Clinical Trials Register

Summary
EudraCT Number:	2016-004051-78
Sponsor's Protocol Code Number:	ISG-STRADA
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:	2021-08-03
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

2016-004051-78

A.3

Full title of the trial

Solitary fibrous tumor: phase II study on TRabectedin versus Adriamycin plus DAcarbazine in advanced patients (STRADA)

A.3.1

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

Treatment for advanced Solitary Fibrous Tumor

Trattamento del tumore fibroso solitario in fase avanzata

A.3.2

Name or abbreviated title of the trial where available

STRADA

A.4.1

Sponsor's protocol code number

ISG-STRADA

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03023124

A.5.4

Other Identifiers

Name:

ISG-STRADA

Number:

STRADA

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	Pharmamar
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	Italian Sarcoma Group
B.5.2	Functional name of contact point	c/o commercialisti Tommasoli Orsi
B.5.3	Address:
B.5.3.1	Street Address	Via Farini 31
B.5.3.2	Town/ city	Bologna
B.5.3.3	Post code	40124
B.5.3.4	Country	Italy
B.5.4	Telephone number	3480074040
B.5.6	E-mail	clinicaltrials@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 - 1 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 1 FLACONCINO
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/3/01/039
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 suspension for injection
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
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	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.2.1.1.1	Trade name	DOXORUBICINA ACCORD HEALTHCARE ITALIA - 2MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 10MG/5ML
D.2.1.1.2	Name of the Marketing Authorisation holder	ACCORD HEALTHCARE ITALIA S.R.L.
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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	doxorubicina
D.3.2	Product code	[doxorubicina]
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	DOXORUBICINA CLORIDRATO
D.3.9.1	CAS number	23214-92-8
D.3.9.2	Current sponsor code	doxorubicina
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	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)	Yes
	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	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.2.1.1.1	Trade name	DACARBAZINA LIPOMED - 200 MG POLVERE PER SOLUZIONE INIETTABILE O PER INFUSIONE 10 FLACONCINI
D.2.1.1.2	Name of the Marketing Authorisation holder	LIPOMED GMBH
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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	dacarbazina
D.3.2	Product code	[dacarbazina]
D.3.4	Pharmaceutical form	Powder for solution for injection
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	DACARBAZINA
D.3.9.1	CAS number	4342-03-4
D.3.9.2	Current sponsor code	dacarbazina
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	200
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

Advanced Solitary Fibrous Tumor

Tumore Fibroso Solitario avanzato

E.1.1.1

Medical condition in easily understood language

Tumore Fibroso Solitario avanzato

Tumore Fibroso Solitario 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

to evaluate the activity of trabectedin and of doxorubicin in combination with DTIC, in patients with advanced SFT according to Response Evaluation Criteria in Solid Tumor (RECIST), version 1.1

Determinazione della proporzione di riposte obbiettive in ciascuno dei due gruppi, definite in base a criteri RECIST 1.1

E.2.2

Secondary objectives of the trial

. Choi Response Rate
2. Overall Survival (OS)
3. Progression Free Survival (PFS)
4. Clinical Benefit Rate
5. Response rate by RECIST after the cross over
6. PFS after the cross over
8. Safety
9.all the primary/secondary efficacy endpoints will be evaluated in the two subgroups obtained by separating T-/M-SFT from high-grade/ D-SFT.

¿ determinazione della proporzione di risposte secondo i criteri Choi
¿ sopravvivenza totale (OS)
¿ tempo libero da progressione di malattia (PFS)
¿ beneficio clinico definito come la somma delle risposte complete, parziali e delle stabilizzazioni di malattia secondo RECIST dopo 6 mesi dall¿avvio del trattamento
¿ determinazione della proporzione di riposte definite in base a criteri RECIST 1.1 dopo cross-over
¿ tempo libero da progressione di malattia (PFS) dopo cross-over
¿ profilo di sicurezza del farmaco
¿ descrivere l¿efficacia dei due trattamenti selezionati nelle due diverse sottopopolazioni di SFT classici/maligni e ad alto grado/dedifferenziati

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. The patient or legal representative must be able to read and understand the informed consent form (ICF) 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.
2. Age =18 years
3. Histological centrally and molecularly confirmed diagnosis of solitary fibrous tumor (inclusive of the last available tumor sample)
4. 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
5. Measurable or evaluable disease with RECIST
6. Evidence of progression by RECIST during the 6 months before study entry
7. Patients must be cytotoxic chemotherapy naïve (patients treated with neoadjuvant/adjuvant chemotherapy cannot be included) or could have received a previous target agent in front-line setting.
8. Eastern Cooperative Oncology Group (ECOG) Performance Status = 2
9. Adequate bone marrow function
10. Adeguate organs funcion
11. Cardiac ejection fraction =50% as measured by echocardiogram
12. Female patients of child-bearing 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.
13. No history of arterial and/or venous thromboembolic event within the previous 12 months.

E.4

Principal exclusion criteria

1. Any prior treatment with cytotoxic chemotherapy
2. >1 line of anticancer targeted agents
3. Previous treatment with any other investigational or not investigational agents within 14 days of first day of study drug dosing
4. 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
5. Previous radiotherapy to 25 % of the bone marrow
6. Major surgery within 4 weeks prior to study entry
7. Other primary malignancy with <5 years clinically assessed disease-free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged to entail a low risk of relapse
8. Pregnancy or breast feeding
9. Cardiovascular diseases resulting in a New York Heart Association Functional Status >2 (24). Medical history of a myocardial infarction < 6 months prior to initiation of study treatment
10. 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
11. Known history of human immunodeficiency virus infection
12. Active or chronic hepatitis B or C requiring treatment with antiviral therapy
13. Medical history of hemorrhage or a bleeding event = Grade 3 (NCI-CTCAE v 4.0) within 4 weeks prior to the initiation of study treatment
14. 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
15. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
16. Expected non-compliance to medical regimens

1. il Paziente o il Suo rappresentante legale devono essere in grado di leggere, comprendere e firmare il consenso informato
2. Età> 18 anni
3. diagnosi patologica di SFT, confermata centralmente (inclusa valutazione dell’ultimo pezzo tumorale disponibile)
4. malattia localmente avanzata o metastatica
5. malattia parametrabile secondo i criteri RECIST, v 1.1
6. evidenza di progressione di malattia secondo i criteri RECIST nei 6 mesi precedenti all’ingresso nello studio
7. nessun precedente trattamento con chemioterapia citotossica (si includono pazienti naïve).Pazienti trattati con terapia neoadiuvante/adiuvane non possono essere inclusi, mentre sono ammessi pazienti che hanno ricevuto terapia target come regime di front-line
8. Eastern Cooperative Oncology Group (ECOG) Performance Status = 2
9. adeguata funzionalità midollare definita come: globuli bianchi >3.0 x 109/L, numero assoluto di neutrofili >1.5 x 109/L, piastrine >100 x 109/L, emoglobina >9 g/dL
10. adeguata funzionalità d’organo,
12. le Pazienti di sesso femminile in età fertile devono avere un test di gravidanza negativo effettuato entro i 7 giorni dall’avvio della prima somministrazione del farmaco in studio. Le donne in post-menopausa devono avere una amenorrea da almeno 12 mesi. Pazienti di sesso maschile e di sesso femminile potenzialmente fertili devono accettare di utilizzare un metodo efficace di controllo delle nascite durante tutto la durata dello studio e per un massimo di 3 mesi dopo la sospensione del farmaco in studio.
13. Storia clinica negativa per eventi tromboembolici occorsi negli ultimi di 12 mesi

Criteri di esclusione
1. precedente trattamento con chemioterapia citotossica
2. >1 linea con agenti antitumorali target
3. precedente trattamento con altri farmaci oncologici entro 14 giorni dal primo giorno di somministrazione del farmaco in studio
4. precedente trattamento con radioterapia entro 14 giorni dal primo giorno di somministrazione del farmaco in studio, o Paziente che non ha recuperato gli eventi avversi di un altro agente somministrato più di 4 settimane prima
5. precedente radioterapia sul 25% del midollo
6. chirurgia maggiore nelle 4 settimane precedenti all’entrata in studio
7. diagnosi di altro tumore maligno primitivo entro i 5 anni precedenti, ad eccezione del basalioma della cute, del carcinoma in situ della cervice uterina, o altre neoplasie che comportano un basso rischio di recidiva
8. gravidanza e/o allattamento
9. patologie cardiache classificate come classe 2 o superiore secondo New York Heart Association embolia polmonare. Anamnesi di un infarto del miocardio <6 mesi prima dell'inizio del trattamento in studio
10. anamnesi positiva per eventi trombotici arteriosi o eventi embolici o eventi cerebrovascolari (inclusi attacchi ischemici transitori) o embolia polmonare, nei 6 mesi precedenti l'inizio del trattamento in studio
11. storia nota di infezione da virus dell'immunodeficienza umana
12. epatite B o C attiva o cronica che richieda un trattamento con terapia antivirale
13. evidenza o storia di qualsiasi diatesi emorragica =3 (NCI-CTCAE v 4.0) nelle 4 settimane precedenti all’avvio del trattamento
14. presenza di qualsiasi altra malattia grave o instabile, o condizione medica, psicologica o sociale, che potrebbe compromettere la sicurezza del soggetto e/o il suo/la sua conformità alle procedure dello studio, o che può interferire con la partecipazione del soggetto allo studio o con la valutazione dei risultati dello studio
15. ipersensibilità nota al farmaco dello studio, o alla classe farmaceutica a cui appartiene, o a eccipienti presenti nella formulazione del farmaco
16. presenza di qualsiasi condizione di malassorbimento
17. attesa non complianza al trattamento medico proposto

E.5 End points

E.5.1

Primary end point(s)

Ongi 6 settimane

Proporzione di riposte obbiettive in ciascuno dei due gruppi, definite in base a criteri RECIST 1.1

E.5.1.1

Timepoint(s) of evaluation of this end point

Every 6 weeks

E.5.2

Secondary end point(s)

Responses according to Choi crieria; Overall Survival; Progession Free Surival; Progression free survival after cross ovver; Safety

Numero di risposte secondo i criteri CHOI; Sopravvivenza globale; tempo libero da progressione di malattia (PFS); tempo libero da progressione di malattia (PFS) dopo cross-over; Sicurezza del trattamento

E.5.2.1

Timepoint(s) of evaluation of this end point

Every 6 weeks
; From start treatment to death for any cause; Every 6 weeks; Every 6 weeks starting from cross over; Every 3 weeks

Ogni 6 settimane ; Da inizio terapia fino a decesso per qualsiasi causa; Ogni 6 settimane; Ogni 6 settimane dopo il cross-over; Ogni 3 settimane

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

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

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

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)

As per disease guidelines

Come da linee guida di malattia

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

2017-05-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-04-26

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

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Clinical trials