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    Summary
    EudraCT Number:2017-004009-42
    Sponsor's Protocol Code Number:I4D-MC-JTJN
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 number2017-004009-42
    A.3Full title of the trial
    A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
    Studio di fase 2 di prexasertib nel carcinoma ovarico recidivante resistente o refrattario al platino
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study in Patients with advanced Ovarian Cancer
    Studio in pazienti affetti da carcinoma ovarico
    A.3.2Name or abbreviated title of the trial where available
    A Study in Patients with advanced Ovarian Cancer
    Studio in pazienti affetti da carcinoma ovarico
    A.4.1Sponsor's protocol code numberI4D-MC-JTJN
    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 SponsorELI LILLY & COMPANY, LILLY CORPORATE CENTER
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center
    B.5.3.2Town/ cityDC 1526 Indianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number00390554257386
    B.5.5Fax number00390554257348
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameLY2606368
    D.3.2Product code [LY2606368]
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLY2606368
    D.3.9.2Current sponsor codeLY2606368
    D.3.9.4EV Substance CodeSUB176839
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number67
    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 platinum-resistant or platinum-refractory high-grade
    serous ovarian, primary peritoneal, or fallopian tube cancer who have failed standard of care treatment.
    Pazienti affetti da carcinoma ovarico sieroso di alto grado con resistenza al platino o refrattario al platino, carcinoma peritoneale primario o carcinoma delle tube tube di Falloppio che non rispondono al trattamento standard di cura.
    E.1.1.1Medical condition in easily understood language
    Patients with Ovarian Cancer
    Pazienti affetti da carcinoma ovarico
    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 10057529
    E.1.2Term Ovarian cancer metastatic
    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 PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    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 PT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube cancer
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10016182
    E.1.2Term Fallopian tube cancer metastatic
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10061269
    E.1.2Term Malignant peritoneal neoplasm
    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 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 estimate the overall response rate for each cohort (Cohort 1: Platinum-resistant, BRCA negative, and received =3 lines of prior therapy, Cohort 2: Platinum-resistant, BRCA negative, and received <3 lines of prior therapy, Cohort 3: Platinum-resistant, BRCA positive, there is no restrictions on number of lines
    of prior therapy, but patients must have received prior PARP inhibitor, Cohort 4: Platinum-refractory, BRCA positive or negative, no restrictions on number of
    lines of prior therapy)
    Stimare il tasso di risposta complessiva per ogni coorte
    Coorte l: Platino-resistenti, BRCA negativi, con =3 linee di terapia precedenti;
    Coorte 2: Platino-resistenti, BRCA negativi, con <3 linee di terapia precedenti;
    Coorte 3: Platino-resistenti, BRCA positivi, nessuna limitazione nel numero di linee di terapia precedenti, ma devono aver ricevuto prima un inibitore poli ADP-ribosio polimerasi (PARP)
    Coorte 4: Platino-refrattari, BRCA positivi o negativi, nessuna limitazione nel numero di linee di terapia precedenti
    E.2.2Secondary objectives of the trial
    1. To characterize the safety and toxicity
    profile of prexasertib, 2. To characterize the PK of prexasertib, 3. To estimate secondary efficacy
    measures including DCR (disease control rate), DoR (duration of response), CA-125 response, PFS (progressioin free survival), OS (overall survival)
    1. Definire il profilo di sicurezza e di tossicità di prexasertib
    2. Definire la farmacocinetica (PK) di prexasertib
    3. Stimare le misure di efficacia secondarie, come DCR (tempo di controllo della malattia), DoR (durata della risposta), risposta CA-125, PFS (sopravvivenza senza progressione), OS (sopravvivenza globale)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Women who have histologically or cytologically verified high-grade serous ovarian,
    primary peritoneal or fallopian tube cancer.
    - Cohorts 1 to 3: Have platinum-resistant disease, which is defined as disease
    progression within 6 months of last dose of platinum-based chemotherapy.
    - Cohort 4: Have primary platinum-refractory disease defined as disease progression
    during or within 4 weeks after the last dose of initial line of platinum-based
    chemotherapy for ovarian cancer.
    - Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy for
    high-grade serous ovarian, primary peritoneal, or fallopian tube cancer (including
    immunotherapy, targeted therapies, or chemotherapy (systemic or intraperitoneal).
    - Cohort 2: Are BRCA negative have received less than 3 prior lines of therapy for
    high-grade serous ovarian, primary peritoneal, or fallopian tube cancer (including
    immunotherapy, targeted therapies, or chemotherapy (systemic or intraperitoneal).
    - Cohort 3: Are BRCA positive and have previously received a PARP inhibitor at any
    time following diagnosis.
    - Cohort 4: Are BRCA positive or negative; no restriction on number of lines of prior
    therapy.
    - Have a performance status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group
    (ECOG) scale
    - Have adequate organ function,
    - Must be able and willing to undergo mandatory tumor biopsy which will be collected following determination of eligibility and before treatment (=28 days before C1D1).
    - Donne affette da carcinoma ovarico sieroso di alto grado o carcinoma peritoneale primario o carcinoma delle tube tube di Falloppio confermato istologicamente o citologicamente.
    - Coorti da 1 a 3: pazienti che hanno manifestato resistenza al platino che è definita come progressione della malattia entro 6 mesi dall'ultima dose di chemioterapia a base di platino.
    - Coorte 4: pazienti che manifestano una malattia primaria refrattaria al platino definita come progressione della malattia durante o entro 4 settimane dall'ultima dose dell'iniziale linea di chemioterapia a base di platino per il carcinoma ovarico
    - Coorte 1: pazienti che sono BRCA negative e hanno ricevuto 3 o più linee precedenti di terapia carcinoma ovarico sieroso di alto grado, carcinoma primario peritoneale o carcinoma delle tube di Falloppio (incluso
    immunoterapia, terapie mirate o chemioterapia (sistemica o intraperitoneale).
    - Coorte 2: pazienti che sono BRCA negativi e che hanno ricevuto meno di 3 linee precedenti di terapia per carcinoma ovarico sieroso di alto grado, carcinoma primario peritoneale o carcinoma delle tube di Falloppio (incluso immunoterapia, terapie mirate o chemioterapia (sistemica o intraperitoneale).
    - Coorte 3: pazienti che sono BRCA positivi e hanno precedentemente ricevuto un inibitore di PARP in qualsiasi periodo dopo la diagnosi.
    - Coorte 4: pazienti che sono BRCA positive o negative; con nessuna restrizione sul numero di linee terapeutiche precedenti.
    - Pazienti che hanno un performance status (PS) di 0 o 1 nella Eastern Cooperative Oncology Group
    (ECOG) scale
    - Pazienti che hanno una adeguata funzione d'organo
    - Pazienti devono essere in grado e disposti a sottoporsi a biopsia tumorale obbligatoria che sarà raccolta dopo la determinazione dell'idoneità allo studio e prima del trattamento (=28 giorni prima di C1D1). La biopsia può essere eseguita prima dell'esecuzione del test di gravidanza e degli esami di laboratorio al C1D1.
    E.4Principal exclusion criteria
    - Cohorts 1-3: Have previously received all of the following agents at any time in the
    platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and
    paclitaxel. It is acceptable to have received 1 or 2 of these agents for platinumresistant
    disease.
    - Have known central nervous system (CNS) malignancy or metastasis.
    - Have at least one of the following:
    history of abdominal fistula or gastrointestinal (GI) perforation
    intra-abdominal abscess within last 3 months prior to the first dose of study drug
    a radiographically confirmed bowel obstruction (including sub-occlusive disease)
    within 3 months prior to the first dose of study drug.
    - Have a symptomatic human immunodeficiency virus (HIV) infection or symptomatic
    activated/reactivated hepatitis A, B, or C (screening is not required).
    - Have a serious cardiac condition, such as:
    symptomatic congestive heart failure or any uncontrolled cardiac disease
    New York Heart Association Class III/IV heart disease
    unstable angina pectoris
    symptomatic or poorly controlled cardiac arrhythmia
    myocardial infarction within the last 3 months
    have a QT interval using Fridericia’s correction (QTcF) of >480 msec on more
    than one electrocardiogram (ECG) obtained during the baseline (screening) period
    family history of long-QT syndrome.
    - Have a history of prior radiotherapy to the whole pelvis.
    - Have chronic daily treatment with corticosteroids (dose >10 mg/day methylprednisolone
    equivalent), excluding inhaled steroids.
    - Coorti 1-3: Pazienti che in precedenza hanno ricevuto tutti i seguenti agenti in qualsiasi momento nel platinum-resistant setting: gemcitabina, doxorubicina liposomiale pegilata e paclitaxel. È accettabile che il paziente abbia ricevuto 1 o 2 di questi agenti per malattia platino-resistente.
    - Pazienti che hanno un carcinoma o metastasi del sistema nervoso centrale (SNC).
    - Pazienti che hanno una già nota e seria patologia (per es. infezione attiva, rischio aumentato di sanguinamenti), che secondo l'opinione dello sperimentatore potrebbe compromettere la capacità della paziente di aderire allo studio o tollerare il trattamento in studio.
    - Pazienti con fattori noti che potrebbero aumentare il rischio di infezioni durante il trattamento in studio. Questi potrebbero includere, ma non essere limitati a, catetere peritoneale permanente o ferite non rimarginate. Cateteri per accesso venoso sono consentiti.
    - Pazienti che hanno almeno uno delle seguenti condizioni: anamnesi di fistola addominale o perforazione gastrointestinale (GI)
    ascesso intra-addominale nei 3 mesi precedenti la prima dose del farmaco in studio, ostruzione intestinale confermata radiograficamente (inclusa malattia subocclusiva) nei 3 mesi precedenti la prima dose del farmaco in studio.
    - Pazienti che hanno un'infezione sintomatica da virus dell'immunodeficienza umana (HIV) o infezione sintomatica da epatite A, B o C attivata / riattivata (non è richiesto lo screening).
    - Pazienti che hanno una grave malattia cardiaca, come ad esempio: insufficienza cardiaca congestizia sintomatica o qualsiasi malattia cardiaca incontrollata, Cardiopatia di classe III / IV (New York Heart Association), angina pectoris instabile,
    aritmia cardiaca sintomatica o scarsamente controllata, infarto del miocardio negli ultimi 3 mesi,
    un intervallo QT (QTcF) > 480 msec in più
    di un elettrocardiogramma (ECG) ottenuto durante il periodo di riferimento (screening) usando il metodo della correzione di Fridericia, storia familiare di sindrome del QT lungo.
    - Pazienti che sono stati sottoposti in precedenza a radioterapia della zona pelvica.
    - Pazienti che hanno ricevuto trattamento cronico giornaliero con corticosteroidi (dose> 10 mg / die metilprednisolone equivalente), esclusi gli steroidi per via inalatoria e topica.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate: proportion of all enrolled patients who achieve a best overall response of PR+CR as determined per RECIST version 1.1.
    ORR: percentuale dei pazienti arruolati che raggiunge la miglior risposta complessiva di PR+CR, come definito da RECIST versione 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    ORR will be performed when all enrolled patients have completed =2 months of follow-up and/or investigator-assessed best response assessments have been completed for all patients.
    L'ORR verrà eseguito quando tutti i pazienti arruolati avranno completato =2 mesi di follow-up e / o saranno completate le valutazioni della migliore risposta determinata dallo sperimentatore per tutti i pazienti.
    E.5.2Secondary end point(s)
    safety & toxicity: The safety endpoints evaluated will include but are not limited to the following: AEs, SAEs, clinical laboratory tests, ECGs vital signs, and physical examinations ; PK: Prexasertib concentrations in plasma; secondary efficacy measures including DCR, DoR, CA-125 response, PFS, OS: DCR: proportion of patients who achieve a best overall response of CR, PR and SD (for at least 4 months) as determined per RECIST version 1.1. • DoR: time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date of documented PD, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented PD. • CA-125 response: at least a 50% reduction in CA-125 levels from a pretreatment sample that is at least twice the upper limit of the reference range and obtained within 2 weeks before starting the treatment, with confirmation after 4 weeks according to GCIG criteria.
    PFS: time from enrollment until the first radiographic documentation (as assessed by the investigator) of progression or death from any cause in the absence of documented PD • OS: time from enrollment until death from any cause
    Definire il profilo di sicurezza e di tossicità di prexasertib. Gli endpoint di sicurezza valutati includeranno, a titolo non limitativo: AE, SAE, test clinici di laboratorio, ECG, parametri vitali ed esami obiettivi.; Definire la farmacocinetica (PK) di prexasertib. Concentrazioni di prexasertib nel plasma; Stimare le misure di efficacia secondarie, come DCR, DoR, risposta CA-125, PFS, OS
    - DCR: percentuale dei pazienti che raggiunge una migliore risposta complessiva di CR, PR e SD (per almeno 4 mesi), come definito da RECIST versione 1.1.
    - DoR: tempo trascorso dalla data in cui i criteri di misurazione di CR o PR
    (a seconda di quale viene registrata prima) sono stati soddisfatti per la prima volta alla prima data di PD documentata, secondo RECIST 1.1, o alla data di decesso per qualsiasi causa in assenza di PD documentata.
    - Risposta CA-125: una riduzione di almeno il 50% dei livelli di CA-125 da un campione pre-trattamento pari ad almeno due volte il limite superiore dell'intervallo di riferimento, ottenuto nelle 2 settimane precedenti l'inizio del trattamento, con conferma dopo 4 settimane secondo i criteri GCIG.
    - PFS: tempo dall'arruolamento alla prima documentazione radiografica (valutata dallo sperimentatore) di progressione o decesso per qualsiasi causa in assenza di PD documentata
    - OS: tempo dall'arruolamento al decesso per qualsiasi causa
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints will be evaluated at the time of the primary endpoint analysis; All secondary endpoints will be evaluated at the time of the primary endpoint analysis; All secondary endpoints will be evaluated at the time of the primary endpoint analysis
    Tutti gli endpoint secondary saranno valutati allo stesso tempo dell'endpoint primario; Tutti gli endpoint secondary saranno valutati allo stesso tempo dell'endpoint primario; Tutti gli endpoint secondary saranno valutati allo stesso tempo dell'endpoint primario
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Health outcome
    Esito sullo stato di salute
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Australia
    Brazil
    Israel
    Korea, Republic of
    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 years1
    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 years1
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 77
    F.4.2.2In the whole clinical trial 180
    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 who are still on prexasertib at the time of study completion may continue to receive prexasertib if they are experiencing clinical benefit and no undue risks. Lilly may allow patients to enroll in a “rollover” protocol to provide long-term continued access for patients enrolled in this study.
    Pazienti che stanno ancora assumendo prexasertib al momento del completamento dello studio
    potranno continuare a ricevere prexasertib qualora essi stanno ricevendo un beneficio clinico
    e non sono soggetti a rischi eccessivi. Lilly potrebbe consentire ai pazienti di avere accesso al
    protocollo "rollover" così da fornire un accesso continuato a lungo termine per i pazienti
    arruolati in questo 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 Decision2018-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-27
    P. End of Trial
    P.End of Trial StatusCompleted
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