Clinical Trials Register

Summary
EudraCT Number:	2020-001001-22
Sponsor's Protocol Code Number:	D910SC00001
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-12-10
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

2020-001001-22

A.3

Full title of the trial

A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center, International Study of Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma (KUNLUN)
NOTE: Official Title should have no more than 240 characters

Randomizowane, wieloośrodkowe, międzynarodowe badanie fazy III prowadzone metodą podwójnie ślepej próby z kontrolą placebo, oceniające durwalumab podawany jednoczasowo z chemioradioterapią radykalną u pacjentów z miejscowo zaawansowanym, nieoperacyjnym płaskonabłonkowym rakiem przełyku (KUNLUN)

A.3.1

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

Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With locally advanced, unresctable ESCC

Badanie oceniające durwalumab podawany w połaczeniu z chemioradioterapią radykalną u pacjentów z miejscowo zaawansowanym, nieoperacyjnym płaskonabłonkowym rakiem przełyku

A.3.2

Name or abbreviated title of the trial where available

KUNLUN

A.4.1

Sponsor's protocol code number

D910SC00001

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
B.5.2	Functional name of contact point	Clinical Study Information Center
B.5.3	Address:
B.5.3.1	Street Address	1800 Concorde Pike
B.5.3.2	Town/ city	Wilmington
B.5.3.3	Post code	DE 19803
B.5.3.4	Country	United States
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	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	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	Cisplatin
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	cisplatin
D.3.9.1	CAS number	15663-27-1
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: 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	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	capecitabine
D.3.4	Pharmaceutical form	Film-coated 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	capecitabine
D.3.9.1	CAS number	154361-50-9
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	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 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.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

Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Miejscowo zaawansowany, nieoperacyjny płaskonabłonkowym rakiem przełyku

E.1.1.1

Medical condition in easily understood language

Specific type of Esophageal cancer called "Esophageal Squamous Cell Carcinoma" (ESCC) that cannot be removed by surgery

Specyficzny typ raka przełyku zwany „Rakiem płaskonabłonkowym przełyku” (ESCC), którego nie można usunąć chirurgicznie

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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10015366
E.1.2	Term	Esophageal carcinoma
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 assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in all randomized patients and in patients with PD-L1 High tumors in terms of PFS using BICR assessments according to RECIST 1.1

Ocena skuteczności durwalumabu + chemioradioterapii radykalnej (dCRT) w porównaniu do placebo + dCRT u wszystkich zrandomizowanych pacjentów i u pacjentów z guzami z wysoką ekspresją PD-L1 pod względem przeżycia wolnego od progresji choroby (PFS) wg kryteriów RECIST 1.1, zgodnie z oceną BICR)

E.2.2

Secondary objectives of the trial

- To assess the efficacy of durvalumab + dCRT compared to placebo + dCRT in all randomized patients and in patients with PD-L1 High tumors in terms of OS, APF24, ORR, DoR, DCR, TTP, PFS2, and OS36
- To assess patient-reported symptoms, functioning, and HRQoL in patients treated with durvalumab + dCRT compared to placebo + dCRT using patient reported outcome measures
- To assess the PK of durvalumab when in combination with dCRT in all randomized patients and in patients with PD-L1 High tumors
- To investigate the immunogenicity of durvalumab and durvalumab in combination with dCRT in all randomized patients and in patients with PD-L1 High tumors

1.Ocena skuteczności durwalumabu+dCRT w porównaniu do placebo + dCRT na podstawie całkowitego przeżycia (OS), odsetka pacjentów żyjących i wolnych od progresji choroby po 24 miesiącach od randomizacji (APF24), wskaźnika odpowiedzi obiektywnej (ORR), czasu trwania odpowiedzi (DoR), wskaźnika kontroli choroby (DCR), czasu do progresji choroby (TTP), czasu od randomizacji do drugiej progresji choroby (PFS2) i odsetka pacjentów żyjących po 36 miesiącach od randomizacji (OS36);
2.Ocena objawów zgłaszanych przez pacjenta, funkcjonowania i jakości życia związanej ze zdrowiem (HRQoL) u pacjentów leczonych durwalumabem + dCRT w porównaniu do placebo+dCRT na podstawie kwestionariuszy PRO
3.Ocena farmakokinetyki (PK) durwalumabu w skojarzeniu z dCRT u wszystkich zrandomizowanych pacjentów i u pacjentów z guzami z wysoką ekspresją PD-L1
4.Ocena immunogenności durwalumabu i urwalumabu w skojarzeniu z dCRT u wszystkich zrandomizowanych pacjentów i u pacjentów z guzami z wysoką ekspresją PD-L1

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• 18 years or older at the time of signing the ICF.
• Histologically or cytologically confirmed esophageal squamous cell
carcinoma, and present with locally advanced disease (Stage II-IVA).
• Unresectable or refusing surgery, and has been deemed suitable for
definitive chemoradiation therapy.
• Patients with at least an evaluable lesion per RECIST 1.1
• Mandatory provision of available tumor tissue for PD-L1 expression
analysis.
• ECOG PS 0 or 1.
• Adequate organ and marrow function.
• Life expectancy of more than 3 months.

1. Co najmniej 18 lat w czasie składania podpisu na formularzu świadomej zgody.
2. Histologicznie lub cytologicznie potwierdzony płaskonabłonkowy rak przełyku, lokalnie zaawansowany (stadium od II do IVA).
3. Pacjenci z nowotworem określonym jako nieoperacyjny lub niewyrażający zgody na zabieg, kwalifikujący się do dCRT (chemioradioterapia radykalna).
4. Pacjenci z co najmniej 1 zmianą możliwą do ceny wg kryteriów RECIST 1.1.
5. Wszyscy pacjenci muszą przekazać próbkę guza w celu analizy ekspresji PD-L1.
6. Stopień sprawności WHO/ECOG PS: 0 lub 1.
7. Adekwatna czynność narządowa i szpiku.
8. Wymagana oczekiwana dalsza długość życia powyżej 3 miesięcy.

E.4

Principal exclusion criteria

• Histologically or cytologically confirmed small cell esophageal carcinoma, esophageal adenocarcinoma or other mixed carcinoma.
• Prior anti-cancer treatment for ESCC.
• Patient with a great risk of perforation and massive bleeding.
• History of allogeneic organ transplantation.
• Active or prior documented autoimmune or inflammatory disorders.
• Uncontrolled intercurrent illness.
• History of another primary malignancy.
• Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
• Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.

1. Histologicznie lub cytologicznie potwierdzony drobnokomórkowy rak przełyku, gruczolakorak przełyku lub inny rak typu mieszanego.
2. Uprzednie leczenie przeciwnowotworowe raka płaskonabłonkowego przełyku (ESCC).
3. Pacjenci z dużym ryzykiem perforacji oraz rozległego krwawienia.
4. Allogeniczny przeszczep narządu w wywiadzie.
5. Aktywne lub wcześniej udokumentowane choroby autoimmunologiczne lub zapalne.
6. Nieleczona choroba współwystępująca.
7. Inny pierwotny nowotwór złośliwy w wywiadzie.
8. Aktywne zakażenie, w tym gruźlica, wirusowe zapalenie wątroby typu B, wirusowe zapalenie wątroby typu C (HCV) lub HIV.
9. Stwierdzona alergia lub nadwrażliwość na jakikolwiek badany lek lub substancje pomocnicze wchodzące w skład badanego leku.

E.5 End points

E.5.1

Primary end point(s)

PFS using BICR assessments according to RECIST 1.1 all randomized patients and in patients with PD-L1 High tumors

PFS (wg kryteriów RECIST 1.1, zgodnie z oceną BICR) u wszystkich zrandomizowanych pacjentów i u pacjentów z guzami z wysoką ekspresją PD-L1

E.5.1.1

Timepoint(s) of evaluation of this end point

up to 56 months

do 56 miesięcy

E.5.2

Secondary end point(s)

- OS, OS36, PFS2
- APF24,ORR, DoR, DCR and TTP per RECIST 1.1 as assessed by BICR
- Time to deterioration and change from baseline in symptoms, functioning, and HRQoL as measured by EORTC QLQ-C30 and QLQ-OES18
- Concentration of durvalumab in blood
- ADA (confirmatory results: positive or negative; titers
- Presence of ADA for durvalumab (confirmatory results: positive or negative; titers)
in all randomized patients and in patients with PD-L1 High tumors

1. OS, OS36, PFS2
2. APF24,ORR, DoR, DCR i TTP wg kryteriów RECIST 1.1, zgodnie z oceną BICR
3. Czas do pogorszenia i zmiana od punktu początkowego w ocenie objawów, funkcjonowania i HRQoL, oceniane za pomocą kwestionariuszy EORTC QLQ-C30 i QLQ-OES18
4. Stężenie durwalumabu we krwi
5. ADA (wyniki potwierdzające: dodatnie lub ujemne; miana) u wszystkich zrandomizowanych pacjentów i u pacjentów z guzami z wysoką ekspresją PD-L1

E.5.2.1

Timepoint(s) of evaluation of this end point

Until end of study

do zakończenia badania

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

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Healthcare resource utilization, Quality of life

Wykorzystanie zasobów służby zdrowia, jakość życia

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

Brazil

Canada

China

Japan

Korea, Republic of

Taiwan

Thailand

United States

Russian Federation

Belgium

France

Netherlands

Poland

Spain

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

Last Subject Last Visit

„LVLS” (Last Visit Last Subject)

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:

260

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

340

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

125

F.4.2.2

In the whole clinical trial

600

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)

After the final analysis, AstraZeneca will continue to supply durvalumab to patients in durvalumab arn up to objective disease progression if treatment is less than 24 months

Po przeprowadzeniu analizy końcowej, AstraZeneca będzie nadal dostarczać durwalumab pacjentom z grupy przyjmującej durwalumab do chwili obiektywnej progresji choroby, jeżeli okres leczenia wynosił mniej niż 24 miesiące.

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

2021-03-12

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	Ongoing

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IMP with orphan designation in the indication
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