Clinical Trials Register

Summary
EudraCT Number:	2011-005334-20
Sponsor's Protocol Code Number:	MO28047
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

2011-005334-20

A.3

Full title of the trial

A multicenter, open-label, single-arm study of pertuzumab in combination
with trastuzumab and a taxane in first line treatment of patients with
HER2- positive advanced (metastatic or locally recurrent) breast cancer

Studio multicentrico, in aperto, a braccio singolo sull'uso di Pertuzumab in associazione a Trastuzumab e a un taxano nel trattamento di prima linea di pazienti con tumore mammario HER 2 -positivo avanzato(metastatico o recidivato localmente)

A.3.1

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

Studio multicentrico, in aperto, a braccio singolo di eprtuzumab in associazione a trastuzumab e a un taxano nel trattamento in prima linea di pazienti con tumore mammario HER 2 -positivo avanzato(metastatico o recidivato localmente)

A.3.2

Name or abbreviated title of the trial where available

PERUSE

A.4.1

Sponsor's protocol code number

MO28047

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	F. HOFFMANN - LA ROCHE LTD.
B.1.3.4	Country	Switzerland
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	F. Hoffmann-La Roche Ltd.
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	ROCHE S.p.A.
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Viale G.B. Stucchi, 110
B.5.3.2	Town/ city	Monza
B.5.3.3	Post code	20052
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390392475070
B.5.5	Fax number	+390392475085
B.5.6	E-mail	italy.info_cta@roche.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	Pertuzumab (rhuMAb 2C4)
D.3.2	Product code	RO 4368451/F01
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	PERTUZUMAB
D.3.9.1	CAS number	380610-27-5
D.3.9.2	Current sponsor code	RO4368451
D.3.9.4	EV Substance Code	SUB16455MIG
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	420
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.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 breast cancer (metastatic or locally recurrent)

Tumore mammario avanzato (metastatico o recidivato localmente)

E.1.1.1

Medical condition in easily understood language

Advanced breast cancer

Tumore mammario avanzato

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	10065430
E.1.2	Term	HER-2 positive breast 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 evaluate the safety and tolerability of pertuzumab in combination with trastuzumab and a taxane.

Valutare la sicurezza e la tollerabilità di pertuzumab in associazione a trastuzumab e a un taxano.

E.2.2

Secondary objectives of the trial

To evaluate pertuzumab in combination with trastuzumab and a taxane
with respect to:
•Progression-free survival (PFS)
•Overall survival (OS)
•Overall response rate (ORR)
•Clinical benefit rate (CBR)
•Duration of response
•Time to response
•Quality of life (Functional Assessment of Cancer Therapy- Breast
[FACT-B] questionnaire for female patients only).

• Valutare l'uso di pertuzumab in associazione a trastuzumab e a un taxano in termini di:
• Sopravvivenza libera da progressione (PFS)
• Sopravvivenza globale (OS)
• Tasso di risposta globale (ORR)
• Tasso di beneficio clinico (CBR)
• Durata della risposta
• Tempo alla risposta
• Qualità della vita (questionario Functional Assessment of Cancer Therapy-Breast [FACT-B] solo per le pazienti di sesso femminile).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed written informed consent approved by the relevant
Institutional Review Board (IRB), or Independent Ethics Committee
(IEC).
2. Male or female patients aged 18 years or over.
3. Histologically or cytologically confirmed and documented
adenocarcinoma of the breast with metastatic or locally recurrent
disease not amenable to curative resection.
4. HER2-positive (defined as either IHC 3+ or in situ hybridization [ISH]
positive) as assessed by local laboratory on primary tumor and/or
metastatic site if primary tumor not available (ISH positivity is defined
as a ratio of 2.0 or greater for the number of HER2 gene copies to the
number of signals for CEP17, or for single probe tests, a HER2 gene count greater than 4).
5. At least one measurable lesion and/or non-measurable disease
evaluable according to Response Evaluation Criteria in Solid Tumors
(RECIST) version 1.1 (Appendix 5).
6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1
or 2 (Appendix 3).
7. LVEF of at least 50%.
8. Negative serum pregnancy test in women of childbearing potential
(WOCBP; premenopausal or less than 12 months of amenorrhea postmenopause,
and who have not undergone surgical sterilization).
9. For WOCBP and male patients with partners of CBP who are sexually
active, agreement to use a highly effective, non-hormonal form of
contraception (such as surgical sterilization) or two effective forms of
non-hormonal contraception (such as a barrier method of contraception
in conjunction with spermicidal jelly) during and for at least 6 months
post-study treatment (refer to Section 4.5.2.1 for details).
10. Life expectancy of at least 12 weeks.

1. Firma del modulo di consenso informato approvato dal comitato etico indipendente (CEI) competente.
2. Pazienti di ambo i sessi di età ≥ 18 anni.
3. Adenocarcinoma della mammella istologicamente o citologicamente confermato e documentato, con malattia metastatica o recidivata localmente che non può essere sottoposta a resezione curativa.
4. Positività a HER-2 (definita come punteggio dell'esame immunoistochimico [IHC] 3+ o positività all'esame di ibridazione in situ [ISH]) del tumore primario e/o del sito metastatico, se non è disponibile un campione del tumore primario, secondo quanto stabilito da un laboratorio locale (la positività ISH è definita da un rapporto di 2,0 o maggiore del numero di copie di geni HER-2 rispetto al numero di segnali CEP17 oppure, per i test a sonda singola, da una conta dei geni HER-2 superiore a 4).
5. Almeno una lesione misurabile e/o malattia non misurabile valutabile in base ai Criteri di valutazione della risposta nelle neoplasie solide (RECIST), versione 1.1.
6. Punteggio del performance status secondo l'Eastern Cooperative Oncology Group (ECOG) di 0, 1 o 2.
7. Frazione di eiezione del ventricolo sinistro (LVEF) almeno del 50%.
8. Test di gravidanza sul siero negativo nelle donne potenzialmente fertili (in premenopausa o in menopausa con amenorrea da meno di 12 mesi, non sottoposte a sterilizzazione chirurgica).
9. Per i pazienti sessualmente attivi (donne potenzialmente fertili e uomini con partner potenzialmente fertili), disponibilità a utilizzare una forma di contraccezione non ormonale altamente efficace (quale la sterilizzazione chirurgica) o due forme efficaci di contraccezione non ormonale (quale metodo di barriera in associazione a gel spermicida) durante il trattamento in studio e per almeno 6 mesi dopo la sua interruzione (per informazioni dettagliate consultare il paragrafo 4.5.2.1 del protocollo di studio).
10. Aspettativa di vita di almeno 12 settimane.

E.4

Principal exclusion criteria

1. Previous systemic non-hormonal anticancer therapy for the metastatic
or locally recurrent disease.
2. Disease-free interval from completion of adjuvant or neoadjuvant
systemic non-hormonal treatment to recurrence within 6 months.
3. Previous approved or investigative anti-HER2 agents in any breast
cancer treatment setting, except trastuzumab and/or lapatinib in the
adjuvant or neoadjuvant setting.
4. Disease progression while receiving trastuzumab and/or lapatinib in
the adjuvant or neoadjuvant setting.
5. History of persistent Grade 2 or higher (National Cancer Institute
[NCI]-Common Toxicity Criteria [CTC], Version 4.0) hematological
toxicity resulting from previous adjuvant or neoadjuvant therapy.
6. Radiographic evidence of central nervous system (CNS) metastases as
assessed by computed tomography (CT) or magnetic resonance imaging
(MRI).
7. Current peripheral neuropathy of Grade 3 or greater (NCI-CTC,
Version 4.0).
8. History of other malignancy within the last 5 years prior to 1st study
drug administration (dosing), except for carcinoma in situ of the cervix
or basal cell carcinoma.
9. Serious uncontrolled concomitant disease that would contraindicate
the use of any of the investigational drugs used in this study or that
would put the patient at high risk for treatment-related complications.
10. Inadequate organ function, evidenced by the following laboratory
results:
•Absolute neutrophil count <1,500 cells/mm3
•Platelet count <100,000 cells/mm3
•Hemoglobin <9 g/dL
•Total bilirubin greater than the upper limit of normal (ULN; unless the
patient has documented Gilbert's syndrome)
•Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase
(ALT [SGPT]) >2.5 × ULN (> 5 × ULN in patients with liver metastases)
•Alkaline phosphatase levels > 2.5 × the ULN (> 5 × ULN in patients
with liver metastases, or >10 × ULN in patients with bone metastases)
•Serum creatinine >2.0 mg/dL or 177 μmol/L
•International normalized ratio (INR) and activated partial
thromboplastin time or partial thromboplastin time (aPTT or PTT) >1.5 ×
ULN (unless on therapeutic anti-coagulation).
11. Uncontrolled hypertension (systolic >150 m m Hg and/or
diastolic >100 mm Hg) or clinically significant (i.e. active)23cardiovascular disease: cerebrovascular accident/stroke or myocardial
infarction within 6 months prior to first study medication, unstable
angina, congestive heart failure (CHF) of New York Heart Association
(NYHA) Grade II or higher, or serious cardiac arrhythmia requiring
medication.
12. Current known infection with HIV, Hepatitis B virus, or Hepatitis C
virus.
13. Dyspnea at rest due to complications of advanced malignancy, or
other disease requiring continuous oxygen therapy.
14. Major surgical procedure or significant traumatic injury within 28
days prior to 1st study drug administration (dosing) or anticipation of
need for major surgery during the course of study treatment.
15. Receipt of intravenous antibiotics for infection within 14 days prior
to enrolment.
16. Current chronic daily treatment with corticosteroids (dose equivalent
to or greater than 10 mg/day methylprednisolone), excluding inhaled
steroids.
17. Known hypersensitivity to any of the study medications or to
excipients of recombinant human or humanized antibodies.
18. History of receiving any investigational treatment within 28 days prior to 1st study drug administration (dosing).

1.Precedente terapia antineoplastica sistemica e non ormonale per la malattia metastatica o recidivata localmente.
2.Intervallo libero da malattia dal completamento della terapia sistemica non ormonale, adiuvante o neoadiuvante, alla recidiva inferiore a 6 mesi.
3.Precedenti agenti anti-HER-2, approvati o sperimentali, per il trattamento del tumore mammario in qualsiasi contesto, eccetto trastuzumab e/o lapatinib nel contesto adiuvante o neoadiuvante.
4.Progressione della malattia in corso di terapia con trastuzumab e/o lapatinib nel contesto adiuvante o neoadiuvante.
5.Anamnesi di tossicità ematologica persistente di grado 2 o superiore (NCI-CTC, versione 4.0) derivante da precedente terapia adiuvante o neoadiuvante.
6.Evidenza radiografica di metastasi a carico del sistema nervoso centrale (SNC), rilevate tramite tomografia computerizzata (TC) o risonanza magnetica (RM).
7.Neuropatia periferica di grado ≥ 3 (Criteri comuni di tossicità [CTC] del National Cancer Institute [NCI], versione 4.0).
8.Anamnesi di altre neoplasie manifestatesi nei 5 anni precedenti la prima somministrazione del farmaco in studio, ad eccezione di carcinoma cervicale in situ o carcinoma a cellule basali.
9.Grave patologia concomitante non adeguatamente controllata che renderebbe controindicato l'uso di qualsiasi farmaco sperimentale utilizzato in questo studio o che porrebbe il paziente ad alto rischio di sviluppare complicanze correlate al trattamento.
10.Inadeguata funzione d'organo, attestata dai seguenti risultati di laboratorio:
•Conta assoluta dei neutrofili < 1.500 cellule/mm3
•Conta piastrinica < 100.000 cellule/mm3
•Emoglobina < 9 g/dl
•Bilirubina totale più elevata del limite superiore della norma (ULN) (a meno che il paziente non presenti una sindrome di Gilbert documentata)
•Aspartato aminotransferasi (AST [SGOT]) o alanina aminotransferasi (ALT [SGPT]) > 2,5 x ULN (> 5 volte l'ULN in pazienti con metastasi epatiche)
•Fosfatasi alcalina > 2,5 × ULN (> 5 × ULN nei pazienti con metastasi epatiche, o > 10 × ULN nei pazienti con metastasi ossee)
•Creatinina sierica >2,0 mg/dl o 177 μmol/l
•Rapporto internazionale normalizzato (INR) e tempo di tromboplastina parziale attivata (aPTT) o tempo di tromboplastina parziale (PTT) > 1,5 × ULN (eccetto pazienti in terapia anticoagulante)
11.Ipertensione non adeguatamente controllata (sistolica > 150 mm Hg e/o diastolica >100 mm Hg) o patologia cardiovascolare clinicamente significativa (ossia attiva: accidente cerebrovascolare/ictus o infarto del miocardio nei 6 mesi precedenti la prima somministrazione del farmaco in studio, angina instabile, insufficienza cardiaca congestizia (ICC) di classe NYHA (New York Heart Association) II o superiore, oppure grave aritmia cardiaca che richieda trattamento farmacologico.
12.Attuale infezione nota da HIV, virus dell'epatite B o dell'epatite C.
13.Dispnea a riposo dovuta a complicanze di neoplasia maligna allo stadio avanzato o altra patologia che richieda ossigenoterapia continua.
14.Procedura di chirurgia maggiore o lesione traumatica significativa nei 28 giorni precedenti la prima somministrazione del farmaco in studio oppure necessità prevista di ricorrere a un intervento di chirurgia maggiore durante il trattamento in studio.
15.Terapia con antibiotici per via endovenosa (EV) per un'infezione nei 14 giorni precedenti l'arruolamento.
16.Trattamento giornaliero cronico in atto con corticosteroidi (dose equiv. a/maggiore di 10 mg/die di metilprednisolone), con l’esclusione degli steroidi inalatori.
17.Nota ipersensibilità a uno qualsiasi dei farmaci in studio o agli eccipienti degli anticorpi ricombinanti umani o umanizzati.
18.Anamnesi di terapia sperimentale di qualsiasi tipo nei 28 giorni precedenti la prima somministrazione del farmaco in studio.

E.5 End points

E.5.1

Primary end point(s)

Assessment of safety and tolerability.

Valutazione di sicurezza e tollerabilità.

E.5.1.1

Timepoint(s) of evaluation of this end point

When all patients have been followed up for at least 12 months after the
last patient receives last study treatment (defined as pertuzumab,
trastuzumab and a taxane), unless they have been lost to follow up,
withdrawn consent, or died, or if the study is prematurely terminated by
the Sponsor, whichever occurs first.
In addition to final analysis, there will be three interim analyses for
safety reporting and publication of safety and efficacy results,
approximately after: 350, 700 and 1000 patients.

Quando tutti i pazienti saranno stati sottoposti a un follow-up di almeno 12 mesi dopo che l'ultimo paziente avrà ricevuto l'ultimo trattamento in studio, eccetto nei casi di perdita al follow-up, revoca del consenso o decesso, oppure di interruzione prematura dello studio da parte dello sponsor, a seconda di quale delle ipotesi si verifichi per prima. Oltre all'analisi finale, sono previste tre analisi ad interim per la segnalazione dei dati sulla sicurezza e la pubblicazione dei dati sulla sicurezza e l'efficacia dopo che saranno stati arruolati circa 350, 700 e 1000 pazienti.

E.5.2

Secondary end point(s)

Analysis of efficacy

Analisi di efficacia

E.5.2.1

Timepoint(s) of evaluation of this end point

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

Quality of life

qualità della vita

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

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)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

231

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

European Union

Algeria

Argentina

Brazil

Canada

Chile

China

Egypt

India

Indonesia

Israel

Japan

Kuwait

Lebanon

Mexico

Peru

Philippines

Qatar

Russian Federation

Saudi Arabia

Singapore

Turkey

United Arab Emirates

Uruguay

Venezuela, Bolivarian Republic of

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

The study will end when all patients have been followed up for at least 12 months after the last patient receives last study treatment (defined as pertuzumab, trastuzumab and a taxane), unless they have been lost to follow up, withdrawn consent, or died, or if the study is prematurely terminated by the Sponsor, whichever occurs first.

Quando tutti i paz. saranno stati sottoposti a un fw-up di almeno 12 mesi dopo che l'ultimo paz. avrà ricevuto l'ultimo trattamento in studio, eccetto nei casi di perdita al fw-up, revoca del consenso o decesso, oppure di interruzione prematura.

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:

1260

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

240

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

1091

F.4.2.2

In the whole clinical trial

1500

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)

After discontinuation from the study patients will return to standard
care.

Dopo il termine dello studio i pazienti ritorneranno alla terapia attualmente utilizzata nella pratica clinica.

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

2012-05-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-04-03

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

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