Clinical Trials Register

Summary
EudraCT Number:	2009-011405-16
Sponsor's Protocol Code Number:	AVANTHER
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:	2009-04-23
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

Spain - AEMPS

A.2

EudraCT number

2009-011405-16

A.3

Full title of the trial

BEVACIZUMAB Y TRASTUZUMAB PREOPERATORIO JUNTO CON PACLITAXEL SEMANAL SEGUIDO, TRAS CIRUGÍA, DE DOXORUBICINA LIPOSOMAL ENCAPSULADA, CICLOFOSFAMIDA Y TRASTUZUMAB EN MUJERES CON CÁNCER DE MAMA HER2 +

A.3.2

Name or abbreviated title of the trial where available

AVANTHER

A.4.1

Sponsor's protocol code number

AVANTHER

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	Fundación Hospital de Madrid
B.1.3.4	Country	Spain
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
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	Yes
D.2.1.1.1	Trade name	AVASTIN 25 mg/ml concentrado para solución para perfusión
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.3.4	Pharmaceutical form
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.3.8	INN - Proposed INN	BEVACIZUMAB
D.3.9.3	Other descriptive name	BEVACIZUMAB
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
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	Anticuerpo monoclonal humanizado
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	HERCEPTIN 150 mg polvo para concentrado para solución para perfusión
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.3.4	Pharmaceutical form	Powder 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.3.8	INN - Proposed INN	TRASTUZUMAB
D.3.9.1	CAS number	180288-69-1
D.3.9.3	Other descriptive name	TRASTUZUMAB
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	8
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	Anticuerpo monoclonal humanizado
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	TAXOL 6 mg/ml concentrado para solución para perfusión
D.2.1.1.2	Name of the Marketing Authorisation holder	BRISTOL MYERS SQUIBB, S.A.
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.3.4	Pharmaceutical form	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.3.8	INN - Proposed INN	PACLITAXEL
D.3.9.3	Other descriptive name	PACLITAXEL
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	80
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	Yes
D.3.11.13.1	Other medicinal product type	Citostático
D.IMP: 4
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	Information not present in EudraCT
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	Ciclofosfamida
D.3.4	Pharmaceutical form	Powder for solution for injection
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.3.8	INN - Proposed INN	CICLOFOSFAMIDA
D.3.9.1	CAS number	50-18-0
D.3.9.3	Other descriptive name	CYCLOPHOSPHAMIDE
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	600
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	Yes
D.3.11.13.1	Other medicinal product type	Antineoplásico (mostaza nitrogenada)
D.IMP: 5
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	MYOCET 50 mg polvo y premezclas concentrado para dispersión liposómica para perfusión
D.2.1.1.2	Name of the Marketing Authorisation holder	CEPHALON EUROPE
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.3.4	Pharmaceutical form
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.3.8	INN - Proposed INN	DOXORUBICINA
D.3.9.1	CAS number	23214-92-8
D.3.9.3	Other descriptive name	DOXORUBICIN
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	50
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	Yes
D.3.11.13.1	Other medicinal product type	Antibiótico citostático

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

Cáncer de mama precoz (estadio II-III) de tipo invasivo pero no inflamatorio

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9
E.1.2	Level	PT
E.1.2	Classification code	10006200
E.1.2	Term	Breast cancer stage II

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9
E.1.2	Level	LLT
E.1.2	Classification code	10006201
E.1.2	Term	Breast cancer stage III

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluar la tasa de respuesta patológica de esta combinación tanto en la mama como en la axila

E.2.2

Secondary objectives of the trial

• Evaluar el papel de los siguientes marcadores moleculares como factores potencialmente predictores de respuesta patológica: ratio FISH HER2 – CEP, tasa de mutación PTEN, tasa de mutación PI3k, expresión IGFR, AKT y VEGF mediante inmunohistoquímica.
• Evaluar la tasa de cardiotoxicidad en adyuvancia de la combinación de ciclofosfamida, DL y trastuzumab.
• Correlacionar las imágenes de resonancia magnética con la respuesta patológica
• Evaluar la supervivencia libre de progresión (SLP) y la supervivencia global (SG)
• Evaluar la seguridad a largo plazo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Edad de 18 a 65 años
2.Pacientes pre- o postmenopáusicas con confirmación histológica de cáncer de mama estadio II o III, HER2 positivo
3.Tumor HER2 positivo confirmado por técnicas FISH o IHC
4.Enfermedad medible ≥ 2 cm
5.Performance status (OMS-ECOG) 0-2
6.Esperanza de vida superior a 12 semanas
7.Valor absoluto de neutrófilos > 1.500/mm3; plaquetas > 100.000/mm3; hemoglobina > 10 g/mm3
8.Función hepática normal (bilirrubina < 1,25 x Límite Superior de la Normalidad (LSN); SGOT/SGPT < 2,5 X LSN; ALP < 3 X LSN; creatinina < 1,5 X LSN
9.Función cardiaca normal (LVEF ≥ 55%) evaluado por MUGA (preferiblemente) o por ecocardiografía
10.Se permite el uso de dosis completas orales o parenterales de anticoagulantes siempre que la paciente haya estado en nivel estable de anticoagulación al menos durante las dos semanas anteriores a la entrada de la paciente en el estudio.
a.Pacientes en tratamiento con heparina deberán presentar un valor basal de aPTT o antes de comenzar el tratamiento con heparina entre 1,5 – 2,5 veces el LSN
b.Pacientes en tratamiento con heparinas de bajo peso molecular deben recibir una dosis diaria de 1,5 – 2 mg/kg (de enoxaparina) o dosis apropiadas del correspondiente anticoagulante conforme a ficha técnica.
c.Las pacientes que estén tomando dicumarínicos deben presentar un INR entre 2.0 y 3.0 en el momento basal y en dos medidas consecutivas 1-4 días anteriores.
11.Pacientes que no reciban medicación anticoagulante deben presentar un INR ≤ 1,5 y un PTT ≤ 1,5 veces el LSN dentro de los 7 días anteriores s la entrada en el estudio
12.Consentimiento informado

E.4

Principal exclusion criteria

1.Tratamiento previo de quimioterapia.
2.Tratamiento previo con inhibidores de HER2 o VEGF.
3.Enfermedad pulmonar previa
4.Hipertensión no controlada (sistólica > 150 mmHg y/o diastólica > 100 mmHg) o enfermedad cardiovascular clínicamente significativa (p.ej. enfermedad activa): ACVA/hemorragia cerebral (≤ 6 meses antes de la inclusión), infarto de miocardio (≤ 6 meses antes de la inclusión), angina inestable, enfermedad cardiaca congestiva de clase NYHA 2 o mayor, o arritmia cardiaca grave que requiera medicación.
5.Historia de coagulopatía o trombosis clínicamente significativa.
6.Historia o evidencia por exploración física / neurológica de enfermedad del sistema nervioso central (no relacionada con el cáncer) (a no ser que esté tratada adecuadamente con tratamiento médico estándar); p.ej., epilepsia no controlada.
7.Cirugía mayor, biopsia abierta o traumatismo significativo durante los 28 días antriores al comienzo en el estudio, o cirugía mayor prevista durante el curso del estudio.
8.Neuropatía periférica > CTC grado 2 a la inclusión
9.Función renal alterada a.Creatinina sérica > 2.0 mg/dL o 177 mmol/L. b.Proteinuria > 2+ evaluada con tiras urinarias (dipstick). Las pacientes con proteinuria de ≥ 2+ basal deberán realizar una recogida de orina de 24 horas y demostrar un valor ≤ 1 g de proteínas/24h.
10.Tratamiento crónico diario con corticosteroides (dosis de > 10 mg/día de metilprednisolona o equivalente) (excluidos esteroides inhalados).
11.Tratamiento diario crónico con aspirina (> 325 mg/día) o clopidogrel (> 75 mg/día).
12.Historia o evidencia de herencia de diátesis hemorrágica o coagulopatía con riesgo de hemorragia.
13.Historia de fístula abdominal, perforación gastrointestinal, o absceso intra-abdominal dentro de los 6 meses previos a la inclusión
14.Infección activa que requiera antibioterapia intravenosa al comienzo del estudio.
15.Herida grave no curada, úlcera péptica o fractura ósea
16.Evidencia de cualquier otra enfermedad, alteración neurológica o metabólica, hallazgo de la exploración física o de laboratorio clínico que proporcione indicios razonables para sospechar una enfermedad o afección para la que está contraindicado el uso de alguno de los fármacos del estudio o que coloque al paciente en riesgo alto de experimentar complicaciones relacionadas con el tratamiento
17.Mujeres embarazadas o sexualmente activas que no estén usando un método adecuado de contracepción.
18.Pacientes que probablemente no puedan realizar un seguimiento apropiado
19.Tratamiento actual o reciente con otro fármaco en investigación o participación en otro ensayo clínico (dentro de los 30 días anteriores al comienzo del estudio)
20.Hipersensibilidad conocida a alguno de los fármacos o sus excipientes, a productos celulares de ovarios de hamster chinos u otros anticuerpos humanos recombinantes
21.Otro tumor primario (incluyendo tumores cerebrales primarios) dentro de los últimos 5 años anteriores a la inclusión en el estudio, excepto carcinoma in situ de cerviz, carcinoma escamoso de la piel, ambos si están adecuadamente tratados, o cáncer de células basales de la piel si está adecuadamente controlado.

E.5 End points

E.5.1

Primary end point(s)

Variable principal:
•Tasa de respuesta patológica (RpC)
Variables secundarias
•Evaluar el papel de los siguientes marcadores moleculares como factores potencialmente predictores de respuesta patológica: ratio FISH HER2 – CEP, tasa de mutación PTEN, tasa de mutación PI3k, expresión IGFR, AKT y VEGF.
•Evaluar la tasa de cardiotoxicidad en adyuvancia de la combinación de ciclofosfamida, DL y trastuzumab.
•Correlacionar las imágenes de resonancia magnética con la respuesta patológica
•Evaluar la supervivencia libre de progresión (SLP) y la supervivencia global (SG).
•Evaluar la seguridad a largo plazo.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

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

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

Information not present in EudraCT

E.8.1.2

Open

Information not present in EudraCT

E.8.1.3

Single blind

Information not present in EudraCT

E.8.1.4

Double blind

Information not present in EudraCT

E.8.1.5

Parallel group

Information not present in EudraCT

E.8.1.6

Cross over

Information not present in EudraCT

E.8.1.7

Other

Information not present in EudraCT

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.8.3

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

El ensayo finalizará cuando el último paciente haya finalizado el tratamiento y completado su visita final.

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

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)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	No
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	No
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	44

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

2009-06-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-05-25

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

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