Clinical Trials Register

Summary
EudraCT Number:	2017-003148-19
Sponsor's Protocol Code Number:	INCB50465-205
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:	2018-03-08
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

2017-003148-19

A.3

Full title of the trial

A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor.

Estudio de fase II, abierto, de 2 cohortes y multicéntrico de INCB050465, un inhibidor de PI3Kδ, en linfoma de células del manto en recidiva o resistente al tratamiento, previamente tratado con o sin un inhibidor de la BTK (CITADEL-205)

A.3.1

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

An open-label study of INCB050465 in patients with relapsed or refractory Mantle Cell Lymphoma with or without prior exposure to a BTK inhibitor.

Un estudio abierto de INCB050465 en pacientes de linfoma de células del manto en recidiva o resistente al tratamiento, previamente tratado con o sin un inhibidor de la BTK

A.3.2

Name or abbreviated title of the trial where available

CITADEL-205

A.4.1

Sponsor's protocol code number

INCB50465-205

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03235544

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	Incyte Corporation
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	Incyte Corporation
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	Incyte Corporation
B.5.2	Functional name of contact point	Medical information
B.5.3	Address:
B.5.3.1	Street Address	1801 Augustine Cut-Off
B.5.3.2	Town/ city	Wilmington
B.5.3.3	Post code	DE 19803
B.5.3.4	Country	United States
B.5.4	Telephone number	+34800 600 724
B.5.6	E-mail	globalmedinfo@incyte.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.3.2	Product code	INCB050465 1 mg tablet
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not yet assigned
D.3.9.2	Current sponsor code	INCB050465
D.3.9.3	Other descriptive name	INCB050465 HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB183790
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
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.3.2	Product code	INCB050465 2.5 mg tablet
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not yet assigned
D.3.9.2	Current sponsor code	INCB050465
D.3.9.3	Other descriptive name	INCB050465 HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB183790
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	2.5
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.3.2	Product code	INCB050465 5 mg tablet
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not yet assigned
D.3.9.2	Current sponsor code	INCB050465
D.3.9.3	Other descriptive name	INCB050465 HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB183790
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	5
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.3.2	Product code	INCB050465 20 mg tablet
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not yet assigned
D.3.9.2	Current sponsor code	INCB050465
D.3.9.3	Other descriptive name	INCB050465 HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB183790
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	20
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

Mantle Cell Lymphoma

Linfoma de células del manto

E.1.1.1

Medical condition in easily understood language

Mantle Cell Lymphoma

Linfoma de células del manto

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	10061275
E.1.2	Term	Mantle cell lymphoma
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 INCB050465 in terms of objective response rate (ORR) in subjects with mantle cell lymphoma (MCL) that is relapsed or refractory after at least 1 but no more than 3 prior systemic treatment regimens.

Evaluar la eficacia de INCB050465 en cuanto a la tasa de respuesta objetiva (TRO) en pacientes con linfoma de células del manto (LCM) que se encuentra en recidiva o es resistente al tratamiento después de al menos 1 pero no más de 3 tratamientos sistémicos anteriores.

E.2.2

Secondary objectives of the trial

• To assess duration of response (DOR).
• To assess complete response rate (CRR).
• To assess progression-free survival (PFS).
• To assess overall survival (OS).
• To assess the best percentage change in target lesion size.
• To characterize the safety and tolerability of INCB050465.

- Evaluar la duración de la respuesta (DR).
- Evaluar la tasa de respuesta completa (TRC).
- Evaluar la supervivencia sin progresión (SSP).
- Evaluar la supervivencia general (SG).
- Evaluar la mejor variación porcentual en el tamaño de la lesión diana.
- Caracterizar la seguridad y tolerabilidad de INCB050465.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects with pathologically confirmed MCL, with documentation of either overexpression of cyclin D1 or t(11;14), who have had at least 1 but no more than 3 prior systemic treatment regimens.
• Men and women, aged 18 or older
• Documented failure to achieve at least PR with or documented disease progression after the most recent treatment regimen.
• Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by CT or magnetic resonance imaging (MRI).
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

Pacientes con LCM confirmado mediante las alteraciones anatomopatológicas, con documentación de sobreexpresión de ciclina D1 o t(11;14), que han recibido al menos 1, pero no más de 3, pautas de tratamiento sistémico anteriores

• Hombres y mujeres de al menos 18 años de edad (excepto en Corea del Sur, donde serán de al menos 19 años de edad)
• Fracaso documentado en lograr al menos RP o progresión de la enfermedad documentada después del tratamiento más reciente
• Presencia de linfadenopatía mensurable por métodos radiológicos o neoplasia linfoide extraganglionar maligna (definida por la presencia de ≥ 1 lesión que mida > 1,5 cm en su dimensión más grande y ≥ 1,0 cm en la dimensión perpendicular más grande según se determine mediante tomografía axial computarizada [TAC] o resonancia magnética [RM])
• Estado general ≤ 2 según el Grupo Oncológico Cooperativo del Este (Eastern Cooperative Oncology Group, ECOG)

E.4

Principal exclusion criteria

• History of central nervous system lymphoma (either primary or metastatic).
• Prior treatment with idelalisib, other selective phosphoinositide 3-kinase (PI3K) δ inhibitors, or a pan-PI3K inhibitor.
• Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of first dose of study treatment.
• Active graft-versus-host disease.
• Liver disease:
- Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation: HBV DNA and HCV RNA must be undetectable. Subjects cannot be positive for hepatitis B surface antigen or anti–hepatitis B core antibody.

• Antecedentes de linfoma en el sistema nervioso central (primario o metastásico)
• Tratamiento anterior con idelalisib, otros inhibidores selectivos de la fosfatidilinositol 3-cinasa (PI3K) δ o un inhibidor de todas las PI3K
• Alotrasplante de células madre en los últimos 6 meses o autotrasplante de células madre en los últimos 3 meses antes de la fecha de administración de la primera dosis del tratamiento del estudio
• Enfermedad de injerto contra huésped activa
• Enfermedad hepática:
- Indicios de infección por el virus de la hepatitis B (VHB) o por el virus de la hepatitis C (VHC), o riesgo de reactivación: el ADN del VHB y el ARN del VHC deben ser indetectables. Los pacientes no pueden presentar antígeno de superficie de la hepatitis B ni anticuerpos contra el antígeno central de la hepatitis B.

E.5 End points

E.5.1

Primary end point(s)

ORR defined as the percentage of subjects with a complete response (CR) or partial response (PR) as determined by independent review committee (IRC) assessment of response according to computed tomography (CT)-based response criteria for lymphomas.

La TRO se define como el porcentaje de pacientes con una respuesta completa (RC) o respuesta parcial (RP), según la evaluación de la respuesta determinada por un comité de revisión independiente (CRI), de acuerdo con los criterios de respuesta basada en la tomografía axial computarizada (TAC) para los linfomas.

E.5.1.1

Timepoint(s) of evaluation of this end point

Response data will be analyzed when all subjects in the respective cohort have received at least 1 postbaseline disease assessment or have progressed, withdrawn from the study, or died.

Los datos de respuesta se analizarán una vez todos los sujetos de cada cohorte hayan tenido al menos una evaluación post-basal de la enfermedad, hayan progresado, discontinuado del estudio o fallecido.

E.5.2

Secondary end point(s)

• DOR defined as the time from first documented evidence of CR or PR until disease progression or death from any cause among subjects who achieve an objective response, as determined by radiographic disease assessment provided by an IRC.
• CRR defined as the percentage of subjects with a CR as defined by response criteria for lymphomas as determined by an IRC.
• PFS defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause.
• Overall survival defined as the time from the date of the first dose of study treatment until death from any cause.
• Best percentage change in target lesion size from baseline, where target lesion size is measured by the sum of the product of diameters of all target lesion sizes.
• Safety measured by adverse events (AEs), 12-lead electrocardiograms (ECGs), chemistry and hematology laboratory values, vital signs, and physical examinations.

- La DR se define como el tiempo transcurrido desde el primer indicio documentado de RC o RP hasta la progresión de la enfermedad o la muerte por cualquier causa en los pacientes que alcancen una respuesta objetiva, según se determine mediante una evaluación radiográfica de la enfermedad proporcionada por un CRI.
- La TRC se define como el porcentaje de pacientes con RC determinada por un CRI según la definición mediante los criterios de respuesta en los linfomas.
- La SSP se define como el tiempo transcurrido desde la fecha de la administración de la primera dosis del tratamiento del estudio hasta la fecha más temprana de progresión de la enfermedad, según se determine mediante una evaluación radiográfica de la enfermedad realizada por un CRI, o la muerte por cualquier causa.
- La SG se define como el tiempo transcurrido desde la fecha de la administración de la primera dosis del tratamiento del estudio hasta el momento de la muerte por cualquier causa.
- Se define como la mejor variación porcentual en el tamaño de la lesión diana desde el momento inicial, donde el tamaño de la lesión diana se mide mediante la suma del producto de los diámetros de los tamaños de todas las lesiones diana.
- La seguridad se determina mediante la evaluación de los acontecimientos adversos (AA), los electrocardiogramas (ECG) de 12 derivaciones, los valores analíticos de bioquímica y hematología, las constantes vitales y las exploraciones físicas.

E.5.2.1

Timepoint(s) of evaluation of this end point

Throughout the study.

A lo largo del 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

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

E.8.1.4

Double blind

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.8.2.4

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

Czech Republic

Denmark

France

Germany

Italy

Poland

Spain

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 study is expected to end when all subjects have discontinued study treatment and have been followed for approximately 10 months after the safety follow-up period.

Se prevé terminar el estudio cuando todos los sujetos hayan discontinuado el tratamiento del estudio y se les haya realizado un seguimiento de aproximadamente 10 meses después del período de seguimiento de seguridad.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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

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

F.4.2.2

In the whole clinical trial

120

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 (subjects may receive treatment as long as they are receiving benefit, tolerate the regimen and have not met withdrawal criteria)

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

2018-03-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-02-16

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

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Clinical trials