Clinical Trials Register

Summary
EudraCT Number:	2015-004530-94
Sponsor's Protocol Code Number:	FCO-PDC-2015-01
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:	2016-02-17
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

2015-004530-94

A.3

Full title of the trial

Pilot study (Phase II) of Pomalidomide, oral Desamethasone and very low-dose Cyclophosphamide in patients with refractory Multiple Myeloma who have received Lenalidomide and Bortezomib.

Estudio Piloto (Fase II) de Combinación de Pomalidomida/Dexametasona asociado a Baja dosis de Ciclofosfamida en Pacientes con Mieloma Múltiple Refractario que han recibido Lenalidomida y Bortezomib

A.3.1

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

Pilot study (Phase II) of Pomalidomide, oral Desamethasone and very low-dose Cyclophosphamide in patients with refractory Multiple Myeloma who have received Lenalidomide and Bortezomib.

Estudio Piloto (Fase II) de Combinación de Pomalidomida/Dexametasona asociado a Baja dosis de Ciclofosfamida en Pacientes con Mieloma Múltiple Refractario que han recibido Lenalidomida y Bortezomib

A.3.2

Name or abbreviated title of the trial where available

FCO-PDC-2015-01

A.4.1

Sponsor's protocol code number

FCO-PDC-2015-01

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	Fundación para la investigación biomédica de Córdoba
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	Fundación para la investigación biomédica de Córdoba
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	Fundación para la investigación biomédica de Córdoba
B.5.2	Functional name of contact point	Antonio Luque
B.5.3	Address:
B.5.3.1	Street Address	Avenida Menéndez Pidal S/N
B.5.3.2	Town/ city	Córdoba
B.5.3.3	Post code	14004
B.5.3.4	Country	Spain
B.5.6	E-mail	antonio.luque@imibic.org

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	Imnovid
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene
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.3.4	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	POMALIDOMIDE
D.3.9.1	CAS number	19171-19-8
D.3.9.3	Other descriptive name	POMALIDOMIDE
D.3.9.4	EV Substance Code	SUB33379
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	4
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.2.5	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	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	CYCLOPHOSPHAMIDE
D.3.9.1	CAS number	50-18-0
D.3.9.4	EV Substance Code	SUB06859MIG
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	15
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.2.1.2	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.3.4	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	DEXAMETHASONE
D.3.9.3	Other descriptive name	DEXAMETHASONE
D.3.9.4	EV Substance Code	SUB07017MIG
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	40
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

Refractory multiple myeloma.

Mieloma múltiple refractario.

E.1.1.1

Medical condition in easily understood language

Refractory multiple myeloma.

Mieloma múltiple refractario.

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluate the overall response rate based on the criterion of the International Myeloma Working Group (IMWG) considering the best response obtained.

Evaluar la tasa de respuesta global en base al criterio del International Myeloma Working Group (IMWG) considerando la mejor respuesta obtenida.

E.2.2

Secondary objectives of the trial

Time to response, duration of response, time to progression, overall survival, progression free survival.
Tolerability and toxicity of the treatment schedule
Studies of biological markers of activity of metronomic chemotherapy

Tiempo Hasta Respuesta, Duración de Respuesta, Tiempo Hasta Progresión, Supervivencia Global, Supervivencia Libre de Progresión.
Tolerabilidad y Toxicidad del esquema de tratamiento
Estudios biológicos de marcadores de actividad de quimioterapia metronómica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subject older than 18 years meeting criterion 2 or 3.
2. Subject diagnosed of multiple myeloma.
3. Patients with symptomatic multiple myeloma relapsed / refractory after receiving at least two treatment cycles including Bortezomib and at least two cycles that include Lenalidomide, combined in the same therapeutic regimen or as part of different chemotherapy regimens.
a) Clinical and / or biological relapse : Patients must have received at least two prior lines of treatment and have relapsed after obtaining at least stable disease for at least one cycle of each of the chemotherapy regimens received before they developed progression of the disease.
i. Clinical relapse: Defined according to the International Myeloma Working Group (IMWG) criteria.
ii. Biological Relapse y: They are defined according to the International Myeloma Working Group (IMWG) criteria.
b) Refractory disease: In this case, patients should have progressed on a processing line or within 60 days after completion before inclusion.
4. Patients with multiple myeloma with measurable disease, defined as the presence of monoclonal component of at least 0.5 g / dL in serum or at least 0.2 g / d in urine, or in those without measurable disease radio presence altered light chain at the time of study entry.
5. Patients with good performance status ECOG defined as ? 2.
6. Signature of informed consent.
7. The patient should be able to meet all scheduled visits and other requirements.
8. Laboratory analysis: Patients must have:
a) absolute neutrophil: ?1000 / uL
b) Platelet Count: ?50.000 / uL
c) Hemoglobin:> 8 g ??/ dL
d) Total bilirubin <2 x upper normal limit
e) AST and ALT: <3 x upper normal limit
f) serum potassium: within normal limits.
9. Childbearing potential women should have a negative pregnancy test.
10. The male patient included in the trial must commit to always use latex condom during any sexual contact with women of childbearing age, even if he has undergone a vasectomy successfully.

1. Paciente mayor de 18 años y que cumpla los criterios 2 y/o 3.
2. Paciente diagnosticado de Mieloma Múltiple sintomático según los criterios estándar.
3. Pacientes con Mieloma Múltiple sintomático en Recaída/Refractario tras haber recibido tratamiento al menos con dos ciclos que incluyan Bortezomib y con al menos dos ciclos que incluyan Lenalidomida, ya sean combinados en el mismo esquema terapéutico o como parte de diferentes esquemas de quimioterapia.
a) Recaída clínica y/o biológica: los pacientes deben haber recibido al menos dos líneas de tratamiento previa y haber recaído después de haber obtenido al menos una enfermedad estable durante un mínimo de un ciclo de cada uno de los regímenes de quimioterapia recibidos antes de que desarrollaran enfermedad progresiva.
i. Recaída clínica: Se define según los criterios definidos por el International Myeloma Working Group (IMWG).
ii. Recaída biología: Se definen según los criterios definidos por el International Myeloma Working Group (IMWG).
b) Enfermedad Refractaria: En este caso los pacientes deben haber progresado durante una línea de tratamiento o en los 60 días posteriores a su finalización antes de su inclusión.
4. Pacientes con MM con enfermedad medible, definida como la presencia de componente monoclonal de al menos 0.5 g/dL en suero o de al menos 0.2 g/d en orina, o en aquellos sin enfermedad medible la presencia de radio de cadenas ligeras alterado al momento de su entrada en el estudio.
5. Pacientes con buen estado general definido como ECOG ? 2.
6. El paciente debe entender el consentimiento informado escrito y firmarlo por propia voluntad.
7. El paciente debe ser capaz de cumplir con las todas visitas programadas y otros requisitos.
8. Criterios de Laboratorio: Los pacientes deben presentar los siguientes recuentos
a) Neutrófilos absolutos: ?1000/µL
b) Contaje Plaquetario: ?50.000/µL
c) Hemoglobina: > 8 gr/dL
d) Bilirrubina total: <2 x límite superior de la normalidad
e) AST y ALT: < 3 x Límite superior de la normalidad
f) Potasio sérico: dentro de los límites de la normalidad.
9. Mujeres en edad fértil deben tener un test de gestación negativo.
10. El paciente varón incluido en el ensayo debe comprometerse a usar siempre preservativo de látex durante cualquier contacto sexual con mujeres en edad fértil, incluso si ha sido sometido a una vasectomía realizada con éxito..

E.4

Principal exclusion criteria

1. Any concomitant diseases, abnormal laboratory or psychiatric disorder that can assume inability of the subject to sign the IC.
2. PS> 3 on the ECOG scale.
3. Previous history of non-hematologic neoplasia, unless the patient has been free of the disease for ? 5 years. Exceptions include the following:
a. basal cell skin carcinoma
b. squamous cell skin carcinoma
c. In situ cervical carcinoma
d. In situ breast carcinoma
4. Patients who are unable or unwilling to undergo an antithrombotic therapy.
5. Positive serology known for HIV or HIV active infectious hepatitis, type B, or C.
6. Depressed cardiac function or clinically significant cardiac disease
7. Severe hypercalcemia
8. Major surgery within 15 days prior to the inclusion or not having recovered from its side effects.
9. Any serious medical condition, including laboratory abnormalities that make the patient to take an unacceptable risk if he participates in this study or that may interfere with the interpretation of the trial data.
10. Patients treated with any investigational drug within the previous 28 days.
11. Any severe medical condition, abnormality in laboratory tests or any psychiatric illness that prevented the signing of written consent.
12. Pregnant women or breast-feeding.
13. Hypersensitivity to drugs or compounds or biological composition similar to study chemistry.
14. Plasma Cell Leukemia.

1. Cualquier Enfermedad concomitante, alteración de laboratorio o desorden psiquiátrico que pueda presuponer incapacidad del sujeto para firmar el CI.
2. PS > 3 según la escala del ECOG (Apéndice II).
3. Historial previo de Neoplasias no-hematológicas, a menos que el paciente haya estado libre de la enfermedad durante ? 5 años. Las excepciones incluyen lo siguiente:
? Carcinoma basocelular de la piel
? Carcinoma escamocelular de la piel
? Carcinoma in situ de cérvix
? Carcinoma in situ de mama
4. Pacientes que son incapaces o no están dispuestos a someterse a una terapia antitrombótica.
5. Serología positiva conocida para el virus de la inmunodeficiencia humana HIV o hepatitis infecciosa activa, tipo B, o C.
6. Función cardiaca deprimida, o enfermedades cardiacas clínicamente significativas
7. Hipercalcemia grave
8. Intervenciones quirúrgicas mayores en los 15 días previos a su inclusión o no haberse recuperado de sus efectos secundarios.
9. Cualquier afección médica grave, incluyendo alteraciones de laboratorio que haga que el paciente tome un riesgo inaceptable si participa en este estudio o que pueden interferir en la interpretación de los datos del estudio.
10. Pacientes tratados con cualquier fármaco en investigación en los 28 días previos.
11. Cualquier condición médica severa, anormalidad en las pruebas de laboratorio o cualquier enfermedad psiquiátrica que impidiese la firma del consentimiento escrito.
12. Mujeres embarazadas o dando lactancia.
13. Hipersensibilidad conocida a drogas o compuestos de composición biológica o química similar a los del estudio.
14. Leucemia de Células Plasmáticas

E.5 End points

E.5.1

Primary end point(s)

Based on the International Myeloma Working Group (IMWG):
Strict Complete response (SCR)
Complete response (CR)
Partial, very good response (VGPR)
Partial response (PR)
Minor response (MR)

En Base al International Myeloma Working Group (IMWG):
Respuesta Completa Estricta (sCR)
Respuesta Completa (CR)
Respuesta Parcial, Muy Buena (VGPR)
Respuesta Parcial (PR)
Respuesta Menor (MR)

E.5.1.1

Timepoint(s) of evaluation of this end point

After every cycle or during the maintenance period.

Al finalizar cada ciclo o durante el periodo de mantenimiento.

E.5.2

Secondary end point(s)

- Overall survival: Since the entry into the study or treatment initiation to date of the patient's death or the last date knowledge that the patient was alive.
- Time to progression: Since the entry into the study or treatment initiation to progression or recurrence of the disease.
Progression-free survival: Since the entry into the study or treatment initiation to progression or recurrence of the disease (including death due to myeloma).
- Free survival events: Since the entry into the study or treatment initiation to progression or recurrence of the disease (including death due to any cause).
- Start of response: Since the entry into the study or treatment initiation to response.
Relapse-free time: Since the end of treatment until progression or recurrence of the disease.
- Duration of response: Since the answer to progression or recurrence of the disease.
- Disease-free survival and recurrence-free survival: Since the answer to progression or recurrence of the disease, but measured only in patients who achieved complete remission or unconfirmed complete remission.

Tolerability and toxicity of treatment: number of adverse events attributable to the study medication, assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE 4.0).

Biological marker studies of metronomic chemotherapy activity:
Angiogenesis markers: Assessments of circulating endothelial cells by CFM and serum levels of VEGF, TSP-1.
Evaluation of the immune system: Determination of regulatory T cells populations.

- Supervivencia global: Desde la entrada en el estudio o el inicio del tratamiento hasta la fecha de la muerte del paciente o la última fecha en que se tuvo conocimiento de que el paciente estaba vivo.
- Tiempo hasta la progresión: Desde la entrada en el estudio o el inicio del tratamiento hasta la progresión o recidiva de la enfermedad.
- Supervivencia libre de progresión: Desde la entrada en el estudio o el inicio del tratamiento hasta la progresión o recidiva de la enfermedad (incluye la muerte por mieloma).
- Supervivencia libre de eventos: Desde la entrada en el estudio o el inicio del tratamiento hasta la progresión o recidiva de la enfermedad (incluye la muerte por cualquier causa).
- Inicio de la respuesta: Desde la entrada en el estudio o el inicio del tratamiento hasta la respuesta.
- Tiempo libre de recidivas: Desde el final del tratamiento hasta la progresión o recidiva de la enfermedad.
- Duración de la respuesta: Desde la respuesta hasta la progresión o recidiva de la enfermedad.
- Supervivencia libre de enfermedad o supervivencia libre de recidiva: Desde la respuesta hasta la progresión o recidiva de la enfermedad, pero medido sólo en pacientes que han obtenido remisión completa o remisión completa sin confirmar.

Tolerabilidad y Toxicidad del esquema de tratamiento: Evaluación del nº de AA atribuibles a la medicación del estudio. Para su valoración se seguirán los criterios del National Cancer Institute (NCI-CTCAE 4.0).

Estudios biológicos de marcadores de actividad de quimioterapia metronómica:
Marcadores de angiogénesis: Evaluaciones de Células Endoteliales Circulantes mediante CFM y de niveles séricos de VEGF, TSP1.
Evaluación del sistema inmune: Determinación de poblaciones T reguladoras.

E.5.2.1

Timepoint(s) of evaluation of this end point

In every visit.

En cada visita.

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

E.8.1.1

Randomised

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

Yes

E.8.4

The trial involves multiple sites in the 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 patient treatment completion or withdrawal due to progression disease, unacceptable toxicity, clinical decision or patient decision.

Finalización del tratamiento del último paciente o abandono por progresión, toxicidad inaceptable, decisión clínica o deseo 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:

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

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.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

Ninguno.

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

2016-11-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-04-01

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2019-05-07

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