Clinical Trials Register

Summary
EudraCT Number:	2019-002834-35
Sponsor's Protocol Code Number:	PARERE
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:	2020-10-21
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

2019-002834-35

A.3

Full title of the trial

Randomized phase II study of PAnitumumab REchallenge followed by REgorafenib versus the reverse sequence in RAS and BRAF WILD-TYPE chemorefractory metastatic colorectal cancer patients.

STUDIO RANDOMIZZATO DI FASE II DI RITRATTAMENTO CON PANITUMUMAB SEGUITO DA REGORAFENIB VERSUS LA SEQUENZA INVERSA NEI PAZIENTI CON CARCINOMA COLORETTALE METASTATICO CHEMIO-REFRATTARIO RAS E BRAF WILD-TYPE.

A.3.1

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

Comparison of two strategies that use the same drugs but with inverted sequence for the treatment of patients with metastatic colorectal cancer who have failed in previous therapies.

Confronto di due strategie che utilizzano gli stessi farmaci ma con sequenza invertita per il trattamento di pazienti con carcinoma colonretto metastatico che hanno fallito a terapie precedenti.

A.3.2

Name or abbreviated title of the trial where available

PARERE

A.4.1

Sponsor's protocol code number

PARERE

A.5.4

Other Identifiers

Name:

PARERE

Number:

PARERE

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	G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST
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	Fondazione GONO
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	Bayer S.p.A.
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	Amgen S.r.l.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fondazione GONO
B.5.2	Functional name of contact point	Ufficio Sperimentazioni sede operat
B.5.3	Address:
B.5.3.1	Street Address	Via Roma, 67
B.5.3.2	Town/ city	Pisa
B.5.3.3	Post code	56126
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39050992192
B.5.5	Fax number	+39050992069
B.5.6	E-mail	parerestudy@gmail.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	Yes
D.2.1.1.1	Trade name	STIVARGA - 40 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 3 FLACONI DA 28 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	BAYER PHARMA AG
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	Regorafenib
D.3.2	Product code	[Regorafenib]
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	Regorafenib
D.3.9.1	CAS number	755037-03-7
D.3.9.2	Current sponsor code	Regorafenib
D.3.9.3	Other descriptive name	Antineoplastic agents, protein kinase inhibitor. Regorafenib is an oral tumour deactivation agent that potently blocks multiple protein kinases, including kinases involved in tumour angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF, BRAFV600E), metastasis (VEGFR3, PDGFR, FGFR) and tumour immunity (CSF1R).
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	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	VECTIBIX - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO 1 FLACONCINO (VETRO) 20 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	AMGEN EUROPE B.V.
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	Panitumumab
D.3.2	Product code	[Panitumumab]
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	PANITUMUMAB
D.3.9.1	CAS number	339177-26-3
D.3.9.2	Current sponsor code	Panitumumab
D.3.9.3	Other descriptive name	Panitumumab is a fully human monoclonal IgG2 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology.
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	20
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)	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	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.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

RAS and BRAF wild-type chemorefractory metastatic colorectal cancer patients

Carcinoma colorettale metastatico chemio-refrattario RAS e BRAF wild-type

E.1.1.1

Medical condition in easily understood language

Colorectal cancer spread at distance, RAS BRAF wild type pretreatted.

Tumore al colon retto diffuso a distanza con geni RAS e BRAF non mutati e già trattato in precedenza con chemioterapie.

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	10052362
E.1.2	Term	Metastatic colorectal 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

The primary objective of this trial is to compare the efficacy in terms of OS of panitumumab followed after disease progression by regorafenib (arm A) versus the reverse sequence (arm B) in chemorefractory mCRC patients with previous benefit from first-line anti-EGFR-based treatment and with RAS/BRAF wt ct-DNA at the time of study entry.

L'obiettivo primario di questo studio è comparare l'efficacia in termini di sopravvivenza complessiva di Panitumumab seguito a progressione da Regorafenib (braccio A) versus la sequenza inversa (braccio B) nei pazienti con tumore del colon-retto metastatico chemio-refrattario con un precedente beneficio dal trattamento di prima linea a base di anti-EGFR e con RAS/BRAF wild-type sul DNA tumorale circolante al momento dell'entrata nello studio.

E.2.2

Secondary objectives of the trial

Secondary objectives of this study are to evaluate the two proposed treatments in terms of:
Duration of Progression-free Survival during the first-line of study treatment (1st-PFS);
Duration of Progression-free Survival during the second-line of study treatment (2nd-PFS);
Duration of Time to failure strategy (TFS);
Objective Response Rate (ORR) during panitumumab and regorafenib;
Overall Toxicity Rate;
G3/4 Toxicity Rate;
Translational analyses.

Obiettivi secondari di questo studio sono valutare le due strategie proposte in termini di:
Durata della sopravvivenza libera da progressione durante la prima linea dello studio (1a-PFS);
Durata della sopravvivenza libera da progressione durante la seconda linea dello studio (2 a - PFS);
Durata del tempo al fallimento della strategia (TFS);
Tasso di risposte obiettive (ORR) durante panitumumab e regorafenib;
Tasso di tossicità complessivo;
Tasso di tossicità G3/4;
Analisi traslazionali su biomarcatori predittivi di resistenza

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age = 18 years.
Histologically proven diagnosis of CRC.
At least one measurable lesion according to RECIST1.1
ECOG PS = 1.
mCRC previously treated for metastatic disease with, or not considered candidates for, fluoropyrimidine, oxaliplatin, irinotecan and anti-angiogenic monoclonal antibody (bevacizumab or aflibercept).
RAS (codons 12, 13, 59, 61, 117 and 146 of KRAS and NRAS genes) and BRAF (V600E mutation) wt status of primary CRC or related metastasis (local laboratory assessment).
Previous first-line anti-EGFR-containing therapy producing at least a partial response or a stable disease = 6 months.
At least 4 months elapsed between the end of first-line anti-EGFR administration and screening.
At least one line of therapy between the end of first-line anti-EGFR administration and screening.
RAS (codons 12, 13, 59, 61, 117 and 146 of KRAS and NRAS genes) and BRAF (V600E mutation) wt status of ct-DNA at screening (central laboratory assessment by means of IdyllaTM ctKRAS-NRAS-BRAF Mutation Test, Biocartis, Inc.).
Neutrophils = 1.5 x 109/L, Platelets =100 x 109/L, Hgb = 9 g/dl.
Total bilirubin = 1.5 fold the upper-normal limits (UNL), ASAT (SGOT) and/or ALAT (SGPT) = 2.5 x UNL (or <5 x UNL in the case of liver metastases), alkaline phosphatase = 2.5 x UNL (or < 5 x UNL in case of liver metastases).
Creatinine clearance = 50 mL/min or serum creatinine = 1.5 x UNL.

Diagnosi istologica di carcinoma del colon-retto.
Tumore del colon-retto metastatico non resecabile precedentemente trattato per la malattia metastatica con fluoropirimidine, oxaliplatino, irinotecano e anticorpo monoclonale anti-angiogenico (bevacizumab o aflibercept), a meno di controindicazioni specifiche per uno o più dei suddetti farmaci;
Stato di RAS (codoni 12, 13, 59, 61, 117 e 146 dei geni KRAS e NRAS) e BRAF (mutazione V600E) wild-type del tumore del colon-retto primitivo o delle metastasi (analisi su tessuto eseguite localmente).
Risposta parziale o stabilità di malattia = 6 mesi con un precedente trattamento di prima linea a base di anti-EGFR.
Intervallo di tempo di almeno 4 mesi tra la fine della somministrazione dell'anti-EGFR in prima linea e lo screening.
Somministrazione di almeno un’altra linea di terapia tra la fine della prima linea con anti-EGFR e lo screening.
Stato di RAS (codoni 12, 13, 59, 61, 117 e 146 dei geni KRAS e NRAS) e BRAF (mutazione V600E) wild-type del DNA tumorale circolante allo screening (analisi molecolare centralizzata con test IdyllaTM ctKRAS-NRAS-BRAF Mutation, Biocartis, Inc.).
Almeno una lesione misurabile secondo i criteri RECIST 1.1.
Età = di 18 anni.
ECOG PS = 1.
Neutrofili =1.5 x 109/L, Piastrine = 100 x 109/L, Emoglobina = 9 g/dl.
Bilirubina totale = 1.5 x limite superiore del valore normale (UNL) e AST (SGOT) e/o ALT (SGPT) = 2.5 x UNL (o 5 x UNL in caso di metastasi epatiche), fosfatasi alcalina = 2.5 x UNL (o < 5 x UNL in caso di metastasi epatiche).
Clearance della creatinina = 50 ml/min o creatinina sierica = 1.5 x UNL.

E.4

Principal exclusion criteria

Previous treatment with regorafenib.
Radiotherapy to any site within 4 weeks before the study
Untreated brain metastases or spinal cord compression or primary brain tumours.
Evidence of bleeding diathesis or coagulopathy.
Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy.
Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (= 6 months), myocardial infarction (= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.
Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months of study enrolment.
Any previous venous thromboembolism = NCI CTCAE Grade 4.
History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first study treatment.
Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.

Precedente trattamento con regorafenib.
Trattamento radioterapico in qualunque sede nelle 4 settimane precedenti lo studio.
Metastasi cerebrali non trattate o compressione midollare o tumori cerebrali primitivi.
Diagnosi di polmonite interstiziale o fibrosi polmonare.
Infezioni attive non controllate o altre malattie concomitanti rilevanti che controindicano la somministrazione di panitumumab e regorafenib.
Evidenza di diatesi emorragica o coagulopatia.
Ipertensione non controllata e precedente storia di crisi ipertensive o encefalopatia ipertensiva.
Malattie cardiovascolari clinicamente significative (in atto) per esempio eventi cerebrovascolari (= 6 mesi), infarto del miocardio (=6 mesi), angina instabile, scompenso cardiaco grado NYHA II, gravi aritmie che necessitano di terapia medica.
Malattie cardiovascolari significative (es. aneurisma dell'aorta che richiede un trattamento chirurgico o recente trombosi arteriosa) entro 6 mesi precedenti l'arruolamento in studio.
Qualsiasi precedente trombo-embolia venosa = NCI CTCAE Grado 4.
Storia di fistola addominale, perforazione gastrointestinale, ascesso intra-addominale o sanguinamento gastrointestinale attivo entro 6 mesi precedenti l'arruolamento in studio.
Mancanza di integrità fisica del tratto gastrointestinale superiore, sindrome da malassorbimento o impossibilità ad assumere una terapia orale.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is Overall Survival defined as the time from randomization to the date of death due to any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.

La durata della sopravvivenza complessiva è definita come il tempo dalla randomizzazione alla data di morte per qualsiasi causa. Per i pazienti ancora in vita al momento dell'analisi, il tempo della sopravvivenza complessiva sarà censorizzato all'ultima data in cui il paziente risulterà vivo.

E.5.1.1

Timepoint(s) of evaluation of this end point

24 months

24 mesi

E.5.2

Secondary end point(s)

1st-Progression free survival (1st-PFS) is defined as the time from randomization to the first documentation of objective disease progression or death due to any cause, whichever occurs first. PFS will be censored on the date of the last evaluable on study tumour assessment documenting absence of progressive disease for patients who are alive, on study and progression free at the time of the analysis. Alive patients having no tumour assessments after baseline will have time to event censored on the date of randomization.; 2nd-Progression free survival (2nd-PFS) is defined as the time from the beginning of the second-line study treatment to the documentation of objective disease progression according to RECIST 1.1 criteria or death due to any cause, whichever occurs first. 2nd-PFS will be censored on the date of the last evaluable on study tumour assessment documenting absence of progressive disease for patients who are alive, on study and 2nd-progression free at the time of the analysis. 2nd-PFS will be analysed both in all patients who initiate a 2nd line (whichever 2nd-line treatment will be adopted) and in the per-protocol population

1a-sopravvivenza libera da progressione (1a-PFS) è definita come il tempo dalla randomizzazione alla prima documentazione di progressione obiettiva di malattia in base ai criteri RECIST 1.1 o morte per qualsiasi causa, qualunque accada prima. 1a-PFS sarà censorizzata alla data dell'ultima valutazione tumorale disponibile che documenta l'assenza di progressione di malattia per i pazienti che sono vivi, in studio e liberi da progressione al momento dell'analisi. I pazienti vivi che non hanno ricevuto nessuna rivalutazione tumorale dopo quella basale saranno censorizzati alla data di randomizzazione.; 2a-sopravvivenza libera da progressione (2a-PFS) è definita come il tempo dall'inizio della seconda linea alla documentazione di progressione obiettiva di malattia in base ai criteri RECIST 1.1 o morte per qualsiasi causa, qualunque accada prima. 2a-PFS sarà censorizzata alla data dell'ultima valutazione tumorale disponibile che documenta l'assenza di progressione di malattia per i pazienti che sono vivi, in studio e liberi dalla seconda progressione al momento dell'analisi. I pazienti vivi che non hanno ricevuto nessuna rivalutazione tumorale dopo la prima progressione saranno censorizzati alla data di prima progressione. 2a-PFS sarà analizzata in tutti i pazienti che iniziano una seconda linea (qualsiasi seconda linea sarà adottata) e nella popolazione per-protocol.

E.5.2.1

Timepoint(s) of evaluation of this end point

6 months; 6 months

6 mesi; 6 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)

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

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

Yes

E.8.2.3.1

Comparator description

stessi farmaci sequenza inversa

same drugs administered with reverse sequence

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

The end of study is defined as the time when all registered patients will have experienced evidence of second disease progression or will be out of treatment as per protocol, toxicity or medical decision.

La fine dello studio è identificata con la data della seconda progressione dell'ultimo paziente o con la data in cui l'ultimo paziente terminerà il trattamento per protocollo , per tossicità o decisione clinica.

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:

160

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

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

214

F.4.2

For a multinational trial

F.4.2.1

In the EEA

214

F.4.2.2

In the whole clinical trial

214

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)

Subject experiencing the second progression of disease will be observed for survival.

I soggetti che avranno la seconda progressione di malattia verranno seguiti per la sopravvivenza

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

2020-09-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-09-24

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