Clinical Trials Register

Summary
EudraCT Number:	2018-000222-61
Sponsor's Protocol Code Number:	DS8201-A-U302
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:	2018-10-09
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

2018-000222-61

A.3

Full title of the trial

A Phase 3, multicenter, randomized, open-label, active-controlled study of DS-8201a, an anti-HER2-antibody drug
conjugate, versus ado-trastuzumab emtansine (T-DM1) for HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane

Estudio en fase III, multicéntrico, aleatorizado, abierto y controlado con principio activo de DS-8201a, un conjugado de fármaco y anticuerpo anti-HER2, frente a ado-trastuzumab emtansina (T DM1) para sujetos con cáncer de mama irresecable y/o metastásico que expresa HER2 tratados previamente con trastuzumab y taxano.

A.3.1

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

Testing a new targeted therapy (DS-8201a) against ado-trastuzumab emtansine (T-DM1) for patients with advanced-stage breast cancer previously treated with trastuzumab and taxane.

Estudio de nueva terapia dirigida (DS-8201a) frente a ado-trastuzumab emtansina (T DM1) para pacientes con cáncer de mama en estadío avanzado previamente tratados con trastuzumab y taxano.

A.4.1

Sponsor's protocol code number

DS8201-A-U302

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03529110

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	Daiichi Sankyo Inc.
B.1.3.4	Country	United States
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	Daiichi Sankyo 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	PI of Hospital Clínico San Carlos - Contact point of REEC
B.5.2	Functional name of contact point	Dr. José Ángel García Sáenz
B.5.3	Address:
B.5.3.1	Street Address	C/ Prof Martin Lagos s/n
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28040
B.5.3.4	Country	Spain
B.5.4	Telephone number	+349133030007868
B.5.6	E-mail	jgsaenz@salud.madrid.org

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.3.2	Product code	DS-8201a
D.3.4	Pharmaceutical form	Powder 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	trastuzumab deruxtecan
D.3.9.2	Current sponsor code	DS-8201a
D.3.9.3	Other descriptive name	Anti-HER2 antibody-drug conjugate
D.3.9.4	EV Substance Code	SUB188940
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	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	Comparator
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	Kadcyla
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for 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	trastuzumab emtansine
D.3.9.1	CAS number	1018448-65-1
D.3.9.3	Other descriptive name	trastuzumab emtansine
D.3.9.4	EV Substance Code	SUB35467
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	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: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	Kadcyla
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Australia
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	Powder for 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	trastuzumab emtansine
D.3.9.1	CAS number	1018448-65-1
D.3.9.3	Other descriptive name	trastuzumab emtansine
D.3.9.4	EV Substance Code	SUB35467
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	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

Unresectable/metastatic breast cancer with human epidermal growth factor receptor 2 (HER2)-positive expression

Cáncer de mama irresecable/metastásico con expresión positiva del factor de crecimiento epidérmico humano 2 (HER2)

E.1.1.1

Medical condition in easily understood language

advanced-stage breast cancer

cáncer de mama en estadío avanzado

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	LLT
E.1.2	Classification code	10027475
E.1.2	Term	Metastatic breast cancer
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the efficacy of DS 8201a to T-DM1 as measured by progression-free survival (PFS).

Comparar la eficacia de DS-8201a con la de T-DM1 según lo determinado a partir de la supervivencia sin progresión (SSP).

E.2.2

Secondary objectives of the trial

• To further compare the efficacy of DS-8201a to T-DM1 on:
- Overall survival (OS);
- Objective response rate (ORR);
- Duration of response (DoR);
- Clinical benefit rate (CBR).
• To further determine pharmacokinetics (PK) of DS-8201a.
• To further evaluate safety of DS-8201a compared to T-DM1.
• To evaluate Health Economics and Outcomes Research (HEOR) endpoints for DS 8201a compared to T-DM1.

• Comparar con mayor profundidad la eficacia de DS-8201a con la de T-DM1 en lo que respecta a:
 - Supervivencia global (SG)
 - Tasa de respuesta objetiva (TRO)
 - Duración de la respuesta (DR)
 - Tasa de beneficio clínico (TBC)
• Determinar con mayor profundidad la farmacocinética (FC) de DS-8201a.
• Evaluar con mayor profundidad la seguridad de DS-8201a en comparación con la de T-DM1.
• Evaluar los criterios de valoración de la Investigación de resultados económicos sanitarios (Health Economics and Outcomes Research, HEOR) para DS-8201a en comparación con T-DM1.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Adults ≥18 years old. (Please follow local regulatory requirements if the legal age of consent for study participation is >18 y old.)
• Pathologically documented breast cancer that:
- is unresectable or metastatic
- has confirmed HER2 positive expression as determined according to American Society of Clinical Oncology – College of American Pathologists guidelines evaluated at a central laboratory.
- was previously treated with trastuzumab and taxane in the advanced/metastatic setting or progressed within 6 mo after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane.
• Documented radiologic progression (during or after most recent treatment or within 6 mo after completing adjuvant therapy).
• Subjects must be HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available.
• Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 4.5 mo after the last dose of DS 8201a or 7 mo after the last dose of T-DM1
• Adequate renal function, defined as:
- Creatinine clearance ≥ 30 mL/min, as calculated using the Cockcroft-Gault equation
• Adequate hepatic function, defined as:
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN) if no liver metastases or < 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline
and
- Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 5 × ULN

• Adultos ≥18 años de edad. (Respete la legislación local si la edad legal de consentimiento para la participación en el estudio es >18 años).
• Cáncer de mama confirmado patológicamente que:
 - sea irresecable o metastásico;
 - presente expresión positiva para HER2 confirmada según se determina en las directrices de la Asociación Estadounidense de Oncología Clínica - Colegio Estadounidense de Anatomopatólogos (American Society of Clinical Oncology – College of American Pathologists) evaluada en un laboratorio central.
 - se haya tratado previamente con trastuzumab y taxano en un marco avanzado/metastásico o haya progresado en el plazo de 6 meses tras el tratamiento neoadyuvante o adyuvante con una pauta con trastuzumab o taxano.
• Progresión radiológica confirmada (durante o después del tratamiento más reciente y en los 6 meses posteriores a la finalización del tratamiento complementario).
• Los sujetos deberán presentar expresión positiva para HER2 según se confirme mediante la evaluación del laboratorio central de la muestra de tejido tumoral más reciente disponible. Si no hay disponible tejido archivado, será necesaria una nueva biopsia.
• Los sujetos de ambos sexos en edad fértil deberán aceptar el uso de un método anticonceptivo altamente eficaz o evitar mantener relaciones sexuales durante y tras la finalización del estudio y al menos en los 4,5 meses posteriores a la última dosis de DS-8201a o 7 meses después de la última dosis de T-DM1.
• Función renal adecuada, definida como:
 - Aclaramiento de creatinina ≥30 ml/min, calculado mediante la ecuación de Cockcroft-Gault.
• Función hepática adecuada, definida como:
 - Bilirrubina total ≤1,5 veces el límite superior de la normalidad (LSN) si no existen metástasis hepáticas o <3 veces el LSN en presencia de síndrome de Gilbert (hiperbilirrubinemia no conjugada) documentado o metástasis hepáticas al inicio del estudio; y
 - Niveles de aspartato transaminasa (AST)/alanina transaminasa (ALT) ≤5 veces el LSN.

E.4

Principal exclusion criteria

• Prior treatment with an anti-HER2-antibody drug conjugate (ADC).
• Uncontrolled or significant cardiovascular disease, including any of the following:
- History of myocardial infarction within 6 mo before randomization
- History of symptomatic congestive heart failure (New York Heart Association Class II to IV)
- Troponin levels consistent with myocardial infarction as defined according to the manufacturer within 28 d prior to randomization
- Corrected QT interval prolongation to > 470 ms (females) or > 450 ms (male) based on average of Screening triplicate 12 lead electrocardiogram (ECG)
- Left ventricular ejection fraction (LVEF) < 50% within 28 d prior to randomization
• Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
• Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
- Subjects with clinically inactive brain metastases may be included in the study.
- Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.

• Tratamiento anterior con un conjugado anticuerpo-fármaco (CAF) anti-HER2.
• Enfermedad cardiovascular no controlada o significativa, incluidos cualquier de los siguientes casos:
 - Antecedentes de infarto de miocardio en los 6 meses anteriores a la aleatorización.
 - Antecedentes de insuficiencia cardíaca congestiva (clases II a IV de la New York Heart Association).
 - Niveles de troponina coherentes con un infarto de miocardio según la definición del fabricante durante los 28 días previos a la aleatorización.
 - Presentar prolongación del intervalo QT corregido >470 ms (mujeres) o >450 ms (varones) según el valor medio del electrocardiograma (ECG) de 12 derivaciones por triplicado durante la selección.
 - Fracción de eyección del ventrículo izquierdo (FEVI) <50 % durante los 28 días previos a la aleatorización.
• Tener antecedentes de enfermedad pulmonar intersticial (EPI) (no infecciosa)/neumonitis que requirió tratamiento con corticosteroides, presentar EPI/neumonitis en curso o cuando no pueda descartarse la sospecha de EPI/neumonitis mediante diagnóstico por imagen durante la selección.
• Compresión de la médula espinal por metástasis o metástasis del sistema nervioso central (SNC) clínicamente activas, definidas como no tratadas y sintomáticas, o que requieran tratamiento con corticosteroides y anticonvulsivos para controlar los síntomas asociados.
 - Pueden incluirse en el estudio sujetos con metástasis cerebrales clínicamente inactivas.
 - Pueden incluirse en el estudio sujetos con metástasis cerebrales tratadas que ya no presenten síntomas y no requieran tratamiento con corticosteroides o anticonvulsivos si se han recuperado del efecto tóxico agudo de la radioterapia. Deberá haber transcurrido un mínimo de 2 semanas entre el final de la radioterapia total de cerebro y la inscripción en el estudio.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is PFS as determined by blinded independent central review (BICR).

El criterio de valoración principal de la eficacia es SSP según lo determinado por la BICR.

E.5.1.1

Timepoint(s) of evaluation of this end point

The end of the study hypothesis-testing period is defined as the date when approximately 331 PFS events per blinded independent central review (BICR) have been observed.

El análisis principal de la SSP se llevará a cabo cuando se hayan observado aproximadamente 331 acontecimientos de SSP evaluados por la BICR.

E.5.2

Secondary end point(s)

The secondary efficacy endpoints are:
• OS
• ORR based on BICR and investigator assessment
• DoR based on BICR and investigator assessment
• CBR based on BICR and investigator assessment
• PFS based on investigator assessment

Los criterios de valoración secundarios de la eficacia son:
• SG
• TRO basándose en la BICR y la evaluación del investigador.
• DR basándose en la BICR y la evaluación del investigador.
• TBC basándose en la BICR y la evaluación del investigador.
• SSP basándose en la evaluación del investigador.

E.5.2.1

Timepoint(s) of evaluation of this end point

If the test of the primary endpoint, PFS based on BICR, is statistically significant, selected secondary endpoints will be tested.

Si el análisis del criterio de valoración principal, SSP según lo determinado por la BICR, es estadísticamente significativo, se analizarán los criterios de valoración secundarios seleccionados.

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

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

Yes

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

Yes

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

Australia

Belgium

Brazil

Canada

China

France

Germany

Hong Kong

Italy

Japan

Korea, Republic of

Spain

Taiwan

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

The end of the study hypothesis-testing period is defined as the date when approximately 331 PFS events per BICR have been observed. The study closure is defined as the date when the last subject discontinues study treatment and applicable follow-up occurs, or the study is ended by the Sponsor.

El final del periodo de comprobación de la hipótesis del estudio se define como la fecha en la que se hayan observado aproximadamente 331 acontecimientos de SSP evaluados por la BICR. El cierre del estudio se define como la fecha en que el último sujeto interrumpe el tratamiento del estudio y se produce el seguimiento correspondiente, o el patrocinador finaliza el estudio.

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:

285

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

215

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

194

F.4.2.2

In the whole clinical trial

500

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None. If there is evidence that the subject is receiving benefit from treatment even though the subject has met a criterion for discontinuation as listed above, the subject may remain on study treatment after discussion with and approval from the Sponsor Medical Monitor.

Ninguna. Si hay evidencia de que el sujeto está recibiendo beneficios del tratamiento a pesar de que el sujeto ha cumplido un criterio de interrupción como se indicó anteriormente, el sujeto puede permanecer en el tratamiento del estudio después de la discusión y la aprobación del Monitor Médico del Promotor.

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

2018-11-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-10-19

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

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IMP with orphan designation in the indication
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