Clinical Trials Register

Summary
EudraCT Number:	2015-002070-21
Sponsor's Protocol Code Number:	265-109
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:	2020-11-04
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

2015-002070-21

A.3

Full title of the trial

Phase 2, Parallel-Arm Study of MGCD265 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Activating Genetic Alterations in Mesenchymal-Epithelial Transition Factor

Studio di Fase 2, a bracci paralleli su MGCD265 in pazienti con tumore al polmone non a piccole cellule avanzato o metastatico con alterazioni genetiche attivanti il fattore di transizione mesenchimale-epiteliale

A.3.1

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

This is a study to assess tumor response to MGCD265 in Patients with Locally Advanced or Metastatic non-small cell lung cancer with genetic alternation of MET.

Questo è uno studio per valutare la risposta tumorale MGCD265 in pazienti con tumore al polmone non a piccole cellule avanzato o metastatico con alterazioni genetiche di MET

A.3.2

Name or abbreviated title of the trial where available

This is a study to tumor response to MGCD265 in Patients with Locally Advanced or Metastatic non-sma

Questo è uno studio per valutare la risposta tumorale a MGCD265 in pazienti con tumore al polmone no

A.4.1

Sponsor's protocol code number

265-109

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02544633

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	MIRATI THERAPEUTICS INCORPORATED
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	Mirati 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	Mirati Therapeutics, Inc.
B.5.2	Functional name of contact point	Clinical Research
B.5.3	Address:
B.5.3.1	Street Address	9393 Towne Centre Drive, Suite 200
B.5.3.2	Town/ city	San Diego
B.5.3.3	Post code	CA 92121
B.5.3.4	Country	United States
B.5.4	Telephone number	0018583323410
B.5.5	Fax number	0018583323410
B.5.6	E-mail	mirati265109@mirati.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	MGCD265
D.3.2	Product code	MGCD265
D.3.4	Pharmaceutical form	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.3.9.1	CAS number	936694-12-1
D.3.9.2	Current sponsor code	MGCD265
D.3.9.3	Other descriptive name	MGCD265
D.3.9.4	EV Substance Code	SUB180240
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	100
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	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	MGCD265
D.3.2	Product code	MGCD265
D.3.4	Pharmaceutical form	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.3.9.1	CAS number	936694-12-1
D.3.9.2	Current sponsor code	MGCD265
D.3.9.3	Other descriptive name	MGCD265
D.3.9.4	EV Substance Code	SUB180240
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	250
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

Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Tumore del polmone non a piccole cellule localmente avanzato o metastatico

E.1.1.1

Medical condition in easily understood language

Lung cancer

Tumore del polmone

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10061873
E.1.2	Term	Non-small cell lung cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10061873
E.1.2	Term	Non-small cell lung cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine the tumor response to MGCD265 in the selected patient population.

Determinare la risposta tumorale a MGCD265 nella popolazione di pazienti selezionata.

E.2.2

Secondary objectives of the trial

To evaluate the safety and tolerability of MGCD265 in the selected population.
To evaluate secondary efficacy endpoints with MGCD265 treatment in the selected population.
To assess correlation between selected tumor gene alterations using different analytical techniques in tumor tissue and circulating tumor deoxyribonucleic acid (ctDNA).
To assess change in genetic alteration status in ctDNA with MGCD265 treatment over time in the selected population.
To assess the population pharmacokinetics/pharmacodynamics (PK/PD)
of MGCD265 in the selected population.

Valutare la sicurezza e la tollerabilità di MGCD265 nella popolazione selezionata.
Valutare gli endpoint secondari di efficacia con il trattamento MGCD265 nella popolazione selezionata.
Valutare la correlazione fra le alterazioni del gene tumorale selezionato utilizzando tecniche analitiche diverse nel tessuto
tumorale e nell'acido desossiribonucleico tumorale circolante (ctDNA).
Valutare la variazione dello stato genetico del ctDNA a seguito del trattamento con MGCD265 nel tempo nella popolazione
selezionata.
Valutare la farmacocinetica/farmacodinamica (PK/PD) di MGCD265 nella popolazione selezionata.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Histologically confirmed NSCLC with metastatic or unresectable,locally advanced disease.
2. Receipt of at least one prior platinum-containing chemotherapy or licensed immunotherapy regimen in the advanced disease setting.
3. Molecular analysis of patient-derived samples using a Sponsor approved method and laboratory that demonstrates a genetic
alteration activating MET in tumor tissue and/or ctDNA. If eligibility is established using a Sponsor-approved local laboratory, a
tumor tissue specimen and/or blood sample is expected to be available for retrospective sequencing in the central laboratory
selected by the Sponsor.
4. Measurable disease, as per RECIST version 1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1,or 2.
6. Adequate bone marrow and organ function demonstrated by:
-Absolute neutrophil count = 1,000/mm3 (= 1.0 × 109/L)
-Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)= 2.5 × Upper Limit of Normal (ULN), or = 5.0 x ULN for
patients with
documented liver metastases. Alkaline phosphatase levels = 2.5 × ULN.
In the presence of extensive bone metastases, there is no upper limit for alkaline phosphatase.
-Total bilirubin = 1.5 x ULN or = 3.0 x ULN for patients with Gilbert Syndrome or documented liver metastases.
7. = 18 years of age.
8. Women of child-bearing potential (WOCBP) or men whose partner is a WOCBP agrees to use contraception while participating in
this study, and
for a period of 6 months following termination of study treatment.
9. Completed informed consent process, including signing IRB/EC approved informed consent form.
10. Willing to comply with clinical trial instructions and requirements.

1.NSCLC confermato istologicamente, con malattia metastatica o non resecabile localmente avanzata.
2.Almeno un regime di chemioterapia contenente platino o immunoterapia autorizzata in contesto avanzato.
3.Analisi molecolare di campioni ricavati dal paziente utilizzando un metodo e un laboratorio approvati dal promotore della
sperimentazione che dimostrano un'alterazione genetica attivante MET nel tessuto tumorale e/o nel ctDNA. Se l'idoneità viene
stabilita sulla base delle analisi condotte in un laboratorio locale, un campione di tessuto tumorale e/o di sangue deve essere
disponibile per il sequenziamento retrospettivo presso il laboratorio centrale selezionato dal promotore della sperimentazione.
4.Malattia misurabile, in conformità con RECIST versione 1.1.
5.Performance status secondo l'ECOG (Eastern Cooperative Oncology Group) 0, 1 o 2 (Appendice 1).
6.Funzionalità adeguata del midollo osseo e degli organi, definita da:
a.Conta assoluta dei neutrofili (ANC)=1.000/mm3 (=1,0 × 109/l)
b.Aspartato amminotransferasi (ALT) e alanina amminotransferasi (AST) = 2,5 volte il limite superiore della norma (ULN); oppure =
5,0 volte il limite ULN in presenza di metastasi epatiche documentate. Livelli di fosfatasi alcalina = 2,5 × ULN. In presenza di
metastasi ossee estese, non esiste un limite superiore per la fosfatasi alcalina.
c.Bilirubina totale = 1,5 x ULN o = 3,0 x ULN per pazienti con sindrome di Gilbert o metastasi epatiche documentate.
7.=18 anni di età.
8.Le donne in età fertile o i soggetti di sesso maschile con partner sessuali femminili in età fertile dovranno accettare di utilizzare
un metodo contraccettivo durante lo studio e per i 6 mesi successivi alla fine del trattamento dello studio.
9.Processo di consenso informato completato, inclusa la firma di un modulo di consenso informato approvato dal CE.
10.Disponibilità a rispettare le istruzioni e i requisiti della sperimentazione clinica

E.4

Principal exclusion criteria

1. Prior treatment with a small molecule or antibody inhibitor of MET or HGF.
2. Prior positive test for EGFR mutation or ALK gene rearrangement:
Testing and documentation is required for patients with adenocarcinoma histology
Testing is not required for patients with non-adenocarcinoma histology;
however if documentation of a positive test is available, the patient will not be eligible
3. Most recent prior sistemic therapy (e.g. chemotherapy or immunotherapy) or investigational agent discontinued =2 weeks before first dose date.
4. Absence of recovery from the adverse effects of prior therapy at the time of enrollment to = Grade 2 (excluding alopecia).
5. History of stroke or transient ischemic attack within the previous 6 months.
6. Any of the following cardiac abnormalities:
-Unstable angina pectoris,
-Congestive heart failure = NYHA Class 3, or
-QTc > 480 msec.
7. Known or suspected presence of another malignancy that could be mistaken for metastatic NSCLC during disease assessments.
8. Symptomatic or uncontrolled brain metastases requiring current treatment (less than 4 weeks from last cranial radiation, 2 weeks from stereotactic radiosurgery[gamma knife] or 2 weeks from last steroids). Known conditions associated with significant risk of intracranial bleeding including but not limited to vascular malformations and pituitary adenoma.
9. Inability to swallow oral medications or pre-existing gastrointestinal disorders that might interfere with proper absorption of oral
drugs.
10. Known hypersensitivity to any of the components of the MGCD265 Drug Product.
11. Pregnancy. WOCBP must have a negative serum or urine pregnancy test documented within the screening period prior start of study drug.
12. Breast-feeding or planning to breast feed during the study or within 6 months after study treatment.
13. Any serious illness, uncontrolled inter-current illness, active or uncontrolled infection, or other medical history, including laboratory results, which, in the Investigator's opinion, would be likely to interfere with the patient's participation in the study, or with the interpretation of the results.

1.Trattamento precedente con una piccola molecola o anticorpo inibitore di MET o HGF.
2.Test precedente positivo per la mutazione di EGFR o il riarrangiamento del gene ALK:
Per i pazienti con istologia di adenocarcinoma sono richiesti i test e la documentazione;
I test non sono richiesti per i pazienti senza istologia di adenocarcinoma; tuttavia se è disponibile la documentazione di un test
positivo, il paziente non sarà idoneo.
3. Più recente terapia sistemica (per esempio: chemioterapia o immunoterapia) o agente sperimentale interrotti da =2 settimane prima della data della prima dose.
4.Mancato recupero al grado = 2 dagli effetti collaterali della terapia precedente al momento dell'arruolamento (esclusa
l'alopecia).
5.Anamnesi di ictus o attacco ischemico transitorio nei 6 mesi precedenti.
6.Qualsiasi delle seguenti anomalie cardiache:
a.Angina pectoris instabile
b.Insufficienza cardiaca congestizia di classe = 3 secondo i criteri NYHA oppure
c.QTc > 480 msec.
7.Presenza nota o sospetta di un'altra neoplasia che potrebbe essere confusa per NSCLC metastatico durante le valutazioni della
malattia.
8.Metastasi cerebrali sintomatiche o non controllate che richiedono un trattamento corrente (meno di 4 settimane dall'ultima radioterapia cranica, 2 settimane dalla radiochirurgia sterotassica [gamma knife] o 2 settimane dall'ultima terapia con steroidi). Condizioni note associate a un rischio significativo di emorragia
endocranica, comprese, a titolo esemplificativo, malformazioni vascolari e adenoma dell'ipofisi.
9.Impossibilità di ingerire farmaci per bocca o disturbi gastrointestinali pre-esistenti che possano interferire con l'assorbimento dei
farmaci assunti per via orale.
10.Ipersensibilità nota a qualsiasi componente del prodotto MGCD265.
11.Gravidanza. Le donne in età fertile devono presentare un test di gravidanza nel siero o nelle urine negativo documentato entro
il periodo di screening prima di iniziare il trattamento con il farmaco dello studio.
12.Allattamento al seno o previsione di allattamento al seno durante lo studio o entro 6 mesi dopo il trattamento dello studio.
13.Eventuali malattie gravi, malattie non controllate concomitanti, infezioni attive o non controllate o altra anamnesi medica,
compresi risultati di laboratorio, che, secondo il giudizio dello sperimentatore, potrebbero interferire con la partecipazione del
paziente allo studio o con l'interpretazione dei risultati.

E.5 End points

E.5.1

Primary end point(s)

Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

Tasso di risposta obiettiva (ORR) secondo i criteri di valutazione della risposta nei tumori solidi versione 1.1 (RECIST 1.1).

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary analysis will be conducted approximately 12 weeks after the last patient is enrolled, allowing for observation of an early disease response and confirmation of PR or CR.

L'analisi primaria sarà condotta circa 12 settimane dopo l'arruolamento dell'ultimo paziente, consentendo l'osservazione di una risposta di malattia precoce e la conferma di PR o CR.

E.5.2

Secondary end point(s)

- Safety characterized by type, incidence,
severity, timing, seriousness and relationship to study treatment of adverse events and laboratory
abnormalities.
- Secondary efficacy endpoints:
¿Duration of Response (DR);
¿ Progression-Free Survival (PFS);
¿ 1-Year Survival Rate; and
¿ Overall Survival (OS).
- Gene alterations in tumor tissue and ctDNA at prescreening/baseline.
- Change in ctDNA through time.
- Blood plasma MGCD265 concentration.
- Blood plasma concentration of selected soluble biomarkers.

- Sicurezza caratterizzata dal tipo, dall'incidenza, dalla gravità, dalla tempistica, dalla serietà e dal rapporto con il trattamento in studio di eventi avversi e anomalie di laboratorio.
- Endpoint di efficacia secondari:
• Durata della risposta (DR)
• Sopravvivenza libera da progressione (PFS, progression-free survival)
• Tasso di sopravvivenza a 1 anno e
• Sopravvivenza complessiva (Overall Survival, OS).
• Alterazioni dei geni nel tessuto tumorale e ctDNA al momento del prescreening/al basale.
- Variazioni del ctDNA nel tempo.
- Concentrazione di MGCD265 nel plasma sanguigno.
- Concentrazione di biomarcatori solubili selezionati nel plasma sanguigno.

E.5.2.1

Timepoint(s) of evaluation of this end point

Signs and symptoms of the patient's cancer diagnosis and/or comorbidities present at baseline will be recorded in the CRF as adverse events.

Segni e sintomi di diagnosi e/o comorbidit¿ del tumore del paziente presenti al basale saranno registrati in CRF come eventi avversi

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

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

Yes

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

Canada

France

Germany

Hungary

Italy

Korea, Republic of

Poland

Spain

Taiwan

United Kingdom

United States

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

Last visit of the last patient undergoing the study

Ultima visita dell'ultimo paziente sottoposto allo 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:

180

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

110

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

F.4.2.2

In the whole clinical trial

290

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)

Patients will return to standard of care but survival status and subsequent therapies will be collected until death or lost to follow-up.

I pazienti torneranno allo standard di cura, ma lo stato di sopravvivenza e terapie successive saranno raccolte fino alla morte o alla perdita al follow up

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

2016-01-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-10-28

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

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Clinical trials