Clinical Trials Register

Summary
EudraCT Number:	2014-001718-25
Sponsor's Protocol Code Number:	56021927PCR3001
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:	2015-07-15
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

2014-001718-25

A.3

Full title of the trial

A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

Estudio de fase III, aleatorizado, controlado con placebo y doble ciego de JNJ-56021927 en combinación con acetato de abiraterona y prednisona en comparación con acetato de abiraterona y prednisona en sujetos con cáncer de próstata metastásico resistente a la castración (CPRCm) que no han recibido nunca quimioterapia

A.3.1

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

An Efficacy and Safety Study of JNJ56021927 in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

Estudio de la Eficacia y Seguridad de JNJ-56021927 en sujetos con cáncer de próstata metastásico resistente a la castración (CPRCm) que no han recibido nunca quimioterapia.

A.4.1

Sponsor's protocol code number

56021927PCR3001

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02257736

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	Janssen-Cilag International NV
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	Janssen-Cilag International NV
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	Janssen-Cilag International NV (Janssen Biologics BV)
B.5.2	Functional name of contact point	Clinical Registry Group
B.5.3	Address:
B.5.3.1	Street Address	Archimedesweg 29
B.5.3.2	Town/ city	Leiden
B.5.3.3	Post code	2333 CM
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+3171524-2166
B.5.5	Fax number	+3171524-2110
B.5.6	E-mail	ClinicalTrialsEU@its.jnj.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.3.2	Product code	JNJ-56021927
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	Not assigned
D.3.9.1	CAS number	0956104-40-8
D.3.9.3	Other descriptive name	JNJ-56021927-AAA
D.3.9.4	EV Substance Code	SUB127215
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	60
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	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	Zytiga
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International NV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	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	ABIRATERONE ACETATE
D.3.9.1	CAS number	154229-18-2
D.3.9.3	Other descriptive name	ABIRATERONE ACETATE
D.3.9.4	EV Substance Code	SUB31647
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.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	Prednisolon acis
D.2.1.1.2	Name of the Marketing Authorisation holder	acis Arzneimittel GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	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	PREDNISOLONE
D.3.9.3	Other descriptive name	PREDNISOLONE
D.3.9.4	EV Substance Code	SUB10018MIG
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	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.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	Prednison acis
D.2.1.1.2	Name of the Marketing Authorisation holder	acis Arzneimittel GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	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	PREDNISONE
D.3.9.3	Other descriptive name	PREDNISONE
D.3.9.4	EV Substance Code	SUB10020MIG
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	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
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

Metastatic castration-resistant prostate cancer (mCRPC)

Cáncer de próstata metastásico resistente a la castración (CPRCm).

E.1.1.1

Medical condition in easily understood language

Prostate cancer

Cáncer de próstata.

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	18.0
E.1.2	Level	PT
E.1.2	Classification code	10036909
E.1.2	Term	Prostate cancer metastatic
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 is to compare the radiographic progression-free survival(rPFS) of JNJ-56021927 in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in subjects with chemotherapy-naïve mCRPC.

El objetivo principal es comparar la supervivencia sin progresión radiográfica (SSPR) de JNJ-56021927 en combinación con el acetato de abiraterona (AcA) y prednisona o prednisolona (AcAP) y AcAP en pacientes con CPRCm que no han sido sometidos a quimioterapia.

E.2.2

Secondary objectives of the trial

1. To characterize the safety profile of JNJ-56021927 in combination with AAP
2. To characterize the population pharmacokinetics (PK) of JNJ-56021927 and abiraterone

1. Caracterizar el perfil de la seguridad de JNJ-56021927 en combinación con AcAP
2. Caracterizar la farmacocinética (FC) de la población que recibe JNJ-56021927 y acetato de abiraterona

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Subject must be a man age ?18 years of age, inclusive
- Adenocarcinoma of the prostate
- Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). If lymph node metastasis is the only evidence of metastasis, it must be greater than or equal to (>=) 2 centimeter (cm) in the longest diameter
- Castration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of PSA, at least 1 week apart with the last androgen deprivation therapy (PSA) >= 2 nanogram per milliliters (ng/mL)
- Participants who received a first generation anti-androgen (eg, bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after the washout period
- Prostate cancer progression documented by prostate-specific antigen (PSA)according to the Prostate Cancer Clinical Trials Working Group (PCWG2)radiographic progression of soft tissues according to modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone according to PCWG2.

- El paciente debe ser un varón ? 18 años de edad
- Adenocarcinoma de próstata
- Enfermedad metastásica documentada mediante gammagrafía ósea con tecnecio-99m (99mTc) o lesiones metastásicas mediante tomografía axial computarizada (TAC) o resonancia magnética (RM) (enfermedad visceral o de ganglios linfáticos). Si la metástasis de los ganglios linfáticos es la única evidencia de metástasis, esta debe tener un diámetro ? 2 cm en la parte más larga
- Cáncer de próstata resistente a la castración demostrado durante el TPA continuo, definido como 3 subidas en el PSA, con al menos una semana de diferencia, con el último PSA ? 2 ng/ml
- Los pacientes que recibieron un antiandrógeno de primera generación (p. ej. bicalutamida, flutamida o nilutamida) deben pasar un periodo de reposo farmacológico de 6 semanas antes de la aleatorización Y deben mostrar una progresión continua de la enfermedad (PSA) (un incremento en el PSA) tras el periodo de reposo farmacológico
- Progresión del cáncer de próstata documentada por el antígeno prostático específico (PSA) de acuerdo con el grupo 2 de trabajo de ensayos clínicos de cáncer de próstata (PCWG2); progresión radiográfica de los tejidos blandos según los criterios de evaluación de la respuesta en tumores sólidos (RECIST), versión 1.1 (Anexo 1) modificados según el PCWG2, o progresión radiográfica de las evaluaciones óseas según el PCWG2

E.4

Principal exclusion criteria

- Small cell or neuroendocrine carcinoma of the prostate
- Known brain metastases
- Prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting
- Previously treated with ketoconazole for prostate cancer for greater than 7 days
- Therapies that must be discontinued or substituted at least 4 weeks prior to randomization include the following:
a) Medications known to lower the seizure threshold, b) Herbal and nonherbal products that may decrease PSA levels (example [eg], saw palmetto, pomegranate) or c) Any investigational agent
- At screening need for parenteral or oral opioid analgesics (eg, codeine, dextropropoxyphene)

Carcinoma de próstata microcítico o neuroendócrino
Metástasis cerebrales conocidas
Quimioterapia previa para el cáncer de próstata, excepto si se administra en el escenario de un tratamiento adyuvante o neoadyuvante
Tratado previamente con ketoconazol para el cáncer de próstata durante más de 7 días
Los tratamientos que deben interrumpirse o sustituirse al menos 4 semanas antes de la aleatorización son:
a) Los medicamentos que se sabe que bajan el umbral convulsivo, b) Los productos a base de hierbas y los que no lo son y que podrían disminuir los niveles de PSA (por ejemplo, palma enana americana, granada), c) Cualquier fármaco en investigación
En la selección, se necesitan analgésicos por vía parenteral o analgésicos opioides por vía oral (p. ej., codeína, dextropropoxifeno)

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is radiographic progression-free survival (rPFS).

El criterio de valoración principal es la supervivencia sin progresión radiográfica (SSPR).

E.5.1.1

Timepoint(s) of evaluation of this end point

Radiographic progression will be assessed by Bone scan and CT/MRI scan.
Bone scan will be performed within 6 weeks of randomisation. CT/MRI will be performed within 42 days of randomisation. Both Bone scans and CT/MRI will be performed on Day 1 of cycle 3, Day 1 of cycle 5 then every 3 subsequent cycles beginning at cycle 7 including EOT visit.

La progresión radiográfica será evaluada por una gammagrafía ósea y un TAC/RM.
La gammagrafía ósea será llevada a 6 semanas tras la aleatorización. TAC/RM serán llevados a cabo 42 días tras la aleatorización. Tanto la gammografía ósea como el TAC/RM serán llevados a cabo el Día 1 del ciclo 3, el Día 1 del ciclo 5 y después cada 3 ciclos empezando en el ciclo 7 hasta la visita de FdT.

E.5.2

Secondary end point(s)

1. Overall survival (OS) is defined as the time from date of randomization to date of death from any cause.
2. Time to chronic opioid use (oral opioid use for ?3 weeks; parenteral opioid use for ?7 days)
is defined as the time from date of randomization to the first date of opioid use
3. Time to initiation of cytotoxic chemotherapy is defined as the time from date of
randomization to the date of initiation of cytotoxic chemotherapy
4. Time to pain progression defined as the time from date of randomization to the first date a subject experience an increase by 2 points from baseline in the BPI-SF worst pain intensity item 3 observed at 2 consecutive evaluations ?4 weeks apart or initiation of chronic opioids, whichever occurs first

1- La supervivencia general (SG) se define como el tiempo transcurrido desde la fecha de la aleatorización hasta la fecha de la muerte por cualquier causa.
2- El tiempo hasta el uso crónico de opioides (uso por vía oral de opioides durante ? 3 semanas; uso parenteral de opioides durante ? 7 días) se define como el tiempo transcurrido desde la fecha de la aleatorización hasta la primera fecha del uso de opioides.
3- El tiempo hasta el inicio de la quimioterapia citotóxica se define como el tiempo transcurrido desde la fecha de la aleatorización hasta la fecha de inicio del tratamiento con quimioterapia citotóxica
4- El tiempo hasta la progresión del dolor se define como el tiempo transcurrido desde la fecha de la aleatorización hasta la primera fecha en que un paciente experimenta un incremento de 2 puntos de los valores iniciales en BPI-SF en el apartado 3 de peor intensidad del dolor observada en 2 evaluaciones consecutivas con ? 4 semanas de diferencia o del inicio del uso crónico de opioides, lo que ocurra primero.

E.5.2.1

Timepoint(s) of evaluation of this end point

Endpoints 1.,2., 3. and 4 will be evaluated at EOT visit and every 3 months during the follow up phase.
For Endpoint 4 the BPI-SF will be performed consecutively for 7 days starting 6 days before Day 1 of each cycle including the EOT visit and every 3 months for up to 12 months after treatment discontinuation during the follow up phase

Las variables 1., 2., 3. Y 4 serán evaluadas hasta la visita FDT y cada 3 meses durante la fase de seguimiento.
Para la variable 4, la BPI-SF será llevada a cabo consecutivamen.te durante 7 días empezando a contar 6 días antes del Día 1 de cada ciclo incluyendo la visita de FdT y durante la fase de seguimiento cada 3 meses durante 12 meses tras finalizar la interrupción del tratamiento

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

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

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

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

Argentina

Australia

Belgium

Brazil

Canada

China

France

Germany

Italy

Japan

Korea, Republic of

Mexico

Netherlands

Russian Federation

South Africa

Spain

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

EoT Visit is within 30 days after the last dose of study drug for all subjects

Visita de fin del tratamiento (FdT) en los 30 días posteriores a la toma de la última dosis del fármaco del estudio para todos los sujetos.

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

864

F.2 Gender

F.2.1

Female

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

297

F.4.2.2

In the whole clinical trial

960

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)

None

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

2015-02-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-02-05

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

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