Clinical Trials Register

Summary
EudraCT Number:	2019-003761-17
Sponsor's Protocol Code Number:	RADAR-1CRPC
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:	2021-05-24
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

2019-003761-17

A.3

Full title of the trial

A RAndomized, open label, multicenter study of Docetaxel versus an Androgen Receptor-targeted agent (abiraterone or enzalutamide) as first-line of therapy in mCRPC patients with adverse prognostic factors (RADAR-1 CRPC)

Studio clinico randomizzato in aperto di docetaxel verso inibitore del recettore androgenico (abiraterone o enzalutamide) come prima linea di terapia nei pazienti con carcinoma prostatico metastatico resistente alla castrazione e fattori prognostici negativi (RADAR-1 CRPC)

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

RADAR-1 CRPC

A.4.1

Sponsor's protocol code number

RADAR-1CRPC

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	FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Direzione scientifica Fondazione Policlinico A.Gemelli IRCCS
B.5.2	Functional name of contact point	Direzione Scientifica Fondazione Po
B.5.3	Address:
B.5.3.1	Street Address	Largo Agostino Gemelli 8
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00168
B.5.3.4	Country	Italy
B.5.4	Telephone number	0630155701
B.5.5	Fax number	0630155701
B.5.6	E-mail	direzione.scientifica@policlinicogemelli.it

D. IMP Identification
D.IMP: 1
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	XTANDI
D.2.1.1.2	Name of the Marketing Authorisation holder	Astellas Pharma Europe B.V.
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	XTANDI
D.3.2	Product code	[L02BB04]
D.3.4	Pharmaceutical form	Capsule, soft
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	00329400
D.3.9.1	CAS number	915087-33-1
D.3.9.2	Current sponsor code	RADAR-1 CRPC
D.3.9.3	Other descriptive name	RADAR-1 CRPC
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	40
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	ZYTIGA
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International NV
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	ZYTIGA
D.3.2	Product code	[L02BX03]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	00323801
D.3.9.1	CAS number	154229-18-2
D.3.9.2	Current sponsor code	RADAR-1 CRPC
D.3.9.3	Other descriptive name	RADAR-1 CRPC
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	500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Docetaxel
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.3.2	Product code	[L01CD02]
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	00105000
D.3.9.1	CAS number	114977-28-5
D.3.9.2	Current sponsor code	RADAR-1 CRPC
D.3.9.3	Other descriptive name	RADAR-1 CRPC
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	19
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

Castration resistant prostate cancer docetaxel and androgen receptor-targeted agent (abiraterone or enzalutamide) naïve.

Carcinoma prostatico resistente alla castrazione e naive al docetaxel e ai trattamenti con agenti inibitori del recettore degli androgeni (abiraterone o enzalutamide).

E.1.1.1

Medical condition in easily understood language

Castration resistant prostate cancer docetaxel and androgen receptor-targeted agent (abiraterone or enzalutamide) naïve.

Carcinoma prostatico resistente alla castrazione e naive al docetaxel e ai trattamenti con agenti inibitoi del recettore degli androgeni (abiraterone o enzalutamide).

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	LLT
E.1.2	Classification code	10076506
E.1.2	Term	Castration-resistant prostate cancer
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 investigate if docetaxel is superior to Androgen Receptor-targeted agent (abiraterone or enzalutamide) for treatment of patients with mCRPC and negative prognostic factors in terms of PFS.

Indagare se il docetaxel è superiore all'agente mirato per il recettore degli androgeni (abiraterone o enzalutamide) nel trattamento di pazienti con mCRPC e fattori prognostici negativi in termini di PFS.

E.2.2

Secondary objectives of the trial

To investigate if docetaxel is superior to Androgen Receptor-targeted agent (abiraterone or enzalutamide) for treatment of patients with mCRPC and negative prognostic factors in terms of biochemical response, radiographic progression, overall survival and quality of life.

Indagare se il docetaxel è superiore all'agente mirato ai recettori degli androgeni (abiraterone o enzalutamide) per il trattamento di pazienti con mCRPC e fattori prognostici negativi in termini di risposta biochimica, progressione radiografica, sopravvivenza globale e qualità della vita.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Willing and able to provide written informed consent
2. Male aged 18 years and above
3. Histologically or cytological confirmed adenocarcinoma of the prostate
4. Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT, MRI. If lymph node metastasis is the only evidence of metastasis, it must be = 2 cm in diameter. Alternatively, metastatic disease can be diagnosed by PET-Choline.
5. Prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria
6. At least one negative prognostic features between:
I. Mildly symptomatic prostate cancer defined as per BPI Question #3 (worst pain in last 24 hours) value 2 or 3 or
II. Asymptomatic prostate cancer defined as per BPI Question #3 (worst pain in last 24 hours) value 0 or 1 and at least one between
• PSA=80 ng/dl
• Gleason Score = 8
• PSA doubling time = 3 months
• Time from start ADT to CRPC less < 1 year
7. Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM).
8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 2
9. Adequate bone marrow and chemistry values defined as:
a. Hemoglobin = 10.0 g/dL independent of transfusion
b. Platelet count =100,000/µL
c. Serum albumin = 3.5 g/dL
d. Serum creatinine < 1.5 x ULN or a calculated creatinine clearance = 60 mL/min
e. Serum potassium = 3.5 mmol/L
f. Liver function:
• Serum bilirubin < 1.5 x ULN (except for patients with documented Gilbert’s disease)
• AST or ALT < 2.5 x ULN
10. Able to swallow the study drug whole as a tablet
11. Life expectancy of at least 6 months
12. Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration.

1. Pazienti in grado di fornire il consenso informato scritto
2. Età di 18 anni e oltre
3. Adenocarcinoma della prostata istologicamente o citologicamente confermato
4. Malattia metastatica documentata radiologicamente.
5. Progressione del cancro alla prostata documentata dal PSA secondo PCWG2 o progressione radiografica secondo i criteri RECIST modificati
6. Almeno una caratteristica prognostica negativa tra:
a. Cancro alla prostata lievemente sintomatico definito come BPI Domanda n. 3 (peggiore dolore nelle ultime 24 ore) valore 2 o 3 o
b. Carcinoma prostatico asintomatico definito come BPI Domanda n. 3 (peggiore dolore nelle ultime 24 ore) valore 0 o 1 e almeno uno tra
- PSA=80 ng / dl
- Punteggio di Gleason = 8
- Tempo di raddoppiamento del PSA = 3 mesi
- Tempo dall'inizio da ADT a CRPC <1 anno
7. Castrato chirurgicamente o medicalmente, con livelli di testosterone <50 ng / dL (<2.0 nM).
8. Stato di prestazione del gruppo di oncologia cooperativa orientale (ECOG) di 0 o 2
9. Valori adeguati del midollo osseo e della chimica definiti come:
a. Emoglobina = 10,0 g / dL indipendente dalla trasfusione
b. Conta piastrinica =100.000 / µL
c. Albumina sierica = 3,5 g / dl
d. Creatinina sierica <1,5 x ULN o clearance della creatinina calcolata = 60 ml / min
e. Potassio sierico = 3,5 mmol / L
f. Funzione epatica:
- Bilirubina sierica <1,5 x ULN (ad eccezione dei pazienti con malattia di Gilbert documentata)
- AST o ALT <2,5 x ULN
10. In grado di deglutire il farmaco di studio
11. Aspettativa di vita di almeno 6 mesi
12. I pazienti che hanno partner in età fertile devono essere disposti a utilizzare un metodo di controllo delle nascite con un'adeguata protezione barriera durante lo studio e per 13 settimane dopo l’ultima somministrazione del farmaco in studio.

E.4

Principal exclusion criteria

1. Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
2. Pathological finding consistent with small cell carcinoma of the prostate greater than 10%
3. Known brain metastasis
4. Use of major opiate analgesics for cancer-related pain (codeine and tramadol are allowed)
5. Prior cytotoxic chemotherapy, Androgen Receptor-targeted agent or biologic therapy for the treatment of CRPC or CSPC (previous bicalutamide is allowed)
6. Radiation therapy for treatment of the primary tumour within 6 weeks of Cycle 1, Day 1
7. Radiation or radionuclide therapy for treatment of metastatic CRPC and CSPC
8. Bicalutamide, nilutamide within 6 weeks of Cycle 1 Day 1
9. Uncontrolled hypertension (systolic BP = 160 mmHg or diastolic BP = 95 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
10. Active or symptomatic viral hepatitis or chronic liver disease
11. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline
12. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy
13. Other malignancy with a previous diagnosis within 5 years (with the exclusions of NMIBC, CIN)

1. L'infezione attiva o altre condizioni mediche che controindichino l’uso del prednisone / prednisolone (corticosteroide)
2. Una componente patologica coerente con carcinoma a piccole cellule della prostata superiore al 10%
3. Metastasi cerebrali note
4. Uso di analgesici oppiacei maggiori (Graziono III WHO) per il dolore correlato al cancro (sono ammessi codeina e tramadolo)
5. Precedente chemioterapia citotossica o precedente agente ormonale di nuova generazione o terapia biologica per il trattamento di CRPC o CSPC (è consentita la precedente bicalutamide)
6. Radioterapia per il trattamento del tumore primario entro 6 settimane dal ciclo 1, giorno 1
7. Terapia con radiazioni o radionuclidi per il trattamento di CRPC metastatico e CSPC
8. Bicalutamide, nilutamide entro 6 settimane dal ciclo 1 giorno 1
9. Ipertensione non controllata (pressione sistolica = 160 mmHg o pressione diastolica = 95 mmHg). I pazienti con una storia di ipertensione sono consentiti purché la pressione arteriosa sia controllata da un trattamento antipertensivo
10. Epatite virale attiva o sintomatica o epatopatia cronica
11. Cardiopatia clinicamente significativa come evidenziato da infarto miocardico, o eventi trombotici arteriosi negli ultimi 6 mesi, angina grave o instabile, o cardiopatia di classe II-IV di New York Heart Association (NYHA) o misurazione della frazione di eiezione cardiaca <50%.
12. Fibrillazione atriale o altre aritmie cardiache che richiedono terapia
13. Altri tumori maligni con una precedente diagnosi entro 5 anni (con le esclusioni di NMIBC).

E.5 End points

E.5.1

Primary end point(s)

To compare the radiographic Progression-Free Survival (rPFS) rate at 9 months of chemotherapy (Arm A, docetaxel plus prednisone) versus androgen receptor targeted therapy (Arm B, enzalutamide or abiraterone acetate plus prednisone) in mCRPC patients with adverse prognostic factors.

Confrontare il tasso di sopravvivenza libera da progressione radiografica (rPFS) a 9 mesi per il docetaxel (braccio A) rispetto a una terapia mirata al recettore androgenico (braccio B, enzalutamide o abiraterone acetato più prednisone) nei pazienti mCRPC con fattori prognostici sfavorevoli.

E.5.1.1

Timepoint(s) of evaluation of this end point

nine months

nove mesi

E.5.2

Secondary end point(s)

To compare efficacy of docetaxel plus prednisone to enzalutamide or abiraterone acetate plus prednisone in terms of PSA response; To compare efficacy of docetaxel plus prednisone to enzalutamide or abiraterone acetate plus prednisone in terms of radiographic progression-free survival (rPFS); To compare efficacy of docetaxel plus prednisone to enzalutamide or abiraterone acetate plus prednisone in terms of overall survival (OS).

Confrontare l'efficacia di docetaxel più prednisone con enzalutamide o abiraterone acetato più prednisone in termini di risposta del PSA; Confrontare l'efficacia di docetaxel più prednisone con enzalutamide o abiraterone acetato più prednisone in termini di sopravvivenza libera da progressione radiografica (rPFS); Confrontare l'efficacia di docetaxel più prednisone con enzalutamide o abiraterone acetato più prednisone in termini di sopravvivenza complessiva (OS).

E.5.2.1

Timepoint(s) of evaluation of this end point

nine months; 18 months; 18 months

nove mesi; 18 mesi; 18 mesi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

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)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

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

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

End of trial will occur 30 days after the last patient last cycle.

La fine della sperimentazione avverrà 30 giorni dopo l'ultimo ciclo dell'ultimo paziente in studio.

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:

120

F.2 Gender

F.2.1

Female

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

200

F.4.2

For a multinational trial

F.4.2.1

In the EEA

200

F.4.2.2

In the whole clinical trial

200

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)

If a patient at the end of treatment will have progression of the disease and still eligible for a treatment he will receive further lines of therapy as per clinical practice.

Pazienti al termine del trattamento se in progressione di malattia ed ancora eleggibili per un trattamento riceveranno ulteriori trattamenti come da pratica clinica.

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

2020-03-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-02

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

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