Clinical Trials Register

Summary
EudraCT Number:	2013-004728-13
Sponsor's Protocol Code Number:	I3Y-MC-JPBL
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2014-05-22
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2013-004728-13

A.3

Full title of the trial

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant with or without LY2835219, a CDK4/6 Inhibitor, for Women with Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo, en el que se evalúa fulvestrant en combinación o no con LY2835219, un inhibidor de las CDK4/6, en mujeres con cáncer de mama localmente avanzado o metastásico, receptor hormonal positivo,
HER2 negativo

A.3.1

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

A Study of LY2835219 Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer

Estudio en el que se evalúa fulvestrant en combinación o no con LY2835219, en mujeres con cáncer de mama localmente avanzado o metastásico, receptor hormonal positivo,
HER2 negativo

A.4.1

Sponsor's protocol code number

I3Y-MC-JPBL

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02107703

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	Lilly 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	Eli Lilly and Company
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Eli Lilly
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Avda de la Industria 30
B.5.3.2	Town/ city	Alcobendas Madrid
B.5.3.3	Post code	28108
B.5.3.4	Country	Spain
B.5.4	Telephone number	34916635354
B.5.5	Fax number	34916633481
B.5.6	E-mail	EU_Lilly_Clinical_Trials@lilly.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	LY2835219
D.3.2	Product code	LY2835219
D.3.4	Pharmaceutical form	Capsule
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	LY2835219
D.3.9.1	CAS number	1231929-97-7
D.3.9.2	Current sponsor code	LY2835219
D.3.9.3	Other descriptive name	LY2835219
D.3.9.4	EV Substance Code	SUB88440
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LY2835219
D.3.9.1	CAS number	1231929-97-7
D.3.9.2	Current sponsor code	LY2835219
D.3.9.3	Other descriptive name	LY2835219
D.3.9.4	EV Substance Code	SUB88440
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	100
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	Faslodex
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca UK Limited
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	Fulvestrant
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	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Fulvestrant
D.3.9.3	Other descriptive name	FULVESTRANT
D.3.9.4	EV Substance Code	SUB13933MIG
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	250
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	Capsule
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

Breast cancer

Cancer de Mama

E.1.1.1

Medical condition in easily understood language

Breast cancer

Cancer de Mama

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	17.0
E.1.2	Level	PT
E.1.2	Classification code	10006187
E.1.2	Term	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

The primary objective of Study JPBL is to compare LY2835219 plus fulvestrant versus placebo plus fulvestrant with respect to PFS for women with HR+, HER2- locally advanced or metastatic breast cancer.

El objetivo principal del estudio I3Y-MC-JPBL (JPBL) es comparar la politerapia con LY2835219 y fulvestrant con la combinación de placebo y fulvestrant, en términos de SSP, en mujeres con cáncer de mama metastásico o localmente avanzado, HR+ y HER2-.

E.2.2

Secondary objectives of the trial

The secondary objectives of the study are to compare LY2835219 plus fulvestrant versus placebo plus fulvestrant with respect to each of the following:
?overall survival (OS)
?OS rate at 1, 2, and 3 years
?objective response rate
?duration of response
?disease control rate
?clinical benefit rate
?safety and tolerability
?pain and symptom burden using the Brief Pain Inventory (BPI), the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the EORTC QLQ-BR23 (breast) questionnaires, and health status scores from the EuroQol 5-Dimension 5 Level (EQ-5D 5L)
?pharmacokinetics (PK) of LY2835219, its metabolites, and fulvestrant
?time to worsening of Eastern Cooperative Oncology Group (ECOG) performance status
?time to first skeletal-related event (SRE; defined as either pathological fracture, spinal cord compression, radiation to the bone, or surgery to the bone)

Los objetivos secundarios del estudio son comparar la politerapia con LY2835219 y fulvestrant con la combinación de placebo y fulvestrant, en relación con los siguientes parámetros:
· Supervivencia global.
· Tasa de SG al cabo de 1, 2 y 3 años.
· Tasa de respuestas objetivas
· Duración de la respuesta
· Tasa de control de la enfermedad.
· Tasa de beneficio clínico .
· Seguridad y tolerabilidad, de acuerdo con los Criterios Terminológicos Comunes para los Acontecimientos Adversos del National Cancer Institute
· Dolor y carga de los síntomas, de acuerdo con el Cuestionario BPI, el Cuestionario de EORTC QLQ-C30 y el Cuestionario EORTC QLQ-BR23, así como con las puntuaciones del estado de salud del cuestionario EQ-5D 5L.
· Farmacocinética (FC) de LY2835219, sus metabolitos y fulvestrant.
· Tiempo transcurrido hasta un empeoramiento de la categoría funcional del ECOG de ? 2
· Tiempo transcurrido hasta el primer acontecimiento de tipo esquelético

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

?Have a diagnosis of HR+, HER2- breast cancer
?Have either locally advanced disease not amenable to curative treatment by surgery or metastatic disease. In addition, participants must fulfill 1 of the following criteria:
- relapsed with radiologic evidence of progression on neoadjuvant or adjuvant endocrine therapy
- relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy
- relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and then subsequently relapsed with radiologic evidence of progression after no more than first-line endocrine therapy (with either an antiestrogen or an aromatase inhibitor) for metastatic disease
- presented de novo with locally advanced or metastatic disease and not received any prior endocrine therapy
- presented de novo with locally advanced or metastatic disease and then relapsed with radiologic evidence of progression after no more than first-line endocrine therapy (with either an antiestrogen or an aromatase inhibitor)
?Have postmenopausal status due to either surgical/natural menopause or ovarian suppression (initiated at least 28 days prior to Day 1 of Cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin
?Have a negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of LY2835219 if postmenopausal status is due to ovarian suppression with a GnRH agonist
?Have either measurable disease or nonmeasurable bone only disease
?Have a performance status ?1 on the ECOG scale
?Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy

Se considerará que las pacientes son idóneas para ser incluidas en el estudio únicamente si cumplen los criterios que se detallan a continuación: 1) presentar un
diagnóstico de cáncer de mama HR+, HER2-; 2) presentar enfermedad metastásica o localmente avanzada inoperable, y haber presentado recidiva tras haber recibido una terapia endocrina previa (con indicios radiológicos
de progresión), o no haber recibido previamente terapia endocrina; 3) ser menopáusica, bien por presentar menopausia quirúrgica/natural o como resultado de la inhibición de la función ovárica con un agonista de la
hormona liberadora de gonadotropina (GnRH), como goserelina; 4) presentar un resultado negativo en una prueba de embarazo en suero realizada en el momento basal (en el transcurso de los 14 días previos a la aleatorización), y estar de acuerdo en utilizar un método anticonceptivo médicamente aprobado durante el estudio y las 12 semanas posteriores a la última dosis de LY2835219, si el estado posmenopáusico se debe a la inhibición de la función ovárica con un agonista de la GnRH; 5) presentar bien enfermedad mensurable o únicamente enfermedad ósea no mensurable; 6) ser mujer y tener >18 años de edad; 7) haber proporcionado el consentimiento informado por escrito, antes de realizar ninguno de los procedimientos específicos del estudio; 8) presentar una función orgánica
adecuada; 9) presentar una categoría funcional ? 1 en la escala ECOG; 10) haber interrumpido los tratamientos antineoplásicos previos, al menos 21 días (en el caso de los fármacos mielodepresores) o 14 días (en el caso de los fármacos que no tengan efecto mielodepresor) antes de recibir el fármaco del estudio, y haberse recuperado de los efectos agudos del tratamiento; 11) estar dispuesta a participar durante la duración del estudio y a seguir los procedimientos del estudio; y 12) ser capaz de tragar cápsulas.

E.4

Principal exclusion criteria

? Are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study
? Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease
? Have clinical evidence or history of central nervous system metastasis
? Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, everolimus, or any CDK4/6 inhibitor
? Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days prior to randomization of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively
? Have received recent (within 28 days prior to randomization) yellow fever vaccination
? Have had major surgery within 14 days prior to randomization of study drug to allow for post-operative healing of the surgical wound and site(s)
? Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest
? Have inflammatory breast cancer or a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years
? Have received an autologous or allogeneic stem-cell transplant
? Have active bacterial or fungal infection, or detectable viral infection

Se excluirá del estudio a cualquier paciente en la que se constate alguno de los siguientes criterios: 13) estar recibiendo en la actualidad un fármaco en fase de investigación en un ensayo clínico, o estar participando en cualquier otro tipo de investigación médica que no se considere compatible con este estudio, desde un punto de vista científico o médico; 14) presentar una crisis visceral, diseminación linfangítica o carcinomatosis leptomeníngea; 15) presentar antecedentes de metástasis en el sistema nervioso central; 16) haber recibido tratamiento previo con quimioterapia (excepto la quimioterapia neoadyuvante/adyuvante), fulvestrant, everolimus o cualquier inhibidor de las CDK4/6; 17) haber recibido tratamiento, en los 14 o 21 días previos a la aleatorización del fármaco del estudio, con un fármaco sin actividad mielodepresora o con efecto mielodepresor, respectivamente, que no haya recibido aprobación por parte de las autoridades reguladoras para ninguna indicación; 18) haber recibido recientemente (en el transcurso de los 28 días previos a la aleatorización) vacunación contra la fiebre
amarilla; 19) haberse sometido a una intervención de cirugía mayor en el transcurso de los 14 días previos a la dosis inicial del fármaco del estudio; 20) presentar antecedentes personales de cualquiera de las siguientes enfermedades: presíncope o síncope de etiología inexplicada o etiología cardiovascular, aquicardia ventricular, fibrilación ventricular o paro cardiaco súbito; 21) presentar enfermedades preexistentes graves que, en opinión del investigador, podrían impedir su participación en este estudio; 22) presentar cáncer de mama inflamatorio o antecedentes de cualquier otro cáncer (excepto cáncer de piel no melanomatoso o carcinoma in situ de cuello uterino), a menos que haya estado en remisión completa al menos durante 3 años, sin ningún tipo de tratamiento;
23) haber recibido un autotrasplante o alotrasplante de hemocitoblastos; 24) presentar infección bacteriana o fúngica activa, o infección vírica detectable; o 25) estar embarazada o en período de lactancia.

E.5 End points

E.5.1

Primary end point(s)

Progression-Free Survival (PFS)

Supervivencia libre de progresion

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline up to Approximately 31 Months

Desde el inicio hasta 31 meses aproximadamente

E.5.2

Secondary end point(s)

- Overall Survival (OS)
- Objective Response Rate
- Duration of Response (DoR)
- Disease Control Rate (DCR)
- Clinical Benefit Rate (CBR)
- Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY2835219, Its Metabolites, and Fulvestrant
- Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status
- Time to First Skeletal-Related Event (SRE)
- Change from Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L)
- Change from Baseline in Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
- Change from Baseline in Quality of Life using the EORTC QLQ-BR23 (breast) Questionnaire
- Change from Baseline in Pain and Symptom Burden Assessment Using the Brief Pain Inventory (BPI)

Supervivencia global
Tasa de respuestas objetivas
Duración de la respuesta
Tasa de control de la enfermedad
Tasa de beneficio clínico
Farmacocinetica: AUC de LY2835219 en Metabolitos y Fulvestrant
Tiempo transcurrido hasta un empeoramiento de la categoría funcional del Eastern Cooperative Oncology Group (ECOG) de ? 2
Tiempo transcurrido hasta el primer acontecimiento de tipo esquelético
Cambio desde elinicio en el estado de salud usando EuroQol 5-Dimension 5 Level (EQ-5D 5L)
Cambio desde el inicio en calidad de vida usando el cuestionario -Core 30 (EORTC QLQ-C30)
Cambio desde el inicio en calidad de vida usando el cuestionario EORTC QLQ-BR23 (breast)
Cambio desde el inicio en dolor y carga de los síntomas, de acuerdo con el Cuestionario Breve para la Evaluación del Dolor (BPI)

E.5.2.1

Timepoint(s) of evaluation of this end point

-Baseline up to Approximately 80 Months for OS.
-Baseline up to Approximately 31 Months for ORR, DoR, DCR, CBR, PK, time to worsening of ECOG, time to SRE.
-Baseline, End of Study (up to approximately 31 months) for changes from baseline in EQ-5D 5L, EORTC QLQ-C30, EORTC QLQ-BR23, BPI.

- Desde el inicio hasta aproximadamente 80 meses para la supervivencia global
- Desde el inicio hasta aproximadamente 31 meses para:
Tasa de respuestas objetivas
Duración de la respuesta
Tasa de control de la enfermedad
Tasa de beneficio clínico
Farmacocinetica: AUC de LY2835219 en Metabolitos y Fulvestrant
Tiempo transcurrido hasta un empeoramiento de la categoría funcional
Tiempo transcurrido hasta el primer acontecimiento de tipo esquelético
- Desde el inicio hasta la finalizacion del estudio en EuroQol 5-Dimension 5 L, EORTC QLQ-C30, EORTC QLQ-BR23, BPI.

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

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

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)

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

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

Belgium

Canada

Denmark

Finland

France

Germany

Greece

Italy

Japan

Korea, Republic of

Mexico

Poland

Romania

Russian Federation

Spain

Switzerland

Taiwan

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

LVLS

Ultima visita ultimo 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

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:

330

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

220

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

131

F.4.2.2

In the whole clinical trial

550

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 study completion, all patients who are on study treatment and who are eligible for the extension period will be unblinded. Patients receiving study treatment and experiencing ongoing clinical benefit may continue to receive study treatment in the extension period until one of the criteria for discontinuation is met. During the extension period, placebo will no longer be administered, and crossover will not be permitted.

Tras finalizar el estudio, todas las pacientes que reciban tratamiento y se consideren idóneas para participar en el período de extensión conoceran el tratamiento asignado. Las pacientes que estén recibiendo el tratamiento y continúen con beneficio clínico podrán continuar recibiendo el tratamiento en el período de extensión, hasta que se constate algun criterio de interrupción. Durante el este período no se continuará administrando placebo y no se permitirá cambiar de grupo de tratamiento.

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

2014-07-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-06-10

P. End of Trial
P.	End of Trial Status	Ongoing

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