Clinical Trials Register

Summary
EudraCT Number:	2019-003733-41
Sponsor's Protocol Code Number:	ISG-MCS
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:	2021-06-04
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2019-003733-41

A.3

Full title of the trial

Phase II study on Trabectedin in advanced rearranged Mesenchymal chondrosarcoma (MCS)

Studio di fase II con trabectedina per il trattamento di giovani adulti e adulti affetti da condrosarcoma mesenchimale (HEY1-NOCOA2 riarrangiato) scheletrico ed extra-scheletrico con malattia avanzata

A.3.1

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

Study on advanced rearranged Mesenchymal chondrosarcoma

Studio per il trattamento dia condrosarcoma mesenchimale (HEY1-NOCOA2 riarrangiato) scheletrico ed extra-scheletrico con malattia avanzata

A.3.2

Name or abbreviated title of the trial where available

ISG-MCS

A.4.1

Sponsor's protocol code number

ISG-MCS

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04305548

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	ITALIAN SARCOMA GROUP
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Pharma Mar S.A
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	I.S.G. Italian Sarcoma Group
B.5.2	Functional name of contact point	Emanuela Marchesi
B.5.3	Address:
B.5.3.1	Street Address	Via Ca Ricchi 33
B.5.3.2	Town/ city	San Lazzaro di Savena (BO)
B.5.3.3	Post code	40068
B.5.3.4	Country	Italy
B.5.4	Telephone number	3335359192
B.5.5	Fax number	0145970
B.5.6	E-mail	emanuela.marchesi@italiansarcomagroup.org

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Yondelis
D.2.1.1.2	Name of the Marketing Authorisation holder	Pharma mar S.A
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/01/39
D.3 Description of the IMP
D.3.1	Product name	trabectedina
D.3.2	Product code	[trabectedina]
D.3.4	Pharmaceutical form	Powder 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	TRABECTEDINA
D.3.9.1	CAS number	114899-77-3
D.3.9.2	Current sponsor code	trabectedina utilizzata in soggetti minorenni
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(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	Yes
D.2.1.1.1	Trade name	Yondelis
D.2.1.1.2	Name of the Marketing Authorisation holder	Pharma mar S.A
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/01/39
D.3 Description of the IMP
D.3.1	Product name	trabectedina
D.3.2	Product code	[trabectedina]
D.3.4	Pharmaceutical form	Powder 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	TRABECTEDINA
D.3.9.1	CAS number	114899-77-3
D.3.9.2	Current sponsor code	Trabectedina usata secondo la sua AIC in pazienti adutili
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(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.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

Patients with advanced, histological and molecularly (presence of the HEY1-NCOA2 fusion) centrally confirmed diagnosis of MCS, with an evidence of RECIST progression within the 6 months prior to starting the study treatment and pre-treated with anthracycline-based chemotherapy

Pazienti giovani adulti o adulti affetti da condrosarcoma mesenchimale HEY1-NCOA2 riarrangiato a partenza scheletrica o extra-scheletrica avanzato e in progressione

E.1.1.1

Medical condition in easily understood language

Advanced Mesenchimal Condrosarcoma

Condrosarcoma mesenchimale in fase avanzata

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	HLT
E.1.2	Classification code	10041298
E.1.2	Term	Soft tissue sarcomas histology unspecified
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this study is to explore the activity of trabectedin from 2nd to 4th line, in patients aged ¿ 16 years with advanced HEY1-NOCA2 positive MCS pre-treated with anthracycline-based chemotherapy. Therefore, with reference to a study population of patients with progressive by RECIST v1.1, locally advanced or metastatic, HEY1-NCOA2 positive MCS pre- treated with one, two or three lines of medical treatment, the primary end-point of the study will be to assess:

Tasso di risposta tumorale (Overall Tumour Response Rate) secondo RECIST v1.1

E.2.2

Secondary objectives of the trial

1. Choi Response Rate
2. Overall Survival (OS)
3. Progression Free Survival (PFS)
4. Clinical Benefit Rate
5. Duration of response
6. Safety

- Tasso di risposta tumorale secondo i criteri Choi
- Sopravvivenza globale (OS)
- Sopravvivenza libera da progressione (PFS)
- Tasso di beneficio clinico (Clinical Benefit Rate)
- Durata della risposta
- Sicurezza del trattamento

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Pharmacogenetics
Version: 1.0
Date: 16/09/2019
Title: Translational Optional study
Objectives: To gain insights on MCS biology and to investigate molecular basis underlining MCS response to trabectedin, pre-treatment samples (FFPE and/or frozen samples with tumor cellularity greater than 70%) will be molecularly profiled. Moreover, in vitro models will be generated to identify HEY1-NCOA2-specific transcriptional targets involved in the response to trabectedin.

Farmacogenetica
Versione: 1.0
Data: 16/09/2019
Titolo: Studio translazionale opzionale
Obiettivi: I campioni tumorali raccolti pre-trattamento, necessari per la revisione centralizzata della diagnosi, verranno profilati anche dal punto di vista molecolare per identificare eventuali prodotti trascrizionali del riarrangiamento HEY1-NCAO2 coinvolti nella risposta a trabectedina.

E.3

Principal inclusion criteria

1. Age = 16 years old
2. Histological centrally confirmed diagnosis of skeletal or extra-skeletal MCS with the documented presence of HEY1-NCOA2 fusion (a paraffin embedded tumour block is required for centralized review)
3. Locally advanced disease (i.e. surgical resection of local disease unfeasible radically or unaccepted by the patient or amenable to become less demolitive or feasible or easier after cytoreduction) and/or metastatic disease
4. Measurable or evaluable disease with RECIST v1.1
5. Evidence of progression by RECIST v1.1 during the 6 months before study entry
6. Patients must be pre-treated with at least one prior chemotherapy treatment containing anthracyclines for the advanced phase of disease and with a maximum of 3 lines
7. Eastern Cooperative Oncology Group (ECOG) Performance Status = 2
8. Adequate bone marrow function
9. Adequate organ function
10. Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study
11. Cardiac ejection fraction >=50% as measured by echocardiogram
12. No history of arterial and/or venous thromboembolic event within the previous 12 months
13. The patient or legal representative must be able to read and understand the informed consent form and must have been willing to give written informed consent and any locally required authorisation before any study-specific procedures, including screening evaluations, sampling, and analyses.
14. Any other factors, that, at judgment of investigator, could affect the safety of the patients according to the available trabectedin safety data

1) Età >= 16 anni
2) Diagnosi istologica e molecolare centralmente confermata di condrosarcoma mesenchimale HEY1-NCAO2 riarrangiato. Per l’arruolamento nello studio è necessario avere a disposizione l’inclusione in paraffina di materiale tumorale derivato da eventuale biopsia pre-trattamento (se effettuata per pratica clinica) o del materiale tumorale di archivio più recente disponibile
3) Malattia localmente avanzata e/o metastatica
4) Malattia misurabile secondo RECIST v1.1
5) Evidenza di progressione secondo RECIST v1.1 nei 6 mesi precedenti l’ingresso in studio
6) I pazienti devono essere stati pre-trattati con almeno un trattamento antitumorale contenente antraciclina per la malattia avanzata fino ad un massimo di 3 linee precedenti
7) ECOG PS <= 2
8) Adeguata funzionalità midollare
9) Adeguata funzionalità d’organo
10) Le pazienti di sesso femminile in età fertile devono avere un test di gravidanza negativo entro 7 giorni prima dell’inizio di ogni ciclo di chemioterapia.
Le donne in post-menopausa devono essere amenorroiche da almeno 12 mesi per essere considerate potenzialmente non fertili.
I pazienti maschi e femmine potenzialmente fertili devono accettare di utilizzare un metodo efficace di controllo delle nascite durante lo studio.
11) Frazione di eiezione cardiaca = 50% misurata mediante ecocardiogramma
12) Anamnesi negativa per eventi trombo-embolici arteriosi e/o venosi negli ultimi 12 mesi
13) Il paziente (o il suo rappresentante legale) deve essere in grado di leggere e comprendere il modulo di consenso informato e deve fornire il proprio consenso informato scritto prima di avviare qualsiasi procedura specifica per lo studio

E.4

Principal exclusion criteria

1. Other primary malignancy with <5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ or other neoplasm judged to entail a low risk of relapse
2. Previous treatment with radiation therapy within 14 days of first day of study drug dosing, or patients who have not recovered from adverse events due to agents previously administered
3. Previous radiotherapy to 25% of the bone marrow
4. Major surgery within 2 weeks prior to study entry
5. Participation in another clinical study with an investigational product, which last dose was taken less than 4 weeks prior to the start of the treatment.
6. Persistent toxicities (= NCI CTCAE v5.0 grade 2) with the exception of alopecia, caused by previous anticancer therapies.
7. Pregnancy or breast feeding
8. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e. congestive heart failure, myocardial infarction within 6 months of study)
9. Medical history of arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within 6 months prior to the initiation of study treatment
10. Known brain metastasis
11. Known chronic liver disease (i.e. chronic active hepatitis and cirrhosis)
12. Known diagnosis of human deficiency virus (HIV) infection
13. Active or chronic hepatitis B or C requiring treatment with antiviral therapy
14. Medical history of hemorrhage or a bleeding event = Grade 3 (NCI-CTCAE v 5.0) within 4 weeks prior to the initiation of study treatment
15. Evidence of any other serious or unstable illness, or medical, psychological, or social condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject’s participation in the study or evaluation of the study results
16. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
17. Expected non-compliance to medical regimens

1) Pazienti mai trattati con chemioterapia contenente antracicline, a meno di controindicazioni maggiori
2) Più di 3 precedenti linee di trattamento antitumorale per la malattia avanzata
3) Anamnesi positiva per altre neoplasie maligne (eccetto carcinoma basocellulare della cute o carcinoma cervicale in situ, adeguatamente trattati), salvo che non siano in remissione da almeno 5 anni e giudicate a potenziale trascurabile di ricaduta
4) Trattamento radioterapico nei 14 giorni precedenti al primo giorno di assunzione di trabectedina; trattamento con qualsiasi agente antitumorale sperimentale nelle 4 settimane precedenti il primo giorno di assunzione di trabectedina. Sono inoltre esclusi i pazienti per i quali la tossicità dei precedenti trattamenti non sia risolta (NCI CTCAE v5.0 grado 2), eccetto l’alopecia
5) Precedente radioterapia che ha coinvolto il midollo osseo per il 25% o oltre
6) Chirurgia maggiore nelle 2 settimane precedenti l’ingresso in studio
7) Donne in gravidanza o in allattamento
8) Malattia cardiovascolare in atto con NYHA grado III/IV. Storia di insufficienza cardiaca o infarto miocardico meno di 6 mesi dall’inizio del trattamento. Sono esclusi pazienti con angina instabile e con aritmia severa a rischio di morte imminente
9) Anamnesi positiva per eventi trombo-embolici arteriosi come infarto cerebro-vascolare (compreso l’attacco ischemico transitorio – TIA) o embolia polmonare nei 6 mesi precedenti l’inizio del trattamento in studio
10) Pazienti con metastasi al sistema nervoso centrale note
11) Pazienti con malattie croniche del fegato (epatite cronica in fase attiva e/o cirrosi epatica)
12) Diagnosi nota di infezione da virus dell’immunodeficienza umana (HIV)
13) Diagnosi di epatite cronica o in fase attiva B o C che richiede una terapia antivirale
14) Anamnesi positiva per emorragia o sanguinamenti di grado ¿ 3 (secondo NCI CTCAE v5.0) nelle 4 settimane antecedenti l’inizio del trattamento in studio
15) Ipersensibilità nota al farmaco in studio o alla classe di appartenenza o ad eccipienti presenti nella formulazione del farmaco in studio
16) Ogni situazione che possa pregiudicare la compliance al trattamento
17) Evidenza di ogni malattia o condizione medica, psicologica o sociale grave o instabile che possa compromettere la sicurezza del paziente e/o la sua compliance alla partecipazione allo studio o alla valutazione dei risultati

E.5 End points

E.5.1

Primary end point(s)

Response rate according Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Tasso di risposta secondo RECIS versione 1.1

E.5.1.1

Timepoint(s) of evaluation of this end point

Every 6 weeks up to week 18, then every 12 weeks

Ogni 6 settimane fino a 18 settimane poi ogni 12 settimane

E.5.2

Secondary end point(s)

Overall Survival; Progression Free Survival; Duration of response; Adverse events related to the treatment; Choi criteria response rate

Sopravvivenza Globale; Progressione libera da sopravvivenza; Durata della risposta; Tossicità del trattamento; Tasso di risposta secondo Choi criteria

E.5.2.1

Timepoint(s) of evaluation of this end point

Overall Survival: At 3 and 5 years; Progression Free Survival (PFS) At 3 and 5 years; Duration of response At weeks 6, 12,18, 30, 42; Adverse events related to the treatment : at each cycle; Choi criteria response rate At weeks 6, 12,18, 30, 42

Sopravvivenza Globale a 3 e 5 anni; Progressione libera da sopravvivenza a 3 e 5 anni; Durata della risposta a settimane 6, 12,18, 30, 42; Tossicità del trattamento: ad ogni ciclo; Tasso di risposta secondo Choi criteria, a settimane 6, 12,18, 30, 42

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

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

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

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

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

LVLS

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

Yes

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

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)

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-06-04.

Yes

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Minors form 16 to 16 yrs

Minori di età compresa tra i 16 e 17 anni (consenso richiesto ai genitori o al tutore/rappresentante legale)

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)

According AIOM disease guideline

Al termine della sperimentazione i pazienti saranno seguiti e trattati in accordo alle linee guida AIOM per il trattamento della patologia

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

2021-02-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-02-23

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials