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    Summary
    EudraCT Number:2017-004166-10
    Sponsor's Protocol Code Number:CO-338-085
    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:2020-11-05
    Trial results View 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 number2017-004166-10
    A.3Full title of the trial
    A Phase 2, Open-label Study of Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma
    Studio di fase 2 in aperto su rucaparib in pazienti con carcinoma uroteliale localmente avanzato o metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma
    Studio di rucaparib in pazienti con carcinoma uroteliale localmente avanzato o metastatico
    A.3.2Name or abbreviated title of the trial where available
    ATLAS
    ATLAS
    A.4.1Sponsor's protocol code numberCO-338-085
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03397394
    A.5.4Other Identifiers
    Name:US INDNumber:129840
    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 SponsorCLOVIS ONCOLOGY, INC
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportClovis Oncology, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClovis Oncology Ireland Limited
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street AddressRegus Dublin Airport, Skybridge House - Dublin Airport
    B.5.3.2Town/ citySwords, County Dublin
    B.5.3.3Post codeK67 P6K2
    B.5.3.4CountryIreland
    B.5.4Telephone number35315665260
    B.5.5Fax number35315665208
    B.5.6E-mailinfo@clovisoncology.com
    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 nameRucaparib 200 mg
    D.3.2Product code [CO-338]
    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 INNRucaparib
    D.3.9.1CAS number 283173-50-2
    D.3.9.2Current sponsor codeCO-338
    D.3.9.4EV Substance CodeSUB74859
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 2
    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 nameRucaparib 250 mg
    D.3.2Product code [CO-338]
    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 INNRucaparib
    D.3.9.1CAS number 283173-50-2
    D.3.9.2Current sponsor codeCO-338
    D.3.9.4EV Substance CodeSUB74859
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.IMP: 3
    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 nameRucaparib 300 mg
    D.3.2Product code [CO-338]
    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 INNRucaparib
    D.3.9.1CAS number 283173-50-2
    D.3.9.2Current sponsor codeCO-338
    D.3.9.4EV Substance CodeSUB74859
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Advanced Unresectable or Metastatic Urothelial Carcinoma
    carcinoma uroteliale localmente avanzato non resecabile o metastatico
    E.1.1.1Medical condition in easily understood language
    bladder cancer
    cancro della vescica
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10044412
    E.1.2Term Transitional cell carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10064467
    E.1.2Term Urothelial carcinoma
    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
    The primary objective for this study is:
    • To evaluate objective response rate (ORR) in molecularly-defined homologous recombination deficiency (HRD)-positive and intent-to-treat (ITT) populations using a prospectively defined molecular signature.
    • Obiettivo primario:
    • Valutare il tasso di risposta obiettiva (ORR) nella popolazione positiva per il deficit di ricombinazione omologa (HRD) definito a livello molecolare e nella popolazione intent-to-treat (ITT) utilizzando una firma molecolare definita prospetticamente.
    E.2.2Secondary objectives of the trial
    The secondary objectives for this study are:
    • To evaluate duration of response (DOR)
    • To estimate progression-free survival (PFS)
    • To estimate overall survival (OS)
    • To evaluate safety and tolerability of rucaparib
    • To evaluate steady-state pharmacokinetics (PK) of rucaparib
    Obiettivi secondari:
    • Valutare la durata della risposta (DOR)
    • Stimare la sopravvivenza libera da progressione (PFS)
    • Stimare la sopravvivenza globale (OS)
    • Valutare la sicurezza e la tollerabilità di rucaparib
    • Valutare la farmacocinetica (PK) allo stato stazionario di rucaparib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Have histologically or cytologically confirmed locally advanced unresectable or metastatic transitional cell carcinoma of the urothelium (renal pelvis, ureter, urinary bladder or urethra)
    • Received 1 or 2 prior treatment standard of care regimens for advanced unresectable or metastatic disease
    • Confirmed radiologic disease progression during or following recent treatment
    • Mandatory biopsy is required during screening
    • Measurable disease per RECIST v1.1
    • Adequate organ function
    • ECOG 0 or 1
    - Avere un carcinoma dell'urotelio (compresi pelvi renale, uretere, vescica urinaria o uretra) a cellule transizionali localmente avanzato (stadiazione TNM [tumore, linfonodi, metastasi] T4b e qualsiasi N; oppure qualsiasi T e N2-3) non resecabile o metastatico confermato istologicamente o citologicamente.
    - Essere stati sottoposti a 1 o 2 precedenti regimi di trattamento con lo standard di cura per malattia avanzata non resecabile o metastatica e aver presentato progressione radiologica confermata della malattia durante o dopo il trattamento più recente.
    - è richiesta obbligatoriamente una biopsia durante lo screening.
    - Presentare malattia misurabile così come definita nei Criteri di valutazione della risposta nei tumori solidi (RECIST), versione 1.1 (v1.1).
    - Presentare funzioni di organo adeguate.
    - Presentare un performance status secondo l'Eastern Cooperative Oncology Group (ECOG) pari a 0 o a 1,
    E.4Principal exclusion criteria
    • Prior treatment with a PARP inhibitor
    • Symptomatic and/or untreated CNS metastases
    • Duodenal stent and/or any gastrointestinal disorder that may interfere with absorption of rucaparib
    - Precedente trattamento con un inibitore di PARP.
    - Metastasi del sistema nervoso centrale (SNC) sintomatiche e/o non trattate.
    - Stent duodenale preesistente e/o qualsiasi difetto o disturbo gastrointestinale che potrebbe interferire con l'assorbimento di rucaparib.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of ORR is defined as a best confirmed response of CR or PR by RECIST v1.1 as assessed by the investigator. The ORR will be summarized with frequencies and percentages for the ITT and HRD-positive populations as well as other HRD subgroups.
    L'endpoint primario di efficacia di ORR è definito come una risposta confermata migliore di CR o PR da RECIST v1.1 come valutato dallo sperimentatore. L'ORR sarà riassunto con frequenze e percentuali per le popolazioni positive ITT e HRD e per altri sottogruppi HRD.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumor assessments will be performed during screening (baseline), at the end of every 8 calendar weeks (±7 days) relative to the first dose of rucaparib (Cycle 1 Day 1) up to 18 months, then every 12 calendar weeks (±7 days), until confirmed radiologic disease progression by RECIST v1.1 criteria, as assessed by the investigator.
    Le valutazioni del tumore saranno eseguite durante lo screening (al basale), alla fine di ogni 8 settimane di calendario (± 7 giorni) rispetto alla prima dose di rucaparib (ciclo 1 giorno 1) fino a 18 mesi, quindi ogni 12 settimane solari (± 7 giorni), fino a conferma della progressione della malattia radiologica secondo i criteri RECIST v1.1, come valutato dallo sperimentatore.
    E.5.2Secondary end point(s)
    Efficacy: Duration of Response (DOR): Duration of confirmed response is defined as the time from the date that a response is first reported to the time that progression is first documented after the confirmed response. Progression-free Survival (PFS): PFS will be calculated as 1+ the number of days from the first dose of rucaparib to disease progression or death due to any cause, whichever occurs first. Patients without a documented event of progression will be censored on the date of their last adequate tumor assessment (ie, radiologic assessment) or date of first dose of rucaparib if no post-baseline tumor assessments have been performed. Overall Survival (OS): Overall survival (OS) is defined as the date from first dose of rucaparib to the date of death due to any cause. Patients who have not died will be censored at the date last known to be alive. Safety: Safety endpoints include incidence of AEs, clinical laboratory abnormalities, and dose modifications. Data from all patients in the safety population will be included in the safety analyses. AEs, clinical laboratory results, vital signs, ECG results, ECOG performance status, body weight, and concomitant medications/ procedures will be tabulated and summarized. PK: The PK data and selected safety and efficacy endpoints will be included in exploratory population PK and exposure-response analyses, and the results will be reported separately.
    Efficacia: Duration of Response (DOR): la durata della risposta confermata è definita come il tempo che intercorre tra la data in cui una risposta viene riportata per la prima volta al momento in cui la progressione viene documentata per la prima volta dopo la risposta confermata. Sopravvivenza priva di progressione (PFS): la PFS sarà calcolata come 1+ il numero di giorni dalla prima dose di rucaparib alla progressione della malattia o alla morte a causa di qualsiasi causa, a seconda della condizione che si verifica per prima. I pazienti senza un evento documentato di progressione saranno censurati alla data dell'ultima valutazione tumorale adeguata (cioè, valutazione radiologica) o alla data della prima dose di rucaparib se non sono state eseguite valutazioni del tumore post-basale. Sopravvivenza generale (OS): la sopravvivenza globale (OS) è definita come la data dalla prima dose di rucaparib alla data del decesso per qualsiasi causa. I pazienti che non sono morti saranno censurati alla data nota per essere viventi. Sicurezza: gli endpoint di sicurezza comprendono l'incidenza di eventi avversi, anomalie cliniche di laboratorio e modifiche della dose. I dati di tutti i pazienti della popolazione di sicurezza saranno inclusi nelle analisi di sicurezza. Saranno tabulati e riassunti gli eventi avversi, i risultati clinici di laboratorio, i segni vitali, i risultati ECG, lo stato delle prestazioni ECOG, il peso corporeo e le terapie / procedure concomitanti. PK: i dati PK e gli endpoint selezionati di sicurezza ed efficacia saranno inclusi nelle analisi PK della popolazione esplorativa e nell'analisi dell'esposizione e i risultati saranno riportati separatamente.
    E.5.2.1Timepoint(s) of evaluation of this end point
    DOR, PFS, OS, refer to E.5.2 Safety; The investigator will assess patients’ safety and will follow the study protocol. During the screening period, unless otherwise required by local regulations, SAEs which are related to protocol-mandated assessments will be reported. Once enrolled and rucaparib is administered, patients will be monitored for all AEs/SAEs/AESIs during study participation and until 28 days after the last dose of rucaparib. After the 28-day window, only treatment-related SAEs and all AESIs, irrespective of causality, need to be reported. Plasma samples are to be collected for PK analysis of rucaparib 1 hour before the morning dose on Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1
    DOR, PFS, OS fare riferimento a E.5.2 Sicurezza; Lo sperimentatore valuterà la sicurezza dei pazienti e seguirà il protocollo di studio. Durante lo screening, se non diversamente richiesto dalle normative locali, verranno segnalate le SAE correlate alle valutazioni obbligatorie del protocollo. Una volta arruolati e il rucaparib somministrato, i pazienti saranno monitorati per tutte le AE/SAE/AESI durante lo studio e fino a 28 giorni dopo l'ultima dose di rucaparib. Trascorsi 28 giorni, devono essere segnalati solo i SAE correlati al trattamento e tutti gli AESI, indipendentemente dalla causalità. Campioni di plasma verranno raccolti per il PK, per analizzare il livello di rucaparib 1 ora prima della dose mattutina al ciclo 2 giorno 1, ciclo 3 giorno 1 e ciclo 4 giorno 1
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Italy
    Spain
    United Kingdom
    United States
    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 months0
    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 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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 92
    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)
    Patients will take rucaparib BID for continuous 28-day cycles until disease progression as assessed by the investigator, or other reason for discontinuation. All patients discontinued from treatment will be followed and information collected for subsequent treatments and survival every 12 weeks from last dose of rucaparib until death, loss to follow-up, withdrawal of consent from study, or closure of the study.
    I pazienti assumeranno Rucaparib BID per cicli continuativi di 28 giorni fino alla progressione della malattia, come valutato dallo sperimentatore, o altri motivi per la sospensione. Tutti i pazienti sospesi dal trattamento saranno seguiti e le informazioni raccolte per i trattamenti successivi e la sopravvivenza ogni 12 settimane dall'ultima dose di rucaparib fino alla morte, la perdita al follow-up, il ritiro del consenso dallo studio o la chiusura dello studio.
    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 Decision2018-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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