Clinical Trials Register

Summary
EudraCT Number:	2018-000843-14
Sponsor's Protocol Code Number:	GEICO_70-E
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:	2018-04-20
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

2018-000843-14

A.3

Full title of the trial

A phase II multicenter, open-label, single arm trial of avelumab in combination with pegylated liposomal doxorubicin in recurrent/metastatic endometrial cancer

Ensayo abierto, multicéntrico, de un solo brazo, de fase II con avelumab en combinación con doxorrubicina liposomal pegilada en pacientes con cáncer endometrial recurrente o metastásico

A.3.1

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

A phase II clinical trial of avelumab in combination with pegylated liposomal doxorubicin in recurrent/metastatic endometrial cancer

Ensayo clínico de fase II con avelumab y doxorrubicina liposomal pegilada en pacientes con cáncer endometrial recurrente o metastásico

A.4.1

Sponsor's protocol code number

GEICO_70-E

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	GEICO (Grupo Español de Investigación en Cáncer de Ovario)
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	Pfizer Spain
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	CRS Unit. Vall d' Hebron Institute of Oncology (VHIO)
B.5.2	Functional name of contact point	CRS Unit (VHIO)
B.5.3	Address:
B.5.3.1	Street Address	C/ Natzaret, 115-117
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08035
B.5.3.4	Country	Spain
B.5.4	Telephone number	+349325434508614
B.5.6	E-mail	smunoz@vhio.net

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	Caelyx
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International NV
D.2.1.2	Country which granted the Marketing Authorisation	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	Concentrate for 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	Caelyx
D.3.9.1	CAS number	C50664300
D.3.9.3	Other descriptive name	PEGYLATED LIPOSOMAL DOXORUBICIN
D.3.9.4	EV Substance Code	SUB33393
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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	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	Avelumab
D.3.2	Product code	MSB0010718C
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	AVELUMAB
D.3.9.3	Other descriptive name	Avelumab
D.3.9.4	EV Substance Code	SUB180078
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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	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

recurrent/metastatic endometrial cancer

cáncer endometrial recurrente o metastásico

E.1.1.1

Medical condition in easily understood language

recurrent/metastatic endometrial cancer

cáncer endometrial recurrente o 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	10014734
E.1.2	Term	Endometrial cancer metastatic
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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	10014736
E.1.2	Term	Endometrial cancer recurrent
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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	10014741
E.1.2	Term	Endometrial cancer stage IV
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 evaluate the efficacy of anti-PDL1 blockade with avelumab in combination with PDL in patients with endometrial cancer.

Evaluar la eficacia del bloqueo de anticuerpos anti-PDL1 empleando la combinación de avelumab con PDL en pacientes con cáncer endometrial.

E.2.2

Secondary objectives of the trial

* To evaluate anti-tumor activity of avelumab and PLD in endometrial cancer patients.

•To evaluate the differences in efficacy of the study combination according to the groups by the genomic-The Cancer Genome Atlas (TCGA) classification; namely POLE, MSI, and Microsatellite Stable (MSS).

•To determine the safety and tolerability of the combination of avelumab and PDL across subjects with advanced endometrial tumors.

•Evaluar la actividad antitumoral de avelumab más PLD en pacientes con cáncer endometrial.

•Evaluar la eficacia de la combinación en estudio en los subgrupos genómicos establecidos por el Cancer Genome Atlas (TCGA) esto es, POLE, MSI, y con estabilidad de microsatélites (MSS).

•Determinar el perfil de seguridad y tolerabilidad de la combinación de avelumab y PDL en pacientes con tumores endometriales avanzados.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Be willing and able to provide written informed consent/assent for the trial.
2.Be at least 18 years of age on day of signing informed consent.
3.Have a histologically or cytologically-documented, advanced (metastatic and/or unresectable) endometrial carcinoma that is incurable. All epithelial endometrial histologies are eligible including: endometrioid, serous, clear-cell carcinoma or squamous. Sarcomas and mesenchymal tumors are excluded.
4.Received only 1 prior line of systemic platinum-based treatment based chemotherapy for advanced, recurrent or metastatic endometrial cancer.
5.Have measurable disease based on RECIST 1.1, (See Appendix 3)
6.Availability of fresh or archival FFPE tumor specimens for analysis for biomarker analysis from a tumor lesion not previously irradiated.
7.ECOG Performance Status (PS) 0 or 1.
8.Demonstrate adequate organ function as defined by the following criteria:
Hematologic: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (without recent transfusion)
Hepatic: Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and ALT levels ≤ 2.5 × ULN or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver).
Renal: Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
9.Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Patients of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 4.3.1 – Contraception, for the course of the study through 60 days after the last dose of study medication.

1.Tener la voluntad y capacidad de dar su consentimiento informado para participar en el estudio.
2.Ser mayor de edad el día de la firma del consentimiento informado.
3.Padecer un carcinoma endometrial avanzado (metastásico y/o inoperable) incurable confirmado histológica y citológicamente. Se admitirá cualquier histología endometrial epitelial, esto es: carcinoma endometrioide, seroso, de células claras o escamoso. Se excluirán los sarcomas y tumores mesenquimales.
4.Haber recibido únicamente una línea de tratamiento de quimioterapia sistémica basada en platino para el cáncer endometrial avanzado, recurrente o metastásico.
5.Tener un estadio de la enfermedad evaluable según los criterios RECIST 1.1 (véase el Apéndice 3).
6.Disponibilidad de muestras tumorales fijadas con formalina y sumergidas en parafina frescas o de archivo que no hayan sido irradiadas previamente.
7.Estado funcional ECOG (PS) de 0 o 1.
8.Demostrar una función orgánica adecuada, determinada según los siguientes criterios:
Hematológicos: Recuento absoluto de neutrófilos (ANC) ≥ 1.5 × 109/L, recuento de plaquetas ≥ 100 × 109/L, y hemoglobina ≥ 9 g/dL (en ausencia de transfusión reciente).
Hepáticos: Nivel total de bilirrubina ≤ 1.5 × el límite superior del rango normal (ULN) y niveles de AST y ALT ≤ 2.5 × ULN o niveles de AST y ALT ≤ 5 x ULN (para sujetos con enfermedad metastásica en el hígado confirmada).
Renales: Depuración estimada de creatinina ≥ 30 mL/min según la fórmula de Cockcroft-Gault (o el método estándar utilizado en el centro)
9.En el caso de las pacientes en edad fértil, prueba negativa de embarazo en suero u orina en las 72 h anteriores a la administración de la primera dosis del fármaco en estudio. En caso de que la prueba diera un resultado positivo o no se pudiera confirmar que es negativo, se deberá realizar una prueba de embarazo en suero. Las pacientes en edad fértil deberán comprometerse a emplear métodos anticonceptivos eficaces (véase Sección 4.3.1 - Anticoncepción) durante el transcurso del estudio y en los 60 días posteriores a la última dosis del fármaco en estudio.

E.4

Principal exclusion criteria

1.Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
2.Receipt of 2 or more prior chemotherapy regimens for advanced, recurrent, or metastatic endometrial cancer
3.History of Clinically significant: cardiovascular disease: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrhythmia requiring medication.
4.Impaired cardiac function defined as left ventricular ejection fraction (LVEF) < 50 % (or below the study site’s lower limit of normal) as measured by MUGA or ECHO or planned concomitant use of potentially cardiotoxic medication.
5.Previous anthracycline-based chemotherapy.
6.Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
7.Concurrent anticancer treatment within 28 days prior to study entry. 8.Has a known history of tuberculosis.
9.Prior organ transplantation including allogenic stem-cell transplantation.
10.Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3
11.Known additional malignancy diagnosed within 5 years prior to registration. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
12.Active central nervous system (CNS) metastases and/or carcinomatous meningitis. 13.Active infection requiring systemic therapy.
14.Active autoimmune disease that might deteriorate when receiving an immune-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
15.Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
16.Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
17.Has previously participated in any other avelumab trial, or received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or any other immune-modulating mAb (including ipilimumab and any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
18.Known history of testing positive for HIV or known acquired immunodeficiency syndrome.
19.Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
20.Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator’s judgment are acceptable.
21.Has received a live vaccine within 4 weeks of planned start of study therapy.
22.Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
23.Other severe acute or chronic medical or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
24.Known alcohol or drug abuse that could interfere with the requirements of the trial.
25.Any other condition that would, in the Investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, social/ psychological issues.

1.Estar participando actualmente en un estudio y estar recibiendo una terapia experimental, o haber participado en algún estudio en el que se le haya administrado un agente experimental, y haber recibido una terapia experimental o haber empleado un dispositivo experimental en las cuatro semanas anteriores a la primera dosis de tratamiento.
2.Haber recibido dos o más regímenes de quimioterapia previos para el cáncer endometrial avanzado, recurrente, o metastásico.
3.Tener antecedentes de enfermedad cardiovascular clínicamente relevante como: accidente cerebrovascular/ictus , infarto de miocardio, angina inestable, insuficiencia cardíaca congestiva, o arritmia cardíaca severa que requiera medicación.
4.Función cardíaca deteriorada definida como una fracción de eyección izquierda (LVEF) < 50 % medida mediante MUGA o ECHO, o previsión de que se vaya a administrar medicación potencialmente cardiotóxica de forma concomitante (véase Sección 5.7.3).
5.Quimioterapia previa basada en antraciclina.
6.Tener un diagnóstico de inmunodeficiencia o estar recibiendo terapia sistémica con esteroides o cualquier otro tipo de terapia inmunosupresora en los siete días anteriores a la primera administración del tratamiento en estudio.
7.Tratamiento oncológico concomitante en los 28 días anteriores a la inclusión en el estudio
8.Haber padecido tuberculosis.
9.Haberse sometido a un trasplante de órgano, incluido el trasplante alogénico de células madre.
10.Antecedentes de hipersensibilidad severa al producto experimental o a alguno de sus componentes, incluidas las reacciones severas de hipersensibilidad a anticuerpos monoclonales (Grado ≥ 3 de los CTCAE del NCI).
11.Haber sido diagnosticada de otro tumor maligno en los cinco años anteriores a la inclusión en el estudio, a excepción del: carcinoma de células basales o células escamosas de la piel para el que se haya administrado una terapia potencialmente curativa o cáncer del cuello uterino.
12.Metástasis activa en el sistema nervioso central (SNC) y/o meningitis carcinomatosa. 13.Infección activa que requiera terapia sistémica.
14.Enfermedad autoinmune activa que podría empeorar al recibir un agente inmunoestimulante. Podrán participar las pacientes con diabetes tipo 1, vitiligo, psoriasis o enfermedades hipo o hipertiroideas que no requieran tratamiento inmunosupresor.
15.Haber padecido un trastorno psiquiátrico o relacionado con el abuso de sustancias que pudiera interferir en el cumplimiento de los requisitos del estudio.
16.Estar embarazada o en periodo de lactancia o tener la intención de concebir o tener hijos durante el transcurso del estudio.
17.Haber participado previamente en otro estudio con avelumab, o haber recibido una terapia anterior con un anti-PD-1, anti-PD-L1, anti-PD-L2, o cualquier otro mAb inmunomodulador (incluyendo el ipilimumab y cualquier otro anticuerpo o fármaco específicamente dirigido a las vías de control (checkpoint) o coestimulación de células T).
18.Antecedentes de haber dado positivo en la prueba de VIH o tener un diagnóstico de síndrome de inmunodeficiencia adquirida.
19.Infección por virus de la hepatitis B (VHB) o virus de la hepatitis C (VHC) en el cribado (antígeno de superficie del VHB positivo o ARN del VHC positivo si la prueba de detección de anticuerpos anti-VHC es positiva).
20.Toxicidad persistente relacionada con la terapia anterior (Grado > 1 según los CTCAE del NCI v. 4.03 ); se aceptará la alopecia, la neuropatía sensorial de Grado ≤ 2, u otros Grados ≤ 2 que, a criterio del investigador, no constituyan un riesgo para la seguridad del paciente.
21.Haber recibido una vacuna viva en las cuatro semanas anteriores a la primera dosis del estudio.
22.Estar embarazada o en periodo de lactancia o tener la intención de concebir o tener hijos durante el transcurso del estudio, periodo que se extenderá desde la visita de preselección o selección hasta los 120 días posteriores a la última dosis del fármaco experimental.
23.Otras patologías agudas graves o crónicas, incluyendo la ideación o comportamientos suicidas activos recientes (en el último año), o alteraciones en los resultados de laboratorio que pudieran incrementar el riesgo asociado a la participación en el estudio o a la administración del tratamiento del estudio, o que pudieran interferir en la interpretación de los resultados del estudio y, a juicio del investigador, harían no apto al paciente para participar en este estudio .
24.Adicción conocida a las drogas o al alcohol que pudiera interferir en el cumplimiento por parte del paciente de los requisitos del estudio.
25.Cualquier patología que, a juicio del investigador, pudiera contraindicar la participación del paciente en el ensayo clínico por razones de seguridad o de falta de adherencia a los procedimientos del estudio (p.ej. infección/inflamación, aspectos sociales/psicológicos).

E.5 End points

E.5.1

Primary end point(s)

•Progression Free Survival rate at 6 months according to RECIST 1.1 criteria

•Supervivencia libre de progresión a los seis meses según los criterios RECIST 1.1.

E.5.1.1

Timepoint(s) of evaluation of this end point

at 6 months

a los seis meses

E.5.2

Secondary end point(s)

•Efficacy: Objective response (OR), Progression-Free Survival (PFS), Duration of Response (DR), according to RECIST 1.1 as assessed by the investigator; median Overall Survival (mOS), and OS rate at 1 and 2 years.

•Efficacy endpoints will be used to evaluate differences between the TCGA groups.

•Safety: AEs (as graded by NCI CTCAE v.4.03); laboratory abnormalities (as graded by NCI CTCAE v.4.03); vital signs (blood pressure, pulse rate); electrocardiograms(ECGs), ECHO or MUGA scans.

•Eficacia: Respuesta objetiva (OR), supervivencia sin progresión (PFS), duración de la respuesta (DR) según los criterios RECIST 1.1 evaluados por el investigador. Mediana de supervivencia global (mOS), y supervivencia global al año y a los dos años.

•Los criterios de valoración de eficacia se emplearán para investigar las diferencias entre los distintos grupos TCGA.

•Seguridad: Efectos adversos (clasificados según los criterios CTCAE del NCI v.4.03); alteraciones en los resultados de laboratorio (clasificados según los criterios CTCAE del NCI v.4.03); signos vitales (presión arterial, frecuencia cardíaca); electrocardiogramas (ECG), pruebas ECHO o MUGA.

E.5.2.1

Timepoint(s) of evaluation of this end point

Eficacy: at 1 and 2 years
Safety: countinously during the trial

Eficacia: al año y a los dos años
Seguridad: de manera continua durante todo el estudio

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

Information not present in EudraCT

E.8.1.4

Double blind

Information not present in EudraCT

E.8.1.5

Parallel group

Information not present in EudraCT

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

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

Última visita 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

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

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)

Standard of care

Práctica clínica habitual

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

2018-06-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-05-29

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

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