Clinical Trials Register

Summary
EudraCT Number:	2017-000580-32
Sponsor's Protocol Code Number:	ARCADIA
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-17
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2017-000580-32

A.3

Full title of the trial

Cabozantinib plus Ddurvalumab in patients with advanced and chemotherapy-treated bladder carcinoma, of urothelial and non-urothelial histology: an open-label, single-centre, phase 2, single-arm proof-of-concept trial: ARCADIA study

Studio di fase 2, in aperto, monocentrico, a singolo braccio , proof of concept, con cabozantinib più durvalumab in pazienti affetti da carcinoma vescicale con istologia urotreliale e non uroteliale in fase avanzata precedentemente trattati con chemioterapia: studio ARCADIA

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Cabozantinib plus Ddurvalumab in patients with advanced and chemotherapy-treated bladder carcinoma, of urothelial and non-urothelial histology: an open-label, single-centre, phase 2, single-arm trial

Studio di fase 2, in aperto, monocentrico, a singolo braccio con cabozantinib più durvalumab in pazienti affetti da carcinoma vescicale con istologia urotreliale e non uroteliale in fase avanzata precedentemente trattati con chemioterapia

A.3.2

Name or abbreviated title of the trial where available

hARnessing CAbozantinib and Durvalumab Immuno-oncology Association: ARCADIA study

A.4.1

Sponsor's protocol code number

ARCADIA

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN00000000

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00000000

A.5.3

WHO Universal Trial Reference Number (UTRN)

U0000-0000-0000

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	IPSEN S.p.A.
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	AstraZeneca S.p.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fondazione IRCCS Istituto Nazionale dei Tumori
B.5.2	Functional name of contact point	Clinical Trial Center
B.5.3	Address:
B.5.3.1	Street Address	Via G. Venezian 1
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20133
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390223903882
B.5.5	Fax number	+390223903991
B.5.6	E-mail	trialcenter@istitutotumori.mi.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	CABOMETYX
D.2.1.1.2	Name of the Marketing Authorisation holder	Ipsen Pharma
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	CABOMETYX
D.3.2	Product code	[CABOMETYX]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Cabozantinib
D.3.9.1	CAS number	1140909-48-3
D.3.9.2	Current sponsor code	XL184, EXEL-7184, EXEL-02977184
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	cabozantinib
D.3.9.1	CAS number	1140909-48-3
D.3.9.2	Current sponsor code	XL184, EXEL-7184, EXEL-02977184
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Imfinzi
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Durvalumab
D.3.2	Product code	[Durvalumab]
D.3.4	Pharmaceutical form	Lyophilisate for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	durvalumab
D.3.9.1	CAS number	1428935-60-7
D.3.9.2	Current sponsor code	MEDI4736
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with metastatic urothelial carcinoma who have relapsed after =1 chemotherapy regimen

Pazienti con carcinoma uroteliale metastatico che sono ricaduti dopo almeno una linea di chemioterapia

E.1.1.1

Medical condition in easily understood language

Patients with metastatic urothelial carcinoma

Pazienti con carcinoma uroteliale 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	10046714
E.1.2	Term	Urothelial carcinoma bladder
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective will be to evaluate whether the combination of durvalumab and cabozantinib will be active and will result in an increased efficacy compared to the available results with the use of both single-agents

Valutare l’efficacia della combinazione durvalumab e cabozantinib in pazienti affetti da carcinoma vescicale avanzato ricaduti o refrattari rispetto al trattamento di entrambi i farmaci utilizzati singolarmente

E.2.2

Secondary objectives of the trial

-the evaluation of the safety and tolerability of durvalumab combined with cabozantinib in a population of chemotherapy pretreated patients with UC
- the evaluation of translational correlates of response and outcome

• Valutare la sicurezza e la tollerabilità di durvalumab e cabozantinib somministrati in combinazione in una popolazione di pazienti pre-trattati.
• Valutare l’attività di potenziali biomarker nei pazienti trattati con cabozantinib e durvalumab

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Written informed consent.
• Age =18 years.
• Body weight >30kg
• Histologically-confirmed diagnosis of UC or variant histologies (e.g. squamous cell carcinoma, adenocarcinoma, micropapillary tumors, BUT excluding pure small cell carcinoma) of the bladder or the urothelium.
• Either bladder, urethral, or upper tract primary tumor will be allowed.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Life expectancy of at = 12 weeks.
• Availability of tumor tissue for PD-L1 IHC assay.
• Measurable and non-measurable disease will be included (e.g. patients with bone metastases only will be allowed for inclusion).
• Failure of 1 or 2 cisplatin-based conventional chemotherapy regimens for metastatic disease (2nd-to-3rd line only).
• Neoadjuvant/adjuvant regimens will be counted provided that a relapse occurred with 6 months of the last cycle of chemotherapy.
• Adequate function of the organs:

a. Absolute neutrophil count (ANC) = 1500/mm3
b. Platelets = 100,000/mm3
c. Hemoglobin = 9 g/dL (= 90 g/L).
d. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3.0 × upper limit of normal.
e. Total bilirubin = 1.5 × the upper limit of normal. For subjects with Gilbert’s disease = 3 mg/dL
g. Serum creatinine = 2.0 × upper limit of normal or calculated creatinine clearance = 30 mL/min using the Cockroft-Gault equation
h. Lipase < 2.0 times the upper limit of normal (ULN)
• Recovery to baseline or = Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) v45 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy
• Ability to swallow tablets
• Contraception for sexually active fertile patients and their partners. Of note, a barrier method is recommended in addition to the use of steroid hormonal contraceptives, because the effects of cabozantinib on the pharmacokinetics of the latter are unknown.
• Evidence of post menopausal status or serum pregnancy test for female pre-menopausal subject

• Firma consenso informato
• Età =18 anni.
• Peso > 30kg
• Diagnosi istologica confermata di carcinoma Uroteliale o con queste varianti (e.g. squamoso , adenocarcinoma, tumore micropapillare ,
con l’esclusione del carcinoma a piccole cellule ) dell’urotelio della vescica
• Sono ammessi tumori della vescica, dell’uretra e del tratto superiore
• ECOG 0 o 1
• Aspettativa di vita =12 settimane
• Disponibilità del tessuto per la valutazione immunoistochimica del test PD-L1 IHC
• I pazienti che hanno malattia misurabile e non misurabile sono includibili (e.s. è permessa l’inclusione anche dei pazienti che hanno solo metastasi ossee )
• Fallimento di 1 o 2 regimi di chemioterapia convenzionale contenente cis- platino (Solo 2 e 3 linea)
• Regimi neoadiuvanti/adiuvanti verrano considerati se la ripresa della malattia avviene entro 6 mesi dall’ultimo ciclo di chemioterapia
• Adeguata funzionalità d’organo:
-Neutrofili ANC = 1500/mm3
-Piastrine =100.00 /mm3
-Emoglobina = 9 g/dl
-ALT / AST < 3.0 xULN
-Bilirubina totale = 1.5 xULN . Per i soggetti con la sindrome di Gilbert =3 mg/dL.
-Lipasi < 2.0 xULN
-Creatinina sierica =2.0 ULN o creatinina clearance = 30 mL/min calcolata con la formula di Cockroft and Goult
• Recupero al baseline o con un grado inferiore a G1, in accordo con il CTCAE v5.0, delle tossicità relate a qualsiasi trattamento precedente , a meno che gli Eventi Avversi (AE) siano non clinicamemente rilevanti e/ o stabili con terapie di supporto
• Capacità a deglutire compresse
• Soggetti che accettino di praticare un’effettiva contraccezione durante l’intera durata dello studio, a meno che esista documentazione di infertilità

E.4

Principal exclusion criteria

• Patients taking regular oral steroids, above the allowed limit of 10mg/day methylprednisolone or analogues, for any reason. Patients must not have had steroids for 28 days prior to study entry.
• Malignancies other than bladder carcinoma within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer (Gleason score = 3 + 4 and PSA < 10 ng/mL undergoing active surveillance and treatment naive).
• Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results.
• Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging evaluation during screening and prior radiographic assessments.
• Patients with treated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria (see pg 29)
• Pregnant female patients. All female patients of childbearing potential with a positive pregnancy test within 2 weeks prior to the first dose of study treatment will be excluded from the study.
• Clinically significant cardiovascular disease, for example, myocardial infarction (within 3months prior to enrolment), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication (beta-blockers and digoxin are allowed)
• Uncontrolled hypertension, stroke or other ischemic or thromboembolic event (DVT, PE) within 6 months before first dose of cabozantinib
• Severe infections within 4 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
• Major surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis. Complete wound healing from major surgery must have occurred 1 month before inclusion and from minor surgery (eg, simple excision, tooth extraction) at least 10 days before inclusion. Subjects with clinically relevant ongoing complications from prior surgery are not eligible
• Concomitant anticoagulation with oral anticoagulants or platelet inhibitors
• Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
• Patients with a history of aneurysms

• Pazienti che assumono regolarmente steroidi orali con un dosaggio superiore a 10 mg/die di metilprednisolone o analoghi per ogni motivo. I pazienti non devono aver assunto steroidi nei 28 gg prima dell’inizio dello studio
• Altra neoplasia differente dal carcinoma della vescica entro i 5 anni precedenti il ciclo 1 giorno 1 con l’ eccezione di quelli con un rischio trascurabile di metastasi o morte e trattati con un intento curativo ( così come i carcinoma in situ della cervice adeguatamente trattati, il tumore della pelle basocellulare squamoso, o carcinoma duttale in situ trattato chirurgicamente con intento curativo ) o il tumore localizzato della prostata trattato con intento curativo ed in assenza di rialzo o ripresa dell ‘antigene prostatico specifico (PSA) o tumore incidentale della prostata (punteggio di Gleason = 3 + 4 e PSA <10 ng / mL sottoposti a sorveglianza attiva e trattamento naive)
• Presenza di qualsiasi malattia significativa non controllata che possa limitare la piena osservanza delle procedure dello studio.
• Pazienti con Metastasi cerebrali attive e o non trattate determinate con valutazione CT scan o Risonanza magnetica durante lo screening o /e nelle valutazioni radiografiche precedenti
• Pazienti con metastasi cerebrali trattate asintomatiche devono rispettare i criteri previsti nel protocollo ( vedi pag 29)
• Donne in stato di gravidanza. Sono escluse dallo studio tutte le donne in età fertile con un test di gravidanza positive entro le 2 settimane dall’inizio del trattamento
• Importanti patologie cardiovascolari, quali:
- Infarto miocardico (IM), entro 3 mesi prima dell’arruolamento, angina instabile, aritmia instabile scompenso cardiaco di grado = 2 secondo i criteri NYHA, aritmie di qualsiasi natura che richiedano l’uso di farmaci (beta-bloccanti o digossina sono permessi),
• Ipertensione non controllata, infarti o eventi trombo embolici o ischemici entro 6 mesi dalla prima dose di cabozantinib
• Infezioni gravi entro 4 settimane prima dell’arruolamento che richiedono ospedalizzazione per complicazioni di infezioni, batteremie o polmonite severa .
• Chirurgia maggiore entro 4 settimane precedenti l’arruolamento nello studio. Chirurgia minore (es. estrazione dei denti) entro 10 giorni dall’inizio dell’arruolamento Trattamento con antibiotici orali o per via endovena entro 2 settimane prima dell’arruolamento . Il trattamento profilattico o per prevenzione delle infezioni del tratto urinario o per la malatttia polmonare ostruttiva cronica è permesso
• Terapia concomitante con anticoagulanti orali anti aggreganti piastrinici
• Problemi ereditari di intolleranza al galattosio, deficit di Lapp lattasi o malassorbimento di glucosio-galattosio.
• Pazienti con pregressa storia di aneurismi

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint of the study will be overall survival (OS)

L’endpoint primario è La sopravvivenza globale (OS)

E.5.1.1

Timepoint(s) of evaluation of this end point

Duration of the study

Durata dello studio

E.5.2

Secondary end point(s)

To assess OS in patients with bone metastases only; To assess OS in patients with pure non-urothelial histology; Assessment of RR (investigator-assessed) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. RR (%) = complete (CR) + partial responses (PR).; Assessment of RR according to the immune-related RECIST criteria; FDG-PET response in bone metastases (EORTC criteria); Response duration (including stable diseases ); Progression-Free Survival (investigator-assessed); Correlative biological/immunologic endpoints; incidence, nature and severity of all-cause and treatment-related adverse events (AE), graded with the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

Valutare OS nei pazienti con sole metastasi ossee; Valutare l’OS nei pazienti con istologia non-uroteliale pura; Valutare RR ( valutata dall’investigatore in accord ai RECIST v.1.1 ). RR (%)= risposte complete (CR) + risposte parziali (PR); Valutare l’RR secondo i RECIST Immuno-relati; Valutare la risposta delle metastasi ossee con PET; Valutare la durata della risposta ( incluse le Stabilità di malattia); Valutare la Sopravvivenza libera da progressione ( valutata dall’investigatore); Endopoint correlative biologici/ Immunologici; Valutare la sicurezza e la tollerabilità del trattamento misurando l’incidenza , la natura e la severità di tutti gli Eventi Avversi (AE) indipendentemente dalla causa e degli AE relati al trattamento ( valutati con il CTCAE v 5.) con i relativi trattamenti correlati

E.5.2.1

Timepoint(s) of evaluation of this end point

Duration of the study; Duaration of the study; Duration of the study; Duration of the study; Duration of the study; Duration of the study; Duration of the study; Duration of the study; Duration of the study

Durata dello studio; Durata dello studio; Durata dello studio; Durata dello studio; Durata dello studio; Durata dello studio; Durata dello studio; Durata dello studio; Durata dello studio

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

122

F.4.2

For a multinational trial

F.4.2.1

In the EEA

122

F.4.2.2

In the whole clinical trial

122

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

All subjects will be followed for survival regardless of further treatments. Every 12 weeks a visit will be carried out or patients will be contacted by telephone.

Follow-up di sopravvivenza: tutti i soggetti saranno seguiti per la sopravvivenza indipendentemente dai successivi trattamenti a cui sarà sottoposto il paziente. Ogni 12 settimana sarà effettuata una visita o i pazienti saranno contattati telefonicamente.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-03-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-11-28

P. End of Trial
P.	End of Trial Status	Ongoing

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IMP with orphan designation in the indication
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