Clinical Trials Register

Summary
EudraCT Number:	2018-003906-26
Sponsor's Protocol Code Number:	ZEN003694-004
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2019-06-11
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

2018-003906-26

A.3

Full title of the trial

A Phase 2 Study of ZEN003694 in Combination with Talazoparib in Patients with Triple-Negative Breast Cancer

Estudio en fase II de ZEN003694 en combinación con talazoparib en pacientes con cancer de mama triple negativo

A.3.1

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

A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer (TNBC)

Estudio de ZEN003694 y talazoparib en pacientes con cancer de mama triple negative (TNBC)

A.4.1

Sponsor's protocol code number

ZEN003694-004

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03901469

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	Zenith Epigenetics Ltd.
B.1.3.4	Country	Canada
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	Zenith Epigenetics Ltd.
B.4.2	Country	Canada
B.4.1	Name of organisation providing support	Pfizer Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Zenith Epigenetics Ltd.
B.5.2	Functional name of contact point	Head of Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	44 Montgomery Street, Suite 4010
B.5.3.2	Town/ city	San Francisco
B.5.3.3	Post code	CA 94104
B.5.3.4	Country	United States
B.5.4	Telephone number	1415470-5600-650
B.5.6	E-mail	lisa@zenithepigenetics.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	ZEN003694
D.3.2	Product code	ZEN003694
D.3.4	Pharmaceutical form	Capsule, hard
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	ZEN003694
D.3.9.1	CAS number	2169952-43-4
D.3.9.2	Current sponsor code	ZEN003694
D.3.9.3	Other descriptive name	ZEN003694
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	12
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	Talazoparib
D.3.2	Product code	PF-06944076, formerly BMN 673, MDV3800, LT-00673
D.3.4	Pharmaceutical form	Capsule, hard
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	TALAZOPARIB
D.3.9.2	Current sponsor code	Talazoparib
D.3.9.3	Other descriptive name	PF-06944076, formerly BMN 673, MDV3800, LT-00673
D.3.9.4	EV Substance Code	SUB180394
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	1.0
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	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	ZEN003694
D.3.2	Product code	ZEN003694
D.3.4	Pharmaceutical form	Capsule, hard
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	ZEN003694
D.3.9.1	CAS number	2169952-43-4
D.3.9.2	Current sponsor code	ZEN003694
D.3.9.3	Other descriptive name	ZEN003694
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	48
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: 4
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	Talazoparib
D.3.2	Product code	PF-06944076, formerly BMN 673, MDV3800, LT-00673
D.3.4	Pharmaceutical form	Capsule, hard
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	TALAZOPARIB
D.3.9.2	Current sponsor code	Talazoparib
D.3.9.3	Other descriptive name	PF-06944076, formerly BMN 673, MDV3800, LT-00673
D.3.9.4	EV Substance Code	SUB180394
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	0.25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Triple Negative Breast Cancer

Cáncer de mama triple negativo

E.1.1.1

Medical condition in easily understood language

Triple Negative Breast Cancer

Cáncer de mama triple negativo

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	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10071115
E.1.2	Term	Node-negative breast cancer
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

Part 1:
- To determine the safety, tolerability, maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ZEN003694 in combination with talazoparib in patients with locally advanced or metastatic triple-negative breast cancer (TNBC)
Part 2:
- To evaluate the efficacy of ZEN003694 in combination with talazoparib in patients with locally advanced or metastatic TNBC

Parte 1:
- Determinar la seguridad, la tolerabilidad, la dosis máxima tolerable (DMT) y la dosis recomendada de la fase 2 (DRF2) de ZEN003694 en
combinación con talazoparib en pacientes con cáncer de mama triple negativo (CMTN) localmente avanzado o metastásico
Parte 2:
- Evaluar la eficacia de ZEN003694 en combinación con talazoparib en pacientes con CMTN localmente avanzado o metastásico

E.2.2

Secondary objectives of the trial

Part 1:
- To determine the pharmacokinetics (PK) of ZEN003694, its metabolite, ZEN003791, and talazoparib
- To evaluate the effects of ZEN003694 and talazoparib on mRNA expression of pharmacodynamic markers
- To evaluate the clinical activity of ZEN003694 in combination with talazoparib by radiographic response rate and progression-free survival
- To determine the effect of ZEN003694 and talazoparib on patient reported health status and quality of life
Part 2:
- To further evaluate the safety and tolerability of ZEN003694 in combination with talazoparib
- To determine the pharmacokinetics (PK) of ZEN003694, its metabolite, ZEN003791, and talazoparib
- To determine the effect of ZEN003694 and talazoparib on patient reported health status and quality of life

Parte 1:
- Determinar la farmacocinética (FC) de ZEN003694, de su metabolito ZEN003791 y de talazoparib
- Evaluar los efectos de ZEN003694 y talazoparib sobre la expresión del ARNm de los marcadores farmacodinámicos
- Evaluar la actividad clínica de ZEN003694 en combinación con talazoparib a través de la tasa de respuesta radiológica y de la
supervivencia sin progression
- Determinar el efecto de ZEN003694 y talazoparib sobre la calidad de vida y el estado de salud comunicados por el propio paciente
Parte 2:
- Continuar evaluando la seguridad y la tolerabilidad de ZEN003694 en combinación con talazoparib
- Determinar la farmacocinética (FC) de ZEN003694, de su metabolito ZEN003791 y de talazoparib
- Determinar el efecto de ZEN003694 y talazoparib sobre la calidad de vida y el estado de salud comunicados por el propio paciente

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Females or males age ≥ 18 years (at time of signing informed consent)
2. Histologically confirmed metastatic or recurrent triple-negative breast cancer (estrogen receptor (ER) ≤10%; progesterone receptor (PR) ≤10%; HER2 negative by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH)
3. Patient is not a candidate for endocrine based therapy by virtue of having an ER and/or PR < 1%, or having progressed on at least 2 prior endocrine based therapies in the locally advanced or metastatic setting
4. Part 1: Progressed on at least 1 prior cytotoxic chemotherapy at least 21 days prior to the start of study treatment. Part 2: Progressed on no more than 3 prior chemotherapy-inclusive regimens for locally advanced or metastatic disease (no limit on prior targeted anticancer therapies such as mechanistic target or rapamycin (mTOR) or CDK4/6 inhibitors, immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against CTL4 or VEGF) at least 21 days prior to the start of study treatment.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Part 2 only: Measurable disease per RECIST version 1.1

1.Hombres o mujeres de edad ≥18 años (en el momento de la firma del consentimiento informado)
2.Cáncer de mama triple negativo recidivante o metastásico confirmado mediante estudio de histología (receptores de estrógenos (RE) ≤10 %;
receptores de progesterona (RP) ≤10 %; HER2 negativo por inmunohistoquímica (IHQ) o hibridación in situ con fluorescencia (FISH)
3.El paciente no es candidato a tratamiento endocrino por tener RE y/o RP<1%, o haber progresado con al menos 2 tratamientos endocrinos anteriores en un context de enfermedad localmente avanzada o metastásica
4.Parte 1 : progresión con, como mínimo, 1 quimioterapia citotóxica previa al menos 21 días antes del inicio del tratamiento del estudio
Parte 2 : progresión con no más de 3 pautas que incluyesen quimioterapia para la enfermedad localmente avanzada o metastásica (sin límite de
tratamientos hormonales o tratamientos antineoplásicos dirigidos, como inhibidores de la diana de la rapamicina en mamíferos [mTOR] o inhibidores de CDK 4/6, fármacos de inmunoncología, inhibidores de la tirosina-cinasa, o anticuerpos monoclonales contra CTL4 o VEGF) al menos 21 días antes del inicio del tratamiento del estudio
5.El paciente no es candidato a tratamiento endocrino o su enfermedad ha progresado tras al menos 2 tratamientos endocrinosprevios para la
enfermedad localmente avanzada o metastásica.
5.Estado funcional del Grupo Oncológico Cooperativo de la costa Este (Eastern Cooperative Oncology Group, ECOG) de 0 o 1
6.Parte 2 solamente: enfermedad medible conforme a los criterios RECIST, versión 1.1

E.4

Principal exclusion criteria

1. Documented germline BRCA1 or BRCA2 mutations
2. Evidence of disease progression during platinum treatment either in the neoadjuvant or in the metastatic setting. For patients receiving platinum in the neoadjuvant setting, at least 12 months must have elapsed between the last dose of platinum-based treatment and enrollment.
3. Patients with inflammatory breast cancer (in Part 2 only)
4. Current or anticipated use of medications known to be strong inhibitors or inducers of CYP3A4 or substrates of CYP1A2 with narrow therapeutic windows. Strong inhibitors, inducers or substrates must be discontinued at least 7 days prior to the first administration of study drug.
5. Current or anticipated use within 7 days prior to the first administration of study drug, or during the study, of strong P-gp inhibitors.
6. Prior anticancer therapy (chemotherapy, radiation, hormone therapy, immunotherapy or investigational agent) within 3 weeks from the start of study drug (except for nitrosoureas and mitomycin C within 6 weeks from start of study drug).

1.Mutaciones documentadas de BRCA1 o BRCA2 en la línea germinal
2.Indicios de progresión de la enfermedad durante el tratamiento con platino, neoadyuvante o para la enfermedad metastásica. En el caso de
los pacientes que hayan recibido tratamiento neoadyuvante con platino, deben haber transcurrido al menos 12 meses entre la última dosis y la
inclusión.
3.Pacientes con cáncer de mama inflamatorio (en Parte 2 únicamente)
4.Uso en curso o previsto de medicamentos que son inhibidores o inductores potentes del CYP3A4 o sustratos del CYP1A2 con un margen
terapéutico estrecho. Se debe interrumpir la administración de estos sustratos, inductores o inhibidores potentes al menos 7 días antes de la
primera administración del fármaco del etudio.
5.Uso de inhibidores potentes de la gp-P en curso o previsto para los 7 días previos a la primera administración del fármaco del estudio o
durante el studio, de inhibidores potentes de la gp-P.
6.Tratamiento antineoplásico previo (quimioterapia, radioterapia,tratamiento hormonal, inmunoterapia o fármaco en fase de investigación ) en las 3 semanas anteriores al inicio del fármaco del estudio (excepto nitrosoureas y mitomicina, cuyo plazo correspondería a las 6 semanas anteriores al inicio del fármaco del estudio)

E.5 End points

E.5.1

Primary end point(s)

Part 1:
- Safety profile of ZEN003694 in combination with talazoparib
- DLT characteristics and MTD determination for ZEN003694 in combination with talazoparib
- RP2D of ZEN003694 in combination with talazoparib for further clinical investigation
Part 2:
- Objective response rate (ORR) defined as a complete response (CR), partial response (PR) or stable disease (SD ≥ 4 cycles) by RECIST 1.1

Parte 1:
- Perfil de seguridad de ZEN003694 en combinación con talazoparib
- Características de TLD y determinación de DMT para ZEN003694 en combinación con talazoparib

E.5.1.1

Timepoint(s) of evaluation of this end point

throughout the trial

durante el estudio

E.5.2

Secondary end point(s)

Part 1:
- Plasma concentrations of ZEN003694, the active metabolite ZEN003791 and talazoparib. The following PK parameters, at a minimum, will be calculated as appropriate: AUC0-last and AUC0-inf, Cmax and minimum or trough concentration (Cmin), dosing interval, and Tmax and half-life (t1/2)
- Overall response rate (ORR)
- Radiographic progression-free survival (rPFS)
- Quality of Life
Part 2:
- Progression-free survival (PFS)
- Radiographic progression-free survival (rPFS)
- Duration of response (DOR)
- Plasma concentrations of ZEN003694, the active metabolite ZEN003791 and talazoparib. The following PK parameters, at a minimum, will be calculated as appropriate: AUC0-last and AUC0-inf, Cmax and minimum or trough concentration (Cmin), dosing interval, and Tmax and half-life (t1/2)
- Quality of Life
- Safety

Parte 1:
- Concentraciones plasmáticas de ZEN003694, del metabolito activo ZEN003791 y talazoparib. El seguimiento de parámetros de FC,como mínimo serán calculados: AUC0-last y AUC0-inf, Cmax y minimo o concentración (Cmin), intervalo de dosis, y Tmax y vida media (t1/2)
- frecuencia de respuesta objetiva (ORR)
- supervivencia sin progresión radiológica (SSPr)
- calidad de vida
Parte 2:
- Supervivencia sin progression (SSP)
- supervivencia sin progresión radiológica (SSPr)
- Duración de la respuesta (DR)
- Concentraciones plasmáticas de ZEN003694, del metabolito activo ZEN003791 y talazoparib. El seguimiento de parámetros de FC,como mínimo serán calculados: AUC0-last y AUC0-inf, Cmax y minimo o concentración (Cmin), intervalo de dosis, y Tmax y vida media (t1/2)
- calidad de vida
- seguridad

E.5.2.1

Timepoint(s) of evaluation of this end point

throughout the trial

durante 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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

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

Belgium

Spain

United States

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 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

E.8.9.2

In all countries concerned by the trial months

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

F.4.2.2

In the whole clinical trial

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 care

tratamiento 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

2019-11-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-10-09

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2023-07-12

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IMP with orphan designation in the indication
Orphan Designation Number:
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