Clinical Trials Register

Summary
EudraCT Number:	2009-010273-20
Sponsor's Protocol Code Number:	EORTC18081
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-12-21
Trial results	View 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

2009-010273-20

A.3

Full title of the trial

Adjuvant peginterferon alfa-2b for 2 years vs Observation in patients with an ulcerated primary cutaneous melanoma with T(2-4)bN0M0: a randomized phase III trial of the EORTC Melanoma Group.

Peginterferone alfa-2b adiuvante per 2 anni a confronto con osservazione in pazienti affetti da melanoma cutaneo primitivo ulcerato con T(2-4)bN0M0: uno studio randomizzato di fase III del gruppo per il melanoma dell'EORTC

A.3.1

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

Adjuvant peginterferon alfa-2b for 2 years vs Observation in patients with an ulcerated primary cutaneous melanoma with T(2-4)bN0M0: a randomized phase III trial of the EORTC Melanoma Group.

A.4.1

Sponsor's protocol code number

EORTC18081

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01502696

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	E.O.R.T.C. - EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER
B.1.3.4	Country	Belgium
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	MERCK and Co. Inc
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	EORTC
B.5.2	Functional name of contact point	Project Mgt & Regulatory Unit
B.5.3	Address:
B.5.3.1	Street Address	Avenue E. Mounier 83/11
B.5.3.2	Town/ city	Brussels
B.5.3.3	Post code	1200
B.5.3.4	Country	Belgium
B.5.4	Telephone number	+32 2 7741072
B.5.5	Fax number	+32 2 7741030
B.5.6	E-mail	regulatory@eortc.be

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	PEGINTRON*SC 6FL 100MCG+6F
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.3.4	Pharmaceutical form	Transdermal system
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Other use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PEGINTERFERON ALFA-2B
D.3.9.1	CAS number	215647-85-1
D.3.9.4	EV Substance Code	SUB12549MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Cylatron (PEG-IFN), Powder for injection (200mcg strenght)
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharpe & Dohme
D.2.1.2	Country which granted the Marketing Authorisation	Switzerland
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.3.4	Pharmaceutical form	Transdermal system
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Other use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PEGINTERFERON ALFA-2B
D.3.9.1	CAS number	215647-85-1
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 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	Cylatron (PEG-IFN), Pozder for Injection (300mcg strengths)
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharpe & Dohme
D.2.1.2	Country which granted the Marketing Authorisation	Switzerland
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.3.4	Pharmaceutical form	Transdermal system
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Other use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PEGINTERFERON ALFA-2B
D.3.9.1	CAS number	215647-85-1
D.3.9.4	EV Substance Code	SUB12549MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	300
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Sylatron (PEG-IFN), for Injection (200mcg strengths)
D.2.1.1.2	Name of the Marketing Authorisation holder	Schering Corporation
D.2.1.2	Country which granted the Marketing Authorisation	United States
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.3.4	Pharmaceutical form	Transdermal system
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Other use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PEGINTERFERON ALFA-2B
D.3.9.1	CAS number	215647-85-1
D.3.9.4	EV Substance Code	SUB12549MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
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	Sylatron (PEG-IFN), for Injection (300mcg strengths)
D.2.1.1.2	Name of the Marketing Authorisation holder	Schering Corporation
D.2.1.2	Country which granted the Marketing Authorisation	United States
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.3.4	Pharmaceutical form	Transdermal system
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Other use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PEGINTERFERON ALFA-2B
D.3.9.1	CAS number	215647-85-1
D.3.9.4	EV Substance Code	SUB12549MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	300
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.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

Ulcerated primary cutaneous melanoma >1mm

Ulcerated primary cutaneous melanoma >1mm (T2b-4bN0M0)

E.1.1.1

Medical condition in easily understood language

Ulcerated primary cutaneous melanoma >1mm

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	14.1
E.1.2	Level	SOC
E.1.2	Classification code	10029104
E.1.2	Term	Neoplasms benign, malignant and unspecified (incl cysts and polyps)
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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 main objective of the trial is to prospectively assess the efficacy, toxicity, quality of life with PEF IFN alfa-2b as compared to observaton after adequate surgery for ulcerated primary cutaneous melanomas with T(2-4)bN0M0. The primary objective is to determine whether post-operative adjuvant therapy with PEG IFN alfa-2b improves relapse-free survival (PFS) as compared to observation.

Valutazione prospettica dell'efficacia, della tossicità e della qualità della vita con peginterferone alfa-2b rispetto all'osservazione a seguito di intervento chirurgico adeguato per pazienti con <csf style="Bold" bold="on">melanoma primitivo cutaneo i ulcerato con T(2-4)bN0M0</csf>

E.2.2

Secondary objectives of the trial

The secondary objectives are :
-To compare adverse event profiles between patients receiving PEG IFN alfa-2b versus patients in the observation arm
-To determine whether post-operative adjuvant therapy with PEG IFN alfa-2b improves overall survival (OS) as compared to observation
-To determine whether post-operative adjuvant therapy with PEG IFN alfa-2b improves distant metastases-free survival (DMFS) as compared to observation
-To compare quality of life between the two arms (PEG IFN alfa-2b versus observation)

Gli obiettivi secondari sono:
-Per confrontare i profili degli eventi avversi tra i pazienti trattati con PEG IFN alfa-2b rispetto ai pazienti nel gruppo di osservazione
-Per determinare se terapia post-operatoria adiuvante con PEG IFN alfa-2b migliora la sopravvivenza generale (OS) rispetto alla sola osservazione
-Per determinare se la terapia post-operatoria adiuvante con PEG IFN alfa-2b migliora metastasi distanti sopravvivenza libera (DMF) rispetto all'osservazione
-Per confrontare la qualità della vita tra i due bracci (PEG IFN alfa-2b rispetto osservazione)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Subjects must have histologically documented ulcerated primary cutaneous melanoma with a Breslow thickness >1mm that has been excised radically 3 months prior to randomization. Excision margins of at least 1cm are required. In the head and neck areas and in case of locations distally on extremities narrower margins are acceptable as long as they are radical.
-In case subjeccts have undergone Sentinel Node staging after the excision of the primary, this must be done within the time frame of 3 months between the date of final excision of the primary and the date of randomization.
-Subjects must have an ECOG performance status of 0 or 1.
-Subjects must be between 18-70 years old.
-Subjects must have adequate hepatic, renal and bone marrow function as defined by the following parameters obtained within 4 weeks prior to initiation of study treatment.
-Subjects must give informed consent according to ICH-GCP or national/local policy.

-I soggetti devono essere istologicamente documentato ulcerate melanoma cutaneo primario di spessore di Breslow> 1mm che è stato asportato radicalmente 3 mesi prima della randomizzazione. Margini di escissione di almeno 1 cm sono necessari. Nelle zone di testa e del collo e in caso di posizioni sulla estremità distale ristretti margini accettabili purché sono radicali.
-In caso subjeccts sono stati sottoposti a gestione temporanea del nodo sentinella dopo l'escissione del primario, questo deve essere fatto entro il termine di 3 mesi tra la data di escissione finale del primario e la data di randomizzazione.
-I soggetti devono avere un performance status ECOG di 0 o 1.
-Soggetti deve essere compreso tra 18-70 anni di età.
-Soggetti devono avere un'adeguata epatica, renale e la funzione del midollo osseo come definito dai seguenti parametri ottenuti entro 4 settimane prima dell'inizio del trattamento in studio.
-Soggetti devono dare il consenso informato secondo ICH-GCP o nazionale / politica locale.

E.4

Principal exclusion criteria

-Subjects suffering form a mucous membrane melanoma or ocular melanoma
-Subjects who have evidence of (non-)regional lymph node metastases or intransit metastases (even if they have been resected)
-Subjects whose disease cannot be completely surgically resected
-Subjects who have not recovered from the effects of recent surgery
-Subjects with a history of prior malignancy within the past 10 years other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ
-Subjects who have severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease
-Subjects with thyroid dysfunction not responsive to therapy
-Subjects with uncontrolled diabetes mellitus
-Subjects suffering from an active autoimmune disease
-Subjects with active and/or uncontrolled infection, including active hepatitis
-Subjects who have a histroy of seropositivity for HIV
-Subjects who hqve a history of neuropsychiatric disorder requiring hospitalization
-Subjects who are known to be actively abusing alcohol or drugs
-Subjects who are pregnant, lactating, or of reproductive potential and not practicing an effective means of contraception
-Subjects with a medical condition requiring chronic systemic corticosteroids
-Subjects who have received any experimental therapy within 30 days prior to randomization in this study
-Subjects who have received any prior chemotherapy, immunotherapy, hormonal or radiation therapy for melanoma
-Subjects who have previously received interferon-alpha for any reason
-Subjects hqving history of epilepsy or other major central nervos system disease
-Subjects having eyes disorders

-Soggetti affetti formare un melanoma delle mucose o melanoma oculare
-Soggetti che hanno evidenza di (non) metastasi nei linfonodi regionali o metastasi InTransit (anche se sono stati sottoposti a resezione)
-I soggetti con malattia non può essere completamente asportato chirurgicamente
-I soggetti che non hanno recuperato dagli effetti del recente intervento chirurgico
-Soggetti con anamnesi di neoplasia maligna prima negli ultimi 10 anni oltre chirurgicamente guarito non-melanoma, cancro della pelle o carcinoma cervicale in situ
-Soggetti che hanno gravi malattie cardiovascolari, aritmie, cioè che richiedono un trattamento cronico, insufficienza cardiaca congestizia (classe NYHA III o IV) o cardiopatia ischemica sintomatica
-I soggetti con disfunzione tiroidea non responsive alla terapia
-I soggetti con diabete mellito non controllato
-Soggetti affetti da una malattia autoimmune attiva
-I soggetti con infezione attiva e / o non controllata, tra cui epatite attiva
-Soggetti che hanno un Histroy di sieropositività per l'HIV
-Soggetti che hqve una storia di disturbi neuropsichiatrici che richiedono ospedalizzazione
-Soggetti che sono noti per essere attivamente abusando di alcol o droghe
-I soggetti che sono in stato di gravidanza, allattamento, o di potenziale riproduttivo e non praticare un mezzo efficace di contraccezione
-Soggetti affetti da patologie croniche che richiedono corticosteroidi sistemici
-Soggetti che hanno ricevuto una terapia sperimentale nei 30 giorni precedenti la randomizzazione in questo studio
-Soggetti che hanno ricevuto alcun precedente chemioterapia, immunoterapia, ormonale o radioterapia per il melanoma
-Soggetti che hanno precedentemente ricevuto l'interferone-alfa, per qualsiasi motivo
Di soggetti con storia di epilessia o hqving altro grande centrale del sistema nervos malattia
-Soggetti con disturbi agli occhi

E.5 End points

E.5.1

Primary end point(s)

-Relapse free survival (RFS)

-La sopravvivenza libera da recidiva (RFS)

E.5.1.1

Timepoint(s) of evaluation of this end point

6 years and 3 months

6 anni e 3 mesi

E.5.2

Secondary end point(s)

-Distant metastasis free survival (DMFS)
-Overal survival (OS)
-Toxicity
-Quality of life

-A distanza sopravvivenza libera da metastasi (DMF)
-Overal sopravvivenza (OS)
-Tossicità
-Qualità della vita

E.5.2.1

Timepoint(s) of evaluation of this end point

-Distant metastasis free survival (DMFS):8 years
-Overal survival (OS):8 years
-Toxicity:during all the conduct of the trial
-Quality of life:6 years and 3 months

-A distanza sopravvivenza libera da metastasi (DMF): 8 anni
-Overal sopravvivenza (OS): 8 anni
-Tossicità: durante tutto lo svolgimento del processo
-Qualità della vita: 6 anni e 3 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

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

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

Yes

E.8.2.3.1

Comparator description

osservazione

observation

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

End of study occurs when all of the following criteria have been satisfied: 1.Thirty days after all patients have stopped protocol treatment 2.The trial is mature (i.e. reached the required number of events) for each of the two final analyses of the endpoints (RFS and OS) as defined in the protocol. 3.The database has been fully cleaned and frozen for each of these 2 final analyses.

Trenta giorni dopo che tutti i pazienti ha interrotto la terapia del protocollo Il processo è maturo per ciascuna delle due analisi finali degli endpoint Il database è stato completamente pulita e congelati per ciascuna di queste due analisi final

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

Number of subjects for this age range:

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:

1080

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

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

1000

F.4.2.2

In the whole clinical trial

1000

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)

At physician's discretion, in the best interest of the patient

A discrezione del medico, nel miglior interesse del paziente

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

2013-09-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-11-29

P. End of Trial
P.	End of Trial Status	Completed

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