Clinical Trials Register

Summary
EudraCT Number:	2017-003507-22
Sponsor's Protocol Code Number:	FPA144-004
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:	2021-01-29
Trial results	View 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

2017-003507-22

A.3

Full title of the trial

A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating FPA144
and Modified FOLFOX6 in Patients with Previously Untreated Advanced
Gastric and Gastroesophageal Cancer: Phase 3 Preceded by Dose-Finding
in Phase 1

FIGHT: Studio di Fase 3 randomizzato, in doppio cieco, controllato per la valutazione di FPA144 e FOLFOX6 modificati in pazienti affetti da tumore gastrico e gastroesofageo avanzato non trattato in precedenza: Fase 3 preceduta da Dose Finding nella Fase 1

A.3.1

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

A Phase 3 Study Evaluating FPA144 and Modified FOLFOX6 in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer: Phase I to be conducted prior to Phase 3

Studio di Fase 3 per la valutazione di FPA144 e FOLFOX6 modificati in pazienti affetti da tumore gastrico e gastroesofageo avanzato non trattato in precedenza: Fase I da svolgersi prima della Fase 3

A.3.2

Name or abbreviated title of the trial where available

FIGHT

A.4.1

Sponsor's protocol code number

FPA144-004

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	FIVE PRIME THERAPEUTICS, INC.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	FIVE PRIME THERAPEUTICS, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Five Prime Therapeutics, Inc.
B.5.2	Functional name of contact point	Medical Lead
B.5.3	Address:
B.5.3.1	Street Address	111 Oyster Point Boulevard
B.5.3.2	Town/ city	South San Francisco
B.5.3.3	Post code	94080
B.5.3.4	Country	United States
B.5.4	Telephone number	0018443335349
B.5.5	Fax number	0014153655600
B.5.6	E-mail	FPA144004@fiveprime.com

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	No
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	Bemarituzumab
D.3.2	Product code	[FPA144]
D.3.4	Pharmaceutical form	Solution for infusion
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	Bemarituzumab
D.3.9.2	Current sponsor code	FPA144
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	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Advanced Gastric and Gastroesophageal Cancer

Cancro gastrico e gastroesofageo avanzato

E.1.1.1

Medical condition in easily understood language

Advanced Gastric and Gastroesophageal Cancer

Cancro gastrico e gastroesofageo avanzato

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	21.0
E.1.2	Level	PT
E.1.2	Classification code	10004267
E.1.2	Term	Benign gastric neoplasm
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

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare OS in patients with FGFR2-selected GC treated with FPA144 + mFOLFOX6 to those treated with placebo combined with mFOLFOX6 (hereinafter referred to as [placebo +mFOLFOX6])

Confrontare la sopravvivenza globale (OS) in pazienti affetti da cancro gastrico o gastroesofageo (GC) selezionato per il recettore del fattore di crescita dei fibroblasti di tipo 2 (FGFR2), trattati con FPA144 + mFOLFOX6, rispetto a quelli trattati con placebo combinato con mFOLFOX6 (di seguito, indicato come placebo + mFOLFOX6)

E.2.2

Secondary objectives of the trial

To compare the following in patients with FGFR2-selected GC treated with FPA144 + mFOLFOX6 to those treated with placebo + mFOLFOX6:
- Investigator-assessed progression-free survival (PFS)
- Investigator-assessed objective response rate (ORR)
- Safety and tolerability
To characterize the following:
- PK profile of FPA144 + mFOLFOX6 in patients with FGFR2-selected GC
- Immunogenicity of FPA144

Confrontare quanto segue in pazienti affetti da GC selezionato per FGFR2 trattati con FPA144 + mFOLFOX6, rispetto a quelli trattati con placebo + mFOLFOX6:
- Sopravvivenza libera da progressione (PFS) valutata dallo Sperimentatore
- Tasso di risposta obiettiva (ORR) valutato dallo Sperimentatore
- Sicurezza e tollerabilità
Caratterizzare quanto segue:
- Profilo PK di FPA144 + mFOLFOX6 in pazienti affetti da GI selezionato per FGFR2
- Immunogenicità di FPA144

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Phase 1 and Phase 3:
1. Disease that is unresectable, locally advanced, or metastatic (not amenable to curative therapy)
2. Understand and sign an Institutional Review Board
(IRB)/Independent Ethics Committee (IEC)-approved ICF prior to any study-specific evaluation
3. Life expectancy of at least 3 months in the opinion of the investigator
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
5. Age =18 years at the time the ICF is signed
6. In sexually active patients (women of child bearing potential [WOCBP] and males), willingness to use 2 effective methods of contraception, of which 1 must be a physical barrier method (condom, diaphragm, or cervical/vault cap) until 6 months after the last dose of FPA144. Other effective forms of contraception include:
• Permanent sterilization (hysterectomy and/or bilateral oophorectomy, or bilateral tubal ligation with surgery, or vasectomy) at least 6 months prior to screening
• WOCBP who are on stable oral contraceptive therapy or intrauterine or implant device for at least 90 days prior to the study, or abstain from sexual intercourse as a way of living
7. Adequate hematological and biological function, confirmed by the following laboratory values within 96 hours prior to enrollment:
Bone Marrow Function
• ANC = 1.5 × 109/L
• Platelets = 100 × 109/L
• Hemoglobin = 9 g/dL
Hepatic Function
• AST and ALT < 3 × ULN; if liver metastases, then < 5 × ULN
• Bilirubin < 1.5 × ULN except in patients with Gilbert's disease
Renal Function
• Calculated CrCl using Cockroft Gault formula = 50 mL/min or estimated glomerular filtrate rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula =50 mL/min
8. INR or prothrombin time (PT) < 1.5 × the ULN except for patients receiving anticoagulation, who must be on a stable dose of warfarin for 6 weeks prior to enrollment
9. Measurable or non-measurable, but evaluable disease using RECIST v1.1
Please refer to protocol section 4 for the additional inclusion criteria.

Fase 1 e Fase 3:
1) Avere una malattia che è non resecabile, localmente avanzata o metastatica (non soggetta a terapia curativa)
2) Comprendere e sottoscrivere un ICF approvato dal Comitato di revisione istituzionale (IRB)/Comitato etico indipendente (IEC) prima di qualsiasi valutazione specifica dello studio
3) Avere un'aspettativa di vita prevista di almeno 3 mesi a giudizio dello Sperimentatore
4) Avere un performance status ECOG (Eastern Cooperative Oncology Group) pari a 0-1
5) Avere un'età = di 18 anni al momento della firma dell’ICF
6) Nei pazienti sessualmente attivi (donne potenzialmente fertili [WOCBP] e uomini in grado di procreare), impegnarsi a usare 2 metodi contraccettivi efficaci, 1 dei quali deve essere un metodo a barriera fisica (profilattico, diaframma o coppetta/cappuccio cervicale) fino a 6 mesi dopo l'ultima dose di FPA144. Fra le altre forme di contraccezione efficace vi sono:
• Sterilizzazione permanente (isterectomia e/o ovariectomia bilaterale o legatura bilaterale delle tube con intervento chirurgico o vasectomia) almeno 6 mesi prima dello Screening
• Donne in età potenzialmente fertile (WOCBP) in terapia contraccettiva orale stabile o dispositivo intrauterino o impiantato per almeno 90 giorni prima dello studio, oppure che si astengono da rapporti sessuali come stile di vita
7) Funzione ematologica e biologica adeguata, confermata dai seguenti valori di laboratorio entro 96 ore prima dell'arruolamento:
Funzione del midollo osseo
• ANC = 1,5 × 109/L
• Piastrine = 100 × 109/L
• Emoglobina = 9 g/dL
Funzione epatica
• AST e ALT < 3× ULN in caso di metastasi epatiche, poi < 5 × ULN
• Bilirubina < 1,5 × ULN tranne in pazienti con malattia di Gilbert
Funzione renale
• CrCl calcolata utilizzando la formula di Cockcroft Gault = 50 mL/min o velocità di filtrazione glomerulare stimata (eGFR) utilizzando la formula Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) = 50 mL/min
8) Rapporto normalizzato internazionale (INR), o tempo di protrombina (PT) < 1,5 × ULN, tranne in pazienti che ricevono terapia anticoagulante che devono aver assunto una dose stabile di warfarina da 6 settimane prima dell'arruolamento
9) Malattia misurabile o non misurabile, ma valutabile usando RECIST v1.1
Si prega di far riferimento alla sezione 4 del protocollo per i successivi criteri di inclusione.

E.4

Principal exclusion criteria

Phase 1 and Phase 3:1. Untreated or symptomatic central nervous system (CNS) metastases (CNS imaging not required). Patients with asymptomatic CNS metastases are eligible provided they have been clinically stable for at least 4 weeks and do not require intervention such as surgery, radiation, or any corticosteroid therapy for management of symptoms related to CNS disease 2. Impaired cardiac function or clinically significant cardiac disease, including any of the following (Criteria a through g): a) Unstable angina pectoris = 6 months prior to enrollment b) Acute myocardial infarction = 6 months prior to enrollment c) New York Heart Association Class II-IV congestive heart failure d) Uncontrolled hypertension (as defined as = 160/90 despite optimal medical management) e) Uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin f) Active coronary artery disease g) Fridericia's correction formula (QTcF) = 480 3. Peripheral sensory neuropathy = CTCAE Grade 2 4. Active infection requiring systemic treatment or any uncontrolled infection =14 days prior to enrollment 5. Known human immunodeficiency virus (HIV) or acquired
immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection 6. History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) 7. Evidence or history of bleeding diathesis or coagulopathy
8. Radiotherapy = 28 days of enrollment. Patients must be recovered from all acute radiotherapy-related toxicities. No radiopharmaceuticals (strontium, samarium) within 8 weeks of enrollment 9. Prior treatment with any selective inhibitor (eg, AZD4547, BGJ398, JNJ-42756493, BAY1179470) of the FGF-FGFR pathway
Please refer to protocol section 4 for the additional exclusion criteria (included the changes related to the amendment).

Fase 1 e Fase 3:1) Metastasi del sistema nervoso centrale (CNS) non trattata o sintomatica (non è necessario imaging del CNS). I pazienti con metastasi del CNS asintomatiche sono idonei a condizione che siano stati clinicamente stabili per almeno 4 settimane e non necessitino di intervento, quale ad esempio intervento chirurgico, radiazione o qualsivoglia terapia corticosteroidea per la gestione dei sintomi correlati alla malattia del CNS 2)Funzione cardiaca compromessa o malattia cardiaca clinicamente significativa, incluso uno qualsiasi dei seguenti (criteri da a fino a g): a) Angina pectoris instabile = 6 mesi prima dell'arruolamento b) Infarto miocardico acuto = 6 mesi prima dell'arruolamento c) Insufficienza cardiaca congestizia di classe II-IV della classificazione della New York Heart Association d) Ipertensione non controllata (definita come = 160/90 nonostante l'assistenza medica ottimale) e) Aritmie cardiache non controllate che richiedono terapia con anti-aritmici diversi da betabloccanti o digossina f) Coronaropatia attiva g) Formula di correzione di Fridericia (QTcF) = 480 3) Neuropatia sensoria periferica ¿ Criteri comuni di terminologia per gli eventi avversi (CTCAE) di Grado 2 4) Infezione attiva che richieda trattamento sistemico o una qualsiasi infezione non controllata = 14 giorni prima dell'arruolamento 5) Noto virus dell'immunodeficienza umana (HIV) o malattie correlate alla sindrome da immunodeficienza acquisita (AIDS), o nota infezione da epatite B o C cronica o attiva 6) Anamnesi di malattia polmonare interstiziale (ad es., polmonite o fibrosi polmonare) 7) Evidenza o anamnesi di diatesi emorragica o coagulopatia 8) Radioterapia = 28 giorni dall'arruolamento. I pazienti devono essersi ristabiliti da tutte le tossicità acute correlate alla radioterapia. Nessun radiofarmaco (stronzio, samario) entro 8 settimane dall'arruolamento 9) Precedente trattamento con un qualsiasi inibitore selettivo (ad es., AZD4547, BGJ398, JNJ-42756493, BAY1179470) della via FGF-FGFR
Si prega di far riferimento alla sezione 4 del protocollo per i successivi criteri di esclusione (incluse le modifiche relative all'emendamento).

E.5 End points

E.5.1

Primary end point(s)

Overall survival (OS), defined as time from randomization until death from any cause

Sopravvivenza globale (OS), definita come il tempo che intercorre dalla randomizzazione fino al decesso per una qualsiasi causa

E.5.1.1

Timepoint(s) of evaluation of this end point

Every 3 months ± 28 days after the End of Treatment visit until up to 24 months after the last patient is enrolled in the study, or until death, loss to follow-up, withdrawal of consent or study termination by the Sponsor (whichever occurs first).

Ogni 3 mesi ± 28 giorni dopo la visita di Fine del trattamento fino a un massimo di 24 mesi dopo l’arruolamento dell’ultimo paziente nello studio, o fino al decesso, perdita al follow-up, ritiro del consenso o interruzione dello studio da parte dello Sponsor (a seconda dell’evento che si verifica per primo).

E.5.2

Secondary end point(s)

-Progression-free survival (PFS), defined as time from randomization until the date of disease progression based on investigator assessment (using RECIST v1.1) or death from any cause, whichever
comes first
- Objective response rate (ORR), defined as the proportion of patients with partial or complete response in all enrolled patients based on
investigator assessment of tumor lesions per RECIST v1.1
-Incidence of AEs, clinical laboratory abnormalities, corneal and retinal findings, and ECG abnormalities
- Pharmacokinetic (PK) parameters, Cmax and Ctrough of FPA144 in combination with mFOLFOX6
- Incidence of treatment-emergent anti-FPA144 antibody response

-Sopravvivenza libera da progressione (PFS), definita come il tempo trascorso dalla randomizzazione fino alla data della progressione della malattia in base alla valutazione dello Sperimentatore (usando Criteri di valutazione della risposta nei tumori solidi versione 1.1 [RECIST v1.1]) o al decesso dovuto a una qualsiasi causa, a seconda di quale dei due eventi si verifichi per primo ;Tasso di risposta obiettiva (ORR), definito come la proporzione di pazienti con risposta parziale o completa in base alla valutazione delle lesioni tumorali da parte dello Sperimentatore secondo RECIST v1.1;Incidenza di EA, anomalie cliniche di laboratorio, esiti corneali e retinici e anomalie dell'elettrocardiogramma (ECG);Parametri farmacocinetici (PK), Cmax e Ctrough di FPA144 in combinazione con mFOLFOX6;Incidenza della risposta anticorpale anti-FPA144 emergente dal trattamento

E.5.2.1

Timepoint(s) of evaluation of this end point

-Radiological/Tumor Assessment: Screening, every 8 weeks from C1D1 until 12 months and then every 12 weeks thereafter, EOT, follow-up (if applicable)
-AEs: throughout the study
-Laboratory Evaluations: screening; C1D1, C1D8, C2D1, C3D1, C4D1, EoT and as clinically indicated
-Vital signs: screening; C1D1, C1D8, C2D1, C3D1, C4D1, EoT; follow-up and as clinically indicated
-Ophthalmologic Examination: Screening, every 8 weeks from C1D1, EOT
-Slit Lamp Examination: Week 16 and then every 8 weeks through EOT, as clinically indicated, including after EOT
-ECG: screening, EoT, as clinically indicated
-PK & Immunogenicity Blood Sample collection: Day 1 of Cycles 1, 3, 5, 9, 17 and EoT
Where:
C1, C2 = Cycle 1, Cycle 2 etc
D1, D2 = Day 1, Day 2 etc
EoT= End of Treatment

Valutaz radiologica/tumorale: Screening ogni 8 sett dal C1G1 fino a 12 mesi e poi ogni 12 settimane, EOT, FU (se pertinente);AE: nel corso dell'intero studio;Valutazioni di laboratorio: screening; C1G1, C1G8, C2G1, C3G1, C4G1, EOT e quando indicato clinicamente;Parametri vitali: screening; C1G1, C1G8, C2G1, C3G1, C4G1, EOT, FU e quando indicato clinicamente;Esame oftalmico: Screening, ogni 8 sett da C1G1, EOT;Biomicroscopia con lampada a fessura: Sett 16 e poi ogni 8 sett fino alla EOT, quando indicato clinicamente, compreso dopo la EOT;ECG: screening, EOT, quando indicato clinicamente;Prelievo di campioni di sangue per farmacocinetica e immunogenicità: G1 dei Cicli 1, 3, 5,9, 17 e EOT.Dove:C1, C2 = Ciclo 1, Ciclo 2, ecc;G1, G2 = Giorno 1, Giorno 2, ecc;EOT = Fine del trattamento

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

immunogenicity, tolerability

immunogenicità, tollerabilità

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Yes

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

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

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

105

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

China

Japan

Korea, Republic of

Taiwan

Thailand

Turkey

United States

Belgium

France

Germany

Hungary

Italy

Poland

Portugal

Romania

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

24 months after the last patient is enrolled in the study

24 mesi dopo che l¿ultimo paziente ¿ stato arruolato nello studio

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:

502

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

130

F.4.2.2

In the whole clinical trial

548

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)

none

nessuno

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

2018-10-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-11-21

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

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Clinical trials