Clinical Trials Register

Summary
EudraCT Number:	2011-001231-23
Sponsor's Protocol Code Number:	FUPOCAN-01-11
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:	2011-09-15
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

2011-001231-23

A.3

Full title of the trial

Estudio fase II para evaluar la eficacia y seguridad de Trastuzumab en combinación con XELOX como primera línea de tratamiento para el cáncer gástrico avanzado o metastásico en pacientes con tumores HER2-positivo

A.3.1

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

Estudio para evaluar la eficacia y seguridad del tratamiento del estudio como primera linea de tratamiento en pacientes con cáncer gástrico Her 2 positivo

A.3.2

Name or abbreviated title of the trial where available

HerXO

A.4.1

Sponsor's protocol code number

FUPOCAN-01-11

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	Fundación para el Progreso de la Oncología en Cantabria
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	Fundación apra el progreso de la Oncología en Cantabria
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	Dynamic Solutions
B.5.2	Functional name of contact point	Ángel Pérez Romero
B.5.3	Address:
B.5.3.1	Street Address	C/azcona 31
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28028
B.5.3.4	Country	Spain
B.5.4	Telephone number	003491 456 11 05
B.5.5	Fax number	003491 456 11 26
B.5.6	E-mail	a.perez@dynasolutions.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	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	Concentrate and solvent 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	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)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Anticuerpo monoclonal IgG1 humanizado producido por células ováricas de hamster chino.
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	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.3.4	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	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/m2 milligram(s)/square meter
D.3.10.2	Concentration type	up to
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	Yes
D.3.11.13.1	Other medicinal product type	Citostático (antimetabolito): análogo de pirimidina
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	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.3.4	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	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/m2 milligram(s)/square meter
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)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Citostático (antimetabolito): análogo de pirimidina
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	Yes
D.2.1.1.1	Trade name	OXALIPLATINO SANDOZ 5 mg/ml polvo para solución para perfusión
D.2.1.1.2	Name of the Marketing Authorisation holder	SANDOZ FARMACEUTICA, 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	Powder 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	OXALIPLATINO
D.3.9.3	Other descriptive name	OXALIPLATINO
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	130
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Otros citostáticos: Derivados del platino

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 Gástrico

E.1.1.1

Medical condition in easily understood language

Cáncer Gástrico

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	14.0
E.1.2	Level	LLT
E.1.2	Classification code	10001150
E.1.2	Term	Adenocarcinoma gastric
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

El objetivo principal es analizar la Supervivencia global de los pacientes.

E.2.2

Secondary objectives of the trial

Supervivencia libre de progresión, tiempo hasta la progresión de la enfermedad, tasa de respuesta global, beneficio clínico, duración de la respuesta, tiempo hasta la respuesta, perfil de seguridad.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Pacientes que hayan otorgado su consentimiento informado por escrito antes de realizar cualquier procedimiento de selección específico del estudio.
2. Varones o mujeres con edad mayor o igual a 18 años.
3. Pacientes con adenocarcinoma gástrico o de la unión gastroesofágica localmente avanzado o recurrente y/o metastático inoperable confirmado histológicamente, no tratable con terapia curativa.
4. Enfermedad medible, de acuerdo a los Criterios para la Evaluación de la Respuesta en Tumores Sólidos (RECIST), valorada con técnicas de diagnóstico por imágenes (TAC o RM), o enfermedad evaluable no medible.
5. Tumores HER2 positivo (tumor primario o metástasis) con sobreexpresión de HER2 determinada por IHQ +++ (IHQ3+) o IHQ ++ confirmado con FISH/SISH positivo (IHQ2+/FISH+).
6. Estado funcional ECOG 2.
7. En el caso de mujeres y varones potencialmente fértiles (< de 12 meses desde la última menstruación en mujeres), deben utilizar un método anticonceptivo eficaz (anticonceptivos orales, sistemas anticonceptivos intrauterinos, métodos de barrera anticonceptivos en combinación con espermicidas o esterilidad obtenida quirúrgicamente) o abstinencia.
8. Esperanza de vida superior a 3 meses, como mínimo.
9. Función renal adecuada: aclaramiento de creatinina > 50 ml/min.
10. Función hepática adecuada: AST y ALT 2,5 x LSN ( 5 x LSN en el caso de presencia de metástasis hepáticas), bilirrubina 1,5 x LSN. Fosfatasa alcalina (FA) < 2,5 x LSN (< 5 x LSN en caso de metástasis hepáticas o < 10 x LSN en caso de metástasis óseas).
11. Función hematológica adecuada: hemoglobina 9 g/dl, neutrófilos 1,5 x 109 /l y plaquetas 100 x 109 /l.
12. Función cardiaca adecuada: FEVI > 50%.
13. Los pacientes deben ser tratados y seguidos en el centro participante.

E.4

Principal exclusion criteria

Quimioterapia previa para enfermedad avanzada/metastásica. Está permitida la terapia adyuvante/neodyuvante previa si el tratamiento ha terminado, como mínimo, 6 meses antes de la fecha de la inclusión del paciente en el estudio.
2. Falta de integridad fisica del tracto gastrointestinal superior o síndrome de malabsorción (p. ej. Los pacientes con gastrectomia parcial o total pueden ser incluidos en el estudio, pero no los que utilicen una sonda de yeyunostomía.
3. Pacientes con hemorragia gastrointestinal activa (significativa o no controlada).
4. Toxicidad residual importante a consecuencia de la terapia previa (excepto alopecia), por ejemplo toxicidad neurológica grado 2 NCI-CTCAE.
5. Pacientes que hayan recibido radioterapia en las 4 semanas previas al inicio del tratamiento del estudio. Se admite un intervalo de 2 semanas si se ha administrado radioterapia paliativa en metástasis óseas periféricas y el paciente se ha recuperado de la toxicidad aguda de la terapia.
6. Pacientes sometidos a cirugía mayor en las 4 semanas previas al inicio de tratamiento del estudio, que no presenten una recuperación total de la intervención quirúrgica.
7. Historia de otra enfermedad neoplásica (en los cinco años antes de la inclusión), con la excepción de la indicación de este estudio, y carcinomas curados de células basales de la piel y de cervix in situ.
8. Enfermedad cardiovascular activa y clínicamente significativa, por ejemplo, hipertensión no controlada, angina inestable, insuficiencia cardiaca congestiva de grado II o superior de la New York Heart Association (NYHA), arritmias cardiacas severas que requieran mediación, o enfermedad vascular periférica grado II o superior, infarto de miocardio o un accidente cerebrovascular 12 meses antes de la inclusión en el estudio y enfermedad intercurrente sistémica grave no controlada, severa u otras enfermedades concomitantes severas y no controladas (por ejemplo infecciones o diabetes mal controlada).
9. Antecedentes o evidencia clínica de metástasis cerebrales.
10. Pacientes sometidos a trasplante alojénico que requieran tratamiento inmunosupresor.
11. Insuficiencia renal moderada (aclaramiento de creatinina basal de 30-50 ml/min calculado mediante la fórmula de Cockroft-Gault) o severa (aclaramiento de creatinina < 30 ml/min, calculado mediante la fórmula de Cockroft-Gault).
12. Adecuada función hepática:
a. Bilirrubina Total 1,5 x LSN.
b. GOT (ASAT)/ GPT (ALAT) 2,5 el LSN. En caso de metástasis hepáticas 5 x LSN.
c. FA de 2,5 veces el LSN.
13. Adecuada función hematológica:
a. Recuento absoluto de neutrofilos de 1,5 x 10 9/ L.
b. Recuento de plaquetas 100 x 10 9 /L.
14. Tratamiento con sorivudina o sus análogos químicamente relacionados, tal como la brivudina.
15. Deficiencia probada de dihidropririmidina dehidrogenasa (DPD).
16. Pacientes que hayan recibido algún fármaco, agente o procedimiento en investigación, o que hayan participado en otro estudio de investigación durante los 30 días anteriores al comienzo del tratamiento con la medicación del estudio.
17. Hipersensibilidad confirmada a cualquiera de los fármacos del estudio.
18. Evidencia de otra enfermedad, disfunción metabólica, hallazgo en el examen físico o hallazgo en las pruebas de laboratorio clínico que originen una sospecha razonable de que exista una condición o enfermedad que contraindique el uso de alguno de los fármacos en investigación o ponga al paciente en un riesgo elevado de complicaciones del tratamiento.
19. Pacientes que reciban tratamiento corticoesteroide crónico o con dosis altas (está permitido el uso de esteroides por vía inhalatoria y los cliclos de tratamiento cortos con esteroides orales para prevención de la emesis o para estimular el apetito)
20. Embarazo o lactancia.
21. Pacientes en edad fértil que no estén dispuestos a utilizar un método anticonceptivo eficaz.
22. Historia de incapacidad psiquiátrica que el investigador considere clínicamente significativa, que impida al paciente otorgar el consentimiento informado o interfiera con el cumplimiento de los procedimientos del estudio.

E.5 End points

E.5.1

Primary end point(s)

La variable principal de estudio será la Supervivencia global, definida como el tiempo desde el inicio del tratamiento hasta que el momento en que el paciente fallece, independientemente del tiempo que haya recibido el tratamiento del estudio y la causa de su fallecimiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

Tiempo libre de pogresión

E.5.2

Secondary end point(s)

supervivencia global

E.5.2.1

Timepoint(s) of evaluation of this end point

supervivencia global

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

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

última visita último paciente

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.1.1.1

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:

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

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

Information not present in EudraCT

F.3.3.2

Women of child-bearing potential using contraception

Information not present in EudraCT

F.3.3.3

Pregnant women

Information not present in EudraCT

F.3.3.4

Nursing women

Information not present in EudraCT

F.3.3.5

Emergency situation

Information not present in EudraCT

F.3.3.6

Subjects incapable of giving consent personally

Information not present in EudraCT

F.3.3.7

Others

Information not present in EudraCT

F.4 Planned number of subjects to be included

F.4.1

In the member state

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)

El tratamiento después del ensayo seguirá la práctica clínica habitual del centro.

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

2011-07-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-06-29

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

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