Clinical Trials Register

Summary
EudraCT Number:	2011-000490-30
Sponsor's Protocol Code Number:	METTEN-01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2011-02-28
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

2011-000490-30

A.3

Full title of the trial

Phase II randomised, open-label, multicentric clinical trial of neoadjuvant treatment comprising chemotherapy and trastuzumab with or without metformin, in women with HER2/ErbB2 positive primary breast cancer.

Ensayo fase II, aleatorizado, abierto, multicéntrico, de tratamiento neoadyuvante con quimioterapia y trastuzumab con o sin la adición de metformina en mujeres diagnosticadas de cáncer de mama primario HER2/ErbB2 positivo.

A.3.1

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

A.4.1

Sponsor's protocol code number

METTEN-01

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	Institut Català d'Oncologia
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	Ministerio de Sanidad, Politica Social e Igualdad
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Institut Català d'Oncologia de Girona
B.5.2	Functional name of contact point	Neus Bosch Pont
B.5.3	Address:
B.5.3.1	Street Address	Avda. França, s/n - Unidad de Investigación Clínica
B.5.3.2	Town/ city	Girona
B.5.3.3	Post code	17007
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034972225827
B.5.5	Fax number	0034972225842
B.5.6	E-mail	nbosch@iconcologia.net

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	METFORMINA TEVA 850 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	TEVA PHARMA S.L.U.
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	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	METFORMINA HIDROCLORURO
D.3.9.3	Other descriptive name	METFORMIN HYDROCHLORIDE
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	850
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	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 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	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 milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 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	PACLITAXEL HOSPIRA 6 mg/ml concentrado para solución para perfusión
D.2.1.1.2	Name of the Marketing Authorisation holder	HOSPIRA PRODUCTOS FARMACÉUTICOS Y HOSPITALARIOS, S.L.
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	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.3.9.3	Other descriptive name	PACLITAXEL
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Women with stage II-III, HER2/ErbB2-positive primary breast cancer elegible for neoadjuvant treatment.

Cáncer de mama primario que sobreexpresa o amplifica HER2.

E.1.1.1

Medical condition in easily understood language

Primary breast cancer

Cáncer de mama primario

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10006279
E.1.2	Term	Breast neoplasm
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 determine the efficacy of adding metformin concomitantly with chemotherapy and trastuzumab in the neoadjuvant treatment of patients with HER2-positive operable breast cancer as measured by the number of pathological complete responses.

Determinar la eficacia medida mediante el nº de respuestas completas patológicas alcanzadas de la Metformina concomitante con quimioterapia y Trastuzumab en el tratamiento neoadyuvante de pacientes con cáncer de mama HER2 positivo operable.

E.2.2

Secondary objectives of the trial

- To assess the safety and tolerability of both treatment regimens.
- To determine the 5-years Disease Free Survival (DFS) from last patient randomization.
- To evaluate the cardiac toxicity associated to both treatment schedules.
- To examine biomarkers´ activity/expression functionally related with AMPK. mTor signaling pathway in tumor tissue
- To determine circulating insulin levels in patients? serum .

-Evaluar seguridad y tolerabilidad de ambos esquemas de tratamiento.
- Determinar SLE (Supervivencia libre de enfermedad) a los cinco años desde la aleatorización de la última paciente.
- Evaluar la toxicidad cardíaca asociada a ambos esquemas de tratamiento.
- Analizar la expresión y/o actividad de biomarcadores relacionados funcionalmente con la via de señalización AMPK ? mTOR en el tejido tumoral.
- Determinar niveles circulantes de insulina en el suero de las pacientes.

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 farmacogenómico en pacientes participantes en el estudio METTEN-01 tratados con Metformina. Versión Hoja información al paciente, versión 1, del 12 de abril del 2012

E.3

Principal inclusion criteria

1. Mujeres.
2. Edad 18-75 años.
3. Puntuación 0-1 de la clasificación ECOG (Eastern Cooperative Oncology Group) (ver ApéndiceB).
4. Cáncer de mama invasivo confirmado histológicamente (incluido el cáncer de mama inflamatorio y el cáncer de mama multifocal:)
- Tumor primario mayor de 2 cm. de diámetro, medido por examen clínico y por mamografía o ecografía.
- Cualquier N
- Sin evidencia de metástasis (M0), (un ganglio supraclavicular aislado afectado está permitido).
Se seguirá la 7ª edición del AJCC Cancer Staging Manual (ver Apéndice C).
5. Sobre-expresión y/o amplificación de HER2 en el componente invasivo del tumor primario, definido según el siguiente criterio:
- IHC 3+
- IHC 2+ y FISH/CISH positivo
6. Estado conocido de los receptores hormonales.
7. Función hematopoyética:
- Recuento absoluto de neutrófilos ?1,5 x109/L
- Recuento de plaquetas ?100 x109/L
- Hemoglobina ?9 g/dl
8. Función hepática:
- Bilirrubina sérica total ?1,5 x límite superior normal (LSN).
- AST y ALT ?2,5 x LSN
- Fosfatasa alcalina ?2,5 x LSN
- Glucosa en ayunas ?70 mg/dl
9. Función renal:
- Creatinina?1,5 x LSNCódigo del protocolo: METTEN-01 Confidencial Versión 2 Fecha 15/05/2011 23
10. Cardiovascular:
- FEVI basal ?50% medida mediante ecocardiografía (ECO) o rastreo MUGA (del inglés, Multiple Gate Acquisition)
11. 20 ?IMC? 30
12. Prueba de embarazo negativa en los 7 días previos a la aleatorización (en las mujeres potencialmente fértiles).
13. Las mujeres fértiles deben utilizar un método anticonceptivo efectivo.
14. Consentimiento informado por escrito.

E.4

Principal exclusion criteria

1. Prior treatment for primary invasive breast cancer.
2. Bilateral breast cancer.

3. Precedent medical history less than 10 years or present history for other malignant neoplasia, except in situ carcinoma of the cervix and basocellular and epidermoid skin carcinoma. Previous diagnosis of melanoma or breast cancer are excluded.

4. Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarct, uncontrolled hypertension, dyspnea at rest, or chronic therapy with oxygen.

5. Metabolic disease (diabetes mellitus type I or II, obesity (BMI ? 30), hyperglycemia (preprandial glucose >128 mg/dl), hypercholesterolemia or hypertrigliceridemia ? grade 3 according to CTC-NCIC version 3.0.
6. History of metabolic acidosis.
7. Chronic neumopathy or respiratory restriction.
8. Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient's safety.
9. Active or uncontrolled infection.
10. Enolism. (daily media consumption of more than 3 alcoholic beverage intake)
11. Hepatic insufficiency.
12. Renal insufficiency (calculated CrCl < 60 mL/min).
13. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent by the patient.
14. Malabsorption syndrome, with disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
15. Concurrent treatment with therapies that can alter insulin levels (including chronic treatment with oral corticoids).
16. Concurrent treatment with an investigational drug or participation in another therapeutic clinical trial.
17. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab, metformin or their excipients. Glucose or galactos absorption problems and hereditary galactose intolerance.
18. Pregnant or lactating women.
and galactosemia o hereditary galactosemia intolerance.
19. Sociologic, familiar or geographical conditions that may compromise clinical trial protocol compliance.

1. Tratamiento previo para el cáncer de mama invasivo primario.
2. Cáncer de mama bilateral.
3. Antecedentes de menos de 10 años o historia actual de otra neoplasia maligna, salvo el carcinoma in situ del cuello uterino y el carcinoma basocelular y epidermoide de piel. Se excluyen los diagnósticos previos de cáncer de mama o de melanoma.
4. Historia conocida de angina no controlada o sintomática, arritmias clínicamente significativas, insuficiencia cardíaca congestiva, infarto transmural de miocardio, hipertensión no controlada, disnea en reposo u oxigenoterapia crónica.
5. Enfermedad metabólica (diabetes mellitus tipo I o II, obesidad (IMC?30), hiperglicemia (glucosa en ayunas>128 mg/dl), hipercolesterolemia o hipertrigliceridemia ?grado 3 según los Criterios Comunes de Toxicidad (CTC-NCIC) versión 3.0 (ver Apéndice D).
6. Historia de acidosis metabólica.
7. Neumopatia crónica o compromiso respiratorio.
8. Enfermedad o trastorno concurrente que haga que la paciente sea inapropiada para participar en el estudio, o cualquier trastorno médico grave que pueda interferir con la seguridad de la paciente.
9. Infección activa o no controlada.
10. Enolismo (consumo medio de >3 bebidas alcohólicas por día).
11. Insuficiencia hepática.
12. Insuficiencia renal (aclaramiento de creatinina < 60 ml/mn).
13. Demencia, estado mental alterado, o cualquier trastorno psiquiátrico que impida que la paciente pueda entender o dar su consentimiento informado.
14. Síndrome de malabsorción, enfermedad que afecte significativamente a la función gastrointestinal, o resección de estómago o intestino delgado.
15. Tratamiento concurrente con fármacos que puedan alterar los niveles de insulina (incluyendo tratamiento crónico con corticoides orales).
16. Tratamiento concurrente con un fármaco en investigación o participación en otro ensayo clínico terapéutico.
17. Reacción de hipersensibilidad inmediata o tardía conocida o idiosincrasia a fármacos químicamente relacionados con metformina, trastuzumab o sus excipientes. Problemas de absorción de glucosa o galactosa e intolerancia hereditaria a galactosa.
18. Mujeres en estado de gestación o lactancia.
19. Condiciones sociológicas, familiares o geográficas que puedan comprometer el cumplimiento del protocolo del ensayo clínico

E.5 End points

E.5.1

Primary end point(s)

-Pathological Complete Response Rate (pCR) . Percentage of patients who present pathological complete response, defined as the absence of infiltrating carcinoma in resected materials and the axilla or the exclusive presence of in situ non-invasive cancer in resected material
(number of patients with pCR)/(total patient numbers according to per protocol population) x 100

Tasa de respuesta patológica completa (RCp): Porcentaje de pacientes que presentan respuesta patológica completa, definida como ausencia de carcinoma infiltrante en la pieza resecada y en la axila o la presencia exclusiva de cáncer in situ no invasivo en la pieza resecada.
? (Nº paciente con RCp)/(Nº total de pacientes según población por protocolo)x100

E.5.1.1

Timepoint(s) of evaluation of this end point

It will assess the pathological response in surgical specimen obtained after completion of neoadjuvant therapy. The first efficacy analysis will be performed when available 37 responses evaluated in both groups of treatment, according to two-step method of Jung

Se evaluará la respuesta patológica en la pieza quirúrgica obtenida tras la finalización del tratamiento neoadyuvante. El primer análisis de eficacia será realizado cuando se disponga de 37 respuestas evaluables en ambos grupos de tratamiento, según el método de dos etapas de Jung.

E.5.2

Secondary end point(s)

1.-Safety and Tolerability. To determine the safety profile from adverse events reported by patients. Every AE will be recorded until 28 days after last study drug intake. Non serious AE related with the drug medication appeared up to 6 month after the last study drug intake must be reported.
2.- 5 year disease-free survival from diagnosis: probability of disease relapse or death by any cause.
3.- Cardiotoxicity rate. Number of patients with cardiotoxicity (according to CTCAE V4.0 criteria) divided among the total patients number or the total number of patients per protocol ( x100).
4.- Biomarkers
5.- Insulin levels.

1.-Seguridad y tolerabilidad: Se determinará el perfil de seguridad a partir de los AA notificados por los pacientes. Se registrarán todos los AA que se manifiesten hasta 28 días después de la última dosis de la medicación del estudio. Los AA no graves relacionados con el tratamiento en estudio que aparezcan hasta 6 meses después de la administración de la última dosis deberán comunicarse.
2.-Supervivencia libre de enfermedad a los 5 años del diagnóstico: probabilidad de recidiva de la enfermedad o muerte por cualquier causa.
3.-Tasa de toxicidad cardíaca: Nº de pacientes que presentan toxicidad cardíaca según los criterios CTCAE v 4.0 dividido por el número total de pacientes o por el número de pacientes por protocolo (x100).
4.-Biomarcadores.
5.-Niveles insulina.

E.5.2.1

Timepoint(s) of evaluation of this end point

It will be held at the end when making the final statistical analysis, after collecting all the study data.

Se realizará al final cuando se realice el análisis estadístico final previa recogida de todos los datos del estudio.

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

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)

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

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

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

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

Last patient last visit will be the end of the trial

El final del ensayo coincide con la última visita del último sujeto reclutado en el ensayo

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:

133

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

178

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)

Not applicable.

No aplica.

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

2011-06-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-06-09

P. End of Trial
P.	End of Trial Status	Ongoing

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