Clinical Trials Register

Summary
EudraCT Number:	2012-001828-35
Sponsor's Protocol Code Number:	CA209-037
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:	2012-12-10
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

2012-001828-35

A.3

Full title of the trial

A Randomized Open-Label Phase III Trial of BMS-936558 versus Investigator?s Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy

Ensayo fase 3, aleatorizado, abierto, de BMS-936558 frente al tratamiento elegido por el investigador en pacientes con melanoma avanzado (irresecable o metastásico) en progresión después de tratamiento con anti-CTLA-4.

A.3.1

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

A study to compare BMS-936558 to the physician?s choice of either dacarbazine or carboplatin and paclitaxel in advanced melanoma patients that have progressed following anti-CTLA-4 therapy

A.4.1

Sponsor's protocol code number

CA209-037

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	Bristol-Myers Squibb International Corporation
B.1.3.4	Country	Belgium
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	Bristol-Myers Squibb International Corporation
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bristol-Myers Squibb International Corporation
B.5.2	Functional name of contact point	EU Study Start-Up Unit
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance - Avenue de Finlande, 4
B.5.3.2	Town/ city	Braine-l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.6	E-mail	clinical.trials@bms.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	BMS-936558
D.3.2	Product code	BMS-936558
D.3.4	Pharmaceutical form	Solution for injection/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	BMS-936558-01
D.3.9.1	CAS number	946414-94-4
D.3.9.2	Current sponsor code	BMS-936558-01
D.3.9.3	Other descriptive name	Anti-PD-1 Human Monoclonal Antibody; MDX-1106
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	10
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	Yes
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.2.1.1.1	Trade name	Dacarbazine Teva, 200 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Teva Pharma B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Lithuania
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 injection/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	DACARBAZINE
D.3.9.1	CAS number	4342-03-4
D.3.9.4	EV Substance Code	SUB06882MIG
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	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.2.1.1.1	Trade name	PARAPLATIN 450 mg/45 mL
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb S.r.l.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for 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	CARBOPLATIN
D.3.9.1	CAS number	41575-94-4
D.3.9.4	EV Substance Code	SUB06614MIG
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	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	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.2.1.1.1	Trade name	Taxol, 100 mg/ 16.7 ml
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb S.r.l
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.9.3	Other descriptive name	PACLITAXEL
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	6
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
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.2.1.1.1	Trade name	Dacarbazine medac 200mg
D.2.1.1.2	Name of the Marketing Authorisation holder	medac
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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 injection or 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	DACARBAZINE
D.3.9.1	CAS number	4342-03-4
D.3.9.4	EV Substance Code	SUB06882MIG
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.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

Unresectable or metastatic melanoma

melanoma irresecable o metastásico

E.1.1.1

Medical condition in easily understood language

Unresectable or metastatic melanoma

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	10027481
E.1.2	Term	Metastatic melanoma
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

The purpose of the study is to compare the response rate and overall survival of patients taking BMS-936558 to those taking study physician?s choice of either dacarbazine or carboplatin and paclitaxel.

El proposito de el estudio es comparar la tasa de respuestas objetivas (ORR) y la supervivencia global (SG) de BMS-936558 con los tratamientos elegidos por el investigador en sujetos con melanoma avanzado

E.2.2

Secondary objectives of the trial

1. Progression-free survival (PFS)
2. Evaluate whether PD-L1 expression is a predictive biomarker for ORR and OS.
3. To evaluate Health Related Quality of Life (HRQoL) as assessed by the European Organization for Research and Treatment of Care (EORTC) QLQ-C30

?Comparar la supervivencia libre de progresión (SLP) de BMS-936558 con el tratamiento elegido por el investigador en sujetos con melanoma avanzado.
?Evaluar si la expresión de PD-L1 es un biomarcador predictivo de la ORR y SG.
?Evaluar la calidad de vida relacionada con la salud (HRQoL) valorada según el QLQ-C30 de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC)

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific
dated: 07-Aug-2012
The objective of this Amendment is to permit the collection and storage of blood samples for use in future exploratory pharmacogenetic research. Bristol-Myers Squibb will use DNA obtained from the blood
sample and health information collected from the main clinical trial, CA209037 to study the association between genetic variation and drug response.

Enmienda sobre muestras de sangre para farmacogenética Número 01 - Específica de centro de fecha 07-agosto-2012.
El objetivo de esta enmienda es permitir la recogida y la conservación de muestras de sangre para uso en estudios de investigación farmacogenética exploratorios futuros. Bristol-Myers Squibb usará el ADN obtenido de la muestra de sangre y la información de salud recogida del cuaderno de recogida de datos del ensayo clínico principal, CA209-037 para estudiar la asociación entre la variación genética y la respuesta a los medicamentos.

E.3

Principal inclusion criteria

1) men & women ? 18 years of age
2) ECOG PS 0-1
3) Histologically confirmed Stage III (unresectable)/Stage IV melanoma
4) Measurable disease by CT/MRI per RECIST 1.1 criteria
5) RECIST defined disease progression during or after ? 2 prior treatment regimens
6) Pre-treatment fresh core or excision tumor biopsy.
7) Archival FFPE tumor material if available.

1)Varones y mujeres ? 18 de años
2)Estado funcional (ECOG PS ) 0-1
3)Melanoma en estadio III (irresecable) o en estadio IV confirmado histológicamente
4)Enfermedad medible mediante TC o RM según los criterios RECIST 1.1.
5)Los sujetos deben haber experimentado progresión de la enfermedad definida por criterios RECIST durante o después de 1 y como máximo, 2 regímenes de tratamiento para melanoma avanzado.
6)Pre-tratamiento básico nuevo o escisión biopsia tumoral
7) Los sujetos deben dar su consentimiento para permitir la adquisición de material existente fijado en formol e incluido en parafina (FFIP) (?muestra de archivo?) (bloque histológico o un mínimo de 10 preparaciones no teñidas) si está disponible, para la realización de estudios correlativos.

E.4

Principal exclusion criteria

1) Any treatment in a BMS-936558 trial.
2) Subjects with condition requiring systemic treatment with either corticosteroids (> 10mg QD prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration.
3) Active, known or suspected autoimmune disease
4) Unknown BRAF status
5) Active brain metastasis or leptomeningeal metastasis.
6) Ocular melanoma
7) Prior therapy with anti-PD-1, anti-PD-L1 or anti-PD-L2.

1)Cualquier tratamiento en un ensayo clínico con BMS-936558.
2)Sujetos con un problema que precise tratamiento sistémico con corticosteroides (> 10 mg de prednisona al día o equivalente) u otros medicamentos inmunosupresores en el plazo de 14 días antes de la administración del fármaco del estudio. Se permiten los esteroides inhalados o tópicos y dosis de esteroides de sustitución suprarrenal > 10 mg de prednisona diaria o equivalente, en ausencia de enfermedad autoinmune activa.
3)Enfermedad autoinmune activa, conocido o sospechado
4)Sujetos cuyo melanoma tiene un estado desconocido de BRAF.
5)Metástasis cerebral activa o metástasis leptomeníngeo.
6)Melanoma ocular.
7) Sujetos que recibieron tratamiento previo con anti-PD-1, anti-PD-L1 o anti PD L2

E.5 End points

E.5.1

Primary end point(s)

To compare the objective response rate (ORR) and overall survival (OS) of BMS-936558 to investigator?s choice in subjects with advanced melanoma

Comparar la tasa de respuestas objetivas (ORR) y la supervivencia global (SG) de BMS-936558 con los tratamientos elegidos por el investigador en sujetos con melanoma avanzado.

E.5.1.1

Timepoint(s) of evaluation of this end point

ORR (Time frame 23 months) ORR is defined as the number of subjects with a Best Overall Response (BOR) of CR or PR divided by the number of randomized subjects.

OS (Timeframe: 23 months) Overall Survival is defined as the time from randomization to the date of death.

ORR (plazo 23 meses)se define como el numero de sujetos con mejor respuesta global con RC entre el numero de pacientes randomizados
OS,(plazo 23 meses) supervivencia global se define como el tiempo entre la randomizacion y la fecha de muerte

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Timeframe: 23 Months
2. Timeframe: 23 Months
3. Timeframe: 23 Months

1)plazo : 23 meses
2) plazo : 23 meses
3)plazo : 23 meses

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

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Biomarker Assessments, Outcomes Research Assessments, Immunogenicity Assessments

Evaluaciones de biomarcadores, evaluaciones de los resultados de investigación, evaluaciones de inmunogenicidad

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

Austria

Belgium

Brazil

Canada

Denmark

France

Germany

Israel

Italy

Netherlands

Spain

Switzerland

United Kingdom

United States

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

LPLV

ultimo paciente, ultima visita

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:

364

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

156

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

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

170

F.4.2.2

In the whole clinical trial

520

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)

At study end, subjects who continue to demonstrate clinical benefit will be eligible to receive study drug via study extension, rollover study, or another mechanism at sponsor's discretion. Sponsor may terminate access to study drug if any of the following occur: marketing application rejected by health authority; study terminated due to safety concerns; subject can obtain medication from a government sponsored/private health program; or therapeutic alternatives become available in local market.

Alfinaldel estu,los sujequesiguenparademostrarelbeneficiclínicseránelegible para recibir el medicamento del estatravés de la extensión del estu,estdeextens,otromecanis a discreción delSponsorElSponspuedeterminarelaccesoa estudiar medicinasi alguna de las siguientes situaciones:solicitud de comercialización rechazapounaautoridadsanitariaestud termina debido seguridad,suj puede obtemedicación de un programagubernamedesalu dpatrocina oprivado,oalternatiterapéuticasdisponiblesmercadolocal.

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

2013-01-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-01-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-12-29

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