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    Summary
    EudraCT Number:2016-002057-38
    Sponsor's Protocol Code Number:64091742PCR2001
    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:2022-01-20
    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 number2016-002057-38
    A.3Full title of the trial
    A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
    Uno studio di fase 2 sulla sicurezza ed efficacia di niraparib in uomini affetti da carcinoma prostatico metastatico resistente alla castrazione e anomalie nella riparazione del DNA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to understand the effect of Niraparib in men with end-stage PCA+
    Uno studio per capire gli effetti di niraparib in uomini affetti da carcinoma prostatico metastatico resistente alla castrazione
    A.3.2Name or abbreviated title of the trial where available
    A study to understand the effect of Niraparib in men with end-stage PCA+
    Uno studio per capire gli effetti di niraparib in uomini affetti da carcinoma prostatico metastatico
    A.4.1Sponsor's protocol code number64091742PCR2001
    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 SponsorJANSSEN CILAG INTERNATIONAL NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportJanssen-Cilag International N.V.
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportJANSSEN CILAG SPA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International N.V.
    B.5.2Functional name of contact pointClinical Registry group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0
    B.5.5Fax number0
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 nameNIRAPARIB
    D.3.2Product code NIRAPARIB
    D.3.4Pharmaceutical form Capsule, soft
    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 codeJNJ-64091742
    D.3.9.3Other descriptive nameniraparib tosylate monohydrate
    D.3.9.4EV Substance CodeSUB177208
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    mCRPC and DNA-repair anomalies
    carcinoma prostatico metastatico resistente alla castrazione e anomalie nella riparazione del DNA
    E.1.1.1Medical condition in easily understood language
    Prostate cancer in adult men that has spread to other parts of the body
    Cancro alla prostata in uomini adulti che si è diffuso ad altre parti del corpo
    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 10036909
    E.1.2Term Prostate cancer metastatic
    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 assess the efficacy of niraparib in subjects with measurable mCRPC and DNA-repair anomalies.
    Valutare l'efficacia di niraparib in soggetti affetti da mCRPC misurabile e anomalie nella riparazione del DNA
    E.2.2Secondary objectives of the trial
    -To assess the efficacy of niraparib in subjects with mCRPC and DNArepair anomalies
    -To evaluate response outcomes of niraparib in subjects with mCRPC and DNA-repair anomalies.
    -To evaluate the safety and tolerability of niraparib.
    -To evaluate duration of tumor response.
    - Valutare l’efficacia di niraparib in pazienti con mCRPC e anomalie nella riparazione del DNA
    - Valutare gli outcome di risposta di niraparib in soggetti affetti da mCRPC e anomalie nella riparazione del DNA
    - Valutare la sicurezza e la tollerabilità di niraparib
    - Per valutare la durata della risposta del carcinoma
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male
    2. >18 years of age (or the legal age of consent in the jurisdiction in
    which the study is taking place).
    3. Signed main study ICF indicating that the subject understands the purpose of, and procedures required for, the study and is willing to participate in the study.
    4. Histologically confirmed prostate cancer (mixed histology is
    acceptable, with the exception of the small cell pure phenotype, which is be excluded).
    5. Documented evidence of disease progression while on treatment with at least 1 taxane-based chemotherapy for prostate cancer
    6. Documented evidence of disease progression while on treatment with at least 1 AR-targeted therapy (eg, abiraterone acetate, enzalutamide, apalutamide) for prostate cancer.
    7. Tumor that is biomarker- positive for DNA-repair anomalies.
    8. Progression of metastatic prostate cancer in the setting of castrate levels of testosterone =50 ng/dL on a gonadotropin releasing hormone analog (GnRHa), or history of bilateral orchiectomy at study entry defined as having one or more of the following:
    a. PSA progression defined by a minimum of 2 rising PSA levels with an interval of =1 week between each determination (per Prostate Cancer Working Group 3 [PCWG3] criteria). The PSA level at the screening visit should be =2 µg/L (2 ng/mL).
    b. Radiographic progression of soft tissue by RECIST 1.1 or bone disease by PCWG3 criteria as defined below:
    I. Soft tissue disease (measurable) by RECIST 1.1 defined as having one or more of the following:
    i. Nodal disease (pelvic or extrapelvic [retroperitoneal, mediastinal,
    thoracic, other]) with lesions =1.5 cm in the short axis.
    ii. Visceral disease (lung, liver, adrenal) with lesions =1 cm in the long axis.
    II. Bone disease (non-measurable) defined as having bone lesions in the absence of measurable soft tissue disease.
    9. Must be able to continue GnRHa during the course of the study if not surgically castrate.
    10. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of =2.
    11. Must be able to swallow whole capsules.
    12. Subject must agree to use medically accepted and highly effective methods of contraception during the course of the study and for 3 months after the last dose of study drug.
    13. To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must agree while on study drug and for 3 months following the last dose of study drug to:
    a. Use a condom during sexual activity.
    b. Not donate sperm.
    14. At screening, the following laboratory parameters must be met:
    a. Absolute neutrophil count (ANC) =1.5 x 10^9/L
    b. Hemoglobin =9.0 g/dL
    c. Platelet count =100 x 10^9/L
    d. Serum albumin =3 g/dL
    e. Serum creatinine =1.5 × upper limit of normal (ULN), or a calculated creatinine clearance =60 mL/min using the Cockcroft-Gault equation
    f. Serum potassium =3.5 mmol/L
    g. Serum total bilirubin =1.5 × ULN or direct bilirubin =1 x ULN (Note: in subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin, and if direct bilirubin is =1.5 × ULN, subject may be eligible)
    h. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =3.0 × ULN or =5 x ULN in the presence of liver metastases i. i CTC count of =1 cells/7.5 mL blood
    1.Maschio
    2.Età pari o superiore a 18 anni (oppure maggiore età legale secondo la giurisdizione del paese in cui si svolge lo studio).
    3.ICF dello studio principale firmato indicante che il soggetto ha compreso lo scopo dello studio e le relative procedure e che intende prendervi parte.
    4.Carcinoma prostatico confermato da esame istologico (istologia mista accettabile) con eccezione del fenotipo puro a piccole cellule
    5.Evidenza documentata di progressione di malattia durante il trattamento conalmeno 1 chemioterapia a base di taxani per il trattamento del carcinoma prostatico.
    6.Evidenza documentata di progressione di malattia durante il trattamento con almeno 1 terapia androgeno soppressiva (AR) (ad es. abiraterone acetato, enzalutamide, apalutamide) per il carcinoma prostatico.
    7.Tumore positivo ai biomarcatori delle anomalie nella riparazione del DNA.
    8.Progressione del carcinoma prostatico metastatico nel contesto di livelli di testosterone castrato =50 ng/dL su un analogo dell'ormone di rilascio le gonadotropine (GnRHa), oppure storia di orchiectomia bilaterale all'ingresso nello studio definito come uno o più dei seguenti criteri:
    a.Progressione PSA definita come almeno 2 livelli PSA in aumento con un intervallo di =1 settimana tra ogni rilevazione (secondo i i criteri Prostate Cancer Working Group 3 (PCWG3) . Il livello di PSA alla visita di screening deve essere =2 µg/L (2 ng/mL).
    b.Progressione radiografica del tessuto molle secondo i criteri RECIST 1.1 o della malattia ossea secondo i criteri (PCWG3) come sotto indicato:
    •Malattia del tessuto molle (misurabile) secondo RECIST 1.1 che presenta una o piu’ delle seguenti caratteristiche:
    i. malattia nodale (pelvica o extrapelvica retroperitoneale,
    mediastinale, toracica, altro]) con lesioni =1.5 cm nell’asse corto
    ii. Malattia viscerale (polmone, fegato, surrene) con lesioni =1 cm sull’asse lungo
    9.II.Malattia ossea (non misurabile) definita dalla presenza di lesioni ossee in assenza di malattia misurabile del tessuto molle Deve essere in grado di proseguire con GnRHa per la durata dello studio se non castrato chirurgicamente.
    10.Performance status ECOG (Eastern Cooperative Oncology Group) =2.
    11.Deve essere in grado di ingerire casule intere.
    12.Il soggetto deve acconsentire a usare metodi contraccettivi accettabili a livello clinico e altamente efficaci per la durata dello studio e per 3 mesi dopo l'ultima dose di farmaco sperimentale.
    13.Per minimizzare il rischio di esposizione al farmaco attraverso lo sperma (anche in uomini già sottoposti a vasectomia, i pazienti devono acconsentire per tutta la durata del trattamento e per i 3 mesi dopo l'ultima dose di farmaco sperimentale a:
    a.Indossare un preservativo durante i rapporti sessuali.
    b.Non donare lo sperma.
    14.Allo screening devono essere soddisfatti i seguenti parametri di laboratorio:
    a.Conta assoluta dei neutrofili (ANC) = 1,5 x 109/l.
    b.Emoglobina =9,0 g/dl.
    c.Conta piastrinica = 100 x 109/L.
    d.Serum albumin =3 g/dL
    e.Creatinina nel siero =1,5 x limite superiore del normale (ULN), oppure clearance della creatinina calcolata = 60 mL/min utilizzando la formula Cockcroft-Gault.
    f.Potassio nel siero =3,5 mmol/L.
    g.Bilirubina totale nel siero =1,5 x ULN oppure bilirubina diretta =1 x ULN (nota: nei soggetti affetti da sindrome di Gilbert, se la bilirubina totale è >1,5 x ULN, misurare la bilirubina diretta e indiretta e se la bilirubina diretta è =1,5 x ULN, i soggetti possono essere idonei)
    h.Aspartato aminotransferasi (AST) oppure alanina aminotransferasi (ALT) =3,0 x ULN or =5 x ULN in presenza di metastasi epatiche
    i.Conta CTC =1 cellule/7.5 mL di sangue

    E.4Principal exclusion criteria
    1. Prior treatment with a PARP inhibitor.
    2. Prior platinum-based chemotherapy for the treatment of prostate cancer.
    3. Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).
    4. Known symptomatic or impending cord compression, except if subject has received definitive treatment for this and demonstrates evidence of clinically stable disease.
    5. Known symptomatic uncontrolled brain or leptomeningeal metastases (controlled is defined as CNS disease which has undergone treatment
    [eg, radiation or surgery] at least 15 days prior to Cycle 1 Day 1).
    6. Known allergies, hypersensitivity, or intolerance to niraparib or its excipients (refer to Investigator's Brochure).
    7. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the
    protocol-specified assessments.
    8. Known disorder affecting gastrointestinal absorption.
    9. Active cancer (other than prostate cancer; or basal cell or squamous cell skin cancer, non-muscle invasive bladder cancer [stages pTaG1 and
    pTaG2], or any other cancer in situ currently in complete remission) within 2 years prior to Cycle 1 Day 1.
    10. Prior radiotherapy =15 days prior to Cycle 1 Day 1, with the exception of a single fraction of radiotherapy for the purposes of palliation, which is permitted.
    11. Corrected QT interval by the Fridericia correction formula (QTcF) on the screening ECG >450 msec.
    12. Receiving concomitant medications that prolong QTc and are unable to discontinue use while receiving study drug.
    13. History of clinically significant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, torsades de pointes).
    14. HIV positive subjects with 1 or more of the following:
    a. Not receiving highly active antiretroviral therapy
    b. A change in antiretroviral therapy within 6 months of the start of screening(except if, after consultation with the sponsor on exclusion criterion 14.c, a change is made to avoid a potential drug-drug
    interaction with the study drug)
    c. Receiving antiretroviral therapy that may interfere with the study drug consult the sponsor for review of medication prior to enrollment)
    d. CD4 count <350 at screening
    e. An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening
    15. =30 days prior to Cycle 1 Day 1 had:
    a. a transfusion (platelets or red blood cells)
    b. chemotherapy
    c. hematopoietic growth factors
    d. an investigational agent for prostate cancer
    e. major surgery
    1.Precedente trattamento con un PARP-inibitore.
    2.Precedente chemioterapia a base di platino per il trattamento del tumore alla prostata
    3.Storia nota oppure diagnosi attuale di sindrome mielodisplastica (MDS) / leucemia mieloide acuta (AML).
    4.Compressione del midollo spinale sintomatica o incombente nota, eccetto il caso in cui il soggetto abbia ricevuto un trattamento definitivo per essa e presenta evidenza di malattia clinicamente stabile.
    5.Metastasi cerebrali o leptomeningee sintomatiche non controllate note (controllate è definito come malattia CNS sottoposta a trattamento [ad es. radiazioni o chirurgia] almeno 15 giorni prima del Ciclo 1 Giorno 1).
    6.Note allergie, ipersensibilità o intolleranza a niraparib o ai suoi eccipienti (fare riferimento al dossier dello sperimentatore)
    7.Presenza di qualsiasi condizione per cui, secondo il giudizio dello sperimentatore, la partecipazione non sarebbe nel miglior interesse del soggetto (ad es. ne comprometterebbe il benessere) o potrebbe impedire, limitare o confondere le valutazioni specificate dal protocollo.
    8.Disturbo noto che incide sull'assorbimento gastrointestinale.
    9.Carcinoma attivo (diverso dal carcinoma prostatico; oppure carcinoma basocellulare o carcinoma a cellule squamose, carcinoma vescicale non muscolo-invasivo [stadi pTaG1 e pTaG2], o qualunque altra neoplasia in situ attualmente in remissione completa) nei 2 anni precedenti al Ciclo 1 Giorno 1.
    10.Precedente radioterapia =15 giorni prima del Ciclo 1 Giorno 1 ad eccezione di una singola frazione di radioterapia a scopo palliativo, che è permessa.
    11.Correzione dell'intervallo QT secondo la formula di Fridericia (QTcF) >450 msec all'ECG in fase di screening.
    12.Somministrazione concomitante di farmaci che prolungano la QTc e non possono interromperla per il periodo di somministrazione del farmaco sperimentale.
    13.Storia di aritmie ventricolari clinicamente rilevanti (ad es. tachicardia ventricolare, fibrillazione ventricolare, torsioni di punta).
    14.Soggetti HIV positivi con 1 o più dei seguenti criteri:
    a.Non ricevere terapie antiretrovirali altamente virali
    b.Una variazione della terapia antiretrovirale nei 6 mesi precedenti all'inizio dello screening (eccetto se, dopo un consulto con lo sponsor sul criterio di esclusione 14.c) la modifica è apportata allo scopo di evitare una potenziale interazione farmaco-farmaco con il farmaco sperimentale)
    c.Somministrazione di una terapia antiretrovirale che può interferire con il farmaco sperimentale (consultare lo sponsor per l'esame del farmaco prima dell'arruolamento)
    d.Conta CD4 <350 allo screening
    e.Un'infezione opportunistica di definizione della sindrome da immunodeficienza acquisita nei 6 mesi precedenti all'inizio dello screening
    15.Nei 30 giorni precedenti al Ciclo 1 Giorno 1 è stato sottoposto a:
    a.Una trasfusione (piastrine o globuli rossi)
    b.Chemioterapia
    c.Fattori di crescita emopoietici
    d.Un agente sperimentale per il carcinoma prostatico
    e.Importante intervento chirurgico
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR) of soft tissue (visceral or nodal disease) as defined by RECIST 1.1 with no evidence of bone progression according to the PCWG3 criteria
    •Risposta oggettiva aTasso di risposta oggettiva (ORR) del tessuto molle (malattia viscerale o nodale) come da definizione di RECIST 1.1 senza evidenza di progressione ossea in accordo ai criteri PCWG.
    E.5.1.1Timepoint(s) of evaluation of this end point
    l'analisi finale di ORR avrà luogo a circa 26 mesi (approssimativamente 6 mesi dopo l’ultimo paziente arruolato).
    Final analysis for the RR will occur approximately 26 months (approximately 6 months from last subject enrolled)
    E.5.2Secondary end point(s)
    -CTC response defined as CTC=0 per 7.5 mL blood at 8 weeks postbaseline
    -OS: time from enrollment to death from any cause
    - rPFS: time from enrollment to radiographic progression or death from
    any cause, whichever occurs first
    -Time to radiographic progression
    -Time to PSA progression
    -Time to symptomatic skeletal event (SSE)
    -Duration of objective response: time from complete response (CR) or
    partial response (PR) to radiographic progression of disease
    -CTC=0 per 7.5 mL di sangue ad 8 settimane dopo il basale
    -OS: intervallo dall'arruolamento alla morte, per qualsiasi causa –rPFS: intervallo dall'arruolamento alla progressione radiografica o alla morte per qualsiasi causa, a seconda dell'evento che si verifica prima. –Tempo prima della progressione radiografica –Tempo prima della progressione PSA –Tempo prima dell'evento scheletrico sintomatico (SSE) -• Durata della risposta oggettiva: tempo dalla risposta completa (CR) oppure risposta parziale (PR) prima della progressione della malattia
    E.5.2.1Timepoint(s) of evaluation of this end point
    Nap
    Nap
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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
    Belgium
    Canada
    Denmark
    France
    Germany
    Israel
    Italy
    Korea, Republic of
    Netherlands
    Russian Federation
    Spain
    Sweden
    Taiwan
    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
    Ultima Visita dell'Ultimo Paziente 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 months6
    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 months1
    E.8.9.2In all countries concerned by the trial days26
    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: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 96
    F.2 Gender
    F.2.1Female No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 69
    F.4.2.2In the whole clinical trial 160
    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)
    Once a subject has completed the Treatment Phase, CT, MRI, or bone scans will be collected every 3m until confirmed radiographic progression. In addition, survival f/u and SSEs will be performed every 3m either via clinic visits, telephone interview, chart review, or other convenient methods. Deaths regardless of causality and SAEs thought to be related to study drugs (including diagnosis of MDS/AML) will be collected and reported within 24 hours of discovery or notification of
    the event.
    Quando il soggetto ha complettato la fase di trattamento, una TAC, RM o scintigrafia totale saranno raccolti fino a 3 mesi fino a confermata progressione radiografica. In aggiunta i survival follow up e SSE (evento scheletrico sintomatico) saranno eseguiti ogni 3 mesi attraverso visite cliniche, interviste telefoniche, revisione delle cartelle o altri metodi.
    I decessi indipendentemente dalla causalità e i SAEs che si pensa siano collegati al farmaco in studio inclusa la diagnosi di MDS/AML sar
    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 Decision2017-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-06-19
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