Clinical Trials Register

Summary
EudraCT Number:	2016-001864-12
Sponsor's Protocol Code Number:	IRFMN-BRC-6992
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2017-11-22
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

2016-001864-12

A.3

Full title of the trial

International, multicenter, phase II, randomized, parallel-arm trial investigating the role of two different metronomic chemotherapy regimens in locally advanced or metastatic triple negative breast cancer patients (TNBC) as maintenance therapy after first line treatment. VICTOR-3 study

Ensayo internacional, multicéntrico, fase II, aleatorizado, con brazos paralelos, que investiga el rol de dos regímenes de quimioterapia metronómica diferentes en pacientes con cáncer de mama triple negativo (CMTN) localmente avanzado o metastático como terapia de mantenimiento tras tratamiento de primera línea. Estudio VICTOR-3.

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

VICTOR-3 Study

Estudio VICTOR-3

A.4.1

Sponsor's protocol code number

IRFMN-BRC-6992

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	IRCCS - Istituto di Ricerche Farmacologiche Mario Negri
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	Pierre Fabre Pharma Srl
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	IRCCS - Istituto di ricerche farmacologiche Maio Negri
B.5.2	Functional name of contact point	Laboratory of Methodology for Clini
B.5.3	Address:
B.5.3.1	Street Address	Via La Masa, 19
B.5.3.2	Town/ city	Milan
B.5.3.3	Post code	20156
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390239014695
B.5.6	E-mail	elena.copreni@marionegri.it

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	Navelbine 20 mg capsule
D.2.1.1.2	Name of the Marketing Authorisation holder	Pierre Fabre Pharma SRL
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	Navelbine
D.3.4	Pharmaceutical form	Capsule, soft
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	VINORELBINE TARTRATE
D.3.9.1	CAS number	125317-39-7
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB20777
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.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	Yes
D.2.1.1.1	Trade name	Capecitabine Mylan - 500 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Mylan SPA
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	Capecitabine
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	CAPECITABINE
D.3.9.1	CAS number	154361-50-9
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	CAPECITABINE
D.3.9.4	EV Substance Code	SUB12474MIG
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	1500
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	Yes
D.2.1.1.1	Trade name	Navelbine 30 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Pierre Fabre Pharma
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	Navelbine
D.3.2	Product code	L01CA04
D.3.4	Pharmaceutical form	Capsule, soft
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	VINORELBINE TARTRATE
D.3.9.1	CAS number	125317-39-7
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB20777
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	30
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

Locally advanced or metastatic triple negative breast cancer (TNBC)

Cáncer de mama triple negativo localmente avanzado o metastásico. (CMTN)

E.1.1.1

Medical condition in easily understood language

Locally advanced or metastatic triple negative breast cancer (TNBC)

Cáncer de mama triple negativo localmente avanzado o metastásico. (CMTN)

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10075566
E.1.2	Term	Triple negative breast cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	PT
E.1.2	Classification code	10055113
E.1.2	Term	Breast cancer metastatic
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10027475
E.1.2	Term	Metastatic breast cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10072740
E.1.2	Term	Locally advanced breast cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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 activity of the two study regimens (oral metronomic schedule of VNR and combination of oral metronomic schedule of VNR with fixed doses of CAPE) in terms of proportion of patients alive and without disease progression after 12 weeks of maintenance therapy.

Evaluar la actividad de los dos regímenes del estudio (esquema oral metronómico de VNR y la combinación del esquema oral metronómico de VRN con dosis bajas de CAPE) en términos de pacientes vivas y sin progresión de la enfermedad después de 12 semanas de terapia de mantenimiento.

E.2.2

Secondary objectives of the trial

To evaluate:
- the two treatment regimens in terms of clinical benefit, overall survival (OS) and progression free survival (PFS).
- the tolerability and safety profile of each treatment regimen

Evaluar:
- Los dos regímenes de tratamiento en términos de beneficio clínico, supervivencia global (SG) y supervivencia libre de progresión (SLP)
- La tolerabilidad y el perfil de seguridad de cada régimen de tratamiento.

Análisis de subgrupos predefinidos por características clínicas para evaluar la consistencia interna de los resultados

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Female, aged ≥ 18 years old;
2. Eastern Cooperative Oncology Group performance status (ECOG –PS) ≤ 1;
3. Locally advanced or metastatic triple-negative breast cancer, i.e. HER2-negative status and ER and PgR negative status (as per local assessment);
4. Treatment with 1st line chemotherapy (with any drug excepted Bevacizumab-based regimens) as per clinical practice, and non-progressive when the treatment was terminated;
5. No more than 6 cycles of the previous chemotherapy;
6. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1);
7. Willingness and ability to comply with the study protocol as judged by the Investigator;
8. For women who are not postmenopausal (i.e., < 2 years after last menstruation) and who are sexually active: agreement to use an adequate method of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly) during the treatment period and for at least 6 months after the last dose of study drug;
9. Provision of a written informed consent signed prior to enrolment according to ICH/GCP.

1. Mujer, > 18 años;
2. Estado de rendimiento ECOG (Eastern Cooperative Oncology Group) ≤ 1;
3. Cáncer de mama triple negativo localmente avanzadoo metastásico, es decir estado HER2-negativo y PgR-negativo (según la evaluación local);
4. Tratamiento con quimioterapia de primera línea (con cualquier fármaco excepto regímenes basados en bevacizumab) según la práctica clínica y sin progresión cuando el tratamiento acabó;
5. No más de 6 ciclos de quimioterapia previa;
6. Al menos una lesión medible de acuerdo con RECIST, versión 1.1;
7. Voluntad y capacidad para cumplir con el protocolo del estudio por decisión del investigador;
8. Para las mujeres que no son postmenopáusicas (es decir, <2 años después de la última menstruación) y que son sexualmente activas: estar de acuerdo en usar un método anticonceptivo adecuado (anticonceptivos orales, dispositivo intrauterino anticonceptivo, método de anticoncepción con barrera espermicida) durante el período de tratamiento y durante al menos 6 meses después de la última dosis del fármaco del estudio;
9. Obtener el consentimiento informado escrito firmado antes de que el paciente se incluya en el estudio de acuerdo con ICH/BPC

E.4

Principal exclusion criteria

1. Previous treatment with vinorelbine or capecitabine;
2. 1st line therapy with a bevacizumab-based regimen;
3. Presence of brain metastases;
4. Any other investigational drug or any anti-cancer treatment (except for radiotherapy, if the treatment field does not include the liver);
5. Inadequate bone marrow, hepatic or renal function including the following:
a. absolute neutrophils count of < 1.5 cells x 109/L, platelet count < 100 cells x 109/L, or hemoglobin < 8 g/L;
b. serum total bilirubin >1.5 × institution upper limit of normal [ULN], aspartate aminotransferase and alanine aminotransferase >2.5 × ULN, or >5 × ULN for patients with liver metastases, alkaline phosphatase >2.5 × ULN, or >5 × ULN for patients with liver metastases, or >10 × ULN for patients with bone metastases;
c. serum creatinine concentration >1.5 × ULN, creatinine clearance <50 mL/min calculated according to Cockcroft-Gault equation, and coagulation parameters international normalized ratio >1.5;
6. With the exception of basal cell carcinoma or cervical cancer in situ, history of another malignancy, unless in remission for 5 years or more and judged of negligible potential of relapse;
7. Known dihydropyrimidine dehydrogenase deficiency;
8. Treatment with sorivudine or its chemically related analogues, such as brivudine, within 4 weeks prior to randomization;
9. Evidence of any significant clinical disorder or concurrent illness or laboratory finding that, at the judgment of the Investigator, contra-indicate the inclusion of the patient in the study;
10. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study assessment and procedures;
11. Unable to swallow tablets;
12. Previous significant surgical resection of stomach or small bowel
13. Patients requiring long-term oxygen therapy
14. Known hypersensitivity to any excipients of oral vinorelbine, oral capecitabine and to fluoropyrimidine.

1. Tratamiento previo con vinorelbina o capecitabina;
2. Terapia de primera línea basada en el régimen de bevacizumab;
3. Presencia de metástasis cerebral;
4. Algún otro fármaco o tratamiento anticáncer (excepto radioterapia, si el campo de tratamiento no incluye el hígado)
5. Inadecuada función de la médula ósea, hepática o renal, incluyendo lo siguiente:
a. Recuento absoluto de neutrófilos de< 1.5 cells x 109/L, recuento de plaquetas < 100 cells x 109/L, o hemoglobina < 8 g/L;
b. Bilirrubina en suero total >1.5 × Límite superior normal del centro (ULN), aspartato aminotransferasa y alanina aminotransferasa >2.5 × ULN, o >5 × ULN para pacientes con metástasis hepática, alcalino fosfatasa >2.5 × ULN, o >5 × ULN para pacientes con metástasis hepática, o >10 × ULN para pacientes con metástasis en el hueso.
c. Concentración de creatinina en suero >1.5 × ULN, aclaramiento de creatinina <50 mL/min calculado de acuerdo con la ecuación de Cockcroft-Gault y parámetros internacionales normalizados promedio >1.5;
6. Con excepción de cáncer de células basales o cáncer cervical in situ, historial de otra neoplasia maligna, a menos que en la remisión de 5 años o más y se juzgue de un potencial insignificante de la recaída;
7. Deficiencia de dihidropirimidina deshidrogenasa conocida;
8. El tratamiento con sorivudina o sus análogos químicos como brivudina, dentro de las 4 semanas previas de la aleatorización;
9. Evidencia de cualquier trastorno clínico significativo o enfermedad concurrente o hallazgo de laboratorio que, a juicio del investigador, contraindique la inclusión del paciente en el estudio;
10. Trastornos psiquiátricos o alteración del estado mental que impidan la comprensión del proceso de consentimiento informado y/o la evaluación y los procedimientos necesarios del estudio;
11. Incapaz de tragar comprimidos;
12. Resección quirúrgica significativa previa del estómago o del intestino delgado;
13. Pacientes que requieran oxigenoterapia a largo plazo;
14. Hipersensibilidad conocida a cualquier excipiente de vinorelbina oral, capecitabina oral y a fluoropyrimidine.

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients alive and without progression after 12 weeks of maintenance therapy (PFS12w).

Proporción de pacientes vivas y sin progresión después de 12 semanas de terapia de mantenimiento (SLP12s).

E.5.1.1

Timepoint(s) of evaluation of this end point

after 12 weeks of maintenance therapy

Después de 12 semanas de terapia de mantenimiento.

E.5.2

Secondary end point(s)

PFS, calculated in each patient as the time from the date of treatment start to the date of first progression or death from any cause, whichever comes first. Subjects not having progressed or died by the end of the study will be censored at the last disease assessment date
OS, calculated for each patient as the time from the date of treatment start to the date of death from any cause. Patients not reported as having died at the end of the study will be censored at the date they were last known to be alive.
Clinical Benefit, defined as proportion of patients with CR+PR+SD and without grade 3-4 adverse events after 12 weeks of maintenance treatment.
Maximum toxicity grade experienced by each patient for each specific toxicity; frequency of patients experiencing adverse events that are recorded as grade 3-5 (also grade 2 for neurotoxicity); adverse events will be graded according to NCI CTC AE, version 4.03.
Type and frequency of serious adverse reactions.

SLP (Supervivencia Libre de Progresión), calculada en cada paciente como el tiempo desde la fecha que comienzan el tratamiento hasta la fecha de la primera progresión o muerte por cualquier causa, lo que ocurra primero. Las pacientes que no hayan progresado o muerto al final del estudio serán censuradas en la fecha de la última evaluación de la enfermedad.
SG (Supervivencia Global), calculada para cada paciente como el tiempo desde la fecha en que empieza el tratamiento hasta la fecha del fallecimiento por cualquier causa. Las pacientes que no hayan muerto al final del estudio serán censuradas en la fecha del último contacto en el que estaban vivas.
Beneficio Clínico definido como la proporción de pacientes con RC+RP+EE y sin eventos adversos de grado 3-4 después de 12 semanas de tratamiento de mantenimiento.
Grado máximo de toxicidad experimentado por cada paciente para cada toxicidad específica; frecuencia de los pacientes que experimentan eventos adversos que son registrados como grado 3-5 (también grado 2 para neurotoxicidad); los eventos adversos serán clasificados según NCI CTC AE, versión 4.03.
Tipo y frecuencia de reacciones adversas graves.

E.5.2.1

Timepoint(s) of evaluation of this end point

PFS, calculated in each patient as the time from the date of treatment start to the date of first progression or death from any cause, whichever comes first.
OS, calculated for each patient as the time from the date of treatment start to the date of death from any cause. Patients not reported as having died at the end of the study will be censored at the date they were last known to be alive.
Clinical benefit: after 12 weeks of treatment

SLP (Supervivencia Libre de Progresión), calculada en cada paciente como el tiempo desde la fecha que comienzan el tratamiento hasta la fecha de la primera progresión o muerte por cualquier causa, lo que ocurra primero
SG (Supervivencia Global), calculada para cada paciente como el tiempo desde la fecha en que empieza el tratamiento hasta la fecha del fallecimiento por cualquier causa. Las pacientes que no hayan muerto al final del estudio serán censuradas en la fecha del último contacto en el que estaban vivas.
Beneficio Clínico: Después de 12 semanas.

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

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

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

E.8.6.2

Trial being conducted completely outside of the EEA

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

Ultima visita último sujeto

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

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:

100

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

180

F.4.2.2

In the whole clinical trial

180

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 will be followed as per clinical practice

A las pacientes se les hará un seguimiento según práctica clínica

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

2018-02-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-02-02

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2018-07-23

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