Clinical Trials Register

Summary
EudraCT Number:	2014-005277-36
Sponsor's Protocol Code Number:	GEM-01-15
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:	2015-01-08
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

2014-005277-36

A.3

Full title of the trial

A randomized Phase II study of vemurafenib plus cobimetinib continuous versus intermittent, in previously untreated BRAFV600- mutation positive patients with unresectable locally advanced or metastatic melanoma.

Estudio fase II aleatorizado de vemurafenib y cobimetinib administrados de forma continua o intermitente, en pacientes con melanoma avanzado irresecable o metastásico con la mutación BRAF V600, no tratados previamente.

A.3.1

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

Clinical Trial to evaluate the efficacy of vemurafenib in combination with cobimetinib (continuous and intermittent) in BRAFV600-mutation positive patients with unresectable locally advanced or metastatic melanoma.

Ensayo clínico para evaluar la eficacia de vemurafenib y cobimetinib (pauta continua e intermitente), en el tratamiento de primera línea de pacientes con melanoma avanzado irresecable o metastásico con la mutación BRAF V600.

A.4.1

Sponsor's protocol code number

GEM-01-15

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	Grupo Español Multidisciplicinar de Melanoma (GEM)
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Roche Farma, S.A
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pivotal, S.L.
B.5.2	Functional name of contact point	Paz González
B.5.3	Address:
B.5.3.1	Street Address	C/ Gobelas, 19. La Florida
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28023
B.5.3.4	Country	Spain
B.5.4	Telephone number	+3491780 12 501255
B.5.5	Fax number	+3491780 13 01
B.5.6	E-mail	paz.gonzalez@pivotal.es

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	Zelboraf 240 mg comprimidos recubiertos con pelicula
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	VEMURAFENIB
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	zelboraf
D.3.9.1	CAS number	918504-65-1
D.3.9.3	Other descriptive name	VEMURAFENIB
D.3.9.4	EV Substance Code	SUB32161
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	240
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	Cobimetinib
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	Cobimetinib
D.3.9.1	CAS number	934660-93-2
D.3.9.2	Current sponsor code	Cobimetinib
D.3.9.3	Other descriptive name	COBIMETINIB
D.3.9.4	EV Substance Code	SUB122319
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	20
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

BRAFV600-mutation positive patients with unresectable locally advanced or metastatic melanoma.

Pacientes con melanoma avanzado irresecable o metastásico con la mutación BRAF V600

E.1.1.1

Medical condition in easily understood language

Unresectable locally advanced or metastatic melanoma.

Melanoma avanzado irresecable o metastásico

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	17.1
E.1.2	Level	LLT
E.1.2	Classification code	10053571
E.1.2	Term	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

To evaluate the efficacy (in terms of PFS) of two schedules of administration of vemurafenib in combination with cobimetinib (continuous and intermittent) in previously untreated BRAFV600- mutation positive patients with unresectable locally advanced or metastatic melanoma.

Evaluar la eficacia, en términos de supervivencia libre de progresión (SLP), de dos pautas de administración de la combinación de vemurafenib y cobimetinib (continua e intermitente), en el tratamiento de primera línea de pacientes con melanoma avanzado irresecable o metastásico con la mutación BRAF V600.

E.2.2

Secondary objectives of the trial

- Efficacy of both schedule of treatment:
* % overall response rate.
* SLP rate at 1 an d 2 years
* Global supervivence at 1 and 2 years.
- Toleralibility of both schedule of treatmen (AEs, SAEs..)

- Evaluar la eficacia de ambos esquemas de tratamiento:
* % de respuestas objetivas (ORR),
* Tasas de SLP a 1 y 2 años
* Supervivencia global (SG): mediana y tasas a 1 y 2 años.
- Evaluar la tolerabilidad de ambas pautas de administración (AEs, SAEs..).

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

Associated translational sub-study to determinate (optional):
- BRAF mutations on cfDNA .
- Determination of expression levels of a panel of genes from mRNA.
- Study of markers in solid biopsy.

Subestudio traslacional asociado (opcional):
- Mutación BRAF determinada en cell free DNA (cfDNA).
- Cuantificación de la expresión de genes seleccionados, a partir de mRNA en sangre.
- Determinar mecanismos de resistencia en biopsias secuenciales de la enfermedad

E.3

Principal inclusion criteria

Disease-Specific Inclusion Criteria:
1. Patients with histologically confirmed melanoma, either unresectable stage IIIc or stage IV metastatic melanoma.
2. Patients must be naïve to treatment for locally advanced unresectable or metastatic disease.
3. Documentation of BRAFV600 mutation-positive status in melanoma tumor tissue.
4. Measurable disease per RECIST v1.1.
5. ECOG performance status of 0 or 1.
6. Additionally, patients to be included in the biomarker sub- study should meet the following criteria:
- Consent to provide archival tissue for biomarker analyses.
- Consent to undergo tumor biopsies.
General Inclusion Criteria:
7. Male or female patient aged major or equal 18 years.
8. Able to participate and willing to give written informed.
9. Life expectancy mayor o igual 12 weeks.
10. Adequate hematologic and end organ function, within 14 days prior to first dose of study drug treatment:
- ANC major or equal 1.5 × 109/L.
- Platelet count major or equal 100 × 109/L.
- Hemoglobin major or equal 9 g/dL.
- Albumin major or equal 2.5 g/dL.
- Bilirubin minor or equal 1.5 × the upper limit of normal (ULN).
- AST, ALT, and alkaline phosphatase minor or equal 3 × ULN, with the following exceptions:
- Patients with documented liver metastases: AST and/or ALT minor or equal 5 × ULN.
- Patients with documented liver or bone metastases alkaline phosphatase minor o equal 5 × ULN.
- Serum creatinina minor o equal 1.5 × ULN or CrCl major or equal 40 mL/min on the basis of measured CrCl from a 24- hour urine collection.
11. Female patients of childbearing potential and male patients with partners of childbearing potential must agree to always use 2 effective forms of contraception during the course of this study and for at least 6 months after completion of study therapy.
12. Negative serum pregnancy test within 10 days prior to commencement of dosing in women of childbearing potential.
13. Absence of any psychological, familial, sociological, or geographical condition that potentially hampers compliance with the study protocol and follow-up after treatment discontinuation schedule.

Criterios específicos de la enfermedad
1. Pacientes con melanoma histológicamente confirmado, ya sea melanoma en estadio IIIc irresecable o metastásico en estadio IV.
2. Los pacientes no podrán haber recibido tratamiento previo por enfermedad localmente avanzada irresecable o metastásica.
3. Confirmación de la presencia de la mutación BRAF V600 en tejido tumoral de melanoma.
4. Pacientes con enfermedad medible según la clasificación RECIST versión 1.1.
5. Estado functional ECOG mayor o igual 1.
6. Pacientes que vayan a participar en el subestudio de biomamarcadores deberán cumplir los siguientes criterios:
- Consentimiento para el análisis de biomarcadores en el tejido tumoral.
- Consentimiento para la obtención de biopsias.
Criterios generales
7. Varones o mujeres mayor o igual a 18 años.
8. Capacidad para participar y disposición a otorgar el consentimiento informado por escrito.
9. Esperanza de vida mayor o igual 12 semanas.
10. Función hematológica y orgánica adecuada, en los 14 días previos a la primera dosis de tratamiento:
- Recuento absoluto de neutrófilos mayor o igual 1.5 x 109//L
- Recuento de plaquetas mayor o igual 100 x 109/L
- Hemoglobina mayor o igual 9 g/dL
- Albúmina mayor o igual 2,5 g/dL
- Bilirrubina sérica menor o igual 1,5 x LSN
- (AST [SGOT]), (ALT [SGPT]) y fosfatasa alcalina menor o igual 3 x LSN, con las siguientes excepciones:
o En pacientes con metástasis hepáticas documentadas la AST y/o ALT serán menor o igual 5 x LSN
o En pacientes con metástasis hepáticas u óseas documentadas la fosfatasa alcalina será menor o igual 5 x LSN
- Creatinina sérica menor o igual 1,5 veces el límite superior de la normalidad (LSN), o aclaramiento de creatinina (CrCl) mayor o igual a 40 mL/m medido en orina de 24h.
11. Las mujeres en edad fértil y los varones con parejas en edad fértil deberán comprometerse a utilizar siempre dos métodos anticonceptivos eficaces durante el transcurso de este estudio y durante al menos 6 meses después de la finalización del tratamiento del estudio.
12. Prueba de embarazo en suero negativa en los 10 días previos al comienzo de la administración en las mujeres en edad fértil.
13. Ausencia de cualquier situación psicológica, familiar, sociológica o geográfica que pueda dificultar el cumplimiento del protocolo del estudio y el calendario de seguimiento después de la suspensión del tratamiento; este tipo de situaciones deberán comentarse con el paciente antes de su incorporación al ensayo clínico.

E.4

Principal exclusion criteria

Cancer-Related Exclusion Criteria:
1. History of prior RAF or MEK pathway inhibitor treatment.
2. Palliative radiotherapy within 14 days prior to the first dose of study treatment.
3. Major surgery or traumatic injury within 14 days prior to first dose of study treatment.
4. Active malignancy other than melanoma that could potentially interfere with the interpretation of efficacy measures. Patients with a previous malignancy within the past 3 years are excluded except for patients with resected BCC or SCC of the skin, melanoma in-situ, carcinoma in-situ of the cervix, and carcinoma in-situ of the breast.
5. History of isolated elevation in prostate-specific antigen in the absence of radiographic evidence of metastatic prostate cancer is allowed.

Exclusion Criteria Based on Organ Function Ocular:
6. History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion (RVO), or neovascular macular degeneration.
7. The risk factors for RVO are listed below. Patients will be excluded if they have the following conditions:
- Uncontrolled glaucoma with intra-ocular pressures > 21 mmHg.
- Serum cholesterol major or equal Grade 2.
- Hypertriglyceridemia major or equal Grade 2.
- Hyperglycemia (fasting) major or equal Grade 2.

Cardiac:
8. History of clinically significant cardiac dysfunction, including the following:
- Current unstable angina.
- Symptomatic congestive heart failure of New York
Heart Association class 2 or higher.
- History of congenital long QT syndrome or mean (average of triplicate measurements) QTcF > 450 msec at baseline or uncorrectable abnormalities
in serum electrolytes (sodium, potassium, calcium, magnesium, phosphorus).
- Uncontrolled hypertension major or equal Grade 2 (patients with a history hypertension controlled with anti- hypertensives to minor or equal Grade 1 are eligible).
- Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%.

Central Nervous System:
9. Patients with active CNS lesions (including carcinomatous meningitis) are excluded. However, patients are eligible if:
- All known CNS lesions have been treated with stereotactic therapy or surgery, AND
- There has been no evidence of clinical and radiographic disease progression in the CNS for major or equal 3 weeks after radiotherapy or surgery.
Whole brain radiotherapy is not allowed, with the exception of patients who have had definitive resection or stereotactic therapy of all radiologically detectable parenchymal brain lesions.

General Exclusion Criteria:
10. Current severe, uncontrolled systemic disease.
11. History of malabsorption or other condition that would interfere with absorption of study drugs.
12. Pregnant or lactating.
13. Unwillingness or inability to comply with study and follow- up procedures.
14. The following foods/supplements are prohibited at least 7 days prior to initiation of and during study treatment:
- St. Johns wort or hyperforin (potent cytochrome P450 CYP3A4 enzyme inducer).
- Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor).

Criterios de exclusión relacionados con el cáncer:
1. Antecedentes de tratamiento previo con inhibidores de la vía de RAF o MEK.
2. Radioterapia paliativa en los 14 días previos a la primera dosis de tratamiento del estudio.
3. Cirugía mayor o lesión traumática relevante en los 14 días previos a la primera dosis de tratamiento del estudio.
4. Neoplasia maligna activa distinta del melanoma que pudiera interferir en la interpretación de las variables de eficacia. Se excluirá a los pacientes con una neoplasia maligna en los 3 años precedentes, salvo aquellos con carcinoma basocelular (CBC) o carcinoma de células escamosas (CCE) de piel, melanoma in situ, carcinoma in situ de cuello uterino o carcinoma in situ de mama extirpados con intención curativa.
5. Se permitirán los antecedentes de elevación aislada del antígeno prostático específico en ausencia de datos radiológicos de cáncer de próstata metastásico.

Criterios de exclusión basados en la función ocular
6.Antecedentes o constancia de patología retiniana en la exploración oftalmológica que se considere un factor de riesgo de desprendimiento de retina neurosensorial, oclusión de venas retinianas (OVR) o degeneración macular neovascular.
7. Los factores de riesgo de OVR se enumeran a continuación. Se excluirá a los pacientes que presenten las siguientes afecciones:
- Glaucoma no controlado con presiones intraoculares > 21 mmHg.
- Hipercolesterolemia de grado mayor o igual a 2.
- Hipertrigliceridemia de grado mayor o igual a 2.
- Hiperglucemia (en ayunas) de grado mayor o igual a 2.

Criterios de exclusión basados en la función cardiaca
8. Antecedentes de disfunción cardíaca clínicamente significativa, lo que comprende:
- Angina de pecho inestable actual.
- Insuficiencia cardíaca congestiva sintomática de clase 2 o superior según la New York Heart Association (NYHA).
- Antecedentes de síndrome de QT largo congénito o QTcF medio (promedio de tres medidas) > 450 ms al inicio del estudio, o alteraciones analíticas no corregidas en los electrolitos séricos (sodio, potasio, calcio, magnesio, fósforo).
- Hipertensión no controlada de grado mayor o igual a 2 (los pacientes con antecedentes de hipertensión controlada con antihipertensores hasta un grado menor o igual a 1 podrán participar).
- Fracción de eyección del ventrículo izquierdo (FEVI) por debajo del límite inferior normal (LIN) del centro o por debajo del 50%.

Criterios de exclusión basados en la función del sistema nervioso central
9. Se excluirá a los pacientes con lesiones activas del sistema nervioso central (SNC), como meningitis carcinomatosa. No obstante, podrán participar en caso de que:
- Todas las lesiones del SNC conocidas hayan sido tratadas con tratamiento estereotáctico o cirugía, Y
- No existan indicios de progresión clínica y radiológica de la enfermedad en el SNC durante mayor o igual a 3 semanas después de la radioterapia o cirugía.
No se permitirá la radioterapia cerebral total, con la excepción de los pacientes que se hayan sometido a una resección definitiva o tratamiento estereotáctico de todas las lesiones cerebrales parenquimatosas radiológicamente detectables.

Criterios de exclusión generales
10. Enfermedad sistémica grave no controlada actual.
11. Antecedentes de malabsorción u otra afección que pudiera interferir en la absorción de los fármacos del estudio.
12. Embarazo o lactancia.
13. Falta de disposición o incapacidad para cumplir los procedimientos del estudio y de seguimiento.
14. El consumo de los siguientes alimentos y suplementos estará prohibido al menos 7 días antes del inicio del tratamiento del estudio y durante el mismo:
- Hierba de San Juan, hipérico o hiperforina (inductor potente de la enzima CYP3A4 del citocromo P450).
- Zumo de pomelo (inhibidor potente de la enzima CYP3A4 del citocromo P450).

E.5 End points

E.5.1

Primary end point(s)

Primary Endpoint PFS ( Progression free survival).

La variable principal del estudio será la SLP (Supervivencia Libre de Progresión).

E.5.1.1

Timepoint(s) of evaluation of this end point

Until progression

Hasta progresión

E.5.2

Secondary end point(s)

- Overall response rate (ORR)
- Progression free survival (PFS) at one and two years
- Overall survival (OS) at one and two years.
- Safety (AEs, SAEs and other of special interest).
- Associated translational sub-study.

- ORR (Porcentaje de respuestas objetivas)
- SLP (Supervivencia libre de Progressión) a 1 año y 2 años.
- SG (Supervivencia Global) a 1 año y 2 años.
- AA (Acontecimientos Adversos)
- AAG (Acontecimientos Adversos Graves).
- AA de especial interés
- Reducciones, interrupciones o restrasos de dosis por AA.
- Otras: estudio traslacional.

E.5.2.1

Timepoint(s) of evaluation of this end point

- Progression free survival (PFS) at one and two years
- Overall survival (OS) at one and two years.

The rest of variables at the end of study.

- SLP (Supervivencia libre de Progressión) a 1 año y 2 años.
- SG (Supervivencia Global) a 1 año y 2 años.

El resto de variables al final del 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

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

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.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

Last visit of the last subject

Última visita del último paciente

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

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:

116

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

116

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

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

116

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)

Expected normal treatment

Tratamiento normal esperado

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

2015-02-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-02-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-09-30

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