Clinical Trials Register

Summary
EudraCT Number:	2016-000764-42
Sponsor's Protocol Code Number:	UC-0140/1606-BIG16-01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-10-31
Trial results	View 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

2016-000764-42

A.3

Full title of the trial

A Phase II Trial Testing Durvalumab Combined With Endocrine Therapy in Patients With ER+/Her2- Breast Cancer Eligible for Neoadjuvant Endocrine Therapy And Who Present CD8+ T Cell Infiltration After 4-6 Weeks Exposure to Immune-Attractant.

Ensayo de fase II que analiza durvalumab en combinación con el tratamiento endocrino en pacientes con cáncer de mama ER+/her2- aptas para tratamiento endocrino neoadyuvante y que presentan infiltración de linfocitos T CD8+ tras 4-6 semanas de exposición a inmunoatrayente.

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

ULTIMATE

A.4.1

Sponsor's protocol code number

UC-0140/1606-BIG16-01

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	UNICANCER
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	UNICANCER
B.5.2	Functional name of contact point	Jérôme Lemonnier
B.5.3	Address:
B.5.3.1	Street Address	101, rue de Tolbiac
B.5.3.2	Town/ city	Paris cedex 13
B.5.3.3	Post code	75654
B.5.3.4	Country	France
B.5.4	Telephone number	33144 23 04 65
B.5.5	Fax number	33144 23 04 69
B.5.6	E-mail	j-lemonnier@unicancer.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	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	Durvalumab
D.3.2	Product code	MEDI4736
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DURVALUMAB
D.3.9.1	CAS number	1428935-60-7
D.3.9.4	EV Substance Code	SUB176342
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	1500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Tremelimumab
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Tremelimumab
D.3.9.1	CAS number	745013-59-6
D.3.9.3	Other descriptive name	TREMELIMUMAB
D.3.9.4	EV Substance Code	SUB37101
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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

Patients with ER+ and HER2- primary non-metastatic breast cancer who are eligible to neoadjuvant endocrine therapy.

Pacientes con cáncer de mama primario no metastásico ER+ y HER2- aptas para tratamiento endocrino neoadyuvante.

E.1.1.1

Medical condition in easily understood language

Non-metastatic breast cancer

Cancer de mama no metastásico

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10006187
E.1.2	Term	Breast cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the efficacy of durvalumab combined with exemestane in patients with CD8+ T cells on pathological response at surgery after a lymphocyte attraction phase.

Evaluar la eficacia de durvalumab combinado con exemestano en pacientes con linfocitos T CD8+ sobre la respuesta patológica en la cirugía tras una fase de atracción de linfocitos.

E.2.2

Secondary objectives of the trial

Efficacy:To evaluate the capacity of several “immune-attractants” approaches to increase CD8+ T cells in the tumor site and to determine the best “immune-attractant”. By comparing the rate of CD8+ T cells after part 1treatment with rate of CD8+ Tcells at baseline. Assess the efficacy of six months durvalumab + exemestane combination therapy in ER+/Her2- BC presenting CD8+ T cells after 6weeks exposure to immune-attractants on secondary endpoints. Evaluate whether durvalumab expands intratumor lymphocytes. Safety:Assess the safety of each treatment. Molecular:Assess the predictive value of mutational load, PDL1 expression on the efficacy of durvalumab. Identify predictive biomarkers,expression and copy number data for the efficacy of durvalumab. Explore the pCR after 6months durvalumab + exemestane according lymphocyte attraction treat. Assess CD8+ cells in surgical specimens of non-pCR patients. Correlate Immune infiltrate intensity with the proportion of tumor cells expressing PD-L1.

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

Research of biomarkers.

Investigación de Biomarcadores

E.3

Principal inclusion criteria

1. Age ≥18 years post-menopausal according to one of the following criteria:
Age > 60 years
Or Bilateral ovariectomy
Or Age ≤ 60, with an uterus and presenting an amenorrhea of more than 12 months and FSH and estradiol in the postmenopausal range
Or Age ≤ 60, without an uterus and FSH and estradiol in the postmenopausal range
2. Histologically proven invasive breast cancer eligible to neoadjuvant endocrine therapy according to multidisciplinary tumor board;
Note: Multicentric/multifocal tumors are allowed if all share the same characteristics.
3. cT2-T4, any N; cT2 are eligible only if the clinical tumor size is > 3cm
4. Non metastatic, M0 (according to clinical staging);
5. Luminal A patients ER-positive by IHC according to the following criteria (local assessment): Grade I or II AND ER-positive (≥ 60%) AND Ki67 <20%;
6. Her2-negative by IHC (score 0 or 1+) and/or FISH/CISH negative according to local assessment;
7. CD8+ T Cell infiltration defined as >10% cells stained with anti-CD8 mAB by IHC at the 3-week biopsy (applicable for inclusion in part 2 only);
8. Available tumor samples from baseline biopsy;
9. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrolment;
10. Adequate organ and marrow function as defined below:
Hemoglobin ≥9.0 g/dL
Absolute neutrophil count ≥1.5 × 109 /L
Platelet count ≥100 × 109/L
Serum bilirubin ≤1.5 × the ULN. This will not apply to patients with confirmed Gilbert’s syndrome, who will be allowed in consultation with their physician.
ALT and AST ≤2.5 × ULN;
Adequate renal function as determined by CKD-EPI formula (using actual body weight)
11. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures;
12. Written informed consent obtained prior to performing any protocol-related procedures, including screening evaluations.

1. Edad ≥ 18 años, postmenopáusica conforme a uno de los criterios siguientes:
Edad > 60 años.
U ovariectomía bilateral.
O edad ≤ 60 años, con útero y con amenorrea de más de 12 meses y niveles de FSH y estradiol dentro del intervalo posmenopáusico.
O edad ≤ 60 años, sin útero y con niveles de FSH y estradiol dentro del intervalo posmenopáusico.
2. Cáncer de mama invasivo (demostrado mediante análisis histológico) apto para tratamiento endocrino neoadyuvante según un comité multidisciplinario de evaluación de tumores.
Nota: Se permite la presencia de tumores multicéntricos/multifocales si todos comparten las mismas características.
3. cT2-T4, cualquier N; en cT2 aptas solo si el tamaño del tumor clínico es > 3 cm.
4. M0, no metastásico (según estadificación clínica).
5. Pacientes con luminal A ER positivos por IHQ según los criterios siguientes (evaluación local): grado I o II Y ER positivos (≥ 60 %) Y Ki67 < 20 %;
6. Her2 negativo por IHQ (puntuación 0 o 1+) y/o FISH/CISH negativo según la evaluación local.
7. Infiltración de linfocitos T CD8+ definida como > 10 % de células teñidas con AcM anti-CD8 por IHQ en la biopsia de la 3.ª semana (aplicable para la inclusión en la parte 2 solamente).
8. Disponibilidad de muestras tumorales de la biopsia basal.
9. Estado funcional de la Organización Mundial de la Salud (OMS)/Eastern Cooperative Oncology Group (ECOG) de 0 o 1 en el momento de la inclusión.
10. Función adecuada de los órganos y la médula ósea según se define a continuación:
Hemoglobina ≥ 9,0 g/dl
Recuento absoluto de neutrófilos ≥ 1,5 × 109/l
Recuento de plaquetas ≥ 100 × 109/l
Bilirrubina sérica ≤ 1,5 × LSN. Este parámetro no se aplicará a las pacientes con síndrome de Gilbert confirmado, a quienes se les permitirá participar tras consultar con su médico.
ALT y AST ≤ 2,5 × LSN.
Función renal adecuada según se determine mediante la fórmula CKD-EPI (utilizando el peso corporal real).

11. Disposición y capacidad de cumplir con las visitas programadas, el plan de tratamiento, las analíticas y otros procedimientos del ensayo.
12. Consentimiento informado por escrito obtenido antes de realizar ningún procedimiento relacionado con el protocolo, incluidas las evaluaciones de selección.

E.4

Principal exclusion criteria

1. Inflammatory breast cancer

2. No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines;

3. Any concurrent chemotherapy, investigational product (IP), biologic therapy for cancer treatment;

4. Previous Radiotherapy treatment to more than 30% of the bone marrow;

5. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose;

6. History of allogenic organ transplantation;

7. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment;

8. Any condition that, in the opinion of the Investigator, would interfere with the evaluation of investigational product or interpretation of patient safety or study results, including ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events from investigational products, or compromise the ability of the patient to give written informed consent;

9. Mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) ≥470 ms;

10. History of active primary immunodeficiency;

11. Known history of active tuberculosis;

12. Active infection including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)

13. Current or prior use of immunosuppressive medication within 14 days before the first dose. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection).
- Systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)

14. Receipt of live, attenuated vaccine within 30 days prior to the first dose of IP.
Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IP.

15. Known allergy or hypersensitivity to any medicinal product used in the trial or any excipient

1. Cáncer de mama inflamatorio.

2. Ninguna exposición previa a tratamiento inmunomediado, incluidos, entre otros, otros anticuerpos anti-CTLA-4, anti-PD-1, anti-PD-L1 y anti-PD-L2 (anti ligando de muerte celular programada 2), excepto las vacunas antineoplásicas terapéuticas.

3. Cualquier tipo de quimioterapia, producto en investigación (PEI) o tratamiento biológico concurrentes para el tratamiento del cáncer.

4. Radioterapia previa a más del 30 % de la médula ósea.

5. Intervención quirúrgica importante (según lo defina el investigador) en los 28 días previos a la primera dosis.

6. Antecedentes de trasplantes de órganos alógenos.

7. Trastornos autoinmunitarios activos o anteriores documentados (incluida enfermedad intestinal inflamatoria [p. ej., colitis o enfermedad de Crohn], diverticulitis con excepción de diverticulosis, celiaquía u otras afecciones gastrointestinales crónicas graves asociadas con diarrea), lupus eritematoso sistémico, síndrome de sarcoidosis o síndrome de Wegener (granulomatosis con poliangitis), enfermedad de Graves, artritis reumatoide, hipofisitis, uveítis, etc. en los últimos 3 años antes del inicio del tratamiento. Estas son excepciones a este criterio:
- Pacientes con vitíligo o alopecia.
- Pacientes con hipotiroidismo (p. ej., después de síndrome de Hashimoto) estable en tratamiento con terapia hormonal sustitutiva o psoriasis que no requiere tratamiento sistémico.

8. Cualquier afección que, según la opinión del investigador, interferiría con la evaluación del producto en investigación o interpretación de los resultados de la seguridad del paciente o del estudio, incluida infección en curso o activa, insuficiencia cardíaca congestiva sintomática, hipertensión no controlada, angina de pecho inestable, arritmia cardiaca, enfermedad pulmonar intersticial o enfermedad psiquiátrica/situaciones sociales que limitarían el cumplimiento con los requisitos del estudio, aumentarían notablemente el riesgo de aparición de acontecimientos adversos de los productos en investigación o pondrían en peligro la capacidad del paciente de otorgar su consentimiento informado por escrito.

9.Intervalo QT corregido medio para la frecuencia cardíaca utilizando la fórmula de Fridericia (QTcF) ≥ 470 ms.

10.Antecedentes de inmunodeficiencia primaria activa.

11.Antecedentes conocidos de tuberculosis activa.

12.Infección activa incluida hepatitis B, hepatitis C o virus de la inmunodeficiencia humana (VIH).

13.Uso actual o anterior de medicamentos inmunodepresores en los 14 días anteriores a la primera dosis. Estas son excepciones a este criterio:
- Corticoides intranasales, inhalados, tópicos o inyecciones locales de corticoides (p. ej., inyección intrarticular).
- Corticoides sistémicos a dosis fisiológicas que no superen los 10 mg/día de prednisona o su equivalente.
- Corticoides como premedicación para reacciones de hipersensibilidad (p. ej., premedicación para TAC).

14. Recepción de vacunas con virus vivos atenuados en los 30 días previos a la primera dosis del PEI.
Nota: Los pacientes, si se incluyen, no deberán recibir vacunas con virus vivos durante el estudio y hasta 30 días después de la última dosis de PEI.

15. Alergia o hipersensibilidad conocidas a cualquier medicamento que se utilice en el ensayo o a cualquiera de sus excipientes.

E.5 End points

E.5.1

Primary end point(s)

Rate of pathological complete response on the surgical specimen.

Tasa de respuesta completa patológica en la muestra quirúrgica.

E.5.1.1

Timepoint(s) of evaluation of this end point

Not Applicable.

E.5.2

Secondary end point(s)

EFFICACY CRITERIA
-Number of CD8+ T cells
- Clinical response after 6 months therapy. Clinical response is determined by tumor assessments performed by palpation
-Assessment of Ki67 on the surgical specimen according to the recommendations from the International Ki67 in Breast cancer Working Group.
-Measurement of TILs according to the recommendations published by the international TILs working group 2014

SAFETY
- According to the CTC-AE v4.03.

TRANSLATIONAL RESEARCH (EXPLORATORY ENDPOINTS):
- Predictive value of Mutational load for the efficacy of durvalumab will be assessed by whole exome sequencing on baseline samples
- Predictive value of PDL1 expression for the efficacy of durvalumab will be assessed both on baseline samples and at 3 weeks biopsy (Ventana SP263 assay)
- Other biomarker research will be defined by the study steering committee at the end of the trial to ensure the optimal use of update technologies and hypotheses

CRITERIOS DE EFICACIA
- Número de linfocitos T CD8+.
- Respuesta clínica tras 6 meses de tratamiento. La respuesta clínica se determina con evaluaciones tumorales mediante palpación.
- Evaluación de Ki67 en la muestra quirúrgica según las recomendaciones del Grupo de Trabajo Internacional de Ki67 en el cáncer de mama.
- Medición de linfocitos infiltrantes tumorales (TIL) según las recomendaciones publicadas por el Grupo de Trabajo Internacional de TIL en 2014.

SEGURIDAD
Según los CTC-AE, v4.03.

INVESTIGACIÓN TRANSLACIONAL (CRITERIOS DE VALORACIÓN EXPLORATORIOS):
El valor predictivo de la carga mutacional para la eficacia de durvalumab se valorará mediante la secuenciación de todo el exoma de las muestras de referencia.
El valor predictivo de la expresión de PDL1 se evaluará en las muestras de referencia y en la biopsia de la 3.ª semana (ensayo Ventana SP263).
El comité directivo del estudio definirá la investigación de otros biomarcadores al final del ensayo para garantizar que se hace un uso óptimo de las tecnologías e hipótesis más actuales.

E.5.2.1

Timepoint(s) of evaluation of this end point

Not Applicable.

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

Yes

E.6.13.1

Other scope of the trial description

identification of predictive biomarkers

Identificación de los biomarcadores predictivos

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

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

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

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

Ultima Visita Ultimo Paciente

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

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.4.2

For a multinational trial

F.4.2.1

In the EEA

240

F.4.2.2

In the whole clinical trial

240

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

2018-03-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-12-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-07-28

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