Clinical Trials Register

Summary
EudraCT Number:	2008-005713-22
Sponsor's Protocol Code Number:	TDM4370g/BO21977
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2009-01-22
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

Spain - AEMPS

A.2

EudraCT number

2008-005713-22

A.3

Full title of the trial

Estudio de Fase III multicéntrico, randomizado, abierto, de la eficacia y seguridad de Trastuzumab-MCC-DM1 frente a Capecitabina + Lapatinib en pacientes con cáncer de mama localmente avanzado o metastático HER2-positivo que han recibido previamente tratamiento basado en Trastuzumab
A randomized, multicenter, phase III open-label study of the efficacy and safety of trastuzumab-MCC-DM1 vs. capecitabine + lapatinib in patients with HER2-positive locally advanced or metastatic breast cancer who have received prior trastuzumab-based therapy.

A.3.2

Name or abbreviated title of the trial where available

EMILIA

A.4.1

Sponsor's protocol code number

TDM4370g/BO21977

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	trastuzumab-MCC-DM1 (T-DM1)
D.3.2	Product code	RO5304020
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	1018448-65-1
D.3.9.2	Current sponsor code	RO5304020
D.3.9.3	Other descriptive name	T-DM1
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	160
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Antibody-drug conjugates (ADCs) composed of a humanised monoclonal antibody (trastuzumab) and a cytotoxic agent (DM-1)
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	XELODA 150 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE REGISTRATION LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.2	Product code	RO09-1978/J12
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	CAPECITABINA
D.3.9.1	CAS number	154361-50-9
D.3.9.3	Other descriptive name	CAPECITABINE
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	XELODA 500 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE REGISTRATION LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.2	Product code	RO09-1978/J13
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	CAPECITABINA
D.3.9.1	CAS number	154361-50-9
D.3.9.3	Other descriptive name	CAPECITABINE
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	500
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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: 4
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	TYVERB 250 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	GLAXO GROUP LTD.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.2	Product code	RO5006991
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	LAPATINIB
D.3.9.3	Other descriptive name	LAPATINIB
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	250
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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

Tratamiento de pacientes con cáncer de mama HER-2 positivo localmente avanzado o metastásico que hayan recibido un taxano y trastuzumab tras progresión de la enfermedad.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10027475
E.1.2	Term	Metastatic breast cancer

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10065430
E.1.2	Term	HER-2 positive breast cancer

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

? Comparar la eficacia de T-DM1 con la de capecitabina más lapatinib en pacientes con cáncer de mama localmente avanzado o metastático HER2-positivo, determinada por la SLP, basándose en la revisión independiente de las evaluaciones del tumor
? Comparar la seguridad de T-DM1 con la de capecitabina más lapatinib

E.2.2

Secondary objectives of the trial

Comparar entre los dos grupos de tratamiento:
? la supervivencia a 1 año y global (SG)
? la SLP basándose en la revisión de las evaluaciones del tumor realizada por el investigador
? el índice de respuesta objetiva global entre los dos grupos de tratamiento, basándose en la revisión de las evaluaciones del tumor realizada tanto por el investigador, como la de un comité independiente
? Calcular la duración de la respuesta objetiva en cada grupo de tratamiento, basándose en la revisión de las evaluaciones del tumor realizada tanto por el investigador, como la de un comité independiente
? la tasa de beneficio clínico basándose tanto en la revisión de las evaluaciones del tumor realizada por el investigador como la de un comité independiente
? el tiempo hasta el fracaso del tratamiento
? el tiempo hasta la progresión sintomática determinado por el FACT-Breast-Trial Outcome Index (FACT-B TOI)
? los costes de los recursos empleados

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Subestudio del banco de muestras de ADN asociado al estudio con trastuzumab-MCC-DM1 (T-DM1) TDM4370g/BO21977 fechado el 08 Octubre 2008 [Nota, este subestudio no se considera un "ensayo clínico" según se define en la Directiva de la UE de Ensayos Clínicos].

E.3

Principal inclusion criteria

Criterios específicos de la enfermedad
1. El estado de HER2 debe ser analizado centralmente y prospectivamente, y debe ser positivo (es decir, IHC 3 ? y/o amplificación génica mediante FISH), basándose en los resultados del análisis realizado en el laboratorio central de este estudio, para que la paciente se considere apta para la inclusión en este estudio.
2. Cáncer de mama invasivo confirmado histológica o citológicamente (enfermedad localmente avanzada o metastática incurable)
3. El tratamiento previo para el cáncer de mama debe incluir lo siguiente:
Un taxano, administrado en monoterapia o en combinación con otro agente y
Trastuzumab como tratamiento adyuvante, en el entorno de la enfermedad localmente avanzada o metastática
4. Progresión documentada del cáncer de mama localmente avanzado o metastático incurable, definida por el investigador:
La progresión se debe haber manifestado durante o después del tratamiento para la enfermedad avanzada o metastática o en los 6 meses siguientes a la terminación del tratamiento adyuvante.
5. Enfermedad medible y/o no medible
b. Criterios generales
6. Edad mayor o igual a 18 años
7. Fracción de eyección cardíaca mayor o igual a 50%, valorada en ECO o MUGA
8. Estado funcional 0 o 1 de acuerdo con el Eastern Cooperative Oncology Group (ECOG)
9. Función de órganos adecuada, evidenciada en las 2 semanas previas a la randomización por los resultados de laboratorio siguientes :
Recuento absoluto de neutrófilos mayor a 1500 células/mm3
Recuento de plaquetas mayor a 100.000 células/mm3
Hemoglobina mayor a 9,0 g/dl
Se permite la administración de transfusiones de eritrocitos para alcanzar este nivel.
Albúmina mayor o igual a 2,5 g/dl
Bilirrubina total menor o igual a 1,5 veces el límite superior de normalidad (LSN)
SGOT (AST), SGPT (ALT) y fosfatasa alcalina menor o igual a 2,5 x LSN, con la siguiente excepción:
Pacientes con metástasis óseas: fosfatasa alcalina menor o igual a 5 x LSN
Aclaramiento de creatinina mayor a 50 ml/min, basado en el cálculo de la velocidad de sedimentación glomerular (VSG) de acuerdo con la fórmula de Cockroft-Gault:
(140 x edad) x (peso en kg) x (0,85 en las mujeres)/72 x creatinina sérica
Índice internacional de normalización (INR) y tiempo de tromboplastina parcial activada (TTPa) menor a 1,5 x LSN (a menos que el paciente esté recibiendo tratamiento anticoagulante)
? Las mujeres potencialmente fértiles deben comprometerse a utilizar un método anticonceptivo eficaz (el paciente y/o su pareja, p. ej. esterilización quirúrgica, dos métodos de barrera seguros, píldoras anticonceptivas o implantes hormonales anticonceptivos) y a continuar utilizándolo durante todo el estudio, de acuerdo con las directrices de las autoridades sanitarias locales
Se seguirán los requisitos específicos de cada país (p. ej. en el Reino Unido, las mujeres potencialmente fértiles y los varones y sus parejas potencialmente fértiles deben utilizar dos métodos anticonceptivos [uno de los cuales debe ser de barrera] durante todo el estudio).

E.4

Principal exclusion criteria

a. Criterios relacionados con el cáncer
1. Tratamiento previo con T-DM1
2. Tratamiento previo con lapatinib o capecitabina.
3. Neuropatía periférica de grado ? 3, de acuerdo con los Criterios de Terminología Común para Acontecimientos Adversos del National Cancer Institute (NCI CTCAE), Versión 3.0
4. Antecedentes de otras enfermedades neoplásicas en los 5 últimos años, excepto carcinoma in situ de cervix tratado adecuadamente, carcinoma de piel no melanomatoso, carcinoma de útero en estadio 1, cáncer de mama HER2-positivo sincrónico o diagnosticado previamente u otros tipos de cáncer con resultado clínico similar a los mencionados anteriormente
5. Cualquier tipo de quimioterapia o tratamiento en investigación administrados en los 21 días previos a la randomización y recuperación de las toxicidades relacionadas con el tratamiento compatibles con otros criterios de selección
6. Administración de radioterapia en los 14 días previos a la randomización
Si el paciente ha recibido radioterapia recientemente, se debe haber recuperado de cualquier toxicidad aguda resultante (a grado menor o igual a 1) antes de la randomización.
7. Metástasis cerebrales no tratadas, sintomáticas o que requieran tratamiento para controlar los síntomas o radioterapia, cirugía u otros tratamientos, incluyendo esteroides, para controlar los síntomas de las metástasis cerebrales, en los 2 meses previos a la randomización
b. Función cardiovascular
8. Antecedentes de ICC sintomática o arritmia ventricular que requiera tratamiento
9. Antecedentes de infarto de miocardio o angina de pecho inestable en los 6 meses previos a la randomización
10. Disnea severa en reposo debida a complicaciones de la enfermedad neoplásica avanzada o que precise oxigenoterapia continua en la actualidad
c. Criterios generales
11. Enfermedad sistémica severa, no controlada (p. ej. trastornos cardiovasculares, pulmonares o metabólicos clínicamente significativos) en la actualidad
12. Embarazo o lactancia
13. Infección confirmada por VIH, virus de hepatitis B o C que esté activa en la actualidad
14. Trastornos que pudieran afectar a la absorción gastrointestinal: síndrome de malabsorción, resección del intestino delgado o el estómago y colitis ulcerosa.
15. Antecedentes de intolerancia (tal como reacción a la infusión de grado 3-4) a trastuzumab
16. Hipersensibilidad a 5-fluorouracilo o deficiencia de dihidropirimidina deshidrogenasa confirmadas
17. Tratamiento en la actualidad con sorivudina o análogos químicamente relacionados, por ejemplo brivudina
18. Incapacidad o falta de disposición para cumplir con los requisitos del protocolo (p. ej. incapacidad para tragar los comprimidos), de acuerdo con el criterio del investigador

E.5 End points

E.5.1

Primary end point(s)

? SLP, que se define desde el momento de la randomización hasta que se manifiesta por primera vez la progresión de la enfermedad o se produce la muerte durante el estudio por cualquier causa (en los 30 días siguientes a la administración de la última dosis del tratamiento del estudio), determinada de acuerdo con la revisión independiente de las evaluaciones del tumor utilizando los criterios RECIST modificados
? Incidencia, características y severidad de los acontecimientos adversos

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

Yes

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

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 study will be considered completed when approximately 417 deaths have been reported.

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	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-01-22.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	17
F.4.2	For a multinational trial
F.4.2.1	In the EEA	190
F.4.2.2	In the whole clinical trial	580

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

2009-03-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-03-06

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-09-22

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