Clinical Trials Register

Summary
EudraCT Number:	2017-000970-12
Sponsor's Protocol Code Number:	INCB50465-204
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-02-01
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2017-000970-12

A.3

Full title of the trial

A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kd Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor.

Studio di fase 2, in aperto a 2 coorti su INCB050465, un inibitore di PI3Kd, in soggetti affetti da linfoma della zona marginale refrattario o recidivante con o senza pregressa esposizione a un inibitore di BTK (CITADEL-204)

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 Marginal Zone Lymphoma with or without prior exposure to a BTK inhibitor.

Uno studio in aperto su INCB050465 in pazienti con linfoma della zona marginale refrattario o recidivante con o senza pregressa esposizione a un inibitore di BTK

A.3.2

Name or abbreviated title of the trial where available

CITADEL-204

A.4.1

Sponsor's protocol code number

INCB50465-204

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03144674

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	000000
B.5.5	Fax number	0000000
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.3.1	Product name	INCB050465 1 mg compressa
D.3.2	Product code	INCB050465 1 mg compressa
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	INCB050465
D.3.9.2	Current sponsor code	INCB050465
D.3.9.3	Other descriptive name	INCB050465 hydrocloride
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	INCB050465 2.5 mg compressa
D.3.2	Product code	INCB050465 2.5 mg compressa
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	INCB050465
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
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	INCB050465 5 mg compressa
D.3.2	Product code	INCB050465 5 mg compressa
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	INCB050465
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	INCB050465 20 mg compressa
D.3.2	Product code	INCB050465 20 mg compressa
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	INCB050465
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Marginal Zone Lymphoma

Linfoma della zona marginale

E.1.1.1

Medical condition in easily understood language

Marginal Zone Lymphoma

Linfoma della zona marginale

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	10025310
E.1.2	Term	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 marginal zone lymphoma that is relapsed or refractory after at least 1 systemic treatment regimen

Valutare l'efficacia di INCB050465 in termini di tasso di risposta obiettiva (Objective Response Rate, ORR) in soggetti affetti da linfoma della zona marginale (Marginal Zone Lymphoma, MZL) refrattario o recidivante dopo almeno 1 regime di trattamento sistemico

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

- Valutare la durata della risposta (Duration of Response, DOR)
- Valutare il tasso di risposta completa (Complete Response Rate, CRR)
- Valutare la sopravvivenza libera da progressione (Progression-Free Survival, PFS)
- Stimare la sopravvivenza globale (Overall Survival, OS)
- Valutare la migliore modifica in percentuale della dimensione della lesione bersaglio
- Caratterizzare la sicurezza e la tollerabilit¿ di INCB050465

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Men and women, aged 18 or older
• Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of = 1 lesion that measures > 1.5 cm in the longest transverse diameter (LDi) and = 1.0 cm in the longest perpendicular diameter as assessed by CT or magnetic resonance imaging (MRI).
• Subjects with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation
provided that bone marrow infiltration of MZL is histologically confirmed.
• Subjects must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
- Subjects with splenic MZL who do not have a tumor to biopsy or an archival tumor tissue sample are eligible for participation provided subject is willing to undergo a bone marrow biopsy or provide an archival bone marrow biopsy that was obtained since
completion of last therapy and within 2 years before the date of the first dose of study treatment;
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

Full list of inclusion criteria is described in section 3.1 of Protocol

• Uomini o donne di età =18 anni
• Linfoadenopatia o tumore maligno linfoide extranodale misurabile radiologicamente (definito dalla presenza di =1 lesione di dimensione >1,5 cm nel diametro trasverso maggiore (Longest transverse Diameter, LDi) e =1,0 cm nel diametro perpendicolare maggiore come valutato mediante TC o risonanza magnetica (RM).
• Soggetti affetti da MZL splenico che non soddisfano i criteri di malattia misurabile radiologicamente descritti qui sono idonei a partecipare, posto che sia confermata istologicamente l'infiltrazione di MZL nel midollo osseo.
• I soggetti devono essere disposti a sottoporsi a biopsia incisionale o escissionale di linfonodo o tessuto o a fornire una biopsia linfonodale o tissutale dal più recente tessuto in archivio disponibile.
- Soggetti con MZL splenica che non hanno una biopsia o tessuto tumorale archiviale sono eleggibili a partecipare purchè il soggetto voglia effettuare una biopsia al midollo osseo o purchè sia disponibile una biopsia di midollo osseo archiviale che è stata effettuata dal completamento dell'ultima terapia ed entro 2 anni dalla data della prima dose di trattamento di studio.
• Stato di validità ECOG (Eastern Cooperative Oncology Group) da 0 a 2.

La lista completa dei criteri di inclusione è descritta nella sezione 3.1 del Protocollo

E.4

Principal exclusion criteria

• Evidence of diffuse large B-cell transformation.
• History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
• Prior treatment with idelalisib, other selective PI3Kd 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 the first
dose of study treatment.
• Active graft versus host disease.
• Liver disease:
- Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

Full list of exclusion criteria is described in section 3.2 of Protocol

• Evidenza di trasformazione a linfoma diffuso a grandi cellule B.
• Anamnesi di linfoma del sistema nervoso centrale (primario o metastatico) o malattia leptomeningea.
• Trattamento pregresso con idelalisib, altri inibitori selettivi di PI3Kd o un pan-inibitore di PI3K.
• Trapianto allogenico di cellule staminali nei 6 mesi precedenti o trapianto autologo di cellule staminali nei 3 mesi precedenti la data della somministrazione della prima dose del trattamento dello studio.
• Malattia del trapianto contro l’ospite attiva.
• Malattia epatica:
- Evidenza di infezione da virus dell'epatite B (HBV) o virus dell’epatite C (HCV).

La lista completa dei criteri di esclusione è descritta nella sezione 3.2 del Protocollo

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

Il tasso di risposta obiettiva è definito come la percentuale di soggetti con una risposta completa (Complete Response, CR) o una risposta parziale (Partial Response, PR), come determinato dalla valutazione della risposta da parte del Comitato di revisione indipendente (Independent Review Committee, IRC) in base ai criteri di risposta per i linfomi basati su tomografia computerizzata (TC).

E.5.1.1

Timepoint(s) of evaluation of this end point

Throughout the study

Durante lo studio

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
¿ OS 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 durata della risposta ¿ definita come il tempo che intercorre dalla prima evidenza documentata di CR o PR fino alla progressione della malattia o al decesso per qualsiasi causa tra soggetti che raggiungono una risposta obiettiva, determinata dalla valutazione radiologica della malattia da parte di un IRC.
- Il tasso di risposta completa ¿ definito come la percentuale di soggetti con una CR, come determinata da un IRC in base ai criteri di risposta per i linfomi.
- La sopravvivenza libera da progressione ¿ definita come il tempo che intercorre tra la data di assunzione della prima dose del trattamento dello studio e la prima data di progressione della malattia, determinata dalla valutazione radiologica della malattia da parte di un IRC, o il decesso per qualsiasi causa.
- La sopravvivenza globale ¿ definita come il tempo che intercorre tra la data di assunzione della prima dose del trattamento dello studio e la data del decesso per qualsiasi causa.
- La migliore modifica in percentuale della dimensione della lesione bersaglio rispetto al valore iniziale, dove la dimensione della lesione bersaglio ¿ data dalla somma del prodotto dei diametri di tutte le dimensioni della lesione bersaglio.
- La sicurezza ¿ misurata mediante la comparsa di eventi avversi (Adverse Event, AE), gli elettrocardiogrammi a 12 derivazioni (ECG), i valori delle analisi chimiche ed ematologiche di laboratorio, i parametri vitali e gli esami obiettivi.

E.5.2.1

Timepoint(s) of evaluation of this end point

Throughout the study

Durante lo studio

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

Yes

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

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

Information not present in EudraCT

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

Canada

Israel

United States

Belgium

Denmark

Germany

Italy

Poland

Spain

United Kingdom

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 will be when all subjects have met any of the study discontinuation criteria or have completed at least 24 months of study participation (starting from first dose of INCB050465).

La fine dello studio avverrà quando tutti i soggetti soddisfatto qualsiasi criteria di discontinuazione dallo studio o hanno completato almeno 24 mesi di partecipazione nello studio (a partire dalla prima dose di INCB050465).

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

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)

At the end of the study, subjects who have completed at least 24 months of study participation (starting from the first dose of study treatment), who remain on active study treatment, and who have no evidence of progressive disease will have the option to continue with INCB050465 monotherapy as part of a rollover Protocol, as local law
permits.

Alla fine dello studio, i soggetti che avranno completato almeno 24 mesi di partecipazione nello studio (a partire dalla prima dose di INCB050465), coloro che rimaranno in trattamento attivo, e coloro che non hanno evidenza di progressione della malattia avranno l'opzione di continuare il trattamento di INCB050465 in monoterapia come parte di un Protocollo "rollover", come permesso la normativa locale.

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

2018-01-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-11-09

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

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