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    Summary
    EudraCT Number:2018-004147-24
    Sponsor's Protocol Code Number:32018
    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 number2018-004147-24
    A.3Full title of the trial
    A Phase II, Randomized, Trial of Niraparib Versus Best Supportive Care as Maintenance Treatment In Patients With Locally Advanced Or Metastatic Urothelial Cancer Whose Disease Did Not Progress After Completion Of First-line Platinum-containing Chemotherapy- MEET URO 12
    Studio clinico di fase 2 randomizzato volto a valutare l’efficacia di Niraparib rispetto alla migliore terapia di supporto come trattamento di mantenimento in pazienti affetti da tumore uroteliale localmente avanzato o metastatico, che non siano andati incontro a progressione di malattia dopo una prima linea chemioterapica contenente platino (Studio Meet-URO 12).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II, Randomized, Trial of Niraparib Versus Best Supportive Care as Maintenance Treatment In Patients With Locally Advanced Or Metastatic Urothelial Cancer Whose Disease Did Not Progress After Completion Of First-line Platinum-containing Chemotherapy- MEET URO 12
    Studio clinico di fase 2 randomizzato volto a valutare l’efficacia di Niraparib rispetto alla migliore terapia di supporto come trattamento di mantenimento in pazienti affetti da tumore uroteliale localmente avanzato o metastatico, che non siano andati incontro a progressione di malattia dopo una prima linea chemioterapica contenente platino
    A.3.2Name or abbreviated title of the trial where available
    MEET URO 12
    MEET URO 12
    A.4.1Sponsor's protocol code number32018
    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 SponsorDIPARTIMENTO DI ONCOLOGIA-UNIVERSITA' DEGLI STUDI DI TORINO
    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 supportTESARO
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationA.O. Ordine Mauriziano di Torino- SCDU Oncologia Medica
    B.5.2Functional name of contact pointDipartimento di Oncologia
    B.5.3 Address:
    B.5.3.1Street AddressVia Magellano 1
    B.5.3.2Town/ cityTorino
    B.5.3.3Post code10128
    B.5.3.4CountryItaly
    B.5.4Telephone number00390115085485
    B.5.6E-mailmassimo.dimaio@unito.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 Zejula
    D.2.1.1.2Name of the Marketing Authorisation holderTESARO
    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 nameZEJULA
    D.3.2Product code [MK-4827]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNIRAPARIB
    D.3.9.1CAS number 1038915-60-4
    D.3.9.2Current sponsor codeL01XX54
    D.3.10 Strength
    D.3.10.1Concentration unit 1X 100 milligrams/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    locally non-resectable or metastatic local urothelial transitional tumor (transitional cell carcinoma both with pure and mixed histology).
    tumore transizionale uroteliale localmente avanzato non resecabile o metastatico (carcinoma a cellule transizionali sia ad istologia pura che mista).
    E.1.1.1Medical condition in easily understood language
    advanced / metastatic urothelium tumor
    tumore dell’urotelio in stadio avanzato / metastatico
    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 LLT
    E.1.2Classification code 10046703
    E.1.2Term Urogenital neoplasm NOS
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare maintenance treatment with Niraparib associated with the best supportive therapy the best supportive therapy alone in patients with locally advanced or metastatic urothelial tumor who have achieved disease control (objective response or disease stability) with a first chemotherapy line containing platinum, in order to determine whether maintenance treatment with Niraparib is effective in terms of prolonging disease progression-free survival.
    Confrontare il trattamento di mantenimento con Niraparib associato alla migliore terapia di supporto vs. la migliore terapia di supporto da sola in pazienti affetti da tumore uroteliale localmente avanzato o metastatico che hanno ottenuto un controllo di malattia (risposta obiettiva o stabilità di malattia) con una prima linea chemioterapica contenente platino, allo scopo di determinare se il trattamento di mantenimento con Niraparib è efficace in termini di prolungamento della sopravvivenza libera da progressione di malattia.
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Established histological or cytological diagnosis of non-resectable or metastatic locally advanced non-resectable urothelial transitional tumor (transitional cell carcinoma both with pure and mixed histology);
    Measurable disease according to RECIST (v1.1) before starting the first chemotherapy line;
    The first chemotherapy line must have been performed with at least 4 cycles and no more than 6 cycles of a regimen containing platinum (cisplatin or carboplatin);
    Absence of disease progression after completion of the first chemotherapy line (complete response, partial response or disease stability according to RECIST criteria v1.1);
    Patients should be enrolled within 28 days of a radiological survey demonstrating disease stability or partial / complete disease response and no more than 42 days after receiving the last dose of chemotherapy;
    Availability of a blood sample to determine the state of germline mutations of BRCA genes;
    Availability of a sample of tumor tissue in the archive to determine the status of the genes involved in the mechanism of homologous recombination (HRD);
    ECOG performance status 0-1.
    Diagnosi istologica o citologica accertata di tumore transizionale uroteliale localmente avanzato non resecabile o metastatico (carcinoma a cellule transizionali sia ad istologia pura che mista);
    Malattia misurabile secondo RECIST (v1.1) prima dell’avvio della prima linea chemioterapica;
    La prima linea chemioterapica deve essere stata effettuata con almeno 4 cicli e non più di 6 cicli di un regime contenente platino (cisplatino o carboplatino);
    Assenza di progressione di malattia dopo il completamento della prima linea chemioterapica (risposta completa, risposta parziale o stabilità di malattia secondo i criteri RECIST v1.1);
    I pazienti devono essere arruolati entro 28 giorni dall’effettuazione di un’indagine radiologica che dimostri stabilità di malattia o risposta di malattia parziale/completa e non più di 42 giorni dopo aver ricevuto l’ultima somministrazione di chemioterapia;
    Disponibilità di un campione di sangue per determinare lo stato delle mutazioni germinali dei geni BRCA;
    Disponibilità di un campione di tessuto tumorale in archivio per determinare lo stato dei geni coinvolti nel meccanismo della ricombinazione omologa (HRD);
    ECOG performance status 0-1.
    Adeguata riserva midollare, adeguata funzionalità renale ed epatica.
    E.4Principal exclusion criteria
    Known hypersensitivity to the components of Niraparib.
    Note active liver disease.
    Previous treatment with a PARP inhibitor agent
    Pre-existing toxicity due to previous therapies of degree> 1 according to NCI CTCAE v4.0; however, alopecia, sensory neuropathy (grade 2 or lower), or other grade 2 or lower toxicities that do not pose a risk to the patient at the trial according PI is accepted.
    Known history of bone marrow compression or meningeal carcinosis or evidence of symptomatic brain disease or leptomeningi at screening CT or RMN images. Encephalic metastases treated, stable and asymptomatic are permitted.
    The diagnosis of other cancers in the last 2 years prior to randomization; are admitted and therefore exceptions are cutaneous squamous tumor or cutaneously treated skin basaloma, in situ carcinoma of the breast or of the cervix, the low-grade prostatic tumor in active surveillance or the prostate tumor already subjected to prostatectomy or radiotherapy which does not demonstrate randomization signs of disease recovery.
    Nota ipersensibilità ai componenti di Niraparib.
    Nota patologia epatica in fase attiva.
    Precedente trattamento con un agente PARP inibitore
    Tossicità preesistente dovuta a precedenti terapie di grado >1 secondo NCI CTCAE v4.0; tuttavia sono accettate l’alopecia, la neuropatia sensitiva (di grado 2 o inferiore), o altre tossicità di grado 2 o inferiore che non costituiscono un rischio per il paziente a giudizio del curante.
    Storia nota di compressione midollare o carcinosi meningea o evidenza di malattia sintomatica dell’encefalo o delle leptomeningi alle immagini TC o RMN di screening. Le metastasi encefaliche sottoposte a trattamento, stabili e asintomatiche sono ammesse.
    La diagnosi di altri tumori negli ultimi 2 anni antecedenti alla randomizzazione; sono ammessi e quindi fanno eccezione il tumore squamoso cutaneo o il basalioma cutaneo trattati adeguatamente, il carcinoma in situ della mammella o della cervice, il tumore prostatico di basso grado in sorveglianza attiva o il tumore prostatico già sottoposto a prostatectomia o radioterapia che non dimostri alla randomizzazione segni di ripresa di malattia.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS)
    Sopravvivenza libera da progressione (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 months
    36 mesi
    E.5.2Secondary end point(s)
    Proportion of objective answers.
    Duration of the answer.
    Global survival.
    Proportion of progression-free patients at 6 months from randomization.
    Safety and tolerability.
    Quality of life (patient-reported outcomes).; Proporzione di risposte obiettive.
    Durata della risposta.
    Sopravvivenza globale.
    Proporzione di pazienti liberi da progressione a 6 mesi dalla randomizzazione.
    Sicurezza e tollerabilità.
    Qualità di vita (patient-reported outcomes).
    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 No
    E.6.5Efficacy No
    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 No
    E.8.1.3Single blind Yes
    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 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: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 39
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state77
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 77
    F.4.2.2In the whole clinical trial 77
    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 Decision2019-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-07
    P. End of Trial
    P.End of Trial StatusOngoing
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