Clinical Trials Register

Summary
EudraCT Number:	2012-003058-10
Sponsor's Protocol Code Number:	IBCSG_42-12/BIG_2-12
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:	2013-07-30
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

2012-003058-10

A.3

Full title of the trial

A randomized phase II study evaluating different schedules of nab-Paclitaxel in metastatic breast cancer

Estudio aleatorizado de fase II para evaluar distintas pautas de administración de nab-paclitaxel en el cáncer de mama metastásico

A.3.1

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

A trial investigating different treatment plans of the medication nab-Paclitaxel, a chemotherapeutic agent in patients with breast cancer that has spread to other parts of the body.

Estudio que investiga los planes de tratamiento de la medicación nab-paclitaxel, un agente quimioterapéutico en pacientes con cáncer de mama que se ha extendido a otras partes del cuerpo.

A.3.2

Name or abbreviated title of the trial where available

SNAP (Schedules of nab-Paclitaxel)

A.4.1

Sponsor's protocol code number

IBCSG_42-12/BIG_2-12

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01746225

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	International Breast Cancer Study Group (IBCSG)
B.1.3.4	Country	Switzerland
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	Celgene International Sàrl
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	International Breast Cancer Study Group (IBCSG)
B.5.2	Functional name of contact point	IBCSG Coordinating Center
B.5.3	Address:
B.5.3.1	Street Address	Effingerstrasse 40
B.5.3.2	Town/ city	Bern
B.5.3.3	Post code	3008
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+4131389 93 91
B.5.5	Fax number	+4131389 93 92
B.5.6	E-mail	ibcsgcc@ibcsg.org

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	Abraxane
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene Europe Limited, Uxbridge, UK
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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 suspension 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	PACLITAXEL
D.3.9.1	CAS number	33069-62-4
D.3.9.4	EV Substance Code	SUB09583MIG
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	5
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	IMP contiene albúmina como excipiente, derivada de la sangre humana, sujeta a la selección de donantes y a los procesos de fabricación del producto.

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

Patients with histologically or cytologically confirmed HER2-negative metastatic (stage IV) breast cancer who have not received chemotherapy for metastatic breast cancer.

Pacientes con cáncer de mama metastásico HER2-negativo (estadio IV) confirmado por histología o por citología no tratadas con quimioterapia para el cáncer de mama metastásico.

E.1.1.1

Medical condition in easily understood language

Patients recently diagnosed with breast cancer that has spread to other parts of the body (metastatic), for which systemic therapy is needed and have not yet received chemotherapy.

Pacientes con diagnóstico reciente de cáncer de mama que se ha extendido a otras
partes del cuerpo (metástasis), que necesitan terapia sistémica y aún no han recibido quimioterapia.

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	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10027475
E.1.2	Term	Metastatic breast cancer
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of three different schedules of nab-Paclitaxel administration, as measured by progression-free survival (PFS), using the historical reference of PFS of docetaxel for first-line treatment of metastatic breast cancer.

Evaluar la eficacia de tres pautas de administración de nab-paclitaxel, determinada por la supervivencia sin progresión (SSP) y usando como referencia histórica la SSP de docetaxel como tratamiento de primera línea en el cáncer de mama metastásico.

E.2.2

Secondary objectives of the trial

To evaluate:
-Tolerability
- Feasibility
- Disease response according to RECIST criteria, including disease control rate
- Overall survival
-To explore the changes in quality of life (QL) over time until treatment discontinuation.
-To investigate the prognostic role of putative markers (SPARC and caveolin) and assess any change in the expression of SPARC and caveolin between primary and the metastatic sites.

Evaluar:
-La tolerabilidad
-La viabilidad
-La respuesta de la enfermedad según los RECIST, incluida la tasa de control de la enfermedad
-La supervivencia global
-Explorar la variación de la calidad de vida (CDV) a lo largo del tiempo hasta la suspensión del tratamiento.
-Investigar el valor pronóstico de los marcadores indirectos SPARC y caveolina y evaluar cualquier variación en la expresión de SPARC y caveolina entre los focos principal y metastásicos.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Histologically or cytologically confirmed HER2-negative metastatic (stage IV) breast cancer.
Measurable or non-measurable, but radiologically evaluable, disease according to RECIST 1.1 criteria.
Female aged 18 years or older.
Life expectancy > 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Either ER-positive or ER-negative disease. Patients with ER-positive disease must be endocrine resistant, defined as having failed at least one prior endocrine therapy for breast cancer, or must be candidates for first-line chemotherapy.
If previously treated with a taxane or anthracycline in the neoadjuvant or adjuvant setting, the period from end of treatment to disease recurrence must have been > 12 months (> 365 days).
Radiation therapy, if given and regardless of site, must be completed at least 2 weeks prior to randomization.
Normal hematologic status. Must meet all criteria: absolute neutrophil count >= 1500/mm3 (1.5 x 109/L), platelets >= 100 x 109/L and hemoglobin >= 9 g/dL (>= 90 g/L)).
Normal renal function (serum creatinine <= 1.5 ULN or calculated creatinine clearance >= 50mL/min according to the Cockcroft and Gault formula).
Normal liver function. Must meet all criteria: ALT (SGPT) and AST (SGOT) <= 3 × upper limit of normal (ULN) (without liver metastases; total bilirubin <= 1.5 mg/dL;. Exceptions: If the patient has liver metastases, ALT (SGPT) and AST (SGOT) must be <= 5 × ULN; total bilirubin <= 1.5 mg/dL. If the patient has Gilberts disease higher bilirubin is acceptable (<= 3 mg/dL)
Normal cardiac function defined as left ventricular ejection fraction within the institutional range of normal as measured by MUGA or echocardiogram.
Women of child bearing potential must have documented negative pregnancy test within 2 weeks prior to randomization and agree to acceptable birth control during the duration of the trial therapy and for a period of 6 months following the last administration of study drug. If for any reason the administration of first dose of trial treatment is not within 2 weeks of the pregnancy test, a second pregnancy test should be performed within two weeks of day 1 of cycle 1.
Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
Completed baseline Quality of Life Form.
The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
Availability of an FFPE block from the primary tumor (breast lesion) for submission to central pathology review and for translational research.
Written consent to pathology material submission, indicating the patient has been informed of and agrees to tissue material use, transfer and handling, must be signed and dated by the patient and the Investigator prior to randomization.

Cáncer de mama HER2-negativo metastásico (estadio IV confirmado por histología o por citología.
Enfermedad mensurable o no mensurable pero radiológicamente evaluable con arreglo a los criterios RECIST 1.1.
Mujeres de edad igual o superior a 18 años.
Esperanza de vida superior a tres meses.
Estado funcional de 0 o 1 según el Eastern Cooperative Oncology Group (ECOG).
Enfermedad ER positiva o ER negativa. Las pacientes con enfermedad ER positiva deben presentar resistencia al tratamiento hormonal, lo que se define como haber fracasado en al menos un tratamiento hormonal previo contra el cáncer de mama, o ser candidatas a quimioterapia de primera línea.
Si han recibido un tratamiento previo con un taxano o antraciclina en un contexto neoadyuvante o adyuvante, el período desde el final del tratamiento hasta la recidiva de la enfermedad deberá haber sido > 12 meses (> 365 días).
La radioterapia, en caso de haber sido administrada e independientemente de la localización, deberá haberse completado al menos 2 semanas antes de la aleatorización.
Estado hematológico normal. Deberán cumplirse todos los criterios siguientes: recuento absoluto de neutrófilos >= 1500/mm3 (1,5 x 109/l), plaquetas >= 100 x 109/l y hemoglobina ?>=9 g/dl (>= 90 g/l).
Función renal normal (creatinina sérica <= 1,5 x LSN o aclaramiento de creatinina calculado >= 50 ml/min según la fórmula de Cockcroft y Gault).
Función hepática normal. Deberán cumplirse todos los criterios siguientes: ALT (SGPT) y AST (SGOT) <= 3 x límite superior de la normalidad (LSN) (sin metástasis hepáticas); bilirrubina total <= 1,5 mg/dl. Excepciones: Si la paciente presenta metástasis hepática, ALT (SGPT) y AST (SGOT) <= 5 × LSN; bilirrubina total <= 1,5 mg/dl. Si la paciente tiene la enfermedad de Gilbert, se acepta un valor mayor de bilirrubina (<= 3 mg/dl).
Función cardíaca normal, definida como fracción de eyección ventricular izquierda dentro del intervalo de referencia normal del centro, determinada mediante MUGA o ecocardiograma.
Las mujeres en edad fértil deberán tener una prueba de embarazo negativa documentada dentro de las 2 semanas previas a la aleatorización y comprometerse a usar un método anticonceptivo aceptable durante el tratamiento del estudio y durante un período de 6 meses tras la última administración del fármaco del estudio. Si por cualquier motivo la administración de la primera dosis del tratamiento del estudio no se lleva a cabo en el plazo de 2 semanas tras la prueba de embarazo, deberá realizarse otra prueba de embarazo en las dos semanas previas al día 1 del ciclo 1.
El consentimiento informado por escrito (IC) deberá haber sido firmado y fechado por la paciente y por el investigador antes de la aleatorización.
Cuestionario de calidad de vida cumplimentado en el período basal.
La paciente ha sido informada y autoriza la transferencia y gestión de datos de conformidad con la normativa nacional sobre protección de datos.
Disponibilidad de un bloque FFIP del tumor primario (lesión mamaria) para revisión anatomopatológica centralizada e investigación traslacional.
El consentimiento por escrito para la remisión de material anatomopatológico, indicando que la paciente ha sido informada y acepta el uso, la transferencia y el procesamiento de material tisular, deberá haber sido firmado y fechado por la paciente y el investigador antes de la aleatorización

E.4

Principal exclusion criteria

Any prior chemotherapy for metastatic breast cancer.
Presence of CNS metastasis.
Peripheral neuropathy grade 2 or higher (CTCAE version 4).
Significant uncontrolled cardiac disease (i.e. unstable angina, recent myocardial infarction within prior 6 months), patients classified as having a New York Heart Association (NYHA) class III or IV congestive heart failure.
Pregnant or lactating.
Prior history of non-breast malignancy (except for adequately controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, in situ carcinoma of the bladder).
Any concurrent condition which in the Investigator?s opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol.
Contraindications or known hypersensitivity to the study medication or excipients.
The use of any anti-cancer investigational agents within 30 days prior to expected start of trial treatment.
Inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator.

Cualquier quimioterapia previa para el cáncer de mama metastásico.
Presencia de metástasis en el SNC.
Neuropatía periférica de grado 2 o superior (CTCAE, versión 4).
Cardiopatía importante no controlada (es decir, angina inestable, infarto de miocardio en los 6 meses previos); pacientes con insuficiencia cardíaca congestiva de clase III o IV según la New York Heart Association (NYHA).
Embarazo o lactancia.
Antecedentes de cáncer distinto del de mama (excepto carcinoma basocelular cutáneo bien controlado, carcinoma in situ de cuello uterino, carcinoma in situ de vejiga).
Cualquier trastorno simultáneo que, en opinión del investigador, desaconseje la participación de la paciente en el ensayo o pueda poner en peligro el cumplimiento del protocolo.
Contraindicaciones o hipersensibilidad conocida a la medicación del estudio o a los excipientes.
Uso de cualquier otro fármaco antineoplásico en investigación en los 30 días previos al inicio previsto del tratamiento del estudio.
Incapacidad o falta de disposición a cumplir el protocolo del estudio o a colaborar plenamente con el investigador.

E.5 End points

E.5.1

Primary end point(s)

Progression-free survival (PFS): time from randomization to documented progressive disease according to RECIST criteria or death, whichever occurs first.

Supervivencia sin progresión (SSP): tiempo transcurrido desde la aleatorización hasta la progresión documentada de la enfermedad según los RECIST o hasta la muerte, lo que ocurra antes.

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary efficacy endpoint of PFS will be evaluated among each of the three treatment arms separately, in three independent tests, and compared to the historic PFS of first-line docetaxel.
The target number of events per group is 63.

El criterio principal de valoración SSP se evaluará entre cada uno de
los tres grupos de tratamiento por separado, en tres pruebas independientes, y
usando como referencia histórica la SSP de docetaxel como tratamiento de primera línea.
El objetivo de acontecimientos por grupo es de 63.

E.5.2

Secondary end point(s)

Tolerability: adverse events according to CTCAE v4
Feasibility: completing treatment according to the protocol for at least 24 weeks
Disease control: overall response or stable disease (or non-CR/non-PD for patients with non-measurable disease) or better (i.e., partial or complete response) according to RECIST criteria for a duration of ?24 weeks
Overall survival: time from randomization to death from any cause
QL: primary endpoint physical well-being
Prognostic markers: SPARC and caveolin expression

Tolerabilidad: acontecimientos adversos según los CTCAE, versión 4.
Viabilidad: cumplimiento del tratamiento conforme al protocolo durante al menos 24 semanas.
Control de la enfermedad: respuesta global de enfermedad estable (o sin RC/sin PE en pacientes con enfermedad no mensurable) o mejor (es decir, respuesta parcial o completa) según los RECIST en un período ? 24 semanas.
Supervivencia global: tiempo transcurrido desde la aleatorización hasta la muerte por cualquier causa.
CDV: el criterio de valoración principal de la CDV es el bienestar físico
Marcadores pronósticos: expresión de SPARC y caveolina

E.5.2.1

Timepoint(s) of evaluation of this end point

The toxicities and feasibility of each of the three treatment arms will be assessed. OS, disease control rate and other measures of disease response will be evaluated for each treatment arm separately.
The primary quality of life endpoint is physical well-being. The change in QL over time until treatment discontinuation for patients on each arm will be explored using repeated measures modeling.
In translational research, on FFPE material from the primary tumor and metastatic sites separately, it will be evaluated whether SPARC and caveolin are prognostic markers for PFS in women with metastatic breast cancer using log-rank tests and Cox regression analysis.

Se evaluarán las toxicidades y la viabilidad de cada uno de los tres grupos de tratamiento. La SG, la tasa de control de la enfermedad y otras medidas de la respuesta se evaluarán en cada grupo de tratamiento por separado.
El criterio de valoración principal de la calidad de vida es el bienestar físico. La variación de la CDV a lo largo del tiempo hasta la suspensión del tratamiento se investigará en las pacientes de cada grupo utilizando un modelo de medidas repetidas.
En la investigación traslacional, con el material FFIP del tumor primario y de los focos de metástasis por separado, se evaluará si la SPARC y la caveolina son marcadores pronósticos de la SSP en mujeres con cáncer de mama metastásico utilizando pruebas de rango logarítmico y análisis de regresión de Cox.

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

Yes

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

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

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)

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

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

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

Belgium

Hungary

Ireland

Italy

Slovenia

Spain

Switzerland

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

Randomization of 240 patients during approximately 30 months, with an additional 12 months of follow up after the last patient is entered. The end of the trial therefore will be approximately 4 years after randomization of the first patient.
All patients will be followed up until 1 year following the enrollment of the last patient (maximum of 42 months, minimum of 12 months).

Se aleatorizarán 240 pacientes durante aproximadamente 30 meses, con 12 meses adicionales de seguimiento después de que entre el último paciente. Por tanto, la finalización del ensayo será de aproximadamente 4 años después de la asignación al azar del primer paciente.
Todos los pacientes serán seguidos hasta 1 año después de la selección del último paciente (un máximo de 42 meses, un mínimo de 12 meses).

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:

200

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

230

F.4.2.2

In the whole clinical trial

240

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)

If at the end of the trial a patient has not progressed and wants to continue nab-Paclitaxel, the agent will be provided until progressive disease. In this case, adverse events, serious adverse events, treatment, and concomitant medications will continue to be collected.

Si al final del ensayo un paciente no ha progresado y quiere seguir nab-paclitaxel, se proporcionará el agente hasta que la enfermedad progrese. En este caso, los eventos adversos, eventos adversos graves, el tratamiento y los medicamentos concomitantes seguirán siendo recopilada.

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

2013-09-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-09-17

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

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