Clinical Trials Register

Summary
EudraCT Number:	2014-005586-75
Sponsor's Protocol Code Number:	CSET2014/2204_PIPSeN
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:	2015-10-05
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

2014-005586-75

A.3

Full title of the trial

A Randomized double-blind Phase II trial evaluating maintenance olaparib versus placebo in patients with platinum-sensitive advanced non-small cell lung cancer

Ensayo clínico fase II aleatorizado doble ciego para evaluar el mantenimiento con olaparib versus placebo en pacientes con cáncer de pulmón no microcítico avanzado sensibles a platino

A.3.1

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

Maintenance therapy in patients with platinum-sensitive advanced non-small cell lung cancer

Terapia de mantenimiento en pacientes sensibles a platino y con cáncer de pulmón no microcítico

A.3.2

Name or abbreviated title of the trial where available

PIPSeN

A.4.1

Sponsor's protocol code number

CSET2014/2204_PIPSeN

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	Gustave Roussy
B.1.3.4	Country	France
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	Astra-Zeneca
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Gustave Roussy
B.5.2	Functional name of contact point	Sponsor CRA
B.5.3	Address:
B.5.3.1	Street Address	114, rue Edouard Vaillant
B.5.3.2	Town/ city	Villejuif
B.5.3.3	Post code	94800
B.5.3.4	Country	France
B.5.6	E-mail	valerie.mairot@gustaveroussy.fr

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	Lynparza
D.2.1.1.2	Name of the Marketing Authorisation holder	Astra Zeneca
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.3.1	Product name	Olaparib
D.3.2	Product code	AZD2281
D.3.4	Pharmaceutical form	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	Olaparib
D.3.9.1	CAS number	763113-22-0
D.3.9.3	Other descriptive name	OLAPARIB
D.3.9.4	EV Substance Code	SUB32234
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	150
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	Lynparza
D.2.1.1.2	Name of the Marketing Authorisation holder	Astra Zeneca
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.3.1	Product name	Olaparib
D.3.2	Product code	AZD2281
D.3.4	Pharmaceutical form	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	Olaparib
D.3.9.1	CAS number	763113-22-0
D.3.9.3	Other descriptive name	OLAPARIB
D.3.9.4	EV Substance Code	SUB32234
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.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	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

Advanced non-small cell lung cancer

Cáncer de pulmón no microcítico avanzado

E.1.1.1

Medical condition in easily understood language

NSCLC

CPNM

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	LLT
E.1.2	Classification code	10025052
E.1.2	Term	Lung cancer non-small cell stage III
E.1.2	System Organ Class	100000004864

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10025055
E.1.2	Term	Lung cancer non-small cell stage IV
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the anti-tumor activity of maintenance olaparib in platinum-sensitive NSCLC as measured by PFS from randomization according to RECIST criteria v1.1

? Evaluar la actividad antitumoral del tratamiento de mantenimiento con olaparib en el CPNM sensible al platino, en su determinación mediante la supervivencia libre progresión (SLP) desde la aleatorización y según los criterios RECIST v1.1

E.2.2

Secondary objectives of the trial

?To evaluate the anti-tumor activity of maintenance olaparib as measured by overall response rate, disease control rate and overall survival
?To evaluate the safety profile of maintenance olaparib
?To evaluate the disease-related symptoms and health-related quality of life on maintenance olaparib as reported by the patients

? Evaluar la actividad antitumoral del tratamiento de mantenimiento con olaparib, en su determinación mediante la tasa global de respuesta, la tasa de control de la enfermedad y la supervivencia global
? Evaluar el perfil de seguridad del tratamiento de mantenimiento con olaparib
? Evaluar los síntomas de la enfermedad y la calidad de vida relacionada con la salud durante el tratamiento de mantenimiento con olaparib, según refieran los pacientes

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion criteria for registration :
1.Provision of written informed consent to treatment and companion translational studies prior to any study specific procedures
2.Patients must be > 18 years of age.
3.Affiliation to an health insurance
4.Histological diagnosis of NSCLC
5.Advanced or metastatic disease (stage IIIB/IV)
6.Access to the original tumor biopsy or planning of a fresh tumor biopsy
7.Chemonaïve for NSCLC
8.Absence of EGFR-sensitising mutation or ALK translocation
9.ECOG Performance Status of 0-1
10.Fit to receive 4-6 cycles of platinum-based induction chemotherapy
11.Measurable lesions by RECIST v1.1 criteria, i.e. at least one lesion, not previously irradiated, that can be accurately measured at baseline as ? 10mm in the longest diameter (except lymph nodes that must have short axis ? 15mm) with computed tomography (CT), magnetic resonance imaging (MRI) or clinical examination and which is suitable for accurate repeated measurements.
12.Patients must have normal organ and bone marrow function measured within 14 days prior to administration of the platinum-based treatment
13.Evidence of non-childbearing status for women of childbearing potential: negative serum pregnancy test within 14 days of study treatment.
14.Both men and women (of childbearing potential) who are sexually active should accept to use adequate contraception, during and for at least 3 months post-treatment
15.Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Inclusion criteria for the genomic DNA study :
1.Provision of informed consent for genomic DNA research.

Inclusion criteria for randomization :
1.Patients previously registered in the PIPSeN study
2.Evidence of radiological partial or complete response after induction chemotherapy according to RECIST v1.1 criteria
3.ECOG Performance Status of 0-1
4.Patients must have normal organ and bone marrow function measured within 14 days prior to administration of olaparib / placebo
5.Evidence of non-childbearing status for women of childbearing potential: negative serum pregnancy test within 14 days of study treatment.

1. Otorgar su consentimiento informado por escrito para el tratamiento y los estudios traslacionales asociados antes de que se realice ningún procedimiento específico del estudio.
2. Edad ?18 años.
3. Cubierto por un seguro sanitario.
4. Diagnóstico histológico de CPNM.
5. Enfermedad avanzada o metastásica (estadio IIIB/IV).
6. Acceso a la biopsia tumoral original o previsión de realizar una nueva biopsia tumoral.
7. No haber recibido quimioterapia previa para el CPNM.
8. Ausencia de mutación sensibilizante de EGFR o translocación de ALK.
9. Estado funcional del ECOG de 0-1.
10. Apto para recibir 6 ciclos de quimioterapia de inducción con platino.
11. Lesiones medibles según los criterios RECIST v1.1, es decir, por lo menos una lesión no irradiada previamente, que pueda medirse con exactitud en el momento basal como ?10 mm de diámetro mayor (excepto los ganglios linfáticos, que deben presentar un eje corto ?15 mm) mediante tomografía computarizada (TAC), resonancia magnética (RMN) o examen clínico y que permita realizar mediciones repetidas exactas.
12. Función normal de órganos y de médula ósea, determinada en el plazo de los 14 días anteriores a la administración del tratamiento con platino:
? Hemoglobina ?10,0 g/dl
? Recuento absoluto de neutrófilos (RAN) ?1,5 × 109/L
? Recuento de plaquetas ?100 × 109/L
? Bilirrubina total ?1,5 × límite superior de la normalidad del centro (LSN)
? AST (SGOT)/ALT (SGPT) ?2,5 × LSN, excepto en presencia de metástasis hepáticas, caso en que deberá ser ?5 × LSN
? Aclaramiento de creatinina >60 ml/min calculado con la fórmula de Cockroft-Gault for cisplatin administration; creatinine clearance > 50mL/min by Cockroft-Gault formula for carboplatin administration

13. Ausencia demostrada de gestación en las mujeres potencialmente fértiles: prueba de embarazo negativa en suero en el plazo de los 14 días anteriores al tratamiento del estudio.
La posmenopausia se define como:
? Amenorrea durante 1 año o más después de la suspensión de tratamientos hormonales exógenos,
? Niveles de LH y FSH en el intervalo posmenopáusico para mujeres menores de 50 años,
? Ovariectomía inducida por radiación, con la última regla >1 año antes,
? Menopausia inducida por quimioterapia, con >1 año desde la última regla,
? O esterilización quirúrgica (ovariectomía bilateral o histerectomía).
14. Los varones y las mujeres (potencialmente fértiles) sexualmente activos deben comprometerse a utilizar métodos anticonceptivos adecuados durante el tratamiento y hasta al menos 6 meses después.
15. Disposición y capacidad de cumplir el protocolo durante todo el estudio, lo que comprende la recepción del tratamiento y las visitas y exámenes programados, incluido el seguimiento.

E.4

Principal exclusion criteria

Non-inclusion criteria for registration :
1.Uncontrolled or symptomatic brain metastases. Controlled brain metastases are defined as stable for 1 month. A scan to confirm the absence of brain metastases is not required. Corticosteroids therapy will be allowed if administered at a stable dose for at least one month before entering the trial.
2.Previous enrolment (or randomisation) in the present study
3.Previous chemotherapy treatment for NSCLC
4.Any previous treatment with a PARP inhibitor, including olaparib.
5.Patients receiving any radiotherapy or considering to require radiotherapy to the lung at the time of study entry or in the near future, except for palliative reasons. The patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to inclusion.
6.Patients receiving the following classes of inhibitors of CYP3A4 (see Section 6.5 for guidelines and wash out periods).
7.Major surgery within 14 days of registration and patients who have not recovered from any effects of any major surgery.
8.Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, coronary artery disease, cardiomyopathy, uncontrolled hypertension, myocardial infarction in the last 3 months, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), superior vena cava syndrome, extensive bilateral lung disease on HRCT scan or any psychiatric disorder that prohibits obtaining informed consent.
9.Pregnant and/or breast-feeding women.
10.Patients who are known to be serologically positive for human immunodeficiency virus (HIV) and/or are receiving antiviral therapy. Systematic serologies to confirm the absence of this disease are not required.
11.Patients with known active hepatic disease (i.e., Hepatitis B or C) Systematic serologies to confirm the absence of these diseases are not required.
12.Patients with a known hypersensitivity to olaparib/placebo, cisplatin, carboplatin, or other platinum containing compounds, or any of the excipients of the product.
13.Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of olaparib/placebo.
14.Symptomatic peripheral neuropathy ? grade 2
15.Patients with uncontrolled seizures
16.Enrolment in another clinical trial (except observational study).

Non-inclusion criteria for the genomic DNA study :
1.Previous allogeneic bone marrow transplant;
2.Blood transfusion in the last 120 days prior to entry to the study

1. Metástasis cerebrales no controladas o sintomáticas. Se define como metástasis cerebrales controladas las que permanecen estables durante 1 mes. No se precisan estudios de neuroimagen para confirmar la ausencia de metástasis cerebrales. Se permitirá el tratamiento con corticosteroides si se administran en dosis estables desde por lo menos 1 mes antes de entrar en el ensayo.
2. Reclutamiento previo (o aleatorización previa) en el presente estudio.
3. Quimioterapia previa para el CPNM.
4. Tratamiento previo con un inhibidor de la PARP, incluido olaparib.
5. Pacientes que estén recibiendo radioterapia de cualquier tipo o que se considere que van a precisar radioterapia en el pulmón en el momento de su entrada en el estudio o en un futuro próximo, excepto con intención paliativa. Los pacientes podrán recibir una dosis estable de bisfosfonatos para las metástasis óseas, antes y durante el estudio, siempre que hayan iniciado el tratamiento como mínimo 4 semanas antes de la inclusión.
6. Pacientes que estén recibiendo las siguientes clases de inhibidores de CYP3A4 (véanse en la sección 6.5 las correspondientes directrices y periodos de lavado).
? Antifúngicos azólicos
? Antibióticos macrólidos
? Inhibidores de la proteasa
Véase una lista de los principales inhibidores potentes de CYP3A4 en el siguiente enlace: http://ansm.sante.fr/Dossiers/Interactions-medicamenteuses/Interactions-medicamenteuses-et-cytochromes/(offset)/1#tablo
7. Intervención quirúrgica mayor en el plazo de los 14 días anteriores a la entrada en el estudio y pacientes que no se hayan recuperado de los efectos de una intervención quirúrgica mayor.
8. Pacientes que se consideren de alto riesgo médico debido a trastornos médicos graves no controlados, enfermedades sistémicas no malignas o infecciones activas no controladas. Entre otros, pueden citarse los siguientes ejemplos: arritmia ventricular no controlada, enfermedad coronaria, miocardiopatía, hipertensión arterial no controlada, infarto de miocardio en los últimos 3 meses, compresión medular inestable (no tratada e inestable durante como mínimo 28 días antes de la entrada en el estudio), síndrome de la vena cava superior, neumopatía bilateral extensa en una TAC de alta resolución o cualquier trastorno psiquiátrico que impida obtener el consentimiento informado.
9. Mujeres embarazadas y/o lactantes.
10. Pacientes seropositivos para el virus de la inmunodeficiencia humana (VIH) y/o en tratamiento con antivirales. No se precisan análisis serológicos sistemáticos para confirmar la ausencia de esta enfermedad.
11. Pacientes con hepatopatía activa conocida (esto es, hepatitis B o C). No se precisan análisis serológicos sistemáticos para confirmar la ausencia de estas enfermedades.
12. Pacientes con hipersensibilidad conocida a olaparib/placebo, cisplatino, carboplatino u otros compuestos con platino, o a cualquiera de los excipientes del producto.
13. Concomitant yellow fever vaccine
14. Pacientes que no puedan deglutir la medicación en administración oral y pacientes con trastornos gastrointestinales que probablemente vayan a alterar la absorción de olaparib/placebo.
15. Neuropatía periférica sintomática de grado ?2.
16. Pacientes con crisis epilépticas no controladas.
17. Reclutamiento en otro ensayo clínico (excepto en estudios observacionales).

E.5 End points

E.5.1

Primary end point(s)

Progression Free Survival

Supervivencia libre de progresión

E.5.1.1

Timepoint(s) of evaluation of this end point

Every 8 weeks

cada 8 semanas

E.5.2

Secondary end point(s)

**Overall response rate and disease control rate
**Overall survival
**Toxicity and safety
**Quality of life

1) Tasa de respuesta global y tasa de control de la enfermedad
La tasa de respuesta global y la tasa de control de la enfermedad se determinarán tal como se describe más adelante según los criterios RECIST v1.1.

2) Supervivencia global
La supervivencia global se medirá desde la aleatorización del paciente hasta su muerte o el último seguimiento si el paciente sigue con vida o la retirada del consentimiento.

3) Toxicidad y seguridad
La toxicidad y la seguridad del tratamiento se determinarán con arreglo a los criterios NCI-CTCAE v4.0.

4) Tolerabilidad y calidad de vida (QLQ-C30 y LC13 de la EORTC)
Los sujetos cumplimentarán a lo largo del estudio dos cuestionarios de investigación de resultados: el cuestionario QLQ-C30 y el módulo específico para el cáncer de pulmón, LC13, de la European Organization for Research and Treatment of Cancer (EORTC).

E.5.2.1

Timepoint(s) of evaluation of this end point

during all the trial

Durante todo el ensayo

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

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

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

LVLS

LVLS (última visita de 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

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:

300

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

200

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

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

125

F.4.2

For a multinational trial

F.4.2.1

In the EEA

500

F.4.2.2

In the whole clinical trial

500

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

2015-10-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-09-08

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

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