| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Non-Small Cell Lung Cancer |
| Carcinoma polmonare non a piccole cellule (NSCLC) |
|
| E.1.1.1 | Medical condition in easily understood language |
| Non-Small Cell Lung Cancer |
| Carcinoma polmonare non a piccole cellule (NSCLC) |
|
| 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 | 10061873 |
| E.1.2 | Term | Non-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 |
Part A of the study (Phase I):
. To investigate the safety and tolerability of DZD9008 when given orally to patients with advanced NSCLC with EGFR or HER2 mutations
. To establish Maximum Tolerated Dose (MTD) (if possible) andRecommended Phase 2 Dose (PR2D) of DZD9008 when given orally inpatients with advanced NSCLC with EGFR or HER2 mutations
Part B of the study (Phase II):
. To evaluate anti-tumor activity of DZD9008 in advanced NSCLC patients with EGFR Exon20ins at defined dose(s) by assessment of Objective Response Rate (ORR) |
Parte A dello studio (Fase I)
- Valutare la sicurezza e la tollerabilità di DZD9008 quando somministrato per via orale a pazienti affetti da NSCLC in stadio avanzato con mutazioni di EGFR o HER2
-Stabilire la dose massima tollerata (MTD) (se possibile) e la dose raccomandata per la fase 2 (RP2D) di DZD9008 quando somministrato per via orale in pazienti affetti da NSCLC in stadio avanzato con mutazioni di EGFR o HER2
Parte B dello studio (Fase II)
- Valutare l’attività antitumorale di DZD9008 in pazienti affetti da NSCLC in stadio avanzato con Exon20ins di EGFR alla/e dose/i definita/e mediante valutazione del tasso di risposta obiettiva (ORR) |
|
| E.2.2 | Secondary objectives of the trial |
Part A of the study (Phase I):
. To characterize the pharmacokinetics (PK) of DZD9008 following a single oral dosing and at steady state after multiple oral dosing in the fasted state, and renal excretion of DZD9008
. To evaluate the effect of food on the exposure of DZD9008 at the defined doses
. To assess preliminary anti-tumor activity of DZD9008 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator
. To retrospectively assess anti-tumor activity of DZD9008 in patients with EGFR Exon20ins according to RECIST 1.1 by Independent Review Committee (IRC)
Part B of the study (Phase II):
. To assess anti-tumor efficacy of DZD9008 using additional endpoints
. To determine the safety and tolerability of DZD9008
. To characterize the PK of DZD9008
. To assess the effect of DZD9008 on patients' disease-related symptoms and health related quality of life (HRQoL) |
Parte A dello studio (Fase I)
- Caratterizzare la PK di DZD9008 dopo una singola sommin orale e allo stato di equilibrio dopo sommin orali multiple a digiuno e l’escrezione renale di DZD9008
- Valutare l’effetto del cibo sull’esposizione di DZD9008 alle dosi definite
- Valutare l’attività antitumorale preliminare di DZD9008 secondo i Criteri di valutazione della risposta nei tumori solidi (RECIST), versione 1.1, da parte dello sperimentatore
- Valutare retrospettivamente l’attività antitumorale di DZD9008 in pazienti con inserzione nell’esone 20 (Exon20ins) di EGFR secondo i criteri RECIST 1.1 da parte del Comitato di revisione indipendente (IRC)
Parte B dello studio (Fase II)
- Valutare l’efficacia antitumorale di DZD9008 utilizzando endpoint aggiuntivi
- Determinare la sicurezza e la tollerabilità di DZD9008
- Caratterizzare la PK di DZD9008
- Valutare l’effetto di DZD9008 sui sintomi correlati alla malattia e sulla qualità della vita correlata alla salute (HRQoL) dei pazienti |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Each patient must meet all of the inclusion criteria
1.Patients must be able to understand the nature of the trial and provide a signed and dated, written informed consent form prior to any study specific procedures, sampling and analyses.
2.Aged at least 18 years old (= 20 if in Japan or per local regulatory/IRB requirement)
3.Histological or cytological confirmed locally advanced or metastatic NSCLC. An adequate amount of tumor tissue (archived tumor tissue, or fresh biopsy if archived tissue is not available) must be available at the time of enrollment for central laboratory confirmation of mutations and/or companion diagnostics development.
4.Patients must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 at ICF signature with no deterioration over the previous 2 weeks.
5.Predicted life expectancy = 12 weeks
6.Patient must have measurable disease according to RECIST 1.1: At least one lesion, not previously irradiated, that can be accurately measured at baseline as = 10 mm in the longest diameter (except lymph nodes which must have short axis =15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for repeated measurement.
7.Patients with brain metastasis (BM) can only be enrolled under the condition that BM is previously treated and stable e.g. no evidence of progression for at least 4 weeks after CNS-directed treatment as ascertained by clinical examination and brain imaging (magnetic resonance image [MRI] or computed tomography [CT] scan) during the screening period), neurologically asymptomatic and not require corticosteroid treatment. If BM has been treated with radiation orsurgery, there should be a time window, e.g. = 4 weeks, before the first dosing of DZD9008 to ensure radiation or surgery related AEs haverecovered to = grade 1.
8.Adequate organ system functions, as outlined below
•Absolute neutrophil count (ANC) = 1.5 x 109/L
•Platelets = 100 x 109/L
•Hemoglobin = 9 g/dL
•Total bilirubin = 1.5 x ULN if no liver metastases or = 3 x ULN in the
presence of documented Gilbert's Syndrome (unconjugated
hyperbilirubinemia) or liver metastases
•Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
= 2.5 x ULN if no liver involvement or = 5 x ULN with liver involvement
•Creatinine = 1.5 x ULN, concurrent with calculated or measured
creatinine clearance = 50 mL/min as calculated by the Cockcroft-Gault
method
•International normalized ratio (INR) = 1.5 x ULN and activated partial
thromboplastin time (APTT) = 1.5 x ULN; Serum amylase = 1.5 x ULN
and serum lipase = 1.5 x ULN
9.For inclusion in the optional genetic research study, patient must provide informed consent for genetic research. If a patient declines to participate in any voluntary exploratory research and/or genetic component of the study, there will be no penalty or loss of benefit to the patient and he/she will not be excluded from other aspect of the study.
Part A of the study (Phase I): due to a limit of character, please refer to the protocol
Part B of the study (Phase II):
Patients must have histologically or cytologically confirmed locally advanced or metastatic NSCLC with EGFR Exon20ins which is confirmed by central laboratory using an analytically validated next generation sequencing-based assay in archived tumor samples (if a patient has more than one FFPE blocks, the most recent tissue is preferred) or any fresh tumor biopsies (if archived tumor sample is not available) prior to the study entry. Patients should have received at least 1 line, but no
more than 3 lines of systemic therapy for metastatic/locally advanced disease. |
Per essere inclusi nello studio, i pazienti devono soddisfare tutti i seguenti critei:
1. I pazienti devono essere in grado di comprendere la natura della sperimentazione e fornire un modulo di consenso informato scritto, firmato e datato prima di qualsiasi procedura, prelievo di campioni e analisi specifici dello studio.
2. Età pari almeno a 18 anni (=20 se in Giappone o in base ai requisiti normativi/CE locali).
3. NSCLC localmente avanzato o metastatico confermato istologicamente o citologicamente. Al momento dell’arruolamento deve essere disponibile una quantità adeguata di tessuto tumorale (tessuto tumorale d’archivio o biopsia fresca se non è disponibile tessuto d’archivio) per la conferma da parte del laboratorio centrale delle mutazioni e/o lo sviluppo di test diagnostici complementari.
4. I pazienti devono presentare uno stato di validità secondo l’Eastern Cooperative Oncology Group (gruppo orientale cooperativo di oncologia, ECOG) pari a 0-1 alla firma del modulo di consenso informato (ICF) senza deterioramento nelle 2 settimane precedenti.
5. Aspettativa di vita prevista =12 settimane
6. Il paziente deve presentare malattia misurabile secondo i criteri RECIST 1.1.: Presenza di almeno una lesione, non precedentemente irradiata, che possa essere accuratamente misurata al basale come =10 mm nel diametro più lungo (eccetto i linfonodi che devono avere un asse corto =15 mm) mediante tomografia computerizzata (TC) o risonanza magnetica (RM) e che sia idonea a misurazioni ripetute.
7. I pazienti con metastasi cerebrali (BM) possono essere arruolati solo se la BM è stata precedentemente trattata e risulta stabile, per es. nessuna evidenza di progressione per almeno 4 settimane dopo il trattamento mirato al sistema nervoso centrale (SNC), come accertato mediante esame clinico e diagnostica per immagini cerebrale (risonanza magnetica [RM] o tomografia computerizzata [TC]) durante il periodo di screening, se risultano neurologicamente asintomatici e non necessitano di trattamento con corticosteroidi. Se la BM è stata trattata con radioterapia o intervento chirurgico, deve esserci una finestra temporale, per es. =4 settimane, prima della prima somministrazione di DZD9008 per garantire che gli EA correlati alla radioterapia o all’intervento chirurgico si siano risolti a grado =1.
8. Adeguate funzionalità sistemico-organiche, come descritto di seguito:
• Conta assoluta dei neutrofili (ANC) =1,5 x 109/l
• Piastrine =100 × 109/l
• Emoglobina =9 g/dl
• Bilirubina totale =1,5 x limite superiore alla norma (ULN) in assenza di metastasi epatiche o =3 x ULN in presenza di sindrome di Gilbert documentata (iperbilirubinemia non coniugata) o metastasi epatiche
• Alanina aminotransferasi (ALT) e aspartato aminotransferasi (AST) =2,5 x ULN in assenza di coinvolgimento epatico o =5 x ULN con coinvolgimento epatico
• Creatinina =1,5 x ULN, in concomitanza con clearance della creatinina calcolata o misurata =50 ml/min come calcolato mediante il metodo di Cockcroft-Gault
• Rapporto internazionale normalizzato (INR) =1,5 x ULN e tempo di tromboplastina parziale attivata (APTT) =1,5 x ULN; amilasi sierica =1,5 x ULN e lipasi sierica =1,5 x ULN
Per limite di caratteri far riferimento al protocollo
Parte A dello studio (Fase I): per limite di caratteri far riferimento al protocollo
Parte B dello studio (Fase II):
I pazienti devono presentare NSCLC localmente avanzato o metastatico, confermato istologicamente o citologicamente, con Exon20ins di EGFR confermata dal laboratorio centrale mediante un test di sequenziamento di nuova generazione, convalidato in modo analitico in campioni tumorali d’archivio (se un paziente presenta più di un blocchetto FFPE, si preferisce il tessuto più recente) o qualsiasi biopsia tumorale fresca (se il campione tumorale d’archivio non è disponibile) prima dell’ingresso nello studio. I pazienti devono aver ricevuto almeno 1 linea, ma non più di 3 linee di terapia sistemica per malattia metastatica/localmente avanzata |
|
| E.4 | Principal exclusion criteria |
1.Treatment with any of the followings:
•For expansion cohorts of Part A and Part B extension cohorts: Patients who have received prior Poziotinib, TAK-788, CLN-081 or BTDX-189 or any other EGFR/HER2 exon20ins small molecule inhibitors treatment should be excluded. Other EGFR TKIs, such as gefitinib, erlotinib, osimertinib, afatinib, dacomitinb are not considered EGFR or HER2 Exon20ins small molecule inhibitors, thus prior treatment with these drugs are allowed unless the patient had an objective response and subsequent progression as assessed by the investigator or treating physician during treatment with that prior TKI, and a minimum wash-out period of 8 days (approximately 5x half-life) prior to the firstadministration of DZD9008 is needed.
•Treatment with EGFR or HER2 antibodies or other antibodies within 4 weeks before the first administration of DZD9008.
•Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days before the first administration of DZD9008.
•Major surgery (excluding placement of vascular access) within 4 weeks before the first administration of DZD9008.
•Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within 4 weeks before the first administration of DZD9008.
•Patients currently receiving (or unable to stop using) medications known to be potent inhibitors or inducers of CYP3A within 2 weeks or 3 weeks, respectively, before the first administration of DZD9008.
•Prior treatment with any onco-immunotherapy (e.g. immune checkpoint inhibitors PD-1, PD-L1, CTLA-4) within 4 weeks before the first administration of DZD9008.
•Treatment with any investigational drug within five half-lives of the compound (or discuss with Dizal Study team)
•Treatment with herbal supplements within 1 week and unable to stop using
2.Any unresolved toxicities from prior therapy greater than CTCAE grade
1 at the time of starting DZD9008 with the exception of alopecia and grade 2 prior platinum-therapy related neuropathy.
3.Spinal cord compression or leptomeningeal metastasis.
4.As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it
undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C, human immunodeficiency virus (HIV) and
COVID-19 (per local practice, suspected subjects should perform COVID-19 antigen testing). Screening for chronic condition is not required.
5.Any of the following cardiac criteria
•Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiograms (ECGs)
•Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block, and second-degree heart block, PR interval > 250 msec.
•Any factors that increase the risk of QTc prolongation, such as heartfailure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in
first degree relatives or any concomitant medication known to prolongthe QT interval
•Prior history of atrial fibrillation within 6 months of first administration of DZD9008, except prior drug treatment related and recovered.
6.For Part B, prior malignancy within 2 years requires active treatment, except for adequately treated basal cell skin carcinoma, in situ cervical carcinoma, or other cancer type which has been disease free for > 2
years with life expectancy >2 years.
Due to limit of characters, please refer to the protocol for a complete list |
1. Trattamento con uno qualsiasi dei seguenti:
• Per le coorti di espansione delle coorti di estensione della Parte A e Parte B: i pazienti che in precedenza hanno ricevuto poziotinib, TAK-788, CLN-081 o BTDX-189 o qualsiasi altro trattamento con inibitori micromolecolari dell’Exon20ins di EGFR/HER2 devono essere esclusi. Altri inibitori tirosin-chinasici (TKI) di EGFR, come gefitinib, erlotinib, osimertinib, afatinib, dacomitinb non sono considerati inibitori micromolecolari dell’Exon20ins di EGFR o HER2, pertanto è consentito un precedente trattamento con questi farmaci, a meno che il paziente non abbia manifestato una risposta obiettiva e una successiva progressione, come valutato dallo sperimentatore o dal medico curante durante il trattamento con quel precedente TKI, ed è necessario un periodo di washout minimo di 8 giorni (circa 5 volte l’emivita) prima della prima somministrazione di DZD9008.
• Trattamento con anticorpi anti-EGFR o anti-HER2 o altri anticorpi nelle 4 settimane precedenti la prima somministrazione di DZD9008.
• Qualsiasi chemioterapia citotossica, agente sperimentale o altro farmaco antitumorale da un precedente regime di trattamento o studio clinico nei 14 giorni precedenti la prima somministrazione di DZD9008.
• Intervento di chirurgia maggiore (escluso il posizionamento di un accesso vascolare) nelle 4 settimane precedenti la prima somministrazione di DZD9008.
• Radioterapia con un campo di radiazioni limitato a scopo palliativo entro 1 settimana dalla prima dose, ad eccezione dei pazienti che ricevono radiazioni a più del 30% del midollo osseo o con un ampio campo di radiazione per i quali la terapia deve essere completata nelle 4 settimane che precedono la prima somministrazione di DZD9008.
• Pazienti che attualmente ricevono (o non sono in grado di interrompere l’uso di) farmaci noti per essere potenti inibitori o induttori del CYP3A, rispettivamente nelle 2 settimane o nelle 3 settimane precedenti la prima somministrazione di DZD9008. • Precedente trattamento con qualsiasi immunoterapia oncologica (per es. inibitori del checkpoint immunitario anti-proteina di morte cellulare programmata [PD]-1, anti-ligando 1 della proteina di morte cellulare programmata [PD-L1] e anti-antigene 4 associato ai linfociti T citotossici [CTLA-4]) nelle 4 settimane precedenti la prima somministrazione di DZD9008.
• Trattamento con qualsiasi farmaco sperimentale entro cinque emivite del composto (o se ne discuta con il personale dello studio Dizal)
• Trattamento con integratori a base di erbe entro 1 settimana e impossibilità ad interromperne l’uso
2. Qualsiasi tossicità non risolta dalla precedente terapia superiore al grado 1 secondo i criteri CTCAE al momento dell’inizio di DZD9008, escluse alopecia e precedente neuropatia correlata alla terapia con platino di grado 2.
3. Compressione del midollo spinale o metastasi leptomeningee.
4. A giudizio dello sperimentatore, qualsiasi evidenza di malattie sistemiche gravi o non controllate, tra cui ipertensione non controllata e diatesi emorragiche attive che, stando all’opinione dello sperimentatore, renda indesiderabile per il paziente partecipare alla sperimentazione o che potrebbe compromettere la conformità al protocollo oppure infezione attiva tra cui epatite B, epatite C, virus dell’immunodeficienza umana (HIV) e COVID-19 (secondo la pratica locale, i soggetti sospetti devono eseguire il test antigenico per il COVID-19). Per le condizioni croniche non è richiesto lo screening.
Per limite di caratteri, far riferiemento al protocollo per una lista completa |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
In Part A, the primary endpoints for determining the MTD and RP2D are the incidence of dose-limiting toxicities (DLTs), adverse events (AEs), serious adverse events (SAEs) and abnormal laboratory test results. The
RP2D definition will be based on integrated analysis of PK, tolerability oranti-tumor efficacy data.
In Part B, the primary endpoints for determining anti-tumor efficacy is ORR according to RECIST 1.1 by independent image review. |
Nella parte A, gli endpoint primari per determinare MTD e RP2D sono l'incidenza della dose-limiting toxicities (DLT), eventi avversi (AE), eventi avversi gravi (SAE) e risultati anomali dei test di laboratorio. La definizione di RP2D sarà basata sull'analisi integrata di PK, tollerabilità o dati di efficacia antitumorale.
Nella parte B, gli endpoint primari per determinare l'efficacia antitumorale sono ORR secondo RECIST 1.1 mediante revisione delle immagini indipendente. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
Part A: around 12 months after FSI
Part B: around 8 months after LSI of Part B |
Parte A: circa 12 mesi dopo la FSI
Parte B: circa 8 mesi dopo LSI della Parte B |
|
| E.5.2 | Secondary end point(s) |
Part A of the study (Phase I):
•PK assessment includes concentrations of DZD9008 in plasma and/or urine of individual patient (secondary)
•Preliminary assessment of anti-tumor efficacy includes the objectiveresponse rate (ORR), which includes the number of CR and PR based on RECIST v1.1, disease control rate (DCR), and duration of response (DoR)
(secondary)
•The effect of food on PK of DZD9008 (secondary)
•To retrospectively assess anti-tumor activity of DZD9008 in patients with EGFR Exon20ins according to RECIST 1.1 by Independent Review Committee (IRC) (secondary)
•Retrospective confirmation of EGFR or HER2 Exon20ins in archived tumor tissue or fresh tumor biopsy or plasma sample (exploratory)
•Metabolite identification (exploratory)
•Other biomarkers (exploratory)
•To explore the relationship between DZD9008 exposure and selected endpoints
Part B of the study (Phase II):
•Safety and tolerability, including adverse events (AEs), serious adverse events (SAEs) and abnormal laboratory test results (secondary)
•PK assessment includes concentrations of DZD9008 in plasma of individual patient (secondary)
•Additional anti-tumor efficacy endpoints include BOR, DOR, PFS and overall survival (OS) (secondary).
•To assess the effect of DZD9008 on patients' disease-related symptoms and health related quality of life (HRQoL) (secondary)
•Collect and store tumor samples for diagnostics development and potential future exploratory research that may influence the development of DZD9008 (Exploratory)
•To collect and store plasma samples for EGFR Exon20ins mutationtesting and necessary technical studies for liquid biopsy companion diagnostic development and approval (Exploratory)
•To collect and store blood-based samples for future exploratory research on genes/genetic aberrations that may influence response to DZD9008 treatment and/or susceptibility to DZD9008.
•Other exploratory biomarker data if needed (pEGFR or other pathway biomarker modulation in tumor tissue by DZD9008 (at defined dose[s]) (exploratory)
•To collect and store blood sample for future exploratory research into genes/genetic variation that may influence PK or response to DZD9008 (Pharmacogenetics study, exploratory).
•To explore the effect of DZD9008 treatment and disease state on health state utility by using EQ-5D-5L health state utility index based on patient reported data.
•To assess AEs of DZD9008 by using subjects reported specific CTCAE symptoms (PRO-CTCAE) and FACIT GP5 questionnaire (exploratory). |
Part A of the study (Phase I):
•PK assessment includes concentrations of DZD9008 in plasma and/or urine of individual patient (secondary)
•Preliminary assessment of anti-tumor efficacy includes the objectiveresponse rate (ORR), which includes the number of CR and PR based on RECIST v1.1, disease control rate (DCR), and duration of response (DoR)
(secondary)
•The effect of food on PK of DZD9008 (secondary)
•To retrospectively assess anti-tumor activity of DZD9008 in patients with EGFR Exon20ins according to RECIST 1.1 by Independent Review Committee (IRC) (secondary)
•Retrospective confirmation of EGFR or HER2 Exon20ins in archived tumor tissue or fresh tumor biopsy or plasma sample (exploratory)
•Metabolite identification (exploratory)
•Other biomarkers (exploratory)
•To explore the relationship between DZD9008 exposure and selected endpoints
Part B of the study (Phase II):
•Safety and tolerability, including adverse events (AEs), serious adverse events (SAEs) and abnormal laboratory test results (secondary)
•PK assessment includes concentrations of DZD9008 in plasma of individual patient (secondary)
•Additional anti-tumor efficacy endpoints include BOR, DOR, PFS and overall survival (OS) (secondary).
•To assess the effect of DZD9008 on patients' disease-related symptoms and health related quality of life (HRQoL) (secondary)
•Collect and store tumor samples for diagnostics development and potential future exploratory research that may influence the development of DZD9008 (Exploratory)
•To collect and store plasma samples for EGFR Exon20ins mutationtesting and necessary technical studies for liquid biopsy companion diagnostic development and approval (Exploratory)
•To collect and store blood-based samples for future exploratory research on genes/genetic aberrations that may influence response to DZD9008 treatment and/or susceptibility to DZD9008.
•Other exploratory biomarker data if needed (pEGFR or other pathway biomarker modulation in tumor tissue by DZD9008 (at defined dose[s]) (exploratory)
•To collect and store blood sample for future exploratory research into genes/genetic variation that may influence PK or response to DZD9008 (Pharmacogenetics study, exploratory).
•To explore the effect of DZD9008 treatment and disease state on health state utility by using EQ-5D-5L health state utility index based on patient reported data.
•To assess AEs of DZD9008 by using subjects reported specific CTCAE symptoms (PRO-CTCAE) and FACIT GP5 questionnaire (exploratory). |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
Part A: around 12 months after FSI
Part B: around 8 months after LSI of Part B |
Part A: around 12 months after FSI
Part B: around 8 months after LSI of Part B |
|
| 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 | No |
| 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 | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Yes |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | Yes |
| 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 | Yes |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | Yes |
| 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 | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| 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 | 9 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 25 |
| 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 |
| Australia |
| Italy |
| Japan |
| Korea, Republic of |
| Spain |
| Taiwan |
| United States |
| France |
|
| 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
|
| For the overall study, the end of the study is defined as 'the last visit of the last patient undergoing the study' |
| Per tutto lo studio , la fine dello studio è definita come "l'ultima visita delll'ultimo paziente in studio' |
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| 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 | 5 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 4 |
| E.8.9.2 | In all countries concerned by the trial months | 2 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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