Clinical Trials Register

Summary
EudraCT Number:	2019-001555-40
Sponsor's Protocol Code Number:	D910GC00001
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2020-10-29
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

Poland - Office for Medicinal Products

A.2

EudraCT number

2019-001555-40

A.3

Full title of the trial

A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN)

Randomizowane badanie fazy III prowadzone metodą podwójnie ślepej próby z kontrolą placebo, oceniające durwalumab w skojarzeniu z chemioterapią FLOT w leczeniu neoadjuwantowym i adjuwantowym, a następnie durwalumab w leczeniu adjuwantowym u pacjentów z operacyjnym rakiem żołądka i połączenia przełykowo-żołądkowego (MATTERHORN)

A.3.1

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

This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy
Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN)

Jest to globalne badanie oceniające durwalumab w leczeniu neoadjuwantowym i adjuwantowym w skojarzeniu z chemioterapią FLOT, po którym następuje adjuwantowe podanie durwalumabu lub placebo u pacjentów z operacyjnym rakiem żołądka i połączenia przełykowo-żołądkowego

A.3.2

Name or abbreviated title of the trial where available

MATTERHORN

A.4.1

Sponsor's protocol code number

D910GC00001

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	AstraZeneca AB
B.1.3.4	Country	Sweden
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	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca Clinical
B.5.2	Functional name of contact point	Study Information Center
B.5.3	Address:
B.5.3.1	Street Address	NA
B.5.3.2	Town/ city	NA
B.5.3.3	Post code	NA
B.5.3.4	Country	United States
B.5.4	Telephone number	1877240-9479
B.5.6	E-mail	information.center@astrazeneca.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	Durvalumab
D.3.2	Product code	MEDI4736
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	durvalumab
D.3.9.1	CAS number	1428935-60-7
D.3.9.2	Current sponsor code	MEDI4736
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
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.2.1.2	Country which granted the Marketing Authorisation	Poland
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	5-Fluorouracil
D.3.4	Pharmaceutical form	Solution for injection/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	5-fluorouracil
D.3.9.1	CAS number	51-21-8
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	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.2.1.2	Country which granted the Marketing Authorisation	Poland
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	Oxaliplatin
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Oxaliplatin
D.3.9.1	CAS number	61825-94-3
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	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.2.1.2	Country which granted the Marketing Authorisation	Poland
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	docetaxel
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	docetaxel
D.3.9.1	CAS number	114977-28-5
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: 5
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.2.1.2	Country which granted the Marketing Authorisation	Poland
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	Leucovorin
D.3.4	Pharmaceutical form	Concentrate for solution for injection/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	leucovorin
D.3.9.1	CAS number	1492-18-8
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Concentrate for solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Histologically documented gastric or gastroesophageal junction adenocarcinoma with
resectable disease (Stage II or higher per AJCC 8th edition).

Histologicznie udokumentowany, operacyjny gruczolakorak żołądka lub połączenia przełykowo-żołądkowego (stopień zaawansowania II lub wyższy wg AJCC, wydanie VIII)

E.1.1.1

Medical condition in easily understood language

Histologically documented gastric or gastroesophageal junction adenocarcinoma with
resectable disease

Histologicznie udokumentowany, operacyjny gruczolakorak żołądka lub połączenia przełykowo-żołądkowego

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10017758
E.1.2	Term	Gastric cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10066354
E.1.2	Term	Adenocarcinoma of the gastroesophageal junction
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 compare Arm A relative to Arm B on event-free survival (EFS)

Porównanie grupy A z grupą B pod względem czasu przeżycia wolnym od zdarzeń (EFS)

E.2.2

Secondary objectives of the trial

To compare Arm A relative to Arm B on overall survival (OS)
To compare Arm A relative to Arm B on pathological complete response (pCR) rate
To compare Arm A relative to Arm B on the proportion of patients who undergo gastrectomy or gastrophagectomy
To compare Arm A relative to Arm B on the rate of complete resection (R0)
To compare Arm A relative to Arm B on metastasis-free survival (MFS) and disease-specific survival (DSS)
To compare Arm A relative to Arm B on disease-free survival in patients who undergo R0 resection surgery
To compare Arm A relative to Arm B on EFS24, EFS36, OS24, OS36, DFS24, and DFS36
To compare Arm A relative to Arm B on efficacy endpoints by PD-L1 expression
To compare Arm A relative to Arm B on disease-related symptoms, impacts, and HRQoL
To evaluate PK of Arm A and Arm B
To assess the immunogenicity of Arm A and Arm B

Porównanie grupy A z grupą B pod względem: całkowitego czasu przeżycia (OS)
histopatologicznej odpowiedzi całkowitej (pCR)
odsetka pacjentów, którzy zostaną poddani resekcji żołądka lub resekcji żołądka i przełyku
odsetka doszczętnej resekcji (R0)
czasu przeżycia wolnym od przerzutów (MFS) i przeżycia do zgonu wywołanego badaną chorobą (DSS)
czasu przeżycia wolnego od wznowy (DFS) u pacjentów, u których wykonano resekcję chirurgiczną R0
EFS24, EFS36, OS24, OS36, DFS24 i DFS36
punktów końcowych dotyczących skuteczności na podstawie ekspresji PD-L1
objawów związanych z chorobą, ich wpływu na pacjenta oraz HRQoL – jakości życia związanej ze zdrowiem
Ocena farmakokinetyki (PK) w grupie A i w grupie B
Ocena immunogenności w grupie A i w grupie B

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients with histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition).
Patients must have undergo radical surgery.
No prior anti-cancer therapy for the current malignancy.
World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
Adequate organ and marrow function
Availability of tumor sample prior to study entry
Must have a life expectancy of at least 24 weeks

Histologicznie udokumentowany, operacyjny gruczolakorak żołądka lub połączenia przełykowo-żołądkowego (tj. pacjent kwalifikuje się do radykalnej operacji; stopień zaawansowania II lub wyższy wg AJCC, wydanie VIII)
Doszczętna resekcja chirurgiczna
Bez stosowania wcześniejszego leczenia przeciwnowotworowego w terapii aktualnie występującego u pacjenta nowotworu złośliwego
Stan sprawności (PS) równy 0 lub 1 w skali Światowej Organizacji Zdrowia (WHO)/ECOG w momencie włączenia do badania
Wydolna czynność narządów i szpiku kostnego
Próbka nowotworu uzyskana przed włączeniem do badania
Oczekiwany czas przeżycia musi wynosić co najmniej 24 tygodnie

E.4

Principal exclusion criteria

Patients with peritoneal dissemination or distant metastasis
Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor
History of allogeneic organ transplantation.
Contra-indication to any of the study drugs
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

Pacjenci z przerzutami do otrzewnej (w tym komórki nowotworowe w płynie otrzewnowym) lub przerzutami odległymi
Pacjenci z rakiem gruczołowo-płaskonabłonkowym, rakiem płaskonabłonkowym lub nowotworem podścieliskowym przewodu pokarmowego
Przebyte allogeniczne przeszczepienie narządu
Stwierdzona alergia lub nadwrażliwość na którykolwiek z badanych leków
Stosowanie leków immunosupresyjnych obecnie lub w okresie 14 dni poprzedzających podanie pierwszej dawki durwalumabu

E.5 End points

E.5.1

Primary end point(s)

EFS (event free survival)

EFS (czas przeżycia wolnym od zdarzeń)

E.5.1.1

Timepoint(s) of evaluation of this end point

EFS will be analyzed at the end of the study using a stratified log-rank test adjusting for the stratification factors of geographic region, clinical lymph node status, and PD-L1 expression status.

EFS będzie analizowany pod koniec badania przy użyciu stratyfikowanego testu log-rang z korektą na zmienne stratyfikacyjne – region geograficzny, kliniczny status zajęcia węzłów chłonnych i status ekspresji PD-L1.

E.5.2

Secondary end point(s)

OS,
pCR rate
Surgery rate
R0 resection rate
MFS, DSS, DFS
EFS24, EFS36, OS24, OS36,DFS24, DFS36
EORTC QLQ-C30, QLQ-STO22, and IL38

OS
Wskaźnik pCR
Odsetek operacji
Odsetek resekcji R0
MFs, DSS, DFS
EFS24, EFS36, OS24, OS36, DFS24, DFS36
EORTC QLQ-C30, QLQ-STO22 i IL38

E.5.2.1

Timepoint(s) of evaluation of this end point

The primary and key secondary endpoints will be evaluated at an interim analysis and all endpoints will be evaluated at the final analysis.

Cel pierwszorzędowy i kluczowe cele drugorzędowe będą oceniane w ramach analiz okresowych a wszystkie punkty końcowe zostaną ocenione w ramach analizy końcowej.

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

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

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)

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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)

E.8.2.2

Placebo

Yes

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

Argentina

Chile

Peru

Korea, Democratic People's Republic of

Taiwan

Brazil

Canada

Japan

Russian Federation

United Kingdom

United States

Belgium

Denmark

France

Germany

Hungary

Netherlands

Poland

Spain

Türkiye

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

End of trial is determined as the last scheduled visit for the last subject participating in the study, as per protocol.

Zakończenie badania określono jako ostatnia zaplanowana wizyta ostatniego uczestnika badania, zgodnie z protokołem

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

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:

450

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

450

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

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

435

F.4.2.2

In the whole clinical trial

900

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

Nie dotyczy

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

2021-01-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-01-21

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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