Clinical Trials Register

Summary
EudraCT Number:	2013-000809-23
Sponsor's Protocol Code Number:	AB12003
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Restarted
Date on which this record was first entered in the EudraCT database:	2014-03-26
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

2013-000809-23

A.3

Full title of the trial

A prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with docetaxel to placebo in combination with docetaxel in first line metastatic Castrate Resistant Prostate Cancer (mCRPC)

Estudio de fase III prospectivo, multicéntrico, randomizado, doble ciego, controlado con placebo y de 2 grupos paralelos para comparar la eficacia y seguridad de masitinib en combinación con docetaxel frente a placebo en combinación con docetaxel en el tratamiento de primera línea de pacientes con cáncer de próstata metastásico resistente a castración (mCPRC)

A.3.1

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

Study to evaluate 2 types of treatment as first line treatment (masitinib + docetaxel or placebo + docetaxel ) in the treatment of patients with metastatic Castrate Resistant Prostate Cancer (mCRPC)

Estudio para comparar la eficacia y seguridad de masitinib en combinación con docetaxel frente a placebo en combinación con docetaxel en el tratamiento de primera línea de pacientes con cáncer de próstata metastásico resistente a castración (mCPRC)

A.4.1

Sponsor's protocol code number

AB12003

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	AB Science
B.1.3.4	Country	France
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	AB Science
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	AB Science
B.5.2	Functional name of contact point	Beatrice Martin
B.5.3	Address:
B.5.3.1	Street Address	3 avenue George V
B.5.3.2	Town/ city	PARIS
B.5.3.3	Post code	75008
B.5.3.4	Country	France
B.5.4	Telephone number	+331 40 70 14 99
B.5.5	Fax number	+331 47 20 24 11
B.5.6	E-mail	beatrice.martin@ab-science.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	masitinib 100mg
D.3.2	Product code	AB1010
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	Masitinib mesylate
D.3.9.1	CAS number	790299-79-5
D.3.9.2	Current sponsor code	AB1010
D.3.9.3	Other descriptive name	MASITINIB
D.3.9.4	EV Substance Code	SUB32266
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	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	masitinib 200mg
D.3.2	Product code	AB1010
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	Masitinib Mesylate
D.3.9.1	CAS number	790299-79-5
D.3.9.2	Current sponsor code	AB1010
D.3.9.3	Other descriptive name	MASITINIB
D.3.9.4	EV Substance Code	SUB32266
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	200
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
D.8 Placebo: 2
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 Castrate Resistant Prostate Cancer (mCRPC).

Cáncer de próstata metastásico resistente a castración

E.1.1.1

Medical condition in easily understood language

metastatic Castrate Resistant Prostate Cancer (mCRPC).

Cáncer de próstata metastásico resistente a castración (mCPRC)

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

Overall survival (OS)

Supervivencia global (SG)

E.2.2

Secondary objectives of the trial

Secondary endpoint
? Survival rate every 6 months
? Overall Progression Free Survival (PFS)
? PFS rate every 12 weeks
? Overall Time To Progression (TTP)
? TTP rate every 12 weeks
? Best response rate, Objective Response rate: Complete Response (CR) or Partial Response (PR) and disease control rate (CR+ PR+ SD) every 12 weeks
? Decline of PSA level ? 30% from baseline at time point
? Quality of life assessment every 6 weeks Quality of Life according to the EORTC QLQ-C30 questionnaire
o Present Pain Intensity score based on the McGill-Melzack Pain Questionnaire (MPQ)
o Analgesic intake
o ECOG Performance Status
o Pain improvement (VAS)
? Pharmacogenomic assessment: Relationship between genomic data and overall survival.
? Safety profile using the NCI CTCAE v4.03 classification

? Tasa de supervivencia cada 6 meses
? Supervivencia global libre de progresión (SLP)
? Tasa de SLP cada 12 semanas
? Tiempo total hasta la progresión (TP)
? Tasa de TP cada 12 semanas
? Índice de mejor respuesta, índice de respuesta objetiva: respuesta completa (RC) o respuesta parcial (RP) y control de la enfermedad (RC+RP+EE) cada 12 semanas
? Disminución de los niveles de PSA ? 30% desde la visita basal en cada punto temporal
? Evaluación de la calidad de vida cada 6 semanas según el cuestionario EORTC QLQ-C30
o Puntuación de la intensidad de dolor actual según el cuestionario del dolor de McGill-Melzack (MPQ)
o Uso de analgésicos
o Estado funcional ECOG
o Mejoría del dolor (VAS)
? Evaluación farmacogenómica relación entre los datos genómicos y la supervivencia global.
? Perfil de seguridad según la clasificación NCI CTCAE v4.03.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

pharmacogenomic study: Relationship between genomic data and overall survival

Evaluación farmacogenómica relación entre los datos genómicos y la supervivencia global.

E.3

Principal inclusion criteria

1. Patient aged ≥ 18 years old, with histologically or cytologically confirmed metastatic Castrate Resistant Prostate Cancer (medical or surgical castration: androgens deprivation by GnHR agonist or antagonist or patient with surgical castration; hormonal castration confirmed biologically (testosterone < 0.5ng/ml) with one of the following criteria:
- Pre-treated with abiraterone with progressed disease documented, OR
- with indication for initiating docetaxel administration (e.g., widespread visceral disease or rapidly progressive disease).

2. Patient with evidence of progressive metastatic disease. Disease progression at trial enrolment is based on progression in at least one variable described in Table 5.
3. Patient with ECOG ? 1
4. Patient with adequate organ function:
? Absolute neutrophil count (ANC) ? 1.5 x 10ç/L
? Haemoglobin ? 10 g/dL
? Platelets (PTL) ? 75 x 109/L
? AST/ALT ? 3x ULN
? Gamma GT ?2.5 x ULN
? Bilirubin ? 1.5x ULN
? Normal creatinine or if abnormal creatinine, creatinine clearance ? 50 mL/min (Cockcroft and Gault formula)
? Albumin > 1 x LLN
? Proteinuria < 30 mg/dL (1+) on the dipstick; in case of proteinuria ? 1+ on the dipstick, 24 hours proteinuria must be ? 1.5g/24h
5. Patient with life expectancy > 6 months
6. Patient with BMI > 18 and patient weight > 40 kg
7. Man who agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for three months after the last treatment intake
8. Patient able and willing to comply with study procedures as per protocol
9. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures are performed. If the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable, the designated legal guardian must sign the informed consent.
10. Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months of treatment.

1. Pacientes mayores de edad (≥ 18 años) con confirmación histológica o citológica de cáncer de próstata metastásico resistente a castración [castración médica o quirúrgica: privación de andrógenos con agonistas de GnHR o antagonistas o pacientes con castración quirúrgica; castración hormonal confirmada biológicamente (testosterona < 0.5 ng/ml)] con uno de los siguientes criterios:
- Pre-tratados con abiraterona con progression de enfermedad documentada, O
- Con indicación para iniciar la administración de docetaxel (e.j., enfermedad visceral generalizada o rápida progresión de enfermedad).

2. Pacientes con evidencia de enfermedad metastásica progresiva. La progresión de la enfermedad en el reclutamiento del ensayo está basada en la progresión de como mínimo una variable de las descritas en la tabla 5.
3. Pacientes con ECOG ? 1
4. Pacientes con una actividad orgánica adecuada:
? Recuento absoluto de neutrófilos (RAN) ? 1,5 x 109/l
? Hemoglobina ? 10 g/dl
? Plaquetas (Plaq.) ? 75 x 109/l
? AST/ALT ? 3 x LSN
? Gamma GT ?2,5 x LSN
? Bilirrubina ? 1,5x x LSN
? Creatinina normal y, en caso de creatinina anómala, aclaramiento de creatinina ? 50 ml/min (fórmula de Cockcroft y Gault)
? Albúmina > 1 x LIN
? Proteinuria < 30 mg/dl (1+) en tira reactiva; si la proteinuria ? 1+ en tira reactiva, la proteinuria de 24 horas debe ser ? 1,5 g/24 horas
5. Pacientes con una esperanza de vida > 6 meses
6. Pacientes con un IMC > 18 y un peso > 40 kg
7. Hombres que accedan a utilizar dos métodos anticonceptivos aceptados médicamente (uno para el paciente y el otro para la pareja) durante el estudio y en los tres meses posteriores a la última toma del tratamiento.
8. Pacientes capaces y dispuestos a seguir los procedimientos del estudio según el protocolo.
9. Pacientes capaces de entender, firmar y fechar el formulario de consentimiento informado en la visita de selección antes de que se lleve a cabo cualquier procedimiento específico del protocolo. Si el médico responsable considera que el paciente tiene un déficit cognitivo o dudoso que pueda cuestionar la capacidad del paciente para dar su consentimiento, deberá ser el tutor legal del paciente quien firme el consentimiento informado.
10. Pacientes capaces de entender la tarjeta del paciente y dispuestos a seguir los procedimientos allí indicados en caso de observar signos o síntomas de neutropenia grave o toxicidad cutánea grave, durante los primeros 2 meses de tratamiento.

E.4

Principal exclusion criteria

1. Patient who has been previously treated with chemotherapy.
2. Patient with bone marrow irradiation > 40% within 12 months before baseline
3. Patient treated for a cancer other than prostate cancer within 3 years before enrollment, with the exception of basal cell carcinoma (and pTa or pT1)
4. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
5. Patient presenting with cardiac disorders defined by at least one of the following conditions:
? Patient with recent cardiac history (within 6 months) of:
o Acute coronary syndrome
o Acute heart failure (class III or IV of the NYHA classification)
o Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
? Patient with cardiac failure class III or IV of the NYHA classification
? Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
? Syncope without known aetiology within 3 months
? Uncontrolled severe hypertension, according to the judgement of the investigator, or symptomatic hypertension
6. Patient with an history of poor compliance or an history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
7. Patient under treatment with any anti-tumour therapy (any radiotherapy, chemotherapy, biologic or anti-androgen therapy except GnRH/LHRH analogs)

1. Pacientes que hayan sido tratados previamente con quimioterapia.
2. Pacientes que hayan recibido irradiación de médula ósea > 40% en los 12 meses anteriores a la visita basal.
3. Pacientes tratados por algún otro cáncer distinto al cáncer de próstata en los 3 años anteriores al reclutamiento en este estudio, excepto por carcinoma de células basales (y pTa o pT1)
4. Pacientes con metástasis activa en el sistema nervioso central (SNC) o con antecedentes de metástasis en el SNC.
5. Pacientes con afecciones cardíacas definidas por, al menos, uno de los siguientes trastornos:
? Pacientes con antecedentes cardíacos recientes (en los 6 meses previos) de:
o síndrome coronario agudo,
o insuficiencia cardíaca aguda (clase III o IV según la clasificación de la NYHA),
o arritmia ventricular significativa (taquicardia ventricular persistente, fibrilación ventricular, muerte súbita reanimada).
? Pacientes con insuficiencia cardíaca de clase III o IV según la clasificación de la NYHA.
? Pacientes con trastornos graves de la conducción cardíaca no evitables mediante electroestimulación cardíaca permanente (bloqueo auriculoventricular 2 y 3, bloqueo sinoauricular).
? Síncope de etiología desconocida en los 3 meses previos.
? Hipertensión grave no controlada, a juicio del investigador, o hipertensión sintomática.

6. Pacientes con antecedentes de falta de cumplimiento terapéutico o drogadicción/alcoholismo, o consumo excesivo de bebidas alcohólicas o enfermedades psiquiátricas presentes o pasadas que pudieran interferir en la capacidad para cumplir el protocolo del estudio o para dar su consentimiento informado.
7. Pacientes en tratamiento con cualquier antineoplásico (radioterapia, quimioterapia, fármacos biológicos o antiandrógenos a excepción de los análogos de la GnRH/LHRH).

E.5 End points

E.5.1

Primary end point(s)

? Overall Survival (OS) is defined as the time from the randomization to the date of documented death

? La supervivencia global (SG) se define como el tiempo desde la fecha de la randomización hasta la fecha del fallecimiento documentado.

E.5.1.1

Timepoint(s) of evaluation of this end point

Date of documented death

Fecha del fallecimiento documentado.

E.5.2

Secondary end point(s)

? Survival rate every 6 months
? Overall Progression Free Survival (PFS)
? PFS rate every 12 weeks
? Overall Time To Progression (TTP)
? TTP rate every 12 weeks
? Best response rate, Objective Response rate: Complete Response (CR) or Partial Response (PR) and disease control rate (CR+ PR+ SD) every 12 weeks
? Decline of PSA level ? 30% from baseline at time point
? Quality of life assessment every 6 weeks Quality of Life according to the EORTC QLQ-C30 questionnaire
o Present Pain Intensity score based on the McGill-Melzack Pain Questionnaire (MPQ)
o Analgesic intake
o ECOG Performance Status
o Pain improvement (VAS)
? Pharmacogenomic assessment: Relationship between genomic data and overall survival.
? Safety profile using the NCI CTCAE v4.03 classification

E.5.2.1

Timepoint(s) of evaluation of this end point

Every 12 weeks

Cada 12 semanas

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

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

Argentina

Austria

Belgium

Brazil

Canada

China

Czech Republic

Greece

Hong Kong

Hungary

India

Italy

Korea, Republic of

Malaysia

Mexico

Morocco

Peru

Philippines

Poland

Romania

Russian Federation

Singapore

South Africa

Spain

Tunisia

Ukraine

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

patient treated until disease progression limiting toxicity or consent withdrawal. Follow-up performed until patient's death

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:

250

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

300

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

200

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)

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

2014-10-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-04-03

P. End of Trial
P.	End of Trial Status	Restarted

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