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    Summary
    EudraCT Number:2018-000617-20
    Sponsor's Protocol Code Number:MITO31
    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: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 number2018-000617-20
    A.3Full title of the trial
    A phase II trial of Olaparib in patients with recurrent ovarian cancer wild type for germline and somatic BRCA 1 and 2 genes: The MITO 31 transalational study.
    Studio clinico di fase 2 di Olaparib in pazienti affette da recidiva platino sensibile di carcinoma ovarico wild type per mutazione somatico o germinale dei geni BRCA1 e 2: studio traslazionale, MITO 31
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II trial of Olaparib in patients with recurrent ovarian cancer wild type for germline and somatic BRCA 1 and 2 genes: The MITO 31 transalational study.
    Studio clinico di fase 2 di Olaparib in pazienti affette da recidiva platino sensibile di carcinoma ovarico wild type per mutazione somatico o germinale dei geni BRCA1 e 2: studio traslazionale, MITO 31
    A.3.2Name or abbreviated title of the trial where available
    MITO 31
    MITO 31
    A.4.1Sponsor's protocol code numberMITO31
    A.5.4Other Identifiers
    Name:MITO 31Number:MITO 31
    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 SponsorISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
    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 supportAstraZeneca S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationdell’Istituto Nazionale per lo Studio e la Cura dei Tumori – Fondazione G. Pascale
    B.5.2Functional name of contact pointUnità Sperimentazioni Cliniche
    B.5.3 Address:
    B.5.3.1Street AddressVia M. Semmola snc
    B.5.3.2Town/ cityNapoli
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone number0815903571
    B.5.5Fax number0817702938
    B.5.6E-mailusc-segreteria@istitutotumori.na.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 No
    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 nameOLAPARIB
    D.3.2Product code [OLAPARIB]
    D.3.4Pharmaceutical form Film-coated 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 INNOlaparib (AZD2281,KU-0059436)
    D.3.9.2Current sponsor codeOLAPARID
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    patients with recurrent ovarian cancer wild type for germline and somatic BRCA 1 and 2 genes
    pazienti affette da recidiva platino sensibile di carcinoma ovarico wild type per mutazione somatico o germinale dei geni BRCA1 e 2
    E.1.1.1Medical condition in easily understood language
    patients with recurrent ovarian cancer wild type for germline and somatic BRCA 1 and 2 genes
    pazienti affette da recidiva platino sensibile di carcinoma ovarico wild type per mutazione somatico o germinale dei geni BRCA1 e 2
    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 10066697
    E.1.2Term Ovarian 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
    To explore a prognostic clinical and molecular biomarker profile in a population of BRCA wild-type recurrent high-grade ovarian cancer patients treated with olaparib as maintenance after response to a platinum based therapy as platinum sensitive recurrence treatment.
    • Identificare fattori prognostici (clinici e biomarcatori molecolari) in una popolazione di pazienti con carcinoma ovarico di alto grado recidivante BRCA wild- type trattate con olaparib come mantenimento dopo risposta a terapia a base di platino come trattamento della recidiva platino sensibile.
    E.2.2Secondary objectives of the trial
    - To assess the activity, safety and tolerability of Olaparib in this population;
    - To describe the clinical and molecular features of patients with PFS>12 months.
    - Valutare l’attività, la sicurezza e la tollerabilità di Olaparib in questa popolazione.
    - Descrivere le caratteristiche cliniche e molecolari delle pazienti con PFS> 12 mesi.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Patients must be =18 years of age.
    b. Female patients with histologically diagnosed relapsed high grade ovarian cancer (including primary peritoneal and /or fallopian tube cancer)
    c. Documented absence of somatic and germline mutations of BRCA1 or BRCA2 genes, that is predicted to be deleterious or suspected deleterious.
    d. ECOG Performance Status of 0–2
    e. Patients must have a life expectancy of at least 16 eeks.
    f. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply with the study requirements.
    g. Availability of tumor and blood samples for molecular analyses
    h. Patients who have received at least 2 previous line of platinum containing therapy prior to randomization
    ° For the penultimate chemotherapy course prior to enrolment on the study:
    - Patient defined as platinum sensitive after this treatment, defined as having disease progression greater than 6 months after completion of their last dose of platinum chemotherapy
    ° For the last chemotherapy course immediately prior to randomization on the study:
    - Patients must be, in the opinion of the investigator, in radiologic response (partial or complete response) according to RECIST 1.1 criteria, or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy), and no evidence of a rising CA-125 compared to nadir value, following completion of this chemotherapy course
    i. Patient must have received, at least 4 cycles of a platinum based chemotherapy regimen (e.g. carboplatin or cisplatin per standard clinical practice)
    j. Patients must be enrolled within 8 weeks of their last dose of chemotherapy
    k. Maintenance treatment, including bevacizumab, is allowed at the end of the penultimate platinum regimen.
    l. Postmenopausal* or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.
    *Postmenopausal is defined as:
    - Amenorrhea for 1 year or more following cessation of exogenous hormonal treatments
    - Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50
    - Radiation-induced oophorectomy with last menses >1 year ago
    - Chemotherapy-induced menopause with >1 year interval since last menses
    - Surgical sterilization (bilateral oophorectomy or hysterectomy)
    m. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
    - Hemoglobin = 10.0 g/dL with no blood transfusion in the past 28 days
    - Absolute neutrophil count (ANC) = 1.5 x 109/L
    - Platelet count = 100 x 109/L
    - Total bilirubin = 1.5 x institutional upper limit of normal (ULN)
    - Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)/ Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT) = 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be = 5x ULN
    - Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of =51 mL/min:
    Estimated creatinine clearance= (140-age [years]) x weight (kg) (x F)a serum creatinine (mg/dL) x 72
    a where F=0.85 for females and F=1 for males.
    1. Pazienti di età =18 anni
    2. Pazienti di sesso femminile con diagnosi istologica di carcinoma ovarico di alto grado recidivato (includendo il carcinoma peritoneale primario e/o delle tube del Falloppio.
    3. Documentata assenza di mutazioni germinali e somatiche dei geni BRCA1 e BRCA2 , che si prevedono essere deleteri o sospetti deleteri.
    4. Permormance Status (PS) secondo Scala ECOG di 0–2
    5. Pazienti con aspettativa di vita almeno di 16 settimane.
    6. Consenso informato firmato ottenuto prima dell'inizio di qualsiasi procedura e trattamento specifici dello studio come conferma della consapevolezza e della volontà del paziente di conformarsi ai requisiti dello studio.
    7. Disponibilità di campioni di tumore e sangue per analisi molecolari.
    8. Pazienti che hanno ricevuto almeno 2 precedenti linee di terapia a base di platino prima della randomizzazione.
    9. Per il penultimo trattamento chemioterapico in corso prima dell’arruolamento nello studio clinico:
    • Paziente definita come platino sensibile dopo questo trattamento, intesa come progredita > 6 mesi dopo la fine dell’ultima dose di chemioterapia a base di platino.
    10. Per la chemioterapia in corso immediatamente prima della randomizzazione nello studio:
    • Pazientiin risposta radiologica (parziale o completa risposta) secondo i criteri RECIST 1.1 o senza evidenza di malattia (se è stata effettuata una citoriduzione chirurgica ottimale prima della chemioterapia) e non evidenza di un incremento del CA 125 comparato con il valore nadir al termine del trattamento in corso.
    11. Le pazienti devono aver ricevuto almeno 4 cicli di chemioterapia a base di platino (es. carboplatino o cisplatino come da pratica clinica standard).
    12. Le pazienti devono essere arruolate entro 8 settimane dall’ultima dose di chemioterapia.
    13. Il trattamento di mantenimento, incluso il bevacizumab, è consentito al termine del penultimo regime chemioterapico a base di platino.
    14. Stato post-menopausale* o ,nelle donne potenzialmente fertili, test di gravidanza sulle urine o sul siero negativo effettuato entro 28 giorni dall’inizio del trattamento
    *Post-menopausa definita come:
    • Amenorrea da 1 anno o più dopo l’interruzione di trattamenti ormonali a base di estrogeni.
    • Livelli di ormone luteinizzante (LH) e ormone follicolo stimolante (FSH) nell’intervallo post-menopausale per le donne di età sotto i 50.
    • Ovariectomia indotta da radiazioni con ultima mestruazione > 1 anno fa.
    • Menopausa indotta da chemioterapia con un intervallo > 1 anno dall’ultima mestruazione.
    • Sterilizzazione chirurgica (ovariectomia bilaterale o isterectomia).
    15. Le pazienti devono avere una normale funzione d’organo e midollare misurata entro 28 giorni prima della somministrazione del trattamento di studio come definito sotto:
    16. Emoglobina = 10.0 g/dLsenza trasfusione di sangue negli ultimi 28 giorni.
    17. Conta assoluta di neutrofili (ANC) = 1.5 x 109/L
    18. Conta piastrinica = 100 x 109/L
    19. Bilirubina totale = 1.5 x il limite superiore del range normale istituzionale.
    20. Aspartato aminotransferasi (AST)/ Alanina aminotransferasi (ALT) = 2.5 x il limite superiore del range normale istituzionale (ULN)salvo che siano presenti metastasi epatiche nel qual caso il limite deve essere = 5x ULN
    21. Le pazienti devono avere una clearance della creatinina calcolata usando l’equazione di Cockcroft-Gault di =51 mL/min:
    22. Clearance creatinina stimata = (140-età [anni]) x peso (kg) (x F)a creatinina sierica (mg/dL) x 72
    a dove F=0.85 per femmine and F=1 per maschi.
    E.4Principal exclusion criteria
    Si rimanda la protocollo per i criteri di esclusione.
    Si rimanda la protocollo per i criteri di esclusione.
    E.5 End points
    E.5.1Primary end point(s)
    PFS
    PFS
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease response will be assessed according to RECIST 1.1 criteria every twelve weeks
    La risposta di malattia sarà valutata ogni 12 settimane secondo i criteri RECIST v1.1.
    E.5.2Secondary end point(s)
    Overall Survival
    Progression Free Survival 2
    Response rates
    Toxicity
    Sopravvivenza globale
    Sopravvivenza libera da progressione 2
    Tasso di risposte
    Tossicità
    E.5.2.1Timepoint(s) of evaluation of this end point
    All patients will be followed for survival until death.
    Disease response will be assessed according to RECIST 1.1 criteria every twelve weeks as per clinical practice. Safety will be assessed by routine physical and laboratory evaluations.
    Le pazienti saranno seguite per la sopravvivenza fino al decesso.
    La risposta alla malattia sarà valutata secondo i criteri RECIST 1.1 ogni 12 settimane.
    La sicurezza sarà valutata mediante esami clinici e di laboratorio.
    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 Yes
    E.6.11Pharmacogenomic Yes
    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
    nessuno
    nessuno
    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 concerned38
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    NA
    NA
    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 Decision2018-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-26
    P. End of Trial
    P.End of Trial StatusOngoing
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