Clinical Trials Register

Summary
EudraCT Number:	2012-003481-41
Sponsor's Protocol Code Number:	FM-12-B01
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:	2013-04-09
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

2012-003481-41

A.3

Full title of the trial

Neoadjuvant chemotherapy with nab-paclitaxel in women with HER2-negative high-risk breast cancer ETNA (Evaluating Treatment with Neoadjuvant Abraxane)

Quimioterapia neoadyuvante con nab-paclitaxel en pacientes con cáncer de mama HER2 negativo de alto riesgo.
ETNA (Evaluación del Tratamiento Neoadyuvante con Abraxane)

A.3.1

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

Preoperative chemotherapy with nab-paclitaxel in women with HER2-negative high-risk breast cancer

Quimioterapia neoadyuvante con nab-paclitaxel en pacientes con cáncer de mama HER2 negativo de alto riesgo.

A.3.2

Name or abbreviated title of the trial where available

ETNA

A.4.1

Sponsor's protocol code number

FM-12-B01

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	FONDAZIONE MICHELANGELO - AVANZAMENTO DELLO STUDIO E CURA DEI TUMORI
B.1.3.4	Country	Italy
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 Sarl
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	Fondazione Michelangelo
B.5.2	Functional name of contact point	Ufficio Operativo
B.5.3	Address:
B.5.3.1	Street Address	Via Giacomo Venezian, 1
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20133
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 02 2390 3451
B.5.5	Fax number	+39 02 2390 2678
B.5.6	E-mail	elisa.coradeschi@fondazionemichelangelo.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
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 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/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	125
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	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.5	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 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	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/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	90
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	antineoplastico

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 HER2-negative, early invasive unilateral breast cancer who are at risk of disease recurrence and suitable for neoadjuvant chemotherapy

Pacientes con cáncer de mama unilateral no metastásico HER2 negativo que tienen un alto riesgo de recidiva y son candidatas a tratamiento con quimioterapia neoadyuvante.

E.1.1.1

Medical condition in easily understood language

Patients with HER2-negative, early invasive unilateral breast cancer who are at risk of disease recurrence and suitable for preoperative chemotherapy

Pacientes con cáncer de mama unilateral no metastásico HER2 negativo que tienen un alto riesgo de recidiva y son candidatas a tratamiento con quimioterapia neoadyuvante.

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10006283
E.1.2	Term	Breast neoplasm malignant female
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 compare the rate of pathologic Complete Response (pCR, defined as ypT0-Tis, ypN0) for abraxane vs paclitaxel

Comparar la tasa de respuesta completa patológica (RCp), definida como ypT0-Tis, ypN0) de abraxane (Abraxane®) vs paclitaxel.

E.2.2

Secondary objectives of the trial

To compare the pCR rates in the two main subgroups of ER and/or PgR positive tumors and triple-negative tumors separately. To compare the rate of clinical overall response (cOR) after the first 4 cycles of abraxane vs paclitaxel. To compare the rate of cOR after the entire preoperative chemotherapy in the study arms. To compare the Event Free Survival (EFS, i.e. disease progression while on primary therapy or disease recurrence after surgery) in the study arms. To compare the Distant EFS (DEFS) in the study arms. To compare the Local EFS (LEFS) in the two study arms. To compare the Regional EFS (REFS) in the two study arms. To compare the overall survival (OS) in the study arms. To evaluate the tolerability of the treatment regimens. To conduct molecular and clinical analyses to assess the presence of predictive markers of benefit.

Comparar la tasa de RCp entre los dos principales subgrupos de
tumores (RE y/o RPg positivos y tumores triple negativo).Comparar la tasa de respuesta global clínica (RGc) tras los
primeros 4 ciclos de abraxane vs paclitaxel.Comparar la tasa de RGc una vez terminada la quimioterapia
neoadyuvante (es decir, antes de la cirugía) entre los brazos de tratamiento (abraxane vs paclitaxel).Comparar la supervivencia libre de evento (SLE, es decir, la progresión de la enfermedad mientras la paciente está siendo tratada con el tratamiento primario o recidiva después de cirugía), entre los brazos de tratamiento (abraxane vs paclitaxel). Comparar la supervivencia libre de evento a distancia (SLED) entre los brazos de tratamiento (abraxane vs paclitaxel).Comparar la supervivencia libre de evento local (SLEL) entre los
dos brazos de tratamiento (abraxane vs paclitaxel).Comparar la supervivencia libre de evento regional (SLER) entre
los dos brazos de tratamiento (abraxane vs paclitaxel)...

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Female patients aged 18 years or older 2. Histologically confirmed invasive unilateral breast cancer 3. HER2-negative disease (defined as 0-1+ by immunohistochemistry or 2+ by immunohistochemistry without HER2 amplification by either FISH, CISH, or other amplification tests done locally) 4. Known hormone receptor status (estrogen receptor [ER], progesterone receptor [PgR]), tumor grade and, if institutional standard permits, known Ki67 value 5. Available paraffin-embedded tumor block taken at diagnostic biopsy for central confirmation of HER2 eligibility, hormone receptor status, Ki67 value and biomarker evaluation is mandatory 6. One of the following clinical stages: a. T2, T3, T4 disease, triple negative (HER2, ER, PgR) b. T2, T3, T4 disease, ER or PgR positive and moderately differentiated or poorly differentiated tumor grade (G II-III) 7. ECOG performance status 0 or 1 8. Written informed consent to participate in the trial (approved by the Institutional Review Board [IRB]/ Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures 9. Willing and able to comply with the protocol

1. Mujeres ? 18 años.
2. Cáncer de mama infiltrante unilateral histológicamente confirmado.
3. HER2 negativo (definido como 0-1+ mediante inmunohistoquímica o 2+ mediante inmunohistoquímica sin amplificación de HER2 mediante FISH, CISH u otra prueba de amplificación realizada en el centro ).
4. Estado conocido de receptores hormonales (receptor estrogénico [RE], receptor de la progesterona [RPg]), grado tumoral y, si lo permite la práctica habitual del centro, valor de Ki67 conocido.
5. Es obligatoria la disponibilidad de un bloque del tumor embebido en parafina obtenido de la biopsia diagnóstica para la confirmación por parte del laboratorio central de la elegibilidad con respecto al HER2, al estado de los receptores hormonales, el valor de Ki67 y para la evaluación de los biomarcadores.
6. Uno de los siguientes estados clínicos:
a. Enfermedad T2, T3, T4, triple negativo (HER2, RE, RPg)
b. Enfermedad T2, T3, T4, RE o RPg positivo y grado tumoral moderada o pobremente diferenciado (G II-III).
7. ECOG ?1

8. Consentimiento informado por escrito (aprobado por el Comité Ético de Investigación Clínica [CEIC] del centro médico participante) obtenido antes de realizar cualquiera de los procedimientos específicos del ensayo.
9. Disposición y capacidad para cumplir con el protocolo.

E.4

Principal exclusion criteria

1. Synchronous bilateral breast cancer or presence of metastatic disease (M1) 2. Surgical axillary staging procedure prior to study entry. Exceptions: 1) FNA of an axillary node is permitted for any patient, and 2) although not recommended, a pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes is permitted 3. Pregnant or lactating women. Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs and for women less than one year after the last menstrual cycle 4. Women with childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception, for example abstinence, an intra-uterine device, or double barrier method of contraception 5. Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy for the currently diagnosed breast cancer prior to study entry 6. Previous investigational treatment for any condition within 4 weeks of randomization date 7. Patients on therapy with a strong CYP3A4 inhibitor 8. Previous or concomitant malignancy of any other type that could affect compliance with the protocol or interpretation of results. Patients with curatively treated basal cell carcinoma of the skin or in situ cervix cancer are generally eligible. 9. Pre-existing motor or sensory neuropathy of grade > 1 for any reason 10. Patients with a history of hypersensitivity due to drugs containing polyoxyethylene castor oil (Cremophor EL) (e.g., ciclosporin), or hardened castor oil (e.g., vitamin preparations for injection, etc.) 11. Other serious illness or medical condition including: history of documented congestive cardiac failure; angina pectoris requiring anti-anginal medication; evidence of transmural infarction on ECG; poorly controlled hypertension (e.g. systolic >180 mm Hg or diastolic >100 mm Hg; however, patients with hypertension which is well controlled on medication are eligible); clinically significant valvular heart disease; high-risk uncontrolled arrhythmias 12. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and precluding informed consent or adversely affecting compliance with study drugs 13. Serious uncontrolled infections (bacterial or viral) or poorly controlled diabetes mellitus 14. Any of the following abnormal baseline hematological values: a. Absolute Neutrophil Count (ANC) < 1.5 ? 109/L b. Platelet count < 100 ? 109/L c. Hemoglobin (Hb) < 10 g/dL 15. Any of the following abnormal baseline laboratory tests a. Serum total bilirubin > 1.5 ? ULN (upper limit of normal) (except for patients with clearly documented Gilbert?s syndrome) b. Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.25 ? ULN c. Alkaline phosphatase > 2.5? ULN d. Serum creatinine > 1.5 ? ULN 16. Baseline left ventricular ejection fraction (LVEF) < 50% by echocardiography or multi-gated scintigraphic scan (MUGA)

1. Cáncer de mama contralateral sincrónico o presencia de enfermedad metastásica (M1), con la excepción del cáncer ductal in situ contralateral.
2. Cirugía de los ganglios linfáticos axilares realizada antes de la entrada en el estudio. Excepciones: 1) en todas las pacientes se permite la PAAF de un ganglio linfático axilar, y 2) aunque no se recomienda, se permite la biopsia selectiva del ganglio centinela antes del tratamiento neoadyuvante para las pacientes con ganglios linfáticos axilares clínicamente negativos.
3. Pacientes embarazadas o lactantes. Debe quedar documentado un resultado negativo en la prueba de embarazo en el caso de las mujeres premenopáusicas cuyo aparato reproductor esté intacto y en el caso de las pacientes en las que haya transcurrido menos de un año desde la última menstruación.
4. Pacientes en edad fértil, a menos que 1) haya sido esterilizada quirúrgicamente o 2) utilice métodos anticonceptivos adecuados (por ejemplo, abstinencia sexual, dispositivo intrauterino o método de doble barrera).
5. Tratamiento previo para el cáncer de mama: radioterapia, quimioterapia, tratamientos biológicos y/o terapia hormonal.
6. Tratamiento en investigación dentro de las 4 semanas anteriores a la aleatorización.
7. Pacientes en tratamiento con un inhibidor potente de CYP3A4 y en tratamiento con warfarina.
8. Enfermedades malignas previas o concomitantes de cualquier tipo que pudieran afectar negativamente al cumplimiento del protocolo o a la interpretación de los resultados. Son elegibles las pacientes con carcinoma basocelular de la piel o carcinoma in situ de cérvix adecuadamente tratados.
9. Neuropatía motora o sensitiva preexistente de grado > 1 debida a cualquier causa.
10. Pacientes con antecedentes de hipersensibilidad a los fármacos que contienen aceite de ricino de polioxietileno (Cremophor EL) (p. ej., ciclosporina), o aceite de ricino hidrogenado (p. ej., preparados vitamínicos para inyección).
11. Otras alteraciones o enfermedades graves, tales como antecedentes de insuficiencia cardíaca congestiva documentada, angina de pecho que requiere tratamiento con antianginosos, evidencia de infarto transparietal por electrocardiograma (ECG), hipertensión arterial mal controlada (p. ej., tensión arterial sistólica >180 mmHg o diastólica >100 mmHg; no obstante, son elegibles las pacientes con hipertensión arterial bien controlada con medicación), valvulopatía clínicamente importante y arritmias no controladas de alto riesgo.
12. Antecedentes de crisis convulsivas, enfermedades del sistema nervioso central o trastornos psiquiátricos no controlados que a juicio del investigador sean clínicamente significativos y afecten a la capacidad de la paciente para dar su consentimiento o para cumplir con el tratamiento del ensayo clínico.
13. Infecciones bacterianas o víricas serias no controladas o diabetes mellitus mal controlada.
14. Cualquiera de los siguientes valores hematológicos basales anómalos:
a. Recuento absoluto de neutrófilos (RAN) < 1,5 ? 109/l
b. Recuento de plaquetas < 100 ? 109/l
c. Hemoglobina (Hb) < 10 g/dl
15. Cualquiera de los siguientes valores basales anómalos en los análisis de laboratorio:
a. Bilirrubina total sérica > 1,5 ? LSN (límite superior de la normalidad) (excepto en el caso de las pacientes con síndrome de Gilbert documentado)
b. Transaminasa alanina (ALT) o transaminasa aspartato (AST) > 1,25 ? LSN
c. Fosfatasa alcalina > 2,5? LSN
d. Creatinina sérica > 1,5 ? LSN
16. Fracción de eyección del ventrículo izquierdo (FEVI) basal < 50% detectada mediante ecocardiografía o ventriculografía isotópica (MUGA).

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is pathological complete response (pCR) defined as absence of invasive disease in breast and nodes (ypT0/ypTis, ypN0).

El criterio de valoración principal es la respuesta patológica completa
(RCp), que se define como ausencia de enfermedad infiltrante en la
mama y en ganglios linfáticos (ypT0/ypTis, ypN0).

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary endpoint will be evaluated at the time of surgery: approximately 40 months after the randomization of the first patient, that is when all the 632 patients required by sample size specifications have completed their courses of treatment and reached the surgery phase.

El análisis principal se llevará a cabo aproximadamente unos 40 meses después de la aleatorización de la primera paciente, que es cuando el total de las 632 pacientes requeridas habrán completado el tratamiento y habrán llegado a la cirugía.

E.5.2

Secondary end point(s)

The secondary endpoints are: - the rate of clinical overall response (cOR) - Event Free Survival (EFS, i.e. disease progression while on primary therapy or disease recurrence after surgery) - Distant EFS (DEFS) - Local EFS (LEFS) - Regional EFS (REFS) - overall survival (OS) - the tolerability of the treatment regimens

Los objetivos secundarios son: comparar la tasa de RCp, comparar la tasa de respuesta global clínica (RGc) tras los primeros 4 ciclos de abraxane vs paclitaxel, comparar la tasa de RGc una vez terminada la quimioterapia neoadyuvante (es decir, antes de la cirugía), comparar la supervivencia libre de evento (SLE), es decir, la progresión de la enfermedad mientras la paciente está siendo tratada con el tratamiento primario o recidiva después de cirugía), comparar la supervivencia libre de evento a distancia (SLED), comparar la supervivencia libre de evento local (SLEL), comparar la supervivencia libre de evento regional (SLER), comparar la supervivencia global (SG), evaluar la tolerabilidad de los regímenes terapéuticos en los dos brazos de tratamiento.

E.5.2.1

Timepoint(s) of evaluation of this end point

cOR will be evaluated after the first 4 cycles (approximately 40 months after the randomization of the first patient, that is when all the 632 patients required by sample size specifications have completed their courses of treatment and reached the surgery phase). The first analysis of EFS will take place 5 years and 10 years after the randomization of the first patient

La tasa de RCp será evaluada después de los primeros 4 ciclos (aproximadamente 40 meses después de la asignación al azar de la primera paciente, es decir, cuando todas las 632 pacientes requeridas hayan completado sus ciclos de tratamiento y hayan sido sometidas a cirugía). El análisis de SLE se llevará a cabo a los 5 y 10 años después de la randomización de la primera paciente.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

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

Australia

Italy

Russian Federation

Singapore

Spain

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

LVLS

Última Visita de la última paciente incluida

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

150

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

150

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:

632

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

632

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

150

F.4.2

For a multinational trial

F.4.2.1

In the EEA

322

F.4.2.2

In the whole clinical trial

632

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)

Patients should be treated according to the investigator's clinical judgment

Las pacientes serán tratadas según criterio del investigador.

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

2013-06-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-05-07

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

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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