Clinical Trials Register

Summary
EudraCT Number:	2012-001896-35
Sponsor's Protocol Code Number:	ETOP3-12
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:	2013-01-11
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

2012-001896-35

A.3

Full title of the trial

A randomized phase III trial of erlotinib versus docetaxel in patients with advanced squamous cell non-small cell lung cancer who failed first line platinum based doublet chemotherapy stratified by VeriStrat Good vs VeriStrat Poor

Sperimentazione clinica di fase III randomizzata con erlotinib verso docetaxel in pazienti affetti da cancro polmonare a cellule squamose avanzato, non a piccole cellule, dopo fallimento della chemioterapia di prima linea con due farmaci a base di platino e stratificati a sulla base del risultato del test VeriStrat ( ''buono'' o ''scarso'').

A.3.1

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

Testing the efficacy of two drugs (erlotinib and docetaxel) in lung cancer patients who have been classified in 2 groups according to the result of a blood test (VeriStrat).

Verifica dell'efficacia di due farmaci (erlotinib e docetaxel) in pazienti con cancro del polmone distinti in due gruppi sulla base del risultato di un test effettuato sul sangue (Veristrat)

A.3.2

Name or abbreviated title of the trial where available

EMPHASIS-lung

A.4.1

Sponsor's protocol code number

ETOP3-12

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01652469

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	IBCSG
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Biosedix 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	Istituto Europeo Oncologia
B.5.2	Functional name of contact point	Ufficio studi clinici
B.5.3	Address:
B.5.3.1	Street Address	via Ramusio 1
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20141
B.5.3.4	Country	Italy
B.5.4	Telephone number	02 57 48 98 48
B.5.5	Fax number	02 57 48 97 81
B.5.6	E-mail	ufficio.studiclinici@ieo.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	TARCEVA*30CPR RIV 150MG
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE SpA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ERLOTINIB HYDROCHLORIDE
D.3.9.1	CAS number	183319-69-9
D.3.9.4	EV Substance Code	SUB21050
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	150
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: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	TARCEVA*30CPR RIV 100MG
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE SpA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ERLOTINIB HYDROCHLORIDE
D.3.9.1	CAS number	183319-69-9
D.3.9.4	EV Substance Code	SUB21050
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	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	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	TAXOTERE*INFUS FL 20MG/1ML
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS SpA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	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	DOCETAXEL TRIHYDRATE
D.3.9.1	CAS number	148408-66-6
D.3.9.4	EV Substance Code	SUB21602
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	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

Squamous cell non-small cell lung cancer in patients who have failed first-line platinum-based doublet chemotherapy.

pazienti con cancro polmonare a cellule squamose avanzato, non a piccole cellule, dopo fallimento della chemioterapia di prima linea con due farmaci a base di platino

E.1.1.1

Medical condition in easily understood language

Lung cancer in patients who failed first-line chemotherapy.

Pazienti con cancro del polmone dopo fallimento della chemioterapia di prima linea

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	HLT
E.1.2	Classification code	10059675
E.1.2	Term	Respiratory tract neoplasms NEC
E.1.2	System Organ Class	100000004855

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Explore the predictive ability of VeriStrat signature, by testing for interaction between treatment arms (Arm A: erlotinib vs Arm B: docetaxel) and VeriStrat status (Good vs Poor) using progression free survival as outcome.

Valutare il valore predittivo di VeriStrat attraverso le interazioni tra gruppi di trattamento (Braccio A: erlotinib vs Braccio B:docetaxel) e stato di VeriStrat (Buono o Scarso)sulla base della sopravvivenza libera da progressione.

E.2.2

Secondary objectives of the trial

Explore whether erlotinib provides progression free survival (PFS) benefit compared to docetaxel in the VSG (VeriStrat Good) group. Compare PFS in the two treatment arms (erlotinib vs docetaxel) in the VSP (VeriStrat Poor) group. Explore the prognostic ability of VeriStrat signature by testing for an overall difference in PFS between the 2 VeriStrat groups. Explore the predictive ability of the VeriStrat signature using the secondary measures of clinical efficacy including overall survival (OS), objective response rate, and disease control rate. - Compare OS, objective response rate and disease control rate between treatment groups separately in the VSG / VSP groups. - Explore the prognostic ability of the VeriStrat signature by testing for an overall difference in OS, objective response rate and disease control rate between the 2 VeriStrat groups.

Valutare se il trattamento con erlotinib comporta un beneficio in termini di sopravvivenza libera da progressioner (PFS) rispetto a docetaxel nel gruppo con Buono VeriStrat (VSG). Confrontare i 2 trattamenti (erlotinib e docetaxel nel gruppo con Scarso VeriStrat (VSP). Valutare il valore prognostico di VeriStrat sulla base di una differenza in PFS nei 2 gruppi di VeriStrat. Valutare il valore predittivo di VeriStrat attraverso misure secondarie di efficacia clinica (sopravvivenza globale (OS),tasso di risposta obiettiva e tasso di controllo della malattia. Confrontare OS,tasso di risposta obiettiva e tasso di controllo della malattia tra gruppi di trattamento, separatamente per ciascun gruppo VSG/VSP. Valutare il valore prognostico di VeriStrat verificando la differenza complessiva in OS, tasso di risposta obiettiva e tasso di controllo della malattia tra i 2 gruppi VeriStrat.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Histologically or cytologically confirmed locally advanced stage IIIB, not amenable to radical radiotherapy, or metastatic stage IV non-small cell lung cancer (NSCLC) of predominant squamous subtype, according XML File Identifier: VFpam2gtadgC2RpbQZtr7dJ94Tw= Page 18/29 to the 7th edition of the TNM classification, including M1a (separate tumor nodule in a contralateral lobe, tumor with pleural nodules or malignant pleural or pericardial effusion) and/or M1b (distant metastasis). - Progressive disease upon or after previous chemotherapy including at least one line of platinum-based chemotherapy. - Adjuvant platinum-based chemotherapy can be considered as platinum-based chemotherapy line if administration ended in the 6 months before registration. - Platinum-based chemotherapy combined with definitive radiotherapy can be considered as platinum-based chemotherapy line if administration ended in the 6 months before registration. Measurable or evaluable disease according to RECIST v1.1 . ECOG performance status 0-2. - Age ≥ 18 years. - Adequate organ function, including: - Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets > 100 x 109/L. - Hepatic: bilirubin <1.5 x ULN; AP, ALT < 3.0 x ULN; AP, ALT <5 x ULN is acceptable in case of liver metastasis. - Renal: calculated creatinine clearance > 40 ml/min based on the Cockroft and Gault formula. - Signed and dated informed consent form. - Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with reproductive potential must have a negative serum or urin pregnancy test within 7 days prior to study registration. Non-reproductive potential for females is defined as surgically sterile or post-menopausal defined as ≥24 months since last menses. Male patients are considered to have reproductive potential unless they are surgically sterile. - Estimated life expectancy >12 weeks. - Patient compliance and geographical proximity that allow adequate follow-up.

1. Stadio III B istologicamente o citologicamente confermato localmente avanzato non sottoponibile a trattamento con radioterapia radicale, o carcinoma polmonare non a piccole cellule (NSCLC) metastatico di stadio IV di sottotipo prevalentemente squamoso, conformemente alla settima edizione della classificazione TNM, tra cui M1a (noduli tumorali separati in un lobo controlaterale, Tumore con noduli pleurici o con versamento pleurico o pericardico maligno) e/o M1b (metastasi a distanza). 2. Malattia in progressione durante o dopo il precedente trattamento chemioterapico comprendente almeno un agente a base di platino. 3. Malattia misurabile o valutabile conformemente ai criteri RECIST v1.1 (Appendice 2). 4. ECOG PS 0-2. 5. Età ≥ 18 anni. 6. Funzionalità degli organi adeguata, tra cui: Riserva di midollo osseo adeguata: ANC > 1,5 x 109/L, piastrine > 100 x 109/L. Funzionalità epatica: bilirubina <1,5 x ULN; AP, ALT < 3,0 x ULN; AP, ALT <5 x ULN accettabile nel caso di metastasi al fegato. Funzionalità renale: clearance della creatinina > 40 ml/min calcolata sulla base della formula di Cockroft e Gault. 7. Modulo di consenso informato firmato e datato. 8. I pazienti di sesso maschie e femminile in età fertile, durante la sperimentazione clinica e per i 12 mesi successivi, devono utilizzare un metodo contraccettivo approvato. Le pazienti di sesso femminile in età fertile devono presentare un test di gravidanza negativo eseguito fino a 7 giorni prima dell'arruolamento nello studio. 9. Speranza di vita stimata >12 settimane. 10. Conformità del paziente e vicinanza geografica che consentano un follow-up adeguato.

E.4

Principal exclusion criteria

Evidence of other medical conditions which would impair the ability of the patient to participate in the trial or might preclude therapy with trial drugs (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease, active infection, uncontrolled diabetes mellitus). - Previous treatment with any EGFR-TKI or docetaxel. - Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least 14 days prior to registration. - Documented presence of activating EGFR mutations, if patient was tested for EGFR mutations. - Previous malignancy within 5 years with the exception of adequately treated cervical carcinoma in situ, breast cancer in situ or localized nonmelanoma skin cancer. - Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, or interfering with compliance for oral drug intake. - Concurrent treatment with experimental drugs or other anti-cancer therapy treatment in a clinical trial within 21 days prior to registration. - Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs or any concomitant drugs contraindicated.

1. Evidenza o altra patologia che andrebbe a compromettere la partecipazione del paziente alla sperimentazione clinica o che potrebbe precludere la terapia con i farmaci previsti dalla sperimentazione (ad es. disturbi respiratori, cardiaci, epatici o renali instabili o non compensati, infezioni in corso, diabete mellito non controllato). 2. Trattamento precedente con qualsiasi EGFR-TKI o docetaxel. 3. Metastasi al cervello documentate, tranne nei casi in cui il paziente abbia completato la terapia locale per le metastasi del sistema nervoso centrale e in cui non siano stati somministrati corticosteroidi per almeno 14 giorni prima dell'arruolamento nello studio. 4. Presenza documentata di mutazioni attivanti l'EGFR, se il paziente è stato sottoposto ad esami per la verifica di mutazioni EGFR. 5. Precedenti tumori nell'arco dei 5 anni precedenti, fatta eccezione per casi di carcinoma cervicale in situ adeguatamente trattato, cancro della mammella in situ o carcinoma della pelle. 6. Disturbi psichiatrici che precludono la comprensione delle informazioni relative agli argomenti trattati dalla sperimentazione clinica, il rilascio del consenso informato o che interferiscono con la conformità all'assunzione dei farmaci per via orale. 7. Trattamento concorrente con farmaci sperimentali o altre terapie anticancro nell'ambito di una sperimentazione clinica eseguite fino a 21 giorni prima dell'arruolamento nello studio. 8. Ipersensibilità nota ai farmaci impiegati nella sperimentazione clinica o a qualsiasi altro componente dei suddetti farmaci o assunzione simultanea di qualsiasi farmaco controindicato.

E.5 End points

E.5.1

Primary end point(s)

Progression free survival.

Sopravvivenza libera da progressione

E.5.1.1

Timepoint(s) of evaluation of this end point

The final evaluation will be done within 6 months after the two-month visit of the last entered patient, approximately 26 months after the inclusion of the first patient.

La valutazione finale verrà eseguita entro 6 mesi dopo la visita di controllo, dopo 2 mesi, dell'ultimo paziente aqrruolato nello studio (approssimativamente 26 mesi dopo l'inclusione del primo paziente).

E.5.2

Secondary end point(s)

Overall survival. Objective response Disease control Toxicities of treatment

Soprevvivenza globale. Risposta obiettiva Controllo della malattia Tossicità del trattamento CTCAE version 4.

E.5.2.1

Timepoint(s) of evaluation of this end point

The final evaluation will be done within 6 months after the two-month visit of the last entered patient, approximately 26 months after the inclusion of the first patient.

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Prospectively evaluate predictive and prognostic value of proteomic (VeriStrat) test

Valutare in modo prospettico del valore predittivo e prognostico del test proteomico VeriStrat

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

Israel

Switzerland

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

All patients are followed for survival status every 12 weeks thereafter, until death, or up to 24 months after the last patient is randomized, at which time the study will formally end.

Tutti i pazienti saranno seguiti per la verifica della sopravvivenza ogni 12 settimane fino al decesso oppure fino a 24 mesi dopo la data di randomizzazione dell'ultimo paziente data di conclusione formale dello 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

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:

400

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

460

F.4.2.2

In the whole clinical trial

500

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)

standard practice

trattamento standard

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

2013-05-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-01-31

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-12-31

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