESTANE - 25 MG COMPRESSE RIVESTITE 30 COMPRESSE IN BLISTER AL-PVDC/PVC-PVDC
    D.2.1.1.2Name of the Marketing Authorisation holderPHeT S.P.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 nameExemestane
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Women with confirmed high grade serous or endometrial epithelial ovarian cancer.
    Donne con carcinoma epiteliale ovarico sieroso di alto grado o endometrioide
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer
    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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 test the superiority of exemestane over placebo in addition to the standard front line treatment in terms of progression free survival (PFS) in patients with Estrogen Receptor (ER) + and/or Progesteron Receptor (PgR) + Epithelial Ovarian Cancer (EOC).
    Determinare la superiorità di exemestane vs placebo, in aggiunta al trattamento di prima linea, in termini di sopravvivenza libera da malattia (PFS) in pazienti con carcinoma epiteliale dell’ovaio positivo per i recettori degli estrogeni (ER) e/o progesterone (PgR).
    E.2.2Secondary objectives of the trial
    - to test whether the percent expression of ER and PgR is predictive of the effect of exemestane on Progression Free Survival (PFS);
    - to test whether the addition of exemestane to the standard front line treatment can prolong Overall Survival (OS);
    - to evaluate objective response rate Overall Response Rate (ORR) of standard front line treatment and exemestane compared with standard front line treatment plus placebo;
    - to assess whether the effect of exemestane is affected by the proliferative index Ki67;
    - to evaluate the effect of exemestane on Quality of Life (QoL) as assessed by the Menopause QoL questionnaire (MENQOL);
    - to evaluate the compliance to the study treatment;
    - to evaluate the safety profile of the standard front line treatment and exemestane compared with the standard front line treatment plus placebo.
    - verificare se la percentuale di espressione di ER e PgR è predittiva dell’effetto di exemestane sulla PFS;
    - verificare se l’aggiunta di exemestane al trattamento standard di prima linea può prolungare la sopravvivenza globale (OS);
    - valutare il tasso di risposta obiettiva (ORR) dell’aggiunta di exemestane al trattamento standard di prima linea rispetto al trattamento standard di prima linea più placebo;
    - valutare se l’effetto di exemestane è influenzato dall’indice di proliferazione Ki67;
    - valutare l’effetto di exemestane sulla qualità della vita (QoL) secondo il Questionario di Qualità di Vita in Menopausa (Menopause Quality of Life questionnaire, MENQOL);
    - valutare la compliance al trattamento sperimentale;
    - valutare il profilo di sicurezza del trattamento standard di prima linea più exemestane rispetto al trattamento standard di prima linea più placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥18 years.
    • Citologically or histologically confirmed high grade serous or endometrial epithelial ovarian cancer.
    • Disease stage IIB to IV according to Federation Internationale des Gynaecologistes et Obstetristes (FIGO) classification
    • Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy.
    a. For patients enrolling after debulking surgery, the following conditions must be met: patient must be randomized at a maximum of 12 and not before 4 weeks after surgery.
    b. For patients who are candidates for neoadjuvant chemotherapy, the following conditions must be met:Stage IIB–IV documented via imaging or a core tissue (not fine needle aspiration) biopsy.
    • Immunoistochemically determined positivity (≥ 10%) for Progesterone and/or Estrogen receptor expression, including determination on cytology smears from ascitic fluid if surgery is differed.
    • Measurable or evaluable disease confirmed by radiological imaging, or histological proven ovarian cancer in the absence of postoperatively measurable or evaluable lesions
    • Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-2.
    • Written, informed consent obtained prior to any study-specific procedures.
    • Età ≥18 anni;
    • Conferma citologica o istologica di carcinoma epiteliale ovarico sieroso di alto grado o endometrioide;
    • Stadio IIB-IV secondo classificazione FIGO
    • Le pazienti devono aver completato il debulking chirurgico, oppure devono essere candidate a chemioterapia neoadiuvante.
    a. Per le pazienti arruolate dopo il debulking chirurgico, devono verificarsi le seguenti condizioni: randomizzazione effettuata entro massimo 12 e non prima di 4 settimane dalla chirurgia.
    b. Per le pazienti candidate a terapia neoadiuvante, devono verificarsi le seguenti condizioni: stadio IIB–IV documentato via imaging o mediante una biopsia tissutale (non ago aspirato).
    • Positività immunoistochimica (≥ 10%) per i recettori del progesterone e/o degli estrogeni, compresa la determinazione su striscio citologico del fluido ascitico se la chirurgia viene rimandata.
    • Malattia misurabile o valutabile confermata mediante immagini radiologiche o con conferma istologica di carcinoma ovarico, in assenza di lesioni misurabili o valutabili post-operatorie.
    • Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-2.
    • Consenso informato scritto ottenuto prima delle procedure studio-specifiche.
    E.4Principal exclusion criteria
    • Previous systemic therapy for ovarian cancer.
    • Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
    • Indadequate bone marrow, hepatic or renal functions, assessed within 7 days prior to randomization.
    • Treatment with hormonal contraceptives during the previous 3 months from diagnosis.
    • Concurrent comorbidities, which contraindicates the administration of chemotherapy or endocrine therapy.
    • Pregnant or lactating patients.
    • Inability or unwillingness to swallow tablets.
    • Precedente terapia sistemica per il carcinoma ovarico.
    • Altra neoplasia negli ultimi 5 anni, eccetto carcinoma in situ della cervice o carcinoma cutaneo squamocellulare adeguatamente trattati, o carcinoma basocellulare della pelle adeguatamente controllato.
    • Inadeguata funzionalità midollare, epatica o renale, valutata entro 7 giorni prima della randomizzazione.
    • Trattamento con contraccettivi ormonali durante i precedenti 3 mesi dalla diagnosi.
    • Patologie concomitanti che controindichino la somministrazione di chemioterapia o terapia endocrina.
    • Pazienti in gravidanza e allattamento.
    • Incapacità o mancanza di volontà di deglutire le compresse.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is PFS, defined for each patient as the time from the date of randomization to the date of local or regional relapse, distant metastasis, second primary malignancy or death from any cause, whichever comes first.
    L'endpoint primario è PFS, definito per ogni paziente come il tempo dalla data di randomizzazione alla data della ricaduta locale o regionale, metastasi distanti, seconda malignità primaria o la morte da qualsiasi causa, qualunque viene prima.
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 MONTHS
    36 MESI
    E.5.2Secondary end point(s)
    - OS, defined for each patient as the time from the date of randomization to the date of death from any cause. - ORR, defined as the number of patients who will experience a complete or partial response divided by the number of patients randomized with at least one target lesion at baseline. - Effect of exemestane on QoL as assessed by the Menopause Quality of Life questionnaire (MENQOL) questionnaire.
    -OS, definito per ogni paziente come il tempo dalla data di randomizzazione alla data di morte da qualsiasi causa.
    -Orr, definito come il numero delle pazienti che sperimenteranno una risposta completa o parziale divisa per il numero delle pazienti randomizzate con almeno una lesione bersaglio al basale.
    -Effetto di exemestane su QoL come valutato dal questionario sulla qualità della menopausa (MENQOL).
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 MONTHS
    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 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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned50
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA50
    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 Yes
    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
    Clinical Study Report (CSR)
    Clinical Study Report (CSR)
    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 months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months36
    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: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 468
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 468
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state468
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 468
    F.4.2.2In the whole clinical trial 468
    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)
    Standard therapy
    Terapia standard
    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 Decision2019-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-11-24
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