Clinical Trials Register

Summary
EudraCT Number:	2016-000662-38
Sponsor's Protocol Code Number:	D419NC00001
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-08-03
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-000662-38

A.3

Full title of the trial

A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects with Select Advanced Solid Tumors

Studio di Fase 1/2 di Durvalumab e Monalizumab in soggetti adulti con tumori solidi avanzati selezionati

A.3.1

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

A study to investigate the study drugs Durvalumab and Monalizumab for use in
patients with cancer

Uno studio per analizzare i farmaci in studio Durvalumab e Monalizumab per l'uso in pazienti con tumore

A.3.2

Name or abbreviated title of the trial where available

A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects with Select Advanced Solid Tumors

Studio di fase 1/2 di durvalumab e monalizumab in soggetti adulti affetti tumori solidi avanzati sel

A.4.1

Sponsor's protocol code number

D419NC00001

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02671435

A.5.4

Other Identifiers

Name:

Number:

D419NC00001

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	MEDIMMUNE, LLC
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	Medimmune LLC
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	Medimmune LLC
B.5.2	Functional name of contact point	AstraZeneca Study Info. Center
B.5.3	Address:
B.5.3.1	Street Address	One Medimmune Way
B.5.3.2	Town/ city	Gaithersburg
B.5.3.3	Post code	20878
B.5.3.4	Country	United States
B.5.4	Telephone number	0018772409479
B.5.5	Fax number	0018772409479
B.5.6	E-mail	information.center@astrazeneca.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.2.1.1.1	Trade name	na
D.2.1.1.2	Name of the Marketing Authorisation holder	na
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	MEDI4736
D.3.4	Pharmaceutical form	Concentrate for 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	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	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.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	No
D.2.1.1.1	Trade name	na
D.2.1.1.2	Name of the Marketing Authorisation holder	na
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	Monalizumab
D.3.2	Product code	[IPH2201]
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	Monalizumab
D.3.9.2	Current sponsor code	na
D.3.10	Strength
D.3.10.1	Concentration unit	mol/mg mole(s)/milligram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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.IMP: 3
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	Erbitux 5 mg/mL solution for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck KGaA
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	L01XC06
D.3.2	Product code	[L01XC06]
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	CETUXIMAB
D.3.9.1	CAS number	205923-56-4
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB01178MIG
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	5
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	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: 4
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.2.1.1.1	Trade name	NA
D.2.1.1.2	Name of the Marketing Authorisation holder	NA
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	Monalizumab
D.3.2	Product code	[IPH2201]
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	Monalizumab
D.3.9.1	CAS number	1228763-95-8
D.3.9.2	Current sponsor code	NA
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	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Advanced solid tumor

Tumori solidi avanzati

E.1.1.1

Medical condition in easily understood language

Cancer

Tumori

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	LLT
E.1.2	Classification code	10065252
E.1.2	Term	Solid tumor
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

Part 1:
To assess safety and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or the highest protocol-defined dose level in the absence of establishing an MTD of durvalumab in combination with monalizumab in subjects with advanced solid tumors.

Part 2:
To assess further the safety and tolerability of either the MTD or the highest protocol-defined dose level, in the absence of establishing a MTD, of durvalumab in combination with monalizumab in subjects with selected advanced solid tumors.

Part 3:
To assess safety and tolerability of durvalumab in combination with monalizumab plus chemotherapy with or without a biologic agent, as clinically indicated in subjects with MSS-CRC.
Please refer to the protocol for a full list of the Primary objectives

Parte 1:
Valutare la sicurezza e la tollerabilita, descrivere le DLT (tossicita limitanti la dose) e determinare la MTD (dose massima tollerata) o il livello di dosaggio piu
alto definito dal protocollo, se non viene stabilita la MTD di durvalumab in combinazione con monalizumab nei soggetti con tumori solidi avanzati.

Parte 2:
Valutare ulteriormente la sicurezza e tollerabilita della MTD o del livello di dosaggio piu elevato definito dal protocollo, qualora non sia stata stabilita una MTD, di durvalumab in associazione a monalizumab in soggetti con tumori solidi avanzati selezionati.

Parte 3:
Valutare la sicurezza e tollerabilita di durvalumab associato a monalizumab piu chemioterapia, con o senza un agente biologico, come clinicamente indicato, nei soggetti con MMS-CRC.

Si prega di fare riferimento al protocollo per la lista completa degli obiettivi primari

E.2.2

Secondary objectives of the trial

Secondary objectives:
• To evaluate preliminary anti-tumor activity
• To further evaluate the anti-tumor activity
• To describe the pharmacokinetics (PK) of each agent in the
combinations under investigation
• To describe the immunogenicity
• To characterise the association between clinical and/or pre-treatment
expression of PD-L1 and human leukocyte antigen (HLA-E) within the
tumor microenvironment
Please refer to the protocol for a full list of the secondary objectives.

Obiettivi secondari:
1. Determinare l'attivita antitumorale preliminare
2. Determinare ulteriormente l'attività antitumorale
3. Descrivere la PK (farmacocinetica) di ciascun agente nelle combinazioni in sperimentazione
4. Descrivere l'immunogenicita
5. Caratterizzare l’associazione tra l’espressione clinica e/o precedente al trattamento del PD-L1 e dell’antigene leucocitario umano (HLA-E) nell’ambito del microambiente tumorale

Si prega di fare riferimento al protocollo per l'elenco completo degli obiettivi secondari

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subjects must have histologic documentation of advanced recurrent or metastatic cancer.
2. Subjects must be at the recurrent/metastatic setting, with selected advanced solid tumors.
3) Subjects must have at least one lesion that is measurable by RECIST v1.1
4) Part 3, Dose exploration, CRC subjects can be treatment naïve but should not have received more than two lines of systemic therapy in the recurrent/metastatic setting.

Please refer to the protocol for a full list of the inclusion criteria.

1. I soggetti devono avere una documentazione istologica del carcinoma recidivante o metastatico avanzato.
2. i soggetti devo avere una condizione ricorrente-metastatico con tumori solidi avanzati selezionati.
3) I soggetti devono avere almeno una lesione misurabile da RECIST v1.1
4) Parte 3, esplorazione della dose, i soggetti con CRC possono essere trattati in modo naïve, ma non dovrebbero aver ricevuto più di due linee di terapia sistemica nel contesto ricorrente / metastatico.

Si prega di fare riferimento al protocollo per l'elenco completo dei criteri di inclusione.

E.4

Principal exclusion criteria

1. Prior treatment with immunotherapy agents. Prior treatment with antitumor vaccines may be permitted upon discussion with the medical monitor.

2. Prior participation in clinical studies that include durvalumab alone or in combination, where the study has registrational intent and the analyses for the primary endpoint have not yet been completed

3. Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the first dose of study treatment

4. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions is acceptable

Please refer to the protocol for a full list of the exclusion criteria.

1. Precedente trattamento con agenti immunoterapici . Un trattamento precedente con vaccini antitumorali è consentito, previa discussione con il responsabile del monitoraggio medico.

2. Precedente partecipazione a studi clinici a scopo registrativo che includono durvalumab, da solo o in combinazione, nei quali le analisi per l’endpoint primario non siano ancora state completate.

3. Ricevimento di qualsiasi terapia antitumorale convenzionale o sperimentale entro 4 settimane prima della prima dose del trattamento di studio

4. Qualsiasi chemioterapia concomitante, immunoterapia, terapia biologica o ormonale per il trattamento del cancro. L'uso concomitante di ormoni per condizioni non correlate al cancro è accettabile

Si prega di fare riferimento al protocollo per l'elenco completo dei criteri di esclusione.

E.5 End points

E.5.1

Primary end point(s)

Primary endpoint:
The primary endpoint is safety as assessed by presence of adverse events (AEs), serious adverse events (SAEs), DLTs, abnormal laboratory parameters, vital signs, and electrocardiogram (ECG) results. AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.

The primary endpoint for evaluating clinical activity in Part 3 (Cohorts C1A and C1B) is objective response (OR) by investigator assessment per RECIST v1.1.

Endpoint primario:
L’endpoint primario è la sicurezza, valutata mediante la presenza di AE (eventi avversi), SAE (eventi avversi gravi), DLT e anomalie nei parametri di laboratorio, parametri vitali e risultati dell’ECG (elettrocardiogramma). Gli AE saranno classificati secondo gli NCI CTCAE (Criteri comuni di terminologia per gli eventi avversi dell’Istituto nazionale statunitense per il cancro) v4.03.

L'endpoint primario per la valutazione dell'attività clinica nella Parte 3 (Coorti C1A e C1B) è la risposta obiettiva (OR) dalla valutazione dello sperimentatore per RECIST v1.1.

E.5.1.1

Timepoint(s) of evaluation of this end point

Monitored throughout the study

monitorando durante lo studio

E.5.2

Secondary end point(s)

1. The endpoints for assessment of antitumor activity based on RECIST v1.1 will include objective response (OR [primary endpoint for Cohorts C1A and C1B]), disease control (DC), duration of response (DoR), and progression-free survival (PFS) by investigator assessment per RECIST v1.1. Overall survival (OS) will also be assessed.
2. The endpoints for assessment of PK include individual subjects' investigational product concentrations in serum at different time points after administration of these agents.
3. The endpoints for assessment of immunogenicity include the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs).
4 The endpoints for assessment of biomarkers predicting subject clinical outcomes will include expression of PD-L1 and HLA-E in pre-treatment tumor biopsies.

1. Gli endpoint per la valutazione dell'attività antitumorale sulla base dei RECIST v1.1 includeranno l'OR (risposta obiettiva), (O end point primario per la Coorte C1A and C1B]), il DC (controllo della malattia), la DoR (durata della risposta), la PFS (sopravvivenza libera da progressione) e l'OS (sopravvivenza complessiva).
2. Gli endpoint per la valutazione della PK includono le concentrazioni sieriche individuali del soggetto in diversi punti temporali successivi alla somministrazione di entrambi gli agenti.

3. Gli endpoint per la valutazione dell'immunogenicità includono il numero e la percentuale di soggetti che sviluppano ADA (anticorpi anti-farmaco) rilevabili.

4. Gli endpoints per la valutazione dei biomarcatori predittivi degli esiti clinici del soggetto includeranno l'espressione di PD-L1 e HLA-E nelle biopsie tumorali.

E.5.2.1

Timepoint(s) of evaluation of this end point

Monitored throughout the study

Monitorando durante lo 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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

First administration to cancer subject

prima somministrazione su soggetti affetti da tumore

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

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

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

Brazil

Canada

Korea, Republic of

New Zealand

United States

Belgium

France

Hungary

Italy

Spain

United Kingdom

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

5 years after the final subject is enrolled or the date the study is closed
by the sponsor, whichever occurs first.

5 anni dopo l'ultima visita dell'ultimo paziente arruolato oppure la data di chiusura dello studio da parte dello Sponsor, a seconda di quale opzione si verifica per prima.

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:

596

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

150

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

200

F.4.2.2

In the whole clinical trial

746

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)

The study treatment will be provided until unacceptable toxicity,
documentation of confirmed progressive disease, or subject withdrawal
for another reason

Il trattamento dello studio verrà somministrato fino ad un'inaccettabile tossicità, documentata progressione della malattia, oppure l'uscita del paziente per altre ragioni

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

2017-02-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-01-19

P. End of Trial
P.	End of Trial Status	Completed

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials