| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Advanced/unresectable or metastatic urothelial carcinoma |
| Carcinoma uroteliale avanzato / non resecabile o metastatico |
|
| E.1.1.1 | Medical condition in easily understood language |
| Urothelial cancer (also known as transition cell carcinoma of the bladder) |
| Tumore uroteliale (noto anche come carcinoma a cellule transizionali della vescica) |
|
| 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 | 20.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10064467 |
| E.1.2 | Term | Urothelial carcinoma |
| E.1.2 | System Organ Class | 100000004864 |
|
| 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 |
1. To compare pembrolizumab (MK-3475) + lenvatinib (MK-7902) to pembrolizumab + placebo with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR).
2. To compare pembrolizumab + lenvatinib to pembrolizumab + placebo with respect to Overall Survival (OS). |
1.Confrontare pembrolizumab (MK-3475) + lenvatinib (MK-7902) rispetto a pembrolizumab + placebo in termini di sopravvivenza libera da progressione (PFS) secondo i criteri di valutazione della risposta nei tumori solidi versione 1.1 (RECIST 1.1) mediante revisione centrale indipendente in cieco (BICR).
2.Confrontare pembrolizumab + lenvatinib rispetto a pembrolizumab + placebo in termini di sopravvivenza complessiva (OS). |
|
| E.2.2 | Secondary objectives of the trial |
1. To compare pembrolizumab + lenvatinib to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR).
2. To evaluate the safety and tolerability of treatment with pembrolizumab + lenvatinib versus pembrolizumab + placebo
3. To evaluate pembrolizumab + lenvatinib and pembrolizumab + placebo with respect to Duration of Response (DOR) per RECIST 1.1 by Blinded Independent Central Review (BICR)
4. To evaluate pembrolizumab + lenvatinib and pembrolizumab + placebo with respect to Disease Control Rate (DCR) per RECIST 1.1 by Blinded Independent Central Review (BICR)
5. To evaluate changes in patient-reported outcomes (PROs) from Baseline and Time to Deterioration (TTD) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29)/Quality of Life (Item 30). |
1.Confrontare pembrolizumab + lenvatinib rispetto a pembrolizumab + placebo in termini di tasso di risposta obiettiva (ORR) secondo i criteri RECIST 1.1 mediante BICR.
2.Valutare la sicurezza e la tollerabilità del trattamento con pembrolizumab + lenvatinib rispetto a pembrolizumab + placebo.
3.Valutare pembrolizumab + lenvatinib rispetto a pembrolizumab + placebo in termini di durata della risposta (DOR) secondo i criteri RECIST 1.1 mediante BICR.
4.Valutare pembrolizumab + lenvatinib rispetto a pembrolizumab + placebo in termini di tasso di controllo della malattia (DCR) secondo i criteri RECIST 1.1 mediante BICR.
5.Valutare le variazioni negli esiti riferiti dal paziente (PRO) rispetto al basale e valutare il tempo al peggioramento (TTD) mediante il questionario per misurare la qualità della vita dell’Organizzazione europea per la ricerca e il trattamento dei tumori (EORTC) a 30 voci (QLQ-C30) relativo allo stato di salute globale e alla qualità della vita (QoL). |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1Hav histologic or cytologic conf diagnosis of advan/unresectable or metastatic urothelial carc renal pelvis,ureter,bladder,urethra.Both transitio cell and mix transitio/nontransitio cell hist are allow,but transitio cellcarc must be predom hist
2Hav least 1meas target lesion RECIST1.1assess local site investig/radiol, per followcriteria:1lymph node lesion measuring>=15mm short axis2)nonnodal lesion measuring >=10 mmlongest diameter3)lesion suitable frepeat measurement with CT/MRI imaging.Lesion
previously irradiat area consid measurable progres has been demonstrated in such lesions
3Hav provid archival tumor tissue sample or newly obtain core or excisional biopsy tumor lesion not previously irrad and adequatePDL1evaluat.Formalinfix, paraffembedd tissue blocks are prefer slides. Newly obtained biopsies are prefer archiv tissue.PDL1 status(CPS>=10orCPS <10)must obtain by centlab dur screening perd prior enrollm
4Hav receiv no prior systemic chemo for advan or metastaticUCwith follow except
-Neoadjuvant platinumbas chemoth for treatment muscleinvasive bladder cancer with recurrenc>12months from completion of the therapy is permit
-Adjuvant platinumbas chemoth follow radical cystectomy,with recurrence>12 months from completion,is permit
5Meet criteria for either option or option b: aHav tumor withPDL1CPS>=1andcons ineligible receive cisplatinbas combin ther,bas on 1 follow
-ECOG PS 2 within7day prior trandom
-CrCl(calculat or measur using institut standard)>=30to<=60mL/min
-NCICTCAEVers4.0 Grade>=2 audiometric hearing loss
-NCICTCAEVers4.0 Grade>=2 peripheral neuropathy
OR
bopinion invest,be cons ineligible receive any platinumbas chemoth(ineligible for cisplatin and carboplatin)bas on
-ECOGPS2within7day prior random and least1of follow
-Docum visceral metastatic dis
-CrCl>=30 to<=60 mL/min
-NCICTCAE Version 4.0 Grade>=2 audiom hear loss
-NCICTCAE Version 4.0 Grade>=2 peripheral neuropathy
-Other reason,identif case report form,for part being unable receive both cisplatin and carboplatin safely.Add criteria for platinum ineligibility will be considered and allowed on a casebycase basis,follow consult Sponsor
6male or female>=18 years age and consider an adult per local regulations on day of signing the inform consent
7HavECOGPS01or2within7dayprior random and life expectancy of>=3 months
8Male particip are eligible participate if agree follow dur interven perd and for least3dayafter last dose of pembro or lenvatinib/placebo:
-Be abstinent heterosexual interc their prefer and usual lifestyle and agree remain abstinent
OR
-Must agree use contracep unless confirm be azoospermic as detail below:
-Agree use male condom plus partner use addit contraceptive method when hav penilevaginal intercourse with WOCBP who isnot currently pregnant
9female part eligible to participate if she isnot pregnant or breastfeeding and at least one of followcond applies:
-Isnot a WOCBP
OR
-IsWOCBP and using contraceptive method that is highly effective with low user dependency, or be abstinent from heterosexual intercourse as her preferred and usual lifestyle,dur intervperd and for least 120days post pembro orn30 days post lenvatinib/placebo
-WOCBPmust hav negative highly sensitive pregnancy test within 24hours before first dose study interven
-urine test cannot be conf as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
-investitor iresponsible review omedical history,menstrual history, and recent sexual activity to decrease the risk of including a woman with an early undetect pregnancy
10The participant(or legally acceptable repres applic)provides written inform consent for the study
11Hav adequately controlled BP with or without antihypertensive medications,defin as BP<=150/90mm Hg at screening and no change antihypert medicat within1week prior to randomization
12Hav adequate organ func |
1Pres diagn istolog o citologic conf carc uroteliale avanz/nn resecabile o metastatico a carico pelvi renale uretere(tratto urinario sup), vescica o uretra.consentita sia isto a cell transiz isto mista cell transiz/nn transiz,carc a cell transiz deve rapp isto pred
2Pres almeno 1 les target misurabile sec criteriRECIST1.1valutata sperim/radio locale centro,base ai seg criteri1les linfon(LN)con asse min>=15mm2les nn nodale diametro mag>=10 mm3les idone ripetiz misuraz con imaging TC/RMI.les situate area prec irradiata
sn considerate misurabili dimostr progres.
3Avere fornito un camp tess tumor arch o biopsia incisionale o escissionale ott recente da les tumor nn prec irradiata adeguata valutPDL1.campioni tess blocchi fissati formalina e inclusi paraf sn preferibili ai vetrini.biopsie ott exnovo sn preferibili risp tess arch.statoPDL1(CPS >=10o<10)deve essere ottenuto lab centr dur per screening prima arruol
4Avere ricev ness prec chemiot sistUC avanzato o metastatico,seg -conse chemiot neoad base platino tratt tum vescica muscoloinvasivo,recidiva >12 mesi compl ter -conse chemiot adiuvante base platino seguito cistectomia radicale,recidiva>12mesi complet ter
5Soddisfare criteri opz a o opz b: aPres uno o più tumori con PDL1 CPS>=10 ed essere consid nn idonei ricevere ter combinata base cisplatino, sec1seg fatt -ECOG PS 2nei7giorni prec la random -CrCl (calcol o misurata uso standard istit)da>=30a<=60 ml/min
-perdita udito audiometrico di grad>=2 sec criteri NCI CTCAE -neuropatia periferica di grado>=2 sec i criteriNCI CTCAE OPP bSec opin sperim consi nn idonei ricevere chemiot base platino(nn idonei cispl e carbopl)base a: -ECOG PS 2 7giorni prec random e almeno1seg fatt: -Mal metastatica viscerale docum - CrCl da>=30a<=60 ml/min - perdita udito audiom grad>=2 sec criteri NCI CTCAE - neuropatia periferica di grad>=2 sec criteri NCI CTCAE - Altro motivo, indicato case report form(CRF)imp sog di ricevere sia il cisplatino che il carboplatino in modo sicuro.criteri di ineleggibilità a ricevere il platino verranno considerati e consentiti su base individuale, dietro consultazione con lo sponsor.
6Essere sesso masch o femm avere età >=18 anni, o considerati adulti sec leggi locali,mom firma consenso infor
7Avere un valore ECOG PS 0,1o2nei 7 gg prec la random e aspett vita>=3mesi
8soggetti di sesso masch sn idonei a partecipare se acconsentono a quanto segue dur il periodo di trattamento e almeno 30 giorni dp ultima dose di pembrolizumab o lenvatinib/placebo: -Praticare astinenza rap eteroses stile vita preferito e abituale(astinenza lungo termine e modo persis)accons oss astinenza maniera continuativa
OPP
-Accet usare met contrac a meno che nn abbia azoospermia confer(vasectomia o secon causa medica)seguito
-Accons uso preservativo masch unito uso da parte partner metodo contracc supplem dur rapp sess penilivaginali con donna età fertile(WOCBP)attualm nn incinta.
9sog sesso fem idoneo partec qualora nn sia gravida o nn allatt seno e soddisfi almeno seg cond:
-Nn donna età fertile
OPP
-donna età fertile e uso met contrac altam eff bassa dip utente,o prat astin rap eterosess stile vita pref e abituale(astin lungo termine e persistente)dur per trattam e per almeno 120 giorni post pembro o 30 giorni post lenvatinib/placebo.
-donna età fertile deve pres un risultato neg test gravidanza altam sensibile entro 24ore prec prima dose trat stu
-caso nn poss conf negatività del test sulle urine è richiesto un test gravid siero.sog deve escluso part sul siero è positi
-sperim resp revis anamnesi medica, anamnesi mestru e recente attività sessuale fine ridurre rischio inclusione una donna con gravid fase iniziale nn rilevata.
10sogg (o rapp legalm accet)fornisce cons inf scritto stud
11Avere press arte(PA)adeg contr con o senza farmaci antipertensivi, PA<=150/90 mmHg screening, e ass modif farmaci antipertensivi entro 1sett prima random
12Avere funz org adeguata |
|
| E.4 | Principal exclusion criteria |
1Has disease that is suitable local ther adminis with curative intent
2Has tumor with any neuroendocrine or small cell comp
3Has history of gastroint cond or proc(gastric bypass,malabsorption)that,opinion investig,may affect oral drug absorption
4Has had major surgery within 3 week prior first dose of stu interv
5Has a prexisting Grade>=3 gastrointestinal or nongastroint fistula
6Has radiographic evidence of major blood vessel invasion/infiltration, or has had clinically significant hemoptysis (at least 0.5 teaspoon of bright red blood) or tumor bleeding within2week prior first dose of stu interv
7Has had signif cardiov impairment within12month first dose stu interv
8Has known intolerance or severe hypers(Grade>=3)pembro or lenvatinib or any of their excipients
9Has receiv lenvatinib monoth or combin withPD1/PDL1 inhibitor or has previously been enroll clinical stu evaluating lenvatinib for bladder cancer, regardless treatm receiv
10Is WOCBP who positive urine pregnancy test within 24 hours before random
11Has receiv prior therapy with an antiPD1,antiPDL1,or antiPDL2inhibitor,indoleaminepyrrole2,3 dioxygenase(IDO1)inhibitor or agent directed to another stimulatory or coinhibitory Tcell rec(CTLA4,OX40,CD137)or any other antibody or drug targeting T-cell costimulatory pathways adjuvant or advanc/metastatic sett
12Has receiv prior radioth metastatic site without use of chemoth radiosens within3weeks first dose stu interv,with excep palliative radioth bone lesions, which is allow if complet2weeks before start stu interve.Particip must have recov from all radiationrelat toxicities, and must not require corticosteroids
13Has receiv live vaccine within30day prior first dose stu interv
14investigator’s judgment, has not recover from toxicity or other compl from any major surgery prior to starting stu interven
15Is currently particip in or has partic trial of investig agent or has use investig device within4weeks prior first dose of stu intervention
16Has anLVEFbelow institutional normal range, as determMUGAorECHO
17Has history or presence abnormal ECG that,investigr opinion, is clinically meaningful
18Has diagnosis immunodef or is receiv systemic steroid therapy (dose exceeding 10 mg daily of prednisone equivalent) or any other form of immunosupp ther within7days prior random
19Has had an active malignancy(except locally advanced or metastaticUC) within the past 36 months
20Has central nervous system(CNS)metastases, unless the participant has completed local therapy and has discontinued use of corticosteroids for this indication for at least 4 weeks before starting treatment in this stu.Any signs or symptoms of CNS metastases must be stable for at least 4 weeks before starting stu intervention
21Has an active autoimmune disease that has required systemic treatment in the past 2 years.
22Has a history of (non-infectious) pneumonitis that required systemic steroids, or current pneumonitis
23Has an active infec requiring systemic therapy
24Has known history of human immunod virus (HIV) infection
25Has known history of or is positive for active hepatitisB or has active hepatitisC
26Has active tuberculosis
27Has history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the stu, interfere with the participant’s participation for the full duration of the stu, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
28Has known psychiatric or substance abuse disorder that would interfer with participant’s ability to cooperate with the requirements of the stu
29Is receiving hemodialysis
30 participant with urine protein>=1 g/24 h will be excluded
31Is pregnant or breastfeeding or expecting to conceive or father children within the project duration of stu,starting with screening visit through120days after the last dose of pembro and lenvatinib/placebo
32Has had an allogeneic tissue/solid organ transplan |
1Ha mal adatta tera locale somminist intento curativo(es chemiot e radiotera per mal stadio3)
2presun tum con compon neuroend o a picc cell
3Pres anamnesi condiz o interv gastrointest(esbypass gastrico, malassorbim) che,giudizio sperim, potrebbe influire assorbim orale farmaco
4subito interv chir magg eseguito nelle 3 sett prec la prima dose trattam stu
5Presuna fistola gastrointest o non gastrointest presistente di grado>=3
6Presevidenza radiograf invas/infiltraz vasi sanguigni grosso calibro o ha manif emottisi clinicam signific(quantità sangue rosso brillante pari almeno 0,5cucch)o sangui tumor2 sett prec prima dose trattam stu
7Ha manifo comprom cardiov significativa12mesi prec prima dose trattam stu
8Presnota intoll o ipersen grave(grado>=3)pembro o lenvatinib o qualsiasi eccip
9Ha ricev lenvatinib monotera o combinaz inibitore PD1/PDL1 o è stato preced arruolato stu clinico valutaz lenvatinib tum vescica, a prescindere trattam ricev
10 donna età fertile con test gravid urine posit 24 ore prec la random
11ricev tera precedente con un inibitore antiPD1,antiPDL1 o antiPDL2,inib indoleamina 2,3diossigenasi pirrolo(IDO1)o agen diret contro recet stimolatorio o coinibitorio cellT (esCTLA4, OX40, CD137)o qualsiasi altro anticorpo o farmaco diret contro i pathway di costimol cellT contesto adiuvante o avanzato/metastatico.
12ricev preced radiotera sede metastatica senza uso chemiot radiosensibilizzante3sett prec prima dose trattam stu,eccez radio palliativa lesioni ossee,consentita se completata 2 sett prima inizio trattam dello stu.sogg devono essersi ristabiliti tossicità correlate alla radiotera e non devono necessitare di corticosteroidi
13Ha ricev un vaccino vivo30gg prec prima dose del trattam dello stu.
14giudizio dello sperim,sogg non ripreso tossicità o da altre complicazioni derivanti da qualsiasi interv chirurgico importante prima dell’inizio del trattam dello stu
15partecipa o ha partecipato a sperim age sperim o uso dispositivo sperim4sett prec prima dose trattam dello stu.
16Pres fraz eiez ventricolare sinistra (LVEF) al di sotto del range normale istituzionale, come determinato mediante MUGA o ECO.
17Ha anamnesi o presun elettrocardiogramma (ECG) anomalo che, secondo l’opinione dello sperim, è clinicam significativo
18Presuna diagnosi immunodef o ricev tera steroidea sistemica (dose sup10mg gg equivalente prednisone) o qualsiasi altra forma tera immunosopp7gg prec random
19Ha avuto tum maligno forma attiva(tranne CU localm avanzato o metastatico) negli ultimi 36 mesi
20Presmetastasi a livello del sistema nervoso centrale (SNC),meno che il sogg non abbia completato la tera locale(radio encefalica, chirurgia o radiochi) e interrotto uso corticosteroidi per questa indicazione almeno 4 sett prima avvio trattam ambito questo stu. Eventuali segni (ad es. radiologici) o sintomi di metastasi del SNC devono rimanere stabili alm4sett prima avvio trattam stu
21Pres mal autoim fase attiva che abbia richiesto un trattam per via sistemica ultimi2anni
22Ha anamnesi polmonite(non infettiva) che ha rich uso steroidi per via sistemica o presuna polmonite atto
23Pres infez attiva con necessità di tera sistemica.
24Pres anamnesi nota di infez virus immunodefumana (HIV)
25Pres anamnesi nota o risulta positivo epatB attiva o epatiteC att(HCV RNA)
26Prestubercolosi forma att
27Pres anamnesi o attuale evidenza condiz, tera o valore lab non normale potreb confon risultati stu, interf con partec sogg tutta durata stu o non miglior inter sogg partec, sec opinione sperim respons trattam
28Presun dist noto natura psichiatrica o abuso sostanze potrebbe interf con capacità sogg osserv requisiti stu
29Sta ricevendo emodialisi
30sogg prot urinarie>=1 g/24 ore saranno esclusi
31Sogg sesso femm gravidanza,fase allatta seno o prevede concepire,o sogg sesso masch prevede generare figli arco durata stimata stu,partire visita screening fino120gg dp ultima dose di pembro e lenvatinib/placebo
32Ha sub trap organo solido/tess allog |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR)
2. Overall Survival (OS) |
1. sopravvivenza libera da progressione (PFS) secondo i criteri di valutazione della risposta nei tumori solidi versione 1.1 (RECIST 1.1) come valutato mediante revisione centrale indipendente in cieco (BICR).
2. sopravvivenza complessiva (OS) |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Up to approximately 40 months
2. Up to approximately 40 months |
1. Fino a circa 40 mesi
2. Fino a circa 40 mesi |
|
| E.5.2 | Secondary end point(s) |
1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR)
2. Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR)
3. Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR)
4. Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
5. Time to Deterioration (TTD) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
6. Number of Participants Who Experience an Adverse Event (AE)
7. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) |
1.Tasso di risposta obiettiva (ORR)secondo i criteri di valutazione della risposta nei tumori solidi versione 1.1 (RECIST 1.1) mediante revisione centrale indipendente in cieco (BICR)
2.Durata della risposta (DOR)secondo i criteri di valutazione della risposta nei tumori solidi versione 1.1 (RECIST 1.1) mediante revisione centrale indipendente in cieco (BICR)
3.Controllo della malattia (DCR)secondo i criteri di valutazione della risposta nei tumori solidi versione 1.1 (RECIST 1.1) mediante revisione centrale indipendente in cieco (BICR)
4.Cambiamenti rispetto al basale nell'Organizzazione europea per la ricerca e il trattamento dei tumori (EORTC) questionario sulla qualità della vita - Core 30 (QLQC30) Stato globale della salute (elemento 29) e qualità della vita (voce 30) Punteggio combinato
5.Valutare il tempo al peggioramento (TTD) mediante il questionario per misurare la qualità della vita dell’Organizzazione europea per la ricerca e il trattamento dei tumori (EORTC) a 30 voci (QLQ-C30) relativo allo stato di salute globale e alla qualità della vita (QoL).
6. Numero di partecipanti che sperimentano un evento avverso (AE)
7. Numero di partecipanti che interrompono il trattamento di studio a causa di un evento avverso (AE) |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Up to approximately 40 months
2. Up to approximately 40 months
3. Up to approximately 40 months
4. Up to approximately 40 months
5. Baseline and up to approximately 40 months
6. Up to approximately 40 months
7. Up to approximately 40 months |
1. Fino a circa 40 mesi
2. Fino a circa 40 mesi
3. Fino a circa 40 mesi
4. Fino a circa 40 mesi
5. Baseline e fino a circa 40 mesi
6. Fino a circa 40 mesi
7. Fino a circa 40 mesi |
|
| 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 | Yes |
| 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) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| 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 | 7 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 75 |
| 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 |
| Argentina |
| Australia |
| Canada |
| Israel |
| Japan |
| Korea, Republic of |
| Russian Federation |
| Taiwan |
| Turkey |
| United States |
| Denmark |
| France |
| Germany |
| Hungary |
| Italy |
| Netherlands |
| Poland |
| Spain |
| United Kingdom |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| 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 | 5 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 5 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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