Clinical Trials Register

Summary
EudraCT Number:	2012-003481-41
Sponsor's Protocol Code Number:	FM-12-B01
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2013-01-11
Trial 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

2012-003481-41

A.3

Full title of the trial

Neoadjuvant chemotherapy with nab-paclitaxel in women with HER2-negative high-risk breast cancer ETNA (Evaluating Treatment with Neoadjuvant Abraxane)

A.3.1

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

Preoperative chemotherapy with paclitaxel in women with HER2-negative high-risk breast cancer

Chemioterapia preoperatoria con paclitaxel in donne con tumore della mammella ad alto rischio HER2-negativo

A.3.2

Name or abbreviated title of the trial where available

ETNA

A.4.1

Sponsor's protocol code number

FM-12-B01

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	FONDAZIONE MICHELANGELO - AVANZAMENTO DELLO STUDIO E CURA DEI TUMORI
B.1.3.4	Country	Italy
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	Celgene International Sarl
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fondazione Michelangelo
B.5.2	Functional name of contact point	Ufficio Operativo
B.5.3	Address:
B.5.3.1	Street Address	Via Giacomo Venezian, 1
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20133
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 02 2390 3451
B.5.5	Fax number	+39 02 2390 2678
B.5.6	E-mail	elisa.coradeschi@fondazionemichelangelo.org

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	Abraxane
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene Europe Limited
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Powder for suspension 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	PACLITAXEL
D.3.9.1	CAS number	33069-62-4
D.3.9.4	EV Substance Code	SUB09583MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	125
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	Yes
D.3.11.13.1	Other medicinal product type	antineoplastico
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.2.1.2	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	PACLITAXEL
D.3.9.1	CAS number	33069-62-4
D.3.9.4	EV Substance Code	SUB09583MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	90
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	Yes
D.3.11.13.1	Other medicinal product type	antineoplastico

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

Patients with HER2-negative, early invasive unilateral breast cancer who are at risk of disease recurrence and suitable for neoadjuvant chemotherapy

Pazienti con tumore della mammella non metastatico, invasivo, unilaterale ed HER2-negativo con elevato rischio di ripresa di malattia ed idonee alla chemioterapia neoadiuvante.

E.1.1.1

Medical condition in easily understood language

Patients with HER2-negative, early invasive unilateral breast cancer who are at risk of disease recurrence and suitable for preoperative chemotherapy

Tumore della mammella non metastatico, invasivo, unilaterale ed HER2-negativo ed idoneo alla chemioterapia preoperatoria.

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	LLT
E.1.2	Classification code	10006283
E.1.2	Term	Breast neoplasm malignant female
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

To compare the rate of pathologic Complete Response (pCR, defined as ypT0-Tis, ypN0) for abraxane vs paclitaxel

Confrontare la percentuale di risposte patologiche complete (RCp; pathological complete remission pCR), definite come ypT0-Tis, ypN0) tra abraxane e paclitaxel.

E.2.2

Secondary objectives of the trial

To compare the pCR rates in the two main subgroups of ER and/or PgR positive tumors and triple-negative tumors separately. To compare the rate of clinical overall response (cOR) after the first 4 cycles of abraxane vs paclitaxel. To compare the rate of cOR after the entire preoperative chemotherapy in the study arms. To compare the Event Free Survival (EFS, i.e. disease progression while on primary therapy or disease recurrence after surgery) in the study arms. To compare the Distant EFS (DEFS) in the study arms. To compare the Local EFS (LEFS) in the two study arms. To compare the Regional EFS (REFS) in the two study arms. To compare the overall survival (OS) in the study arms. To evaluate the tolerability of the treatment regimens. To conduct molecular and clinical analyses to assess the presence of predictive markers of benefit.

Confrontare separatamente le percentuali di RCp nei due principali sottogruppi tumorali con recettori ormonali (recettore estrogenico, recettore progestinico) positivi e tumori triplo-negativi. Confrontare tra i bracci di trattamento (abraxane vs paclitaxel): - la percentuale di risposte obiettive cliniche dopo i primi 4 cicli trattamento. - la percentuale di ROc alla fine dell’intera chemioterapia preoperatoria - la sopravvivenza libera da eventi (eventi definiti come progressione di malattia durante la prima chemioterapia o ripresa di malattia dopo la chirurgia) - la sopravvivenza libera da metastasi - la sopravvivenza libera da eventi locali - la sopravvivenza libera da eventi regionali - la sopravvivenza globale Valutare la tollerabilità dei regimi di trattamento. Condurre analisi molecolari e cliniche per verificare la presenza di marcatori predittivi.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Female patients aged 18 years or older 2. Histologically confirmed invasive unilateral breast cancer 3. HER2-negative disease (defined as 0-1+ by immunohistochemistry or 2+ by immunohistochemistry without HER2 amplification by either FISH, CISH, or other amplification tests done locally) 4. Known hormone receptor status (estrogen receptor [ER], progesterone receptor [PgR]), tumor grade and, if institutional standard permits, known Ki67 value 5. Available paraffin-embedded tumor block taken at diagnostic biopsy for central confirmation of HER2 eligibility, hormone receptor status, Ki67 value and biomarker evaluation is mandatory 6. One of the following clinical stages: a. T2, T3, T4 disease, triple negative (HER2, ER, PgR) b. T2, T3, T4 disease, ER or PgR positive and moderately differentiated or poorly differentiated tumor grade (G II-III) 7. ECOG performance status 0 or 1 8. Written informed consent to participate in the trial (approved by the Institutional Review Board [IRB]/ Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures 9. Willing and able to comply with the protocol

1. Pazienti di sesso femminile di età superiore ai 18 anni 2. Tumore della mammella invasivo unilaterale confermato istologicamente 3. Tumore HER2-negativo (definito come 0-1+ mediante immunoistochimica o 2+ mediante immunoistochimica senza amplificazione di HER2 (mediante test FISH, CISH o altri test di amplificazione) 4. Stato dei recettori ormonali RE e PGR, grado del tumore e, se gli standard del centro lo permettono, il valore di Ki67). 5. E’ obbligatoria la disponibilità di un pezzo istologico tumorale, fissato in paraffina, prelevato alla biopsia diagnostica, per confermare centralmente lo stato di HER2, lo stato recettoriale, il valore di Ki67 e per la valutazione dei biomarcatori 6. Uno dei seguenti stadi clinici: a. T2, T3, T4, triplo negativo (HER2, RE, RPG) b. T2, T3, T4, RE o RPG positivo e tumore moderatamente differenziato o poco differenziato (G II-III) 7. ECOG performance status 0 o 1 8. Consenso Informato scritto (approvato dal Comitato Etico) ottenuto prima di qualsiasi procedura di screening specifica per lo studio. 9. Paziente disponibile e capace di rispettare quanto richiesto dal protocollo

E.4

Principal exclusion criteria

1. Synchronous bilateral breast cancer or presence of metastatic disease (M1) 2. Surgical axillary staging procedure prior to study entry. Exceptions: 1) FNA of an axillary node is permitted for any patient, and 2) although not recommended, a pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes is permitted 3. Pregnant or lactating women. Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs and for women less than one year after the last menstrual cycle 4. Women with childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception, for example abstinence, an intra-uterine device, or double barrier method of contraception 5. Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy for the currently diagnosed breast cancer prior to study entry 6. Previous investigational treatment for any condition within 4 weeks of randomization date 7. Patients on therapy with a strong CYP3A4 inhibitor 8. Previous or concomitant malignancy of any other type that could affect compliance with the protocol or interpretation of results. Patients with curatively treated basal cell carcinoma of the skin or in situ cervix cancer are generally eligible. 9. Pre-existing motor or sensory neuropathy of grade > 1 for any reason 10. Patients with a history of hypersensitivity due to drugs containing polyoxyethylene castor oil (Cremophor EL) (e.g., ciclosporin), or hardened castor oil (e.g., vitamin preparations for injection, etc.) 11. Other serious illness or medical condition including: history of documented congestive cardiac failure; angina pectoris requiring anti-anginal medication; evidence of transmural infarction on ECG; poorly controlled hypertension (e.g. systolic >180 mm Hg or diastolic >100 mm Hg; however, patients with hypertension which is well controlled on medication are eligible); clinically significant valvular heart disease; high-risk uncontrolled arrhythmias 12. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and precluding informed consent or adversely affecting compliance with study drugs 13. Serious uncontrolled infections (bacterial or viral) or poorly controlled diabetes mellitus 14. Any of the following abnormal baseline hematological values: a. Absolute Neutrophil Count (ANC) < 1.5  109/L b. Platelet count < 100  109/L c. Hemoglobin (Hb) < 10 g/dL 15. Any of the following abnormal baseline laboratory tests a. Serum total bilirubin > 1.5  ULN (upper limit of normal) (except for patients with clearly documented Gilbert’s syndrome) b. Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.25  ULN c. Alkaline phosphatase > 2.5 ULN d. Serum creatinine > 1.5  ULN 16. Baseline left ventricular ejection fraction (LVEF) < 50% by echocardiography or multi-gated scintigraphic scan (MUGA)

1. Concomitante tumore della mammella bilaterale o presenza di malattia metastatica (M1) 2. Procedure chirurgiche di stadiazione dell’interessamento linfonodale ascellare. Eccezioni: 1) l’ ago aspirato di un linfonodo ascellare è permesso per ogni paziente e 2) anche se non raccomandata, è permessa la biopsia del linfonodo sentinella in pazienti con linfonodi ascellari clinicamente negativi 3. Donne in gravidanza o in allattamento. La documentazione di un test di gravidanza negativo deve essere disponibile per le donne in premenopausa con organi riproduttivi intatti e per le donne che abbiano avuto l'ultimo ciclo mestruale da meno di un anno. 4. Donne potenzialmente fertili a meno che (1) siano state sottoposte a sterilizzazione chirurgica o (2) che utilizzino adeguate misure di contraccezione, ad esempio astinenza, dispositivo intrauterino o metodo di contraccezione doppia barriera 5. Radioterapia, chemioterapia, bioterapia e/o terapia ormonale per il tumore della mammella prima dell'ingresso in studio 6. Qualunque precedente trattamento sperimentale nelle 4 settimane precedenti la randomizzazione. 7. Pazienti in trattamento con un potente inibitore del CYP3A4 8. Precedente o concomitante neoplasia maligna di ogni altro tipo che possa interferire con la compliance al protocollo o con l’interpretazione dei risultati. Le pazienti affette da carcinoma cutaneo basocellulare o da carcinoma in situ della cervice uterina, purché adeguatamente trattati, sono eleggibili. 9. Presenza di neuropatia motoria o sensoriale di grado > 1 per qualsiasi motivo 10. Pazienti con anamnesi di ipersensibilità ai farmaci contenenti poliossietilene olio di ricino (Cremophor EL) (ad esempio la ciclosporina) o olio di ricino idrogenato (ad esempio i preparati vitaminici da iniezione, ecc.) 11. Altre malattie o condizioni mediche gravi incluse: insufficienza cardiaca congestizia documentata; angina pectoris qualora richieda farmaci anti-angina; anamnesi di infarto transmurale documentato con ECG; ipertensione scarsamente controllata (e.g., sistolica>180 mm Hg o diastolica >100 mm Hg; le pazienti con ipertensione in controllo farmacologico sono, comunque, eleggibili); malattia valvolare cardiaca clinicamente significativa; aritmia non controllata ad alto rischio 12. Pazienti con anamnesi di epilessia non controllata, disordini a carico nel sistema nervoso centrale o incapacità psichiatrica giudicata dal ricercatore clinicamente rilevante e tale da pregiudicare il consenso informato o incidere negativamente sulla compliance ai trattamenti in studio 13. Infezioni gravi non controllate (batteriche o virali) o diabete mellito scarsamente controllato 14. Uno dei seguenti valori ematologici anormali alla valutazione basale: a. Conteggio assoluto dei neutrofili (ANC) < 1,5  109/L b. Conteggio delle piastrine < 100  109/L c. Emoglobina (Hb) < 10 g/dL 15. Uno dei seguenti valori anormali di laboratorio alla valutazione basale: a. Bilirubina sierica totale > 1,5  limite superiore di norma (ULN, upper limit of normal) (eccetto pazienti con documentata sindrome di Gilbert) b. Alanina transaminasi (ALT) o aspartato transaminasi (AST) > 1,25  ULN c. Fosfatasi alcalina > 2,5 ULN d. Creatinina sierica > 1,5  ULN 16. Frazione di eiezione ventricolare sinistra (LVEF) al basale < 50% (ecocardiografia o MUGA)

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is pathological complete response (pCR) defined as absence of invasive disease in breast and nodes (ypT0/ypTis, ypN0).

L’end point primario è la risposta patologica completa (pCR) definita come assenza di malattia invasiva a livello della mammella e dei linfonodi (ypT0/ypTis, ypN0).

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary endpoint will be evaluated at the time of surgery: approximately 40 months after the randomization of the first patient, that is when all the 632 patients required by sample size specifications have completed their courses of treatment and reached the surgery phase.

L’obiettivo primario verrà valutato al momento della chirurgia: approssimativamente 40 mesi dopo l’arruolamento della prima paziente (ossia quando tutte le 632 pazienti avranno completato il loro trattamento e avranno raggiunto la fase della chirurgia)

E.5.2

Secondary end point(s)

The secondary endpoints are: - the rate of clinical overall response (cOR) - Event Free Survival (EFS, i.e. disease progression while on primary therapy or disease recurrence after surgery) - Distant EFS (DEFS) - Local EFS (LEFS) - Regional EFS (REFS) - overall survival (OS) - the tolerability of the treatment regimens

Gli endpoint secondari sono: - la percentuale di risposte obiettive cliniche (ROc) - la sopravvivenza libera da eventi (eventi definiti come progressione di malattia durante la prima chemioterapia o ripresa di malattia dopo la chirurgia) - la sopravvivenza libera da metastasi - la sopravvivenza libera da eventi locali - la sopravvivenza libera da eventi regionali - la sopravvivenza globale la tollerabilità dei regimi di trattamento

E.5.2.1

Timepoint(s) of evaluation of this end point

cOR will be evaluated after the first 4 cycles (approximately 40 months after the randomization of the first patient, that is when all the 632 patients required by sample size specifications have completed their courses of treatment and reached the surgery phase). The first analysis of EFS will take place 5 years and 10 years after the randomization of the first patient

ROc verrà valutato dopo i 4 cicli di chemioterapia neoadiuvante (approssimativamente 40 mesi dopo l’arruolamento della prima paziente (ossia quando tutte le 632 pazienti avranno completato il loro trattamento e avranno raggiunto la fase della chirurgia)) EFS verrà valutata a 5 e a 10 anni dall'arruolamento del primo paziente

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

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

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

Australia

Russian Federation

Singapore

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

LVLS

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

150

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

150

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:

632

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

632

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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

122

F.4.2

For a multinational trial

F.4.2.1

In the EEA

322

F.4.2.2

In the whole clinical trial

632

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 should be treated according to the investigator's clinical judgment

Le pazienti verranno trattate secondo il giudizio clinico del medico curante

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

2013-02-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-02-14

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2023-02-28

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Clinical trials