| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Relapsed platinum resistant small-cell lung cancer (SCLC) |
| Carcinoma polmonare a piccole cellule (SCLC) recidivante platino-resistente |
|
| E.1.1.1 | Medical condition in easily understood language |
| Lung cancer |
| Carcinoma Polmonare |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10041067 |
| E.1.2 | Term | Small cell lung cancer |
| E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To assess efficacy of intervention in terms of objective response with berzosertib + topotecan |
| Valutare l'efficacia dell'intervento in termini di risposta oggettiva con berzosertib + topotecan |
|
| E.2.2 | Secondary objectives of the trial |
-To assess efficacy of intervention in terms of duration of response with berzosertib + topotecan
- To assess efficacy of intervention in terms of PFS with berzosertib + topotecan
- To assess efficacy of intervention in terms of OS with berzosertib + topotecan followed by subsequent therapy
- To evaluate the safety and tolerability of berzosertib + topotecan
- To collect plasma concentration data via sparse PK sampling to contribute to population PK and exposure-response analyses of efficacy and safety of berzosertib and topotecan (and associated metabolites).
- To investigate the relationship between exposure of berzosertib and QTc
- To evaluate molecular and morphological biomarkers of response in tumor tissue and in plasma during berzosertib + topotecan
- To identify germline genetic polymorphisms that may be predictive of differences in the berzosertib + topotecan PK and efficacy (PGx). |
- Valutare l'efficacia dell'intervento in termini di:
durata della risposta con berzosertib + topotecan;
sopravvivenza libera da progressione (PFS) con berzosertib + topotecan;
sopravvivenza globale (OS) con berzosertib + topotecan e successiva terapia.
- Valutare la sicurezza e la tollerabilità di berzosertib + topotecan
- Raccogliere dati sulla concentrazione plasmatica tramite campionamento sparso PK per contribuire alle analisi della popolazione PK e del rapporto esposizione-risposta sull'efficacia e la sicurezza di berzosertib e topotecan (e dei metaboliti associati).
- Studiare la relazione tra l'esposizione di berzosertib e QTc
- Valutare biomarcatori molecolari e morfologici di risposta nel tessuto tumorale e nel plasma durante berzosertib + topotecan
- Identificare polimorfismi genetici germinali che possono essere predittivi di differenze nella PK e nell'efficacia (PGx) di berzosertib + topotecan. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1.Are = 18 years of age at the time of signing the informed consent. 2.Histologically confirmed SCLC 3. Radiologically confirmed progression after first-line or chemoradiation platinum-based treatment (carboplatin or cisplatin), with or without immunotherapy, for treatment of limited or extensive stage SCLC, with a PFI < 90 days. The PFI is measured by the elapsed time from the last day of the regimen of a platinum-based treatment until the first day of documented disease progression 4. Measurable disease according to RECIST 1.1 at Screening. Evidence of measurable disease must be confirmed by the IRC prior to start of treatment 5. Tumor tissue provision: archival (collected within 12 months before date of ICF signature for Screening) or fresh biopsy specimen, if medically feasible 6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) =2 and Karnofsky Scale =60% (see App8) 7. Have adequate hematologic function as indicated by:-Platelet count = 100,000/mm3 -Hemoglobin = 9.0 g/L. Prior red blood transfusions are allowed
-Absolute neutrophil count = 1,500/µL with no growth factor treatment within 14days of obtaining the screening blood sample
-Total bilirubin level = 1.5 × upper limit of normal (ULN), except in the case of known Gilbert syndrome, in which case total bilirubin must be = 2 ULN, an
aspartate aminotransferase (AST) and an alanine aminotransferase (ALT) level =3.0 × ULN or =5 × ULN in presence of liver metastases -Adequate renal function defined as creatinine clearance =60 mL/min by calculation using the Cockcroft-Gault formula or measured by 24h urine collection. The Cockcroft-Gault formula is (l40 - age)×weight kg)/(72×serum creatinine [mg/dL])×0.85 (if female)
8.Are male or female 9. Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies. Male participants: Agree to the following during the Study Intervention Period and for at least 6 months after the last study intervention dose:
-Refrain from donating sperm PLUS, either: -Abstain from any activity that allows for exposure to ejaculate
OR -Use a male condom: When having sexual intercourse with a woman of childbearing potential WOCBP, who is not currently pregnant, and advise her to use a highly effective contraceptive method with a failure rate of<1% per year, as described in App 3, since a condom may break or leak.
-Male participants must use a condom with pregnant female partners
Female participants:Are not pregnant or breastfeeding, and at least 1 of the following conditions applies:-Not a WOCBP OR -If a WOCBP, use a highly effective contraceptive method (i.e., with a failure rate of < 1% per year), preferably with low user dependency, as described in App 3 for the following time periods: o Before the first dose of the study intervention, if using hormonal contraception:
-Has completed at least one 4-Week cycle of an oral contraception pill and either had or has begun her menses OR Has used a depot contraceptive or extended-cycle oral contraceptive for least 28 days and has a documented negative pregnancy test using a highly sensitive assay AND A barrier method, as described in App3. o During the Study Intervention Period o After the Study Intervention Period (i.e., after the last study intervention dose is administered) for at least 6months after the last study intervention dose and agree not to donate eggs (ova, oocytes) for reproduction during this period The Investigator evaluates the effectiveness of the contraceptive method in relationship to the first dose of study intervention. Have a negative serum pregnancy test, as required by local regulations, within 24h before the first study intervention dose.
Additional requirements for pregnancy testing during and after study intervention are in App5.
10.Capable of giving signed ICF, as indicated in App2, which includes compliance with the requirements and restrictions listed in the ICF and this protocol. |
18 anni o + al momento della firma del consenso informato.
Tumori solidi avanzati istologicamente comprovati, per cui non esista una terapia standard efficace/non abbia dato risultati/non venga tollerata
Stato delle prestazioni del Gruppo di oncologia cooperativa orientale (PS ECOG)=1 e scala di Karnofsky=70%
PS ECOG=2 e scala di Karnofsky=60%
SCLCistologicamente confermato
Progressione confermata radiologicamente dopo trattamento di prima linea o chemioradioterapia a base di platino (carboplatino o cisplatino), con o senza immunoterapia, per il trattamento di SCLC in stadio limitato o esteso,con PFI<90 giorni. Il PFI misurato dal tempo trascorso dall'ultimo giorno del regime di un trattamento a base di platino fino al primo giorno di documentata progressione di malattia
Malattia misurabile in base ai criteri RECIST1.1 allo Screening. Evidenza di malattia misurabile confermata dall’IRC prima dell'inizio del trattamento Fornitura di tessuto tumorale: d’archivio(raccolto entro 2 mesi prima della data della firma dell'ICF) per lo Screening) o campione bioptico fresco
Funzione ematologica adeguata:• Conta piastrinica=100.000/mm3• Emoglobina=9,0 g/l. Sono consentite precedenti trasfusioni di globuli rossi•Conta assoluta dei neutrofili=1.500/µl senza trattamento con fattore di crescita entro 14giorni dall'ottenimento del campione di sangue allo screening• Livello di bilirubina totale=1,5×limite superiore della norma(ULN), tranne nel caso di sindrome di Gilbert nota, nel qual caso la bilirubina totale deve essere=2 ULN, un livello di AST e un livello di ALT=3,0×ULN o =5 × ULN in presenza di metastasi epatiche• Adeguata funzionalità renale=clearance della creatinina=60 ml/min mediante calcolo con la formula di Cockcroft-Gault o misurata mediante raccolta delle urine delle 24h. La formula di Cockcroft-Gault è (l40 - età)×peso kg)/72×creatinina sierica [mg/dl])×0,85 (per le donne)
Maschio o femmina
Uso Contraccettivi da parte di M/F 2°norme locali sui metodi di contracc per coloro che partecipano a studi clinici.
Partecipanti di sesso maschile:durante lo studio e per almeno 6 mesi dopo l'ultima dose di intervento dello studio:•Astenersi dal donare sperma e INOLTRE:•Astenersi da qualsiasi attività che consenta l'esposizione all'eiaculazione OPPURE•Usare un preservativo quando si hanno rapporti sessuali con una donna in età fertile (WOCBP), che non è attualmente incinta, e consigliarle di usare un metodo contraccettivo con un tasso di fallimento <1% all'anno,poiché un preservativo potrebbe rompersi o perdere.•I partecipanti di sesso maschile devono usare il preservativo con partner di sesso femminile in gravidanza.
Partecipanti di sesso femminile:NO incinte o allattare al seno+almeno una delle seguenti condizioni:•NO WOCBP O Se WOCBP, dovrà usare un metodo contraccettivo con fallimento<1%/anno), preferibilmente con bassa dipendenza dall'utente per i seguenti periodi di tempo:o Prima della prima dose dell'intervento dello studio, se utilizza la contraccezione ormonale:¿Ha completato almeno un ciclo di 4Week di una pillola contraccettiva orale e ha avuto o ha iniziato le mestruazioni O Ha utilizzato un contraccettivo depot o un contraccettivo orale a ciclo prolungato per almeno 28day e dispone di un test di gravidanza negativo documentato e altamente sensibile+Un metodo barriera.Durante il Periodo di intervento dello studio;Dopo il periodo di intervento dello studio (ovvero, dopo la somministrazione dell'ultima dose dell’intervento dello studio) per almeno 6 mesi dopo l'ultima dose dell’intervento dello studio. Non donare uova (ovuli, ovociti) per la riproduzione durante questo periodo.Il PI valuta l'efficacia del metodo contraccettivo in relazione alla prima dose dell'intervento dello studio.Risultare negativa al test di gravidanza sierologico entro 24hprima della prima dose dell’intervento dello studio.
Capacità di fornire l'ICF firmato, che include la conformità ai requisiti e alle restrizioni elencate nell'ICF e nel presente protocollo. |
|
| E.4 | Principal exclusion criteria |
| 1.Clinic relevant, uncontroll intercurrent illness (sev active infection including, severe acute resp syndrome coronav-2 Infection/coronav disease2019, immune deficie, uncontroll diabetes, uncontroll arterial hypert, symptomatic cong heart failure (NY Heart Association Classification =Class II), unst angina pectoris, myocar infarct, uncontroll cardiac arrhyth, cerebral vascular accident/stroke, or any psychiatric illness/social situations that would limit compliance with study requirem.Exceptions:Participants with-HIV infection are eligible if they are on effective antiretrovir therapy with undetect viral load within 6m, provided there is no expected drug-drug interaction. HIV test is not mandated for study inclusion. If performed, the participant must be consented for testing as per local standard guidance.-chronic HBV inf are eligible if the HBV viral load is undetect on suppressive therapy (if indicated), and if they have ALT, AST, and total bilirubin levels < ULN, and provided there is no expected drug-drug interaction. Refer to the Table1 for tests required at scr and during Study Interv Period.-history of HCV inf are eligible if they have been treated and cured. If currently on treat, they are eligible if they have an undetec HCV viral load, and if they have ALT, AST, and total bilirubin levels < ULN. Refer to the SoA for tests required at screening and during Study Interv Period.2.Unstable brain metastases; participants with known brain metastases may be enrolled if they are clinically stable (without evidence of progr by imaging for at least 4w prior to 1st study intervention dose and any neurologic symptoms have returned to BL), have no evidence of new brain metast, and are on a stable or decr dose of steroids for at least 14d prior to study interv.Participants with carcinomatous meningitis are excluded regardless of clinical stability.Scr CNS imaging is not mandatory.3.Prior malignant disease within the last 3 years.Exceptions: fully resected basal cell carc of the skin or squ cell carc of the skin, in situ cervical cancer, fully resect ductal carc in situ of the breast, superficial or noninvasive bladder canc, and StageIA, GradeI endometrioid endometrial canc with no myometrial invasion, that has undergone curative therapy.Participants with other loc malignan treated with curative intent need to be discussed with the Medical Monitor.4.Participants not recovered from AEs Grade>1 from prior anticancer therapies, including surgeries.Exception:Grade2AEs not constituting a safety risk(e.g.,alopecia), based on the Inv's judgment; must consult with the medical Mon prior to enroll.Prior/Concomitant Therapy5.Two or more lines of prior systemic anticancer treat including retreat with a plat-based regimenPrior treat with 6.topoiso I inhibitor including topotecan and irinotecan;7.an ATR inhibitor;8.Prior or concurrent treat with a nonpermitted drug/intervention:-Part who may have received any of the following anticancer therapy(ies) within the follow time wind from the d1 of study interv admin:oSmall molecule inhibitor therapy (including inv) within 2w or 5 half-lives, whichever is longer oAny type of anticancer antibody or ABdrug conj within 4w oSyst chemothwithin 4w (within 6w for nitrosoureas/mitomycinC) oPrior curative-intent high-dose radiotherapy within 4w. Prior palliative radiothto metastatic lesion(s) is permitted provided it was completed at least 1w prior d1 of study interv administration and toxicities recovered to Grade =1. oAny other type of anticancer ther, not listed above, within 4w.-Conco use of strong inhib or inducers of cytP4503A4 (CYP3A4)enz that cannot be discontinued for at least 1w prior to admin of study intervention and for the duration of study intervention. -Other prohibited concomitant medications listed in Section 6.5.3. 9.Concur participation in another interv clinical study is not permitted.There areNOrestrictions on prior clinical study particip provided the above washout periods are followed. |
| Malatintercorrnon controll clinic rilevante(attiva), tra cui,esmanonesaustivo,infezattivagrave(tra cui sindrrespacutagraveda Corona-2/malattiadaCrona2019), defimmuni,diabetenocontroll,ipertartnoncontroll,insuffcardcongestiziasintom(classificazdellaNYHeartAss=ClasseIII),angpectorisinstabile,infartodelmiocardio, aritmiacarnoncontroleincidentecerebrovaoictus.MediaQTccalcolata(utilizzilcalcolodellecorrezdiFridericia)>450msecperisoggettidisessoMe>470msecperi soggettiFEventualemalattiapsich/situazsocialechelimiterebberolaconformitàairequdellostudioECCEZIONIIparteconinfezHIVsonoidoneiseinterapiaantiretroviraleefficaceconcaricavirnonrilevabileentro6mesi,a condizionechenonsiano previsteinterazfarmaco-farm.IltestdelHHIVnonèobbligatperl'inclusionenellostudio.Sevieneeseguito,ènecessarioilconsensodelpartecinbaseallelineeguidastandardlocaliIpartecconevidenzadiHBVcronicasonoidoneisecaricaviraledell'HBVnonèrilevabiledurantelaterapiasoppressiva(seindicata),sehannolivellidi ALTASTebilirubin tot<ULNe senonsono revisteinterazfarmaco-farm.Fareriferimentoal Progrdelle valutaz(SoATab1)pergliesamirichiestialloscreduranteilPeriododiintervdellostudio.Parteccon un’anamnesidi infezioneHCVsonoidoneisesonostati trattatiecurati.PartecipanticonHCVchesonoattualmintreattamsono idoneisehannocarica viraleHCVnonrilevabile e sehanno livelli diALT,ASTeBilTOT<ULN.Fare rifa SoA (Tab1)per gli esami richiesti allo sce durante il Perdi intervellostudioMetasterebraliinstabili;tuttavia, i partecon metastcerebrote possonoesarruolatiinquesto stclincicose sono clinicamstabili(senza eviddi prograll’imaging peralmeno4weekprima delladose1dell’intervdello studio e se i sintomi neurosono tornal basale)non presentanoeviddinuovemetastasi cerebreassumonounadosestabileo decrescdisteroidiperalmeno14giorniprima dell'intervdello studio.Partecipanticonmeningitecarcinomatosasonoesclusi indipendentdallastabilitàclinicaL’imagingdelSNCallo scrnon è obbligatorio3Precedentemalattiamalignanegliultimi3anni.Leeccezincludonocarca cellbasali della pelle completresecatoocarca cellsquamose della pelle, carccervicale in situ, carcduttale in situ della mammellacompletamenteresecato,carcdella vescica superfo non inv e carcendometrioide allo stadio IA,gradoI senza invmiometriale,cheèstatosottopostoaterapiacurativa.L’idoneitàdeipartecipanticon altritumorimalignilocaltrattaticonintentocurativodeveesserediscussacon il Respdel monitormedico.4PartecipanticonanamnesinotadisindrLi-Fraumenie atassia-teleangectasia.5Partecnon guaritidaEAdi Grado>1 derivda precedentiterapie antitumor, inclusiintervchirurgici.EccezioneEA di Grado2che non costituisconounrischioperlasicurezza(ad esalopecia),in baseal giudiziodelPIè necessario consultare il Respdel monitormedicoprima dell’arruol.Terapia prec/conc7Prectrattconuninibdella topoisoI,inclusitopotecanirinotecan8Prectrattcon un inibitore di ATR9Trattpreco conccon un farmaco/intervento non consentito:Partecchepotraver ricuna delle seguenti terapie antitumentro le seguenti finestre tempodal1°daydi somministrdegli interventi dello studio:Tercon inibdi piccmolecole(compresi prodsper)entro2sett 5emivite,asecdel periodo+lungo-Qualsiasi tipo di Abantitumoro coniudi farmaci anticorpali entro 3sett-Chemiotsistemica entro 4sett(entro6settper nitrosouree/mitomicina C)-Precedradioterad alte dosi con intento curativo entro 4settÈconsna precradiotpalliper le lesmetasta, a condizche sia stata complalmeno1settprimadel1°daydi somministdegli intervdellostudioechele tossicità siano ripralGrad=1Qualstipoditer antitum,nonelencsopr,entro4sett.UsoconcdipotiniboinduttdeglienzdelcitP4503A4(CYP3A4)chenonpuòessinterrottoperalmeno1settiprimadellasomministrazionedell'interventodellostudioeperladuratadell'interventodellostudio.AltrifarmconcproibitiSezione6.5.3.Espdistclprec/conc10NOpartecconcaunaltrostclincinterv.Non sono previste restrizalla partecipazperstudiclinprec,acondizchevenganorispiperdiwashoutindicati.Altreesclusioni11Ipersensnota agli intervdellost,auncompostostruttsimileoaeccipientiutilizzati |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Objective response according to RECIST 1.1 as assessed by the IRC |
| Risposta obiettiva secondo RECIST 1.1 valutata dall'IRC |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Objective response assessed by IRC during study |
| Risposta oggettiva valutata dall'IRC durante lo studio |
|
| E.5.2 | Secondary end point(s) |
-Duration of response according to RECIST 1.1 as assessed by the IRC.
- Progression-free survival according to RECIST 1.1
- Overall survival
- Change from baseline in physical functioning measured by the EORTC QLQ-C30; cough, dyspnea, and chest pain measured by EORTC QLQLC13; health state as measured by VAS as a component of the EQ-5D-5L
- Occurrence of AEs and treatment-related AEs and occurrence of clinically significant changes in vital signs,
laboratory parameters and 12-lead ECG findings
- Change from baseline in functioning scales and symptom scales/items measured by EORTC QLQ-C30 and EORTC QLQ-LC13
- Time to deterioration in functioning scales and symptom scales/items
- Concentrations of berzosertib (berzosertib metabolites) and topotecan in plasma
- Relative changes from Baseline in ECG parameter QTc in relation to berzosertib plasma concentration
- Association of baseline and on treatment biomarkers with response to treatment
- Association of germline genetic polymorphisms as detected in normal blood DNA with berzosertib and topotecan clinical efficacy.
- occurrence of DLTs in JPN participants.
- - OR and DOR |
-Durata della risposta secondo RECIST 1.1 come valutato dall'IRC.
- Sopravvivenza libera da progressione secondo RECIST 1.1
- Sopravvivenza globale
- Variazione rispetto al basale nel funzionamento fisico misurato dall'EORTC QLQ-C30; tosse, dispnea e dolore toracico misurati da EORTC QLQLC13;
stato di salute misurato dalla VAS come componente dell'EQ-5D-5L
- insorgenza di eventi avversi e eventi avversi correlati al trattamento e insorgenza di cambiamenti clinicamente significativi nei segni vitali,
parametri di laboratorio e risultati ECG a 12 derivazioni
- Variazione rispetto al basale nelle scale di funzionamento e nelle scale / item dei sintomi misurato da EORTC QLQ-C30 e EORTC QLQ-LC13
- Tempo al deterioramento delle scale di funzionamento e delle scale / oggetti dei sintomi
- Concentrazioni di berzosertib (metaboliti di berzosertib) e topotecan nel plasma
- Variazioni relative rispetto al basale nel parametro ECG QTc in relazione a concentrazione plasmatica di berzosertib
- Associazione dei biomarcatori al basale e al trattamento con risposta a trattamento
- Associazione di polimorfismi genetici germinali rilevati nella norma DNA del sangue con berzosertib e efficacia clinica di topotecan.
- presenza di DLT nei partecipanti JPN.
- - OR e DOR |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
- DOR and PFS: from first documentation of objective response to PD or
death, occurring within 2 scheduled tumor assessments after last
evaluable assessment or first study intervention
- OS: from first study intervention to death
- QLQ questionnaires: throughout study
- AEs measured during study
. time to deterioration from first study intervention and first occurrence
of worsening in HRQoL score
- Concentrations of berzosertib and topotecan in plasma at blood test
timepoint.
- ECG par. all times after dosing with concurrent QTc and plasma
concentration assessment
- Occurence of DLTs until end of Cycle 1 in JPN
- OR and DOR: from first documentation of objective response to PD or
death, within 2 scheduled tumor assessments after last evaluable
assessment or 1st intervention. |
- DOR e PFS: dalla prima documentaz di risp oggettiva a PD o morte, che si verifica entro 2valutaz del tumore programmate dopo l'ultima valutaz valutabile o 1° intervento di studio
- OS: dal primo intervento in studio alla morte
- Questionari QLQ: durante lo studio
- EA misurati durante lo studio. tempo al deterioram dal 1° interv di studio e dalla prima occorrenza di peggioram del punt HRQoL
- Concentraz di berzosertib e topotecan nel plasma all'analisi del sangue punto temporale
- ECG par. tutte le volte dopo la somministrazdi QTc e plasma concom valutaz della concentraz
- Presenza di DLT fino alla fine del ciclo 1 in JPN
- OR e DOR: dalla prima documentazione di risposta oggettiva a PD o morte, entro 2 valutaz del tumore programm dopo l'ultima valutabile
valutaz o 1 ° intervento. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Yes |
| E.6.11 | Pharmacogenomic | Yes |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 1 |
| 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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 18 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| China |
| Japan |
| United States |
| Belgium |
| France |
| Hungary |
| Italy |
| Spain |
|
| E.8.7 | Trial 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
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 3 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 3 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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