Clinical Trials Register

Summary
EudraCT Number:	2013-001862-41
Sponsor's Protocol Code Number:	CBYL719A2201
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:	2013-10-02
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

2013-001862-41

A.3

Full title of the trial

A phase II randomized, double-blind placebo controlled, study of letrozole with or without BYL719 or buparlisib, for the neoadjuvant treatment of postmenopausal women with hormone receptor-positive HER2-negative breast cancer.

Estudio de fase II, aleatorizado, doble ciego, controlado por placebo, de letrozol
con o sin BYL719 o buparlisib para el tratamiento neoadyuvante de mujeres
postmenopáusicas con cáncer de mama con receptor hormonal positivo y HER2
negativo.

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

CBYL719A2201

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	Novartis Farmacéutica , S.A.
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Novartis Pharma AG
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	Novartis Farmacéutica, S.A.
B.5.2	Functional name of contact point	Departamento Médico Oncología (GMO)
B.5.3	Address:
B.5.3.1	Street Address	Gran Vía de les Corts Catalanes, 764
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08013
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34900353036
B.5.5	Fax number	+34932479903
B.5.6	E-mail	eecc.novartis@novartis.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	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	BYL719
D.3.2	Product code	BYL719
D.3.4	Pharmaceutical form	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	Not available
D.3.9.1	CAS number	1217486-61-7
D.3.9.2	Current sponsor code	BYL719
D.3.9.3	Other descriptive name	BYL719
D.3.9.4	EV Substance Code	SUB31405
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	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	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	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	BYL719
D.3.2	Product code	BYL719
D.3.4	Pharmaceutical form	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	Not available
D.3.9.1	CAS number	1217486-61-7
D.3.9.2	Current sponsor code	BYL719
D.3.9.3	Other descriptive name	BYL719
D.3.9.4	EV Substance Code	SUB31405
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	200
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	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	BKM120
D.3.2	Product code	BKM120
D.3.4	Pharmaceutical form	Capsule, hard
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	buparlisib
D.3.9.1	CAS number	BKM120
D.3.9.2	Current sponsor code	BKM120
D.3.9.3	Other descriptive name	BKM120
D.3.9.4	EV Substance Code	SUB30592
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	10
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: 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	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	BKM120
D.3.2	Product code	BKM120
D.3.4	Pharmaceutical form	Capsule, hard
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	buparlisib
D.3.9.1	CAS number	BKM120
D.3.9.2	Current sponsor code	BKM120
D.3.9.3	Other descriptive name	BKM120
D.3.9.4	EV Substance Code	SUB30592
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	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	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: 5
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	FEMARA
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Farmacéutica, S.A.
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	letrozole
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	LETROZOLE
D.3.9.1	CAS number	112809-51-5
D.3.9.2	Current sponsor code	LETROZOLE
D.3.9.3	Other descriptive name	LETROZOLE
D.3.9.4	EV Substance Code	SUB08444MIG
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	2.5
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	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 4
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

neoadjuvant hormone-receptor positive HER2-negative breast cancer

Cáncer de mama

E.1.1.1

Medical condition in easily understood language

neoadjuvant hormone-receptor positive HER2-negative breast cancer

Cáncer de mama

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

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 assess the anti-tumor activity of BYL719 QD plus letrozole and buparlisib QD plus letrozole versus letrozole alone in increasing the pathologic complete response (pCR) rate during neo-adjuvant treatment for each of the two groups: i) PIK3CA mutated and ii) PIK3CA wild tumor types.

Evaluar la actividad antitumoral de BYL719 q.d. más letrozol y buparlisib q.d. más
letrozol, frente a letrozol como fármaco único a la hora de aumentar la tasa de
respuesta patológica completa (RPC) durante el tratamiento neoadyuvante en
pacientes postmenopáusicas con cáncer de mama con RH+ y HER2- en cada una
de las dos cohortes: tumores con 1) PIK3CA mutado y 2) PIK3CA no mutado.

E.2.2

Secondary objectives of the trial

- objective response rate (RR, complete + partial) for each of the 2 groups, namely i) PIK3CA mutated and ii) PIK3CA wild tumor types.
-- safety and tolerability of the combinations for each of the two groups...
--estimate rate of breast conserving surgery

- Evaluar la tasa de respuesta objetiva (TR, completa + parcial) en cada una de las
dos cohortes: 1) PIK3CA mutado y 2) PIK3CA no mutado.
- Evaluar la seguridad y la tolerabilidad de las combinaciones de fármacos en cada
una de las dos cohortes: 1) PIK3CA mutado y 2) PIK3CA no mutado.
- Estimar la tasa de cirugía con conservación de mama en cada una de las dos cohortes: 1) PIK3CA mutado y 2) PIK3CA no mutado.
- Evaluar la asociación entre los cambios en Ki67 desde la basal hasta el día 15 y
desde la basal hasta la cirugía, con RPC en cada una de las dos cohortes: 1)
PIK3CA mutado y 2) PIK3CA no mutado.
- Evaluar la puntuación del índice de pronóstico endocrino preoperatorio (PEPI) en cada una de las 2 cohortes: 1) PIK3CA mutado y 2) PIK3CA no mutado.
- Caracterizar la farmacocinética de BYL719/buparlisib y letrozol administrados en combinación.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patient has T2-T3, any N, M0, operable breast cancer.
- Patients must have measurable tumor.
- Patient has diagnostic biopsy available for the analysis of PIK3CA mutation and Ki67 level.
- Patient has estrogen-receptor and/or progesterone positive breast cancer as
per local laboratory testing.
Patient has HER2 negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0 or 1+ as per local laboratory testing.
- Patient has known PIK3CA mutation status (mutated or wild-type) as defined
by a Novartis designated laboratory. (Patients with unknown PIK3CA mutation
status will not be enrolled).
- Patient has Ki67 level status determined centrally.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance
status ? 1 which the investigator believes is stable at the time of screening.

- Pacientes con cáncer de mama operable T2-T3, cualquier N, M0.
- Pacientes con un tumor medible.
- Pacientes con una biopsia de diagnóstico disponible para el análisis de la
mutación de PIK3CA y el nivel de Ki67.
- Pacientes con cáncer de mama con receptor de estrógenos y/o progesterona
positivo según las pruebas analíticas locales.
- Pacientes con cáncer de mama con HER2 negativo definido como negativo en la prueba de hibridización in situ o un estado de IHQ de 0 o 1+ según las pruebas analíticas locales.
- Pacientes con un estado de mutación conocido de PIK3CA (mutado o no
mutado) según la definición del laboratorio designado por Novartis (No se incluirán pacientes con un estado de mutación de PIK3CA desconocido).
- Pacientes con un estado de nivel de Ki67 determinado centralmente.
- Pacientes con un estado funcional ? 1 del Eastern Cooperative Oncology Group (ECOG) que el investigador considera estable en el momento de la selección.

E.4

Principal exclusion criteria

- Patient has locally recurrent or metastatic disease.
- Patient has received any systemic therapy (e.g. chemotherapy, targeted
therapy, immunotherapy) or radiotherapy for current breast cancer disease
before study entry.
- Patient with clinically manifest diabetes mellitus (fasting glucose > 120 mg/dl
or 6.7 mmol/L), or documented steroid induced diabetes mellitus.
- Patient has a score ? 12 on the PHQ-9 questionnaire.
- Patient selects a response of ?1, 2 or 3? to question number 9 on the PHQ-9
questionnaire regarding potential for suicidal thoughts or ideation (independent
of the total score of the PHQ-9).
- Patient has a GAD-7 mood scale score ? 15.
- Patient has a medically documented history of or active major depressive
episode, bipolar disorder (I or II), obsessive-compulsive disorder,
schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation
(e.g. risk of doing harm to self or others), or with an active severe personality
disorder (defined according to DSM- IV). Note: for patients with psychotropic
treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug.
- Patient has ? CTCAE grade 3 anxiety.

- Pacientes con una enfermedad metastásica o localmente recurrente.
- Pacientes que hayan recibido un tratamiento sistémico (p. ej. quimioterapia,
tratamiento dirigido, inmunoterapia) o radioterapia para el cáncer de mama
actual antes de la entrada en el estudio.
- Pacientes con diabetes mellitus clínicamente manifiesta (glucosa en ayunas >120 mg/dl o 6,7 mmol/L o diabetes mellitus inducida por esteroides documentada.
- Pacientes con una puntuación ? 12 en el cuestionario PHQ-9.
- Pacientes que seleccionen la respuesta ?1, 2 o 3? en la pregunta número 9 del
cuestionario PHQ-9 relativa al potencial de pensamientos o ideación suicidas
(independiente de la puntuación total del PHQ-9).
- Pacientes con una puntuación de ? 15 en la escala sobre el estado de ánimo
GAD-7.
- Pacientes con antecedentes médicamente documentados de o episodio depresivo mayor activo, trastorno bipolar (I o II), trastorno obsesivocompulsivo,
esquizofrenia o antecedentes de intentos de suicidio o pensamientos suicidas u homicidas (p. ej., riesgo de autolesionarse o hacer daño a los demás) o pacientes con trastornos graves activos de la personalidad (definidos en el DSM IV). Nota: para las pacientes en tratamiento con psicotrópicos en curso en la visita basal, la dosis y el esquema no se deberán haberse modificado durante las 6 semanas anteriores al inicio del fármaco del estudio.
- Pacientes con ansiedad de grado ? 3 de los CTCAE.

E.5 End points

E.5.1

Primary end point(s)

Pathologic complete response

La respuesta patológica completa

E.5.1.1

Timepoint(s) of evaluation of this end point

following 24 weeks of treatment

Después de 24 semanas de tratamiento

E.5.2

Secondary end point(s)

--ORR
--safety & tolerability
--breast conserving surgery
--changes in Ki67
--assessment of PEPI score
--PK for buparlisib/BYL719 and letrozole

--Evaluar la tasa de respuesta objetiva (TR, completa + parcial)
--Evaluar la seguridad y la tolerabilidad
--Estimar la tasa de cirugía con conservación de mama
--Evaluar los cambios en Ki67
--Evaluar la puntuación del índice de pronóstico endocrino preoperatorio (PEPI)
--Caracterizar la farmacocinética de BYL719/buparlisib y letrozol administrados en combinación

E.5.2.1

Timepoint(s) of evaluation of this end point

Along the trial

Durante todo el 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

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Yes

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

Yes

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

Argentina

Australia

Austria

Belgium

Brazil

Canada

China

Colombia

Czech Republic

Denmark

Finland

France

Greece

Hong Kong

Hungary

India

Italy

Japan

Lebanon

Netherlands

Norway

Peru

Poland

Russian Federation

Singapore

South Africa

Spain

Sweden

Taiwan

United Kingdom

United States

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

Until disease progression, surgery, unacceptable toxicity, death or discontinuation plus 30 days for safety follow-up

Hasta la progresión de la enfermedad, cirugía, toxicidad inaceptable, muerte o suspensión de más de 30 días para la seguridad de seguimiento.

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

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:

300

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

218

F.4.2.2

In the whole clinical trial

372

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)

After discontinuing study treatment further treatment is left to the physician's discretion.
No cross-over is allowed.

Después de descontinuar el tratamiento del estudio, se deja a criterio del médico un tratamiento adicional.
No se permite cruzado.

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

2013-11-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-11-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-07-08

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