Clinical Trials Register

Summary
EudraCT Number:	2011-005132-26
Sponsor's Protocol Code Number:	CA209-025
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:	2012-08-02
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

2011-005132-26

A.3

Full title of the trial

A Randomized, Open-Label, Phase 3 Study of BMS-936558 vs. Everolimus in Subjects with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

Studio di fase III randomizzato in aperto di BMS-936558 verso Everolimus in soggetti con carcinoma a cellule renali a cellule chiare, in stadio avanzato o metastatico, che hanno ricevuto precedente terapia anti angiogenica.

A.3.1

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

Study of BMS-936558 vs. Everolimus in Pre-Treated Advanced Or Metastatic Clear-cell RCC

Studio di confronto tra BMS-936558 e Everolimus in soggetti con carcinoma a cellule renali a cellule chiare, in stadio avanzato o metastatico, precedentemente trattati.

A.4.1

Sponsor's protocol code number

CA209-025

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	BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
B.1.3.4	Country	Belgium
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	Bristol-Myers Squibb International Corporation
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bristol-Myers Squibb International Corporation
B.5.2	Functional name of contact point	EU Study Start-Up Unit
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance - Avenue de Finlande, 8
B.5.3.2	Town/ city	Braine-l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.6	E-mail	clinical.trials@bms.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	NA
D.3.2	Product code	BMS-936558
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.3.9.1	CAS number	946414-94-4
D.3.9.2	Current sponsor code	BMS-936558-01
D.3.9.3	Other descriptive name	Anti-PD-1 Human Monoclonal Antibody; MDX-1106
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	10
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Comparator
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	Afinitor 5 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.4	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.3.8	INN - Proposed INN	EVEROLIMUS
D.3.9.1	CAS number	159351-69-6
D.3.9.4	EV Substance Code	SUB02065MIG
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	5
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	Afinitor 10 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.4	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.3.8	INN - Proposed INN	EVEROLIMUS
D.3.9.1	CAS number	159351-69-6
D.3.9.4	EV Substance Code	SUB02065MIG
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	10
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

Advanced or metastatic (medically or surgically unresectable) clear-cell Renal Cell Carcinoma

Carcinoma a cellule renali a cellule chiare in stadio avanzato o metastatico (medicalmente o chirurgicamente non resecabile).

E.1.1.1

Medical condition in easily understood language

Advanced or metastatic (medically or surgically unresectable) clear-cell Renal Cell Carcinoma

Carcinoma a cellule renali a cellule chiare in stadio avanzato o metastatico (medicalmente o chirurgicamente non resecabile).

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10038414
E.1.2	Term	Renal cell carcinoma stage IV
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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10050513
E.1.2	Term	Metastatic renal cell carcinoma
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	11.0
E.1.2	Level	HLT
E.1.2	Classification code	10038408
E.1.2	Term	Renal cell carcinomas
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

The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of BMS-936558 vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy.

Confrontare il beneficio clinico, misurato dalla durata della sopravvivenza complessiva (OS), indotto da BMS-936558 rispetto all’Everolimus in soggetti con carcinoma a cellule renali in stadio avanzato o metastatico che hanno ricevuto precedente terapia anti angiogenica

E.2.2

Secondary objectives of the trial

1.Progression-free survival 2.Objective response rate 3.Duration of objective response 4.Duration of OS in PD-L1 positive vs negative subgroups 5.Overall safety & tolerability 6.Disease related symptom progression rate

1. Confrontare la sopravvivenza libera da progressione (PFS) indotta da BMS-936558 rispetto a Everolimus 2. Valutare il beneficio clinico in termini di percentuale di risposta obiettiva (ORR) indotto da BMS-936558 rispetto a Everolimus 3. Valutare la durata della risposta obiettiva tra i due bracci di trattamento, BMS-936558 e Everolimus 4. Valutare la durata della risposta obiettiva tra i due bracci di trattamento, BMS-936558 e Everolimus nel sottogruppo di soggetti positivi all’espressione della proteina PD-L1 rispetto a quelli che non esprimono la proteina PD-L1 5. Valutare la sicurezza complessiva e la tollerabilità tra BMS-936558 e Everolimus 6. Valutare la percentuale di soggetti che mostrano sintomi di progressione correlati alla malattia nei due bracci di trattamento, misurati attraverso la specifica scala di valutazione FKSI-DRS, sotto scala del FKSI-15

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Men & women ≥ 18 years of age 2.Histologic confirmation of RCC with clear-cell component 3.Advanced/metastatic RCC 4.Measurable disease per RECIST 1.1 criteria 5.Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting 6.No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within 6 months of enrollment 7.Karnofsky Performance Score ≥ 70%

1. Uomini e donne di età maggiore o uguale a 18 anni 2. Conferma istologica di carcinoma a cellule renali a cellule chiare 3. Carcinoma a cellule renali in stadio avanzato o metastatico 4. Patologia misurabile secondo i criteri RECIST 1.1 5. I soggetti devono aver ricevuto uno o due precedenti regimi di trattamento con farmaci anti angiogenici (inclusi, ma non limitati a, sunitinib, sorafenib, pazopanib, axitinb, tivozanib e bevacizumab) in stadio avanzato o metastatico. Sono anche permesse precedenti terapie con citochine (per esempio IL-2, IFN-alfa), vaccino terapia o trattamento con farmaci citotossici 6. I soggetti non devono aver ricevuto più di tre regimi di trattamento in stadio avanzato o metastatico e devono avere evidenza di progressione dopo l’ultimo regime di trattamento e entro i 6 mesi che precedono l’arruolamento nello studio. 7. Karnofsky Performance Score (KPS) ≥ 70% 8. Un blocchetto di tessuto tumorale fissato in formalina (FFPE) e incluso in paraffina o vetrini non colorati contenenti sezioni di tessuto (di archivio o recenti) devono pervenire al laboratorio centralizzato al fine di permettere l’assegnazione del soggetto al braccio di trattamento.

E.4

Principal exclusion criteria

1.Any CNS metastases or history of CNS metastases 2.Prior therapy with an mTOR inhibitor 3.Any active known or suspected autoimmune disease. 4.Uncontrolled adrenal insufficiency 5.Active chronic liver disease 6.Prior malignancy active within past 3 years, except for locally curable cancers

1. Sono esclusi soggetti con metastasi attive o passate del sistema nervoso centrale. Una TAC o una RMN del cervello sarà effettuata entro i 30 giorni che precedono il giono 1 della prima dose di farmaco. 2. Precedente trattamento con inibitori mTOR (inclusi, ma non limitati a, everolimus, temsirolimus, sirolimus e ridaforolimus) 3. Soggetti con malattia autoimmune attiva, nota o sospetta, sono esclusi. Possono essere arruolati i soggetti con vitiligine, diabete mellito di tipo I, ipotiroidismo residuo dovuto a tiroidite autoimmune che richiede solo la sostituzione ormonale, o condizione clinica che non si prevede possa recidivare in assenza di un fattore scatenante esterno. 4. Soggetti con una condizione clinica che richieda trattamento sistemico sia con corticosteroidi (> 10mg al giorno di un equivalente del prednisone) o altri farmaci immunosoppressivi, nell’arco dei 14 giorni precedenti al giorno 1 della prima dose di farmaco sono esclusi. In assenza di malattia autoimmune attiva sono consentiti steroidi per inalazione o ad uso topico, e dosi di steroidi > 10mg al giorno di equivalenti del prednisone per insufficienza surrenalica. 5. Incontrollata insufficienza surrenalica 6. Nota storia di positività al test dell’HIV o nota affezione alla sindrome da immunodeficineza (AIDS). 7. Positività al test per l’epatite B o per l’epatite C che riveli una infezione acuta o cronica 8. Precedente trattamento con terapia anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, o anticorpo anti-CTLA-4 o qualunque altro anticorpo o farmaco che abbia come target specifico la costimolazione delle cellule T 9. Ogni conosciuta patologia attiva cronica del fegato 10. Precedente tumore attivo entro i passati 3 anni, eccetto tumori curabili localmente

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is overall survival.

Sopravvivenza Complessiva (OS)

E.5.1.1

Timepoint(s) of evaluation of this end point

Overall survival will be followed at every clinic visit (every 2-4 weeks) while on treatment and then every 3 months.

I soggetti saranno seguiti per la sopravvivenza ad ogni visita durante il trattamento (ogni 2-4 settimane) e poi ogni 3 mesi nelle visite successive.

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

1.Disease assessments Q 8 wks after randomization for 12 months then Q 12 wks until progression of disease 2.See above 3.See above 4.At time of OS analysis (see #38 for timeframe of collection of OS) 5.Continuously throughout study treatment and up to 100 days from last dose 6.Baseline, Day 1 of each cycle (starting with cycle 2), then at first 2 follow-up visits

1. La verifica della stato della malattia del soggetto viene fatta ogni 8 settimane dopo la randomizzazione per 12 mesi e poi ogni 12 settimane fino a progressione. 2. La verifica della stato della malattia del soggetto viene fatta ogni 8 settimane dopo la randomizzazione per 12 mesi e poi ogni 12 settimane fino a progressione. 3. La verifica della stato della malattia del soggetto viene fatta ogni 8 settimane dopo la randomizzazione per 12 mesi e poi ogni 12 settimane fino a progressione. 4. Al tempo dell’analisi della sopravvivenza complessiva 5. Continuamente durante il trattamento con il farmaco in studio e fino a 100 giorni dopo l’ultima dose 6. Al baseline, al giorno 1 e ad ogni ciclo (a partire dal Ciclo 2) e infine alle prime due visite di follow-up

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

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

Yes

E.6.13.1

Other scope of the trial description

BiomarkerAssessments,OutcomesResearchAssessments,HealthResourceUtilization,ImmunogenicityAssessments

Valut. Biomarker,Immunogenicità,valut. risultati ricerca e utilizzo dati sullo stato di salute

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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)

Yes

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

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

Argentina

Canada

Israel

Japan

Russian Federation

United States

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

The primary analysis of survival will be conducted after approximately 569 subjects have died (approx.42 months from start of randomization) Additional survival follow-up may continue for up to 5 years from the primary analysis of survival. The study will end once survival follow-up has concluded.

L'analisi primaria dell'OS sarà condotta dopo la morte di circa 569 soggetti(~42mesi dopo randomizzazione)Ulteriori visite di follow-up possono continuare fino a 5 anni dopo analisi primaria.Lo studio finirà a conclus. dei follow-up di sopravvivenza

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

Number of subjects for this age range:

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:

493

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

329

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

439

F.4.2.2

In the whole clinical trial

975

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)

At study end, subjects who continue to demonstrate clinical benefit will
be eligible to receive study drug via study extension, rollover study, or
another mechanism at sponsor's discretion. Sponsor may terminate
access to study drug if occur something according to section 3.2 of protocol.

Al termine dello studio i soggetti che continueranno a dimostrare un beneficio clinico saranno idonei a ricevere ancora il farmaco in studio. Il farmaco sarà fornito attraverso una estensione del presente studio, tramite uno studio di roll-over o attraverso un altro procedimento consentito dalla legge a discrezione dello sponsor. Lo Sponsor può interrompere l’accesso al farmaco se accadono una delle circostanze descritte nella sezione 3.2.

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

2012-10-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-07-25

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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