| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Advanced or metastatic triple-negative breast cancer |
| carcinoma mammario triplo negativo avanzato o metastatico |
|
| E.1.1.1 | Medical condition in easily understood language |
| Advanced or metastatic triple-negative breast cancer |
| cancro al seno avanzato o metastatico |
|
| 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 | 10027475 |
| E.1.2 | Term | Metastatic breast cancer |
| 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 |
To evaluate the efficacy –in terms of progression-free survival (PFS)– of
first line atezolizumab in combination with paclitaxel and bevacizumab
(Avastin®) in patients with unresectable locally advanced or metastatic
TNBC. |
Valutare l'efficacia –in termini di sopravvivenza libera da progressione
(PFS)-di atezolizumab in combinazione con paclitaxel e bevacizumab
(Avastin®) come terapia di prima linea in pazienti con TNBC localmente
avanzato o metastatico non resecabile. |
|
| E.2.2 | Secondary objectives of the trial |
Efficacy
To assess the efficacy –in terms of time to response (TTR), objective
response rate (ORR), clinical benefit rate (CBR), duration of response
(DoR), overall survival (OS), and best percentage of change in target
tumor lesions– of first-line atezolizumab in combination with paclitaxel
and bevacizumab (Avastin®) in these patients.
Safety
To evaluate the safety and tolerability of the addition of atezolizumab to
the combination of paclitaxel and bevacizumab (Avastin®) in these
patients.
Exploratory objectives:
• To assess the efficacy of first-line atezolizumab in combination with
paclitaxel and bevacizumab (Avastin®) based on Immune-Related
RECIST (irRECIST).
• To evaluate predictive or prognostic biomarkers associated with
disease activity status or response to treatment.
• To identify possible mechanisms of resistance to study treatment
through the comparative analysis of potential biomarkers from paired
pre-treatment and post-progression tumor and/or blood samples. |
Efficacia:
Valutare efficacia–in termini di tempo alla risposta(TTR),tasso
di risposta oggettiva(ORR),tasso di beneficio clinico(CBR),durata della
risposta (DoR), sopravvivenza globale(OS),migliore percentuale di
cambiamento nelle lesioni tumorali target–di atezolizumab con
paclitaxel+bevacizumab(Avastin®)come terapia di prima linea nei
pazienti.
Sicurezza:
Valutare sicurezza e tollerabilità dell'aggiunta di atezolizumab
con paclitaxel+bevacizumab(Avastin®)nei pazienti.
Obiettivi esplorativi:Valutare l'efficacia di atezolizumab con
paclitaxel+bevacizumab(Avasitn®)come terapia di prima linea,sulla base
di RECIST immuni-correlati(irRECIST).Esaminare i biomarcatori tumorali
predittivi o prognostici associati allo stato di attività della patologia o
alla risposta al trattamento.Identificare i possibili meccanismi di
resistenza ai trattamenti in studio attraverso l'analisi comparativa di
potenziali biomarcatori da campioni tumorali e/o sanguigni pretrattamento
e post-progressione associati |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Signed ICF prior to participation in any study-related activities
2. Male or female patients=18 years at the time of signing ICF
3. Ability to comply with the study protocol, in the investigator's judgment
4. Histologically confirmed TNBC –regardless of PD-L1 status– per ASCO/CAP criteria based on local testing on the most recent analyzed biopsy. Triple-negative is defined as <1% expression for ER and PgR as determined by IHC,and negative for HER2 (0–1+ by immunohistochemistry [IHC] or 2+ and negative by ISH test)
5. Unresectable locally advanced or metastatic disease documented by CT scan or MRI that is not amenable to resection with curative intent
6. No prior chemotherapy and/or targeted therapy and/or immunotherapy and/or antiangiogenic agent for MBC. Patients who have received (neo)adjuvant taxane-based chemotherapy and/or immunotherapy and/or an antiangiogenic agent are required to have a DFI of at least 12months after completion of each of these treatments. For (neo)adjuvant non-taxane-based chemotherapy, a DFI of at least 6months is required
7. Resolution of all acute toxic effects of prior anti-cancer therapy to grade = 1 as determined by the NCI-CTCAE v.5.0
8. Evidence of measurable disease or non-measurable disease as per RECIST v.1.1. Patients with only bone lesions are also eligible
9. Willingness and ability to provide the most recent tumor biopsy since last progression from either metastatic or primary tissues at the time of the inclusion to perform exploratory studies. If not feasible, patient eligibility should be evaluated by a Sponsor's qualified designee. An additional tumor biopsy from either metastatic or primary (only if metastatic biopsies cannot be obtained for inaccessible lesion or subject safety concern) tissues would be collected at disease progression or study termination whenever it is feasible
10. ECOG Performance Status of 0 or 1
11. Life expectancy of =12 weeks
12. Adequate hematologic and organ function within 14 days before the first study treatment on C1D1, defined by the following parameters:a.Hematological:i.WBC count >3.0x109/L; ii. ANC>1.5 X 109/L; iii. Lymphocyte count 0.5x109/L (500L); iv. Platelet count 75.0x109/L; v. Hemoglobin > 9.0g/dL b. Hepatic: Bilirubin =1.5 times ×ULN (=3xULN in the case of Gilbert's disease); AST and ALT= 2.5×ULN (in the case of liver metastases =5×ULN);ALP=2.5×ULN(=5×ULN in the case of liver and/or bone metastases). c. Serum albumin=2.5g/dL d. Renal: Serum creatinine<1.5×ULN or creatinine clearance=50 mL/min based on Cockcroft-Gault glomerular filtration rate estimation. No proteinuria by dipstick urinalysis (trace proteinuria is allowed). In cases of proteinuria at least 1+ by urinalysis, proteinuria should be less than 500mg by 24-h urine collection. e. Coagulation:For patients not receiving therapeutic anticoagulation: PTT or aPTT and INR=1.5×ULN.For patients receiving therapeutic anticoagulation: stable anticoagulant regimen.
13. Negative HIV test at screening. Patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ¿ 200/¿L, and have an undetectable viral load.
14. Negative HBsAg test and negative total HBcAb tests at screening, or positive total HBcAb test followed by a negative HBV DNA test at screening. Current treatment with anti-viral therapy for HBV is not allowed.
15. Negative HCV antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening.
16. Women of childbearing potential must have a negative serum pregnancy test within 14 days before study treatment initiation and agree to remain abstinent (refrain from heterosexual intercourse) or use one highly effective contraceptive method, or two effective contraceptive methods, as defined in the protocol during the treatment period for at least 5 months after the last dose of atezolizumab, and for at least 6 months after the last dose of paclitaxel and bevacizumab (Avastin®). |
Firmare il CI prima della partecipazione
Pazienti di sesso maschile/femminile=18 anni alla firma del CI
Idoneità a rispettare il protocollo, a giudizio dello sperimentatore
TNBC istologicamente confermato indipendent da PDL1
In base a criteri ASCO/CAP,basati su esami localizzati dell'ultima biopsia analizzata.Triplo neg definito come espressione<1% x ER e PgR determinato da IHC e neg x HER(01+ x IHC o 2+ e neg in base al test ISH)
Patologia localmente avanzata o metastatica no resecabile documentata da TC/MRI,no suscettibile di resezione con intento curativo
No precedente chemioterapia e/o terapia mirata e/o immunoterapia e/o agente antiangiogeno x MBC.Pazienti che hanno ricevuto chemioterapia(neo)adiuvante a base di taxano e/o immunoterapia e/o un agente antiangiogeno e/o immunoterapia e/o un agente antiangiogeno sono tenuti ad avere DFI almeno 12mm dopo il completamento di ciascun trattamento.X la chemioterapia(neo)adiuvante non a base di taxano è richiesto DFI almeno 6mm
Risoluzione fino a gradi=1 di tutti gli effetti tossici acuti della precedente terapia antitumorale determinata mediante NCICTCAE v.5.0
Presenza di patologia obiettivamente misurabile o non misurabile come da RECIST v.1.1. Ammessi pazienti con solo lesioni ossee
Disponibilità e capacità di fornire la + recente biopsia tumorale da tessuti metastatici o primari dall'ultima progressione fino al momento dell'inclusione nello studio. Se non fosse possibile, l'ammissibilità del paziente deve essere valutata da persona qualificata designata dallo Sponsor. Alla progressione della malattia o fine studio,appena possibile,verrà prelevata ulteriore biopsia tumorale da tessuti metastatici o primari (solo se non possibile ottenere biopsie metastatiche a causa di lesioni inaccessibili o in caso di rischi per la sicurezza del soggetto)
Performance Status secondo ECOG di 0 o 1
Aspettativa di vita=12sett
Adeguata funzione ematologica e organica nei 14gg precedenti il primo trattamento di studio nel G1C1, definito dai seguenti parametri: a.Ematologici:1. WBC >3,0x109/L 2.ANC >1,5x109/L (senza supporto fattore stimolante colonie granulocitarie nelle 2sett precedenti il G1C1) 3.Conta dei linfociti 0,5x109/L (500L) 4.Conta piastrinica 75,0x109/L(senza trasfusione nelle 2sett precedenti il G1C1) 5.Emoglobina>9,0g/dL(possono ricevere trasfusioni o terapie eritropoietiche x soddisfare criterio) b.Epatici:Bilirubina=1,5 volte × ULN)(=3 x ULN nel caso della malattia di Gilbert);ASTe ALT=2,5×ULN (in caso di metastasi epatiche=5×ULN); (ALP)=2,5×ULN (=5xULN in caso di metastasi epatiche e/o ossee). c.Albumina sierica=2,5g/dL d.Renali:Creatinina sierica<1,5×ULN o clearance creatinina=50mL/min in base alla stima della VFG Cockcroft- Gault. Assenza di proteinuria nelle analisi urine(consentite tracce). In caso di almeno 1+ proteinuria nelle analisi urine,deve essere <500mg nelle urine delle 24h e.Coagulazione:Per pazienti non sottoposti a terapia anticoagulante: PTT o aPTT e INR =1,5×ULN.X pazienti sottoposti a terapia anticoagulante:Regime anticoagulante stabile.
Esito neg a test HIV allo screening. Pazienti a test HIV+ allo screening sono ammessi a condizione di essere sotto terapia antiretrovirale stabile, e presentare un conteggio CD4 di <200/microL e carica virale non rilevabile
Esito neg a test HBsAg e esito neg al test HBcAb allo screening, oppure esito pos a test HBcAb totale seguito da un esito neg a test DNA HBV allo screening. No trattamenti in corso con terapia antivirale x HBV.
Esito nega a test anticorpi HCV allo screening, oppure esito pos a test anticorpi HCV seguito da un esito neg a test HCV RNA allo screening
Donne in età fertile dovranno risultare neg a test gravidanza sierologico nei 14gg precedenti l'inizio della terapia e accettare di praticare astinenza o utilizzare 1 o 2 metodi contraccettivi altamente efficaci come definiti x protocollo, durante il trattamento x almeno 5mm dopo ultima dose atezolizumab, e x almeno 6mm dopo ultima dose di paclitaxel e bevacizumab |
|
| E.4 | Principal exclusion criteria |
-Known active uncontrolled or symptomatic CNS metastases as indicated by clinical symptoms,cerebral edema,and/or progressive growth.Patients w/ a history of CNS metastases are eligible if meet following criteria:•Evidence of measurable disease or non-measurable disease as per RECIST v.1.1.•Patient has no history of intracranial hemorrhage•Patient has not undergone stereotactic radiotherapy within 7days prior to initiation of study treatment, whole-brain radiotherapy within 14days prior to initiation of study treatment, or neurosurgical resection within 28days prior to initiation of study treatment•Patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted
-History of leptomeningeal disease
-Uncontrolled tumor-related pain
-Active or history of autoimmune disease or immune deficiency
-Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
-Uncontrolled or symptomatic hypercalcemia (ionized calcium>1.5mmol/L; calcium>12mg/dL)
-History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
-Active tuberculosis
-Significant cardiovascular disease 6months prior to initiation of study treatment. These include New York Heart Association Class II or greater cardiac disease, myocardial infarction, unstable arrhythmia, or unstable angina, symptomatic pericarditis, ventricular arrhythmias –except for benign premature ventricular contractions, arrhythmias or conduction abnormalities requiring a pacemaker or not controlled with medication, and prior peripheral vascular disease including any cerebrovascular accident including transient ischemic attack, any pulmonary embolism, any prior deep vein thrombosis, and/or any grade =2 peripheral vascular disease
-LVEF<50% as determined by MUGA scan or ECHO
-Uncontrolled hypertension (SBP greater than 160mmHg and DBP greater than 100mmHg)
-Major surgical procedure (defined as requiring general anesthesia) or significant traumatic injury within 28days of start of study drug, or patients who have not recovered from the side effects of any major surgery
-Concurrent malignancy(ies) or malignancy(ies) within 5years of study enrolment except for carcinoma in situ of the cervix, nonmelanoma skin carcinoma, or stage I uterine cancer. For other cancers considered to have a low risk of recurrence, discussion with the Medical Monitor is required
-Treatment with therapeutic oral or IV antibiotics or severe infection 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics are eligible for the study
-Prior allogeneic stem cell or solid organ transplantation
-Treatment w/ a live, attenuated vaccine within 4weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5months after the final dose of atezolizumab
-Extracranial radiotherapy or limited-field palliative radiotherapy within seven days prior to study enrolment, or patients who have not recovered from radiotherapy-related toxicities to baseline or grade=1
-Treatment w/ investigational therapy within 28days prior to initiation of study treatment
-Treatment w/ systemic immunosuppressive medication within 2weeks prior to initiation of treatment (including, but not limited to,corticosteroids,cyclophosphamide,azathioprine, methotrexate, thalidomide, and anti-TNF-a agents)or anticipation of need for systemic immunosuppressive medication during study treatment
-Chronic daily intake of antiplatelet drugs
-History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgement, contraindicate patient participation in the clinical study
-Concurrent participation in other interventional clinical trials |
-Nota metastasi del SNC attiva incontrollata o sintomatica evidenziata da sintomi clinici,edema cerebrale e/o progressivo incremento.Pazienti con anamnesi pos x metastasi del SNC ammessi se soddisfano:•Presenza di patologia obiettivamente misurabile o no misurabile da RECIST v.1.1•No anamnesi pos x emorragia intracranica•Paziente no sottoposto a radioterapia stereotassica nei 7gg precedenti inizio trattamento,o radioterapia cerebrale completa nei 14gg prec inizio trattamento,o resezione neurochirurgica nei 28gg prec inizio trattamento•Paziente senza esigenza di assumere corticosteroidi come terapia x patologia del SNC.È consentita terapia anticonvulsivante a dosaggio stabile
-Anamnesi pos x malattia leptomeningea
-Dolore non controllato in relazione al tumore
-Insorgenza o anamnesi pos malattie autoimmuni o deficit immunitario
-Versamento pleurico incontrollato,versamento pericardico o ascite che richiedano procedure drenaggio ricorrenti
-Ipercalcemia incontrollata o sintomatica(calcio ionizzato >1,5mmol/l;calcio >12mg/dL)
-Anamnesi pos x fibrosi polmonare idiopatica,polmonite in organizzazione,polmonite indotta da farmaci o polmonite idiopatica o evidenze di polmonite attiva allo screening con TAC torax
-Tubercolosi attiva
-Patologie cardiovascolari significative nei 6mm prec inizio trattamento.Si intendono incluse patologie cardiache Classe II o sup secondo New York Heart Association,infarto del miocardio,aritmia cardiaca instabile o angina instabile,pericardite sintomatica,aritmie ventricolari (escluse contrazioni ventricolari premature benigne),aritmie o anomalie di conduzione che necessitino pacemaker o non controllate farmacologicamente,così come precedenti patologie vascolari periferiche,inclusi accidenti cerebrovascolari come attacco ischemico transitorio,embolia polmonare,trombosi venosa profonda preesistente e/o patologia vascolare periferica di gr=2
-LVEF<50% determinata con MUGA o ECHO
-Ipertensione non controllata (PAS sup a 160mmHg e PDS a 100mmHg)
-Intervento chirurgico importante (con anestesia generale) o lesione traumatica significativa nei 28gg precedenti assunzione farmaco in studio,o pazienti non ancora ristabiliti dagli effetti collaterali di qualsiasi intervento chirurgico importante
-Neoplasie concomitanti o neoplasie insorte entro 5aa da arruolamento, ad ecc:carcinoma in situ della cervice,carcinoma cutaneo non melanoma, cancro uterino allo stadio I.X altri tumori considerati a basso rischio di recidiva è necessario discutere con osservatore medico
-Terapia con antibiotici x via orale o IV o infezione grave nelle 2sett prec inizio trattamento Ammessi pazienti con antibiotici profilattici
-Precedente trapianto cellule staminali allogeniche o trapianti organi solidi
-Terapia con vaccino vivo attenuato 4sett prec inizio trattamento,o previsione della necessità di tale vaccino durante trattamento con atezolizumab o nei 5mm precedenti la dose finale atezolizumab
-Radioterapia extracranica o radioterapia palliativa a campo limitato nei 7gg prec arruolamento,o pazienti non ancora ristabiliti da tossicità correlate alla radioterapia fino alle condizioni di base o al grado=1
-Trattamento con terapia sperimentale nei 28gg prec inizio trattamento.
-Trattamento con farmaci immunosoppressivi sistemici nelle 2sett prec inizio trattamento (inclusi,corticosteroidi,ciclofosfamide,azatioprina,metotrexato,talidomide e agenti anti-TNF-A)o necessità prevista di farmaci immunosoppressivi sistemici durante trattamento
-Assunzione giornaliera cronica di farmaci antipiastrinici(es. aspirina dosi 325mg/die o sup o farmaci antinfiammatori no steroidei che inibiscono funzione piastrinica)
-Anamnesi pos x gravi reazioni anafilattiche allergiche a anticorpi chimerici o umanizzati o a proteine di fusione
-Altra patologia concomitante grave e/o incontrollata che, a giudizio dello sperimentatore, sconsigli la partecipazione del paziente allo studio clinico
-Partecipazione concomitante a altre sperimentazioni cliniche interventistiche |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Median PFS, defined as the period of time from treatment initiation to
the first occurrence of disease progression or death from any cause,
whichever occurs first, as determined locally by the investigator using RECIST v.1.1. |
PFS mediano, definito come il periodo di tempo dall'inizio del
trattamento alla prima insorgenza di progressione della malattia o morte
per qualsiasi causa, a seconda di quale si verifichi prima, determinata
localmente dallo sperimentatore utilizzando RECIST v.1.1. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Analysis will be performed on full analysis and per-protocol sets. |
L'analisi verrà eseguita su analisi complete e su gruppi in base al
protocollo. |
|
| E.5.2 | Secondary end point(s) |
Efficacy
• TTR, defined as the time from the treatment initiation to time of the
first objective tumor response (tumor shrinkage of = 30%) observed for
patients who achieved a complete response (CR) or partial response
(PR), as determined locally by the investigator using RECIST v.1.1.
• ORR, defined as the sum of CR and PR as determined locally by the
investigator using RECIST v.1.1.
• CBR, defined as the sum of objective responses (CR or PR), or stable
disease (SD) for at least 24 weeks, as determined locally by the
investigator using RECIST v.1.1.
• DoR, defined as the time from the first occurrence of a documented
objective response to disease progression or death from any cause,
whichever occurs first, as determined locally by the investigator using
RECIST v.1.1.
• OS, defined as the time from treatment initiation to death from any
cause or last patient contact.
• Best percentage of change from baseline in the size of target tumor
lesions, defined as the biggest decrease, or smallest increase in case of
no observed increase, as determined locally by the investigator using
RECIST v.1.1.
Safety
Incidence and severity of adverse events (AEs), serious adverse events
(SAEs) according to the National Cancer Institute's – Common
Terminology Criteria for Adverse Events (NCI-CTCAE) v.5.0, including
dose reductions, delays, and treatment discontinuations.
Exploratory endpoints
• Immune-related PFS (irPFS) and immune-related ORR (irORR) based
on investigator assessment using irRECIST.
• Relationship between tumor- and/or immune-related biomarkers and
treatment efficacy (PD-L1 expression and tumor-infiltrating lymphocytes
[TILs]; mutational tumor load; cytokine profiling; etc.).
• Changes in mutation and copy number in oncogenes, tumor
suppressors, and/or other genes associated with disease progression
assessed in liquid biopsy and/or tumor samples. |
Efficacia
• TTR, definito come il periodo di tempo dall'inizio del trattamento alla
prima risposta tumorale oggettiva (riduzione della massa tumorale =
30%) osservata in pazienti che hanno raggiunto una risposta completa
(CR) o una risposta parziale (PR), determinata localmente dallo
sperimentatore utilizzando RECIST v.1.1.
• ORR, definito come la somma di CR e PR determinata localmente dallo
sperimentatore utilizzando RECIST v.1.1.
• CBR, definita come la somma delle risposte oggettive (CR O PR), o
come malattia stabile (SD) per almeno 24 settimane, determinata
localmente dallo sperimentatore utilizzando RECIST v.1.1.
• DoR, definito come il periodo di tempo dalla prima insorgenza di una
risposta oggettiva documentata fino alla progressione della malattia o
morte per qualsiasi causa, a seconda di quale si verifichi prima,
determinata localmente dallo sperimentatore utilizzando RECIST v.1.1.
• OS, definito come il periodo di tempo dall'inizio del trattamento alla
morte per qualsiasi causa o all'ultima visita del paziente.
• Migliore percentuale di variazione rispetto al basale nella dimensione
delle lesioni tumorali target, definita come maggiore diminuzione, o, se
nessun aumento viene osservato, come minore aumento, determinata
localmente dallo sperimentatore utilizzando RECIST v.1.1
Sicurezza
Incidenza e gravità degli eventi avversi (AE), degli eventi avversi gravi
(SAE) secondo i criteri terminologici comuni per gli eventi avversi del
National Cancer Institute (NCI-CTCAE) v.5.0, inclusi riduzioni di dose,
ritardi e interruzioni del trattamento. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
Analysis will be performed on full analysis and per-protocol sets.; L'analisi verrà eseguita su analisi complete e su gruppi in base al
protocollo. |
|
| 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 | No |
| 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) | 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 | No |
| 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 | 2 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 6 |
| 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 |
| France |
| Germany |
| Italy |
| Portugal |
| Spain |
| United Kingdom |
|
| 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
|
The End of study will occur 12 months after the last patient has been
enrolled in the study (coinciding with date of treatment initiation) or
when at least 67 PFS events with 100 patients included have been
reached, whichever occurs later. |
La fine dello studio si verificherà 12 mesi dopo che l'ultimo paziente è
stato arruolato nello studio (in coincidenza con la data di inizio del
trattamento) o quando saranno raggiunti almeno 67 eventi PFS con 100
pazienti inclusi, a seconda di quale si verifica più tardi. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| 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 | 2 |
| 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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