Clinical Trials Register

Summary
EudraCT Number:	2014-004438-24
Sponsor's Protocol Code Number:	M14-483
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:	2021-09-07
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

2014-004438-24

A.3

Full title of the trial

ABT-414 alone or ABT-414 plus temozolomide versus lomustine or temozolomide for recurrent glioblastoma: a randomized phase II study of the EORTC Brain Tumor Group.

ABT 414 in monoterapia o ABT 414 in associazione a temozolomide versus lomustina o temozolomide nel trattamento del glioblastoma recidivante: sperimentazione randomizzata di fase 2 dell’EORTC Brain Tumor Group

A.3.1

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

ABT-414 alone or ABT-414 plus temozolomide versus temozolomide or lomustine alone in subjects with recurrent glioblastoma.

ABT-414 in monoterapia o ABT-414 in associazione a temozolomide versus lomustina o temozolomide in monoterapia nel trattamento di soggetti con glioblastoma recidivante

A.3.2

Name or abbreviated title of the trial where available

not available

non disponibile

A.4.1

Sponsor's protocol code number

M14-483

A.5.4

Other Identifiers

Name:

1410-BTG EORTC Protocol Number

Number:

1410-BTG EORTC Protocol Number

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	ABBVIE DEUTSCHLAND GMBH & CO. KG
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Abbvie 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	AbbVie Ltd.
B.5.2	Functional name of contact point	EU Clinical Trials Helpdesk
B.5.3	Address:
B.5.3.1	Street Address	AbbVie House, Vanwall Business Park, Vanwall Road
B.5.3.2	Town/ city	Maidenhead, Berkshire
B.5.3.3	Post code	SL6 4UB
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+44 1628 773355
B.5.5	Fax number	+44 1628 672566
B.5.6	E-mail	eu-clinical-trials@abbvie.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	No
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/3/14/1305
D.3 Description of the IMP
D.3.1	Product name	ABT-414
D.3.2	Product code	ABT-414
D.3.4	Pharmaceutical form	Powder 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	ABT-414
D.3.9.2	Current sponsor code	ABT-414
D.3.9.4	EV Substance Code	SUB83643
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)	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	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	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	TEMOZOLOMIDE CRINOS - 140 MG CAPSULE RIGIDE 5 CAPSULE IN FLACONE IN VETRO CON CHIUSURA A PROVA DI BAMBINO
D.2.1.1.2	Name of the Marketing Authorisation holder	CRINOS S.P.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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	TEMOZOLOMIDE
D.3.2	Product code	TEMOZOLOMIDE
D.3.4	Pharmaceutical form	Capsule, hard
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	TEMOZOLOMIDE
D.3.9.2	Current sponsor code	non applicabile
D.3.9.3	Other descriptive name	TEMOZOLOMIDE
D.3.9.4	EV Substance Code	SUB10889MIG
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	5
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	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	TEMOZOLOMIDE CRINOS - 140 MG CAPSULE RIGIDE 5 CAPSULE IN FLACONE IN VETRO CON CHIUSURA A PROVA DI BAMBINO
D.2.1.1.2	Name of the Marketing Authorisation holder	CRINOS S.P.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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	TEMOZOLOMIDE
D.3.2	Product code	TEMOZOLOMIDE
D.3.4	Pharmaceutical form	Capsule, hard
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	TEMOZOLOMIDE
D.3.9.2	Current sponsor code	NON APPLICABILE
D.3.9.3	Other descriptive name	TEMOZOLOMIDE
D.3.9.4	EV Substance Code	SUB10889MIG
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	20
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: 4
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	TEMOZOLOMIDE CRINOS - 140 MG CAPSULE RIGIDE 5 CAPSULE IN FLACONE IN VETRO CON CHIUSURA A PROVA DI BAMBINO
D.2.1.1.2	Name of the Marketing Authorisation holder	CRINOS S.P.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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	TEMOZOLOMIDE
D.3.2	Product code	TEMOZOLOMIDE
D.3.4	Pharmaceutical form	Capsule, hard
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	TEMOZOLOMIDE
D.3.9.2	Current sponsor code	NON APPLICABILE
D.3.9.3	Other descriptive name	TEMOZOLOMIDE
D.3.9.4	EV Substance Code	SUB10889MIG
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	100
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: 5
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	No
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	LOMUSTINA
D.3.2	Product code	LOMUSTINA
D.3.4	Pharmaceutical form	Capsule, hard
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	LOMUSTINA
D.3.9.2	Current sponsor code	NON APPLICABILE
D.3.9.3	Other descriptive name	LOMUSTINE
D.3.9.4	EV Substance Code	SUB08567MIG
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.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

Glioblastoma Multiforme

E.1.1.1

Medical condition in easily understood language

Recurrent Glioblastoma, a rare and aggressive type of brain tumor.

Glioblastoma recidivante, una tipologia di tumore cerebrale raro ed aggressivo

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	PT
E.1.2	Classification code	10018336
E.1.2	Term	Glioblastoma
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

Overall Survival and Progression Free survival according to RANO criteria and assessed at interim analysis.

Sopravvivenza globale e sopravvivenza libera da progressione in accordo ai criteri RANO valutate in occasione dell’analisi ad interim.

E.2.2

Secondary objectives of the trial

Progression Free Survival according to RANO criteria, Objective Response Rate, Overall Survival in the subgroup with EGFRvIII mutation.

Sopravvivenza libera da progressione in base ai criteri RANO, tasso di risposta oggettiva, Sopravvivenza globale nel sottogruppo di soggetti con mutazione EGFRvIII

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

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

Pharmacogenetics
Version: si veda protocollo principale
Date: 15/04/2015
Title: see main protocol
Objectives: There is a pharmacogenetic sub-study where the samples will be stored at AbbVie.
There is also an optional translational and genetic sub-study where the samples will be biobanked with EORTC.

Farmacogenetica
Versione: si veda protocollo principale
Data: 15/04/2015
Titolo: si veda protocollo principale
Obiettivi: E' previsto un sottostudio di farmacogenetica in cui campioni verranno conservati presso AbbVie.
Inoltre è prevista una ricerca traslazionale opzionale e un sottostudio genetico nei quali I campioni verranno conservati presso la biobanca dell'EORTC

E.3

Principal inclusion criteria

1. Histologically confirmed de novo (primary) GBM with unequivocal tumor progression or recurrence.
2. In case of testing at the time of first progression: either at least 3 months after the end of radiotherapy or have tumor progression that is clearly outside the radiation field or have tumor progression
unequivocally proven by surgery/biopsy
3. Age = 18 years
4. Absence of any psychological, familial, sociological or geographical
factors potentially hampering compliance with the study protocol and
follow-up schedule; such conditions should be assessed with the patient before registration in the trial.
5. Availability of adequate biological material (formalin-fixed paraffin embedded [FFPE] tumor) for central testing of EGFR amplification
6. Presence of EGFR amplification confirmed by central assessment; patients with undetermined EGFR status are excluded
7. WHO Performance status 0 - 2
8. No more than one line of chemotherapy (concurrent and adjuvant TMZ based chemotherapy including in combination with another
investigational agent is considered one line of chemotherapy).
Chemotherapy must have been completed at least 4 weeks prior to randomization.

1)Soggetti con glioblastoma de novo (primario) confermato istologicamente, con evidenza univoca di progressione tumorale o recidivanti.
2)Se l’esame istologico è stato eseguito al momento della prima progressione, è necessario che siano trascorsi almeno 3 mesi dalla fine della radioterapia oppure che vi sia evidenza di progressione tumorale nettamente al di fuori del sito irradiato oppure che la progressione tumorale sia inequivocabilmente confermata da chirurgia/biopsia
3)Soggetti di età = 18 anni
4)Soggetti che non presentano alcun fattore di natura psicologica, familiare, sociologica o geografica che potrebbero interferire con l’adesione ai requisiti del protocollo di sperimetazione e al programma di follow-up; è necessario verificare l’eventuale presenza di tali condizioni prima di arruolare il paziente nella sperimentazione.
5)Soggetti per cui è disponibile un campione adeguato di materiale biologico (campione tumorale fissato in formalina e incluso in paraffina (FFPE) da inviare al laboratorio centralizzato per essere sottoposto ad analisi per rilevare l’amplificazione del gene per l’EGFR
6)Soggetti con amplificazione del gene per l’EGFR confermata dal laboratorio centralizzato; saranno esclusi i pazienti con lo status EGFR non definito.
7)Soggetti con punteggio WHO Performance status 0 – 2
8)Soggetti che non hanno ricevuto più di una linea di chemioterapia (si considera una linea di chemioterapia il trattamento con TMZ concomitante e adiuvante, anche se in combinazione con altro agente sperimentale). La chemioterapia deve essere stata completata almeno 4 settimane prima della randomizzazione

E.4

Principal exclusion criteria

1. Prior treatment with nitrosoureas
2. Prior treatment with bevacizumab
3. Previous exposure to EGFR targeted agents, including EGFRvIII
targeting agents
4. Prior discontinuation of temozolomide chemotherapy for toxicity
reasons
5. Prior RT with a dose over 65 Gy, stereotactic radiosurgery or
brachytherapy unless the recurrence is histologically proven
6. Previous other malignancies, except for any previous malignancy
which was treated with curative intent more than 5 years prior to
randomization, and except for adequately controlled limited basal cell
carcinoma of the skin, squamous carcinoma of the skin or carcinoma in
situ of the cervix
7. Women of childbearing potential must have a negative serum or urine
pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG)
within 72 hours prior to randomization

1)Trattamento pregresso con nitrosouree
2)Trattamento progresso con bevacizumab
3)Esposizione pregressa ad agenti anti-EGFR, compresi agenti diretti contro l’EGFRvIII
4)Soggetti che non abbiano interrotto un pregresso trattamento chemioterapico con temozolomide a causa di tossicità
5)Soggetti che hanno ricevuto radioterapia pregressa a dosi superiori a 65 Gy, radiochirurgia stereotassica oppure brachiterapia, eccetto se la recidiva viene confermata istologicamente
6)Storia di altre neoplasie maligne, ad eccezione di qualsiasi neoplasia maligna trattata con intento curativo oltre 5 anni prima della randomizzazione e ad eccezione di limitato e adeguatamente controllato: carcinoma cutaneo basocellulare, carcinoma cutaneo squamocellulare oppure carcinoma in situ della cervice uterina
7)Le donne in età fertile devono avere un risultato negativo al test di gravidanza su siero o urine (sensibilità minima 25 IU/L oppure unità equivalenti di HCG) nelle 72 ore precedenti la randomizzazione.

E.5 End points

E.5.1

Primary end point(s)

Overall Survival and Progression Free survival according to RANO criteria and assessed at interim analysis.

Sopravvivenza globale e sopravvivenza libera da progressione in accordo ai criteri RANO valutate in occasione dell’analisi ad interim

E.5.1.1

Timepoint(s) of evaluation of this end point

Overall Survival at final analysis and Progression Free Survival at interim futility analysis after observation of 45 PFS events.

Sopravvivenza globale rilevata all’analisi finale e sopravvivenza libera da progressione in base ai criteri RANO valutate in occasione dell’analisi ad interim dopo l’osservazione di 45 eventi PFS

E.5.2

Secondary end point(s)

• Progression Free Survival
• Overall Response Rate (ORR)
• Overall Survival in the subgroup with Epithelial Growth Factor
Receptor (EGFRvIII) mutation.

•Sopravvivenza libera da progressione
•Tasso di risposta oggettiva (ORR)
•Sopravvivenza globale nel sottogruppo di soggetti con mutazione EGFRvIII

E.5.2.1

Timepoint(s) of evaluation of this end point

• Progression Free Survival as assessed by RANO from date of randomization to date of first objective progression (or death).
• The overall response rate will be evaluated at each assessment of disease according to RANO criteria.
• Subgroup with EGFR vIII mutation will be measured up to 28 months (study length), until death, or lost to follow up.

•Sopravvivenza libera da progressione in base ai criteri RANO valutata dalla data della randomizzazione alla data della prima progressione obiettiva (o morte)
•Il tasso di risposta oggettiva sarà calcolato ad ogni valutazione della patologa in base ai criteri RANO
•Il sottogruppo con mutazione EGFRvIII sarà misurato fino a 28 mesi (lunghezza della sperimentazione), fino alla morte, o fino a perdita del follow-up

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

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Translational research

Ricerca traslazionale

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)

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

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Canada

Korea, Republic of

Mexico

Puerto Rico

Singapore

Taiwan

United States

Austria

Belgium

Finland

France

Germany

Hungary

Ireland

Italy

Netherlands

Poland

Spain

Switzerland

United Kingdom

Czechia

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

Subjects will be followed until death or lost to follow up

I pazienti verranno seguiti fino alla morte o fino alla fine del follow-up

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:

120

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

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Brain Cancer Patients - terminally ill.

Pazienti con cancro al cervello - malati terminali.

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

160

F.4.2.2

In the whole clinical trial

240

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)

Will be discussed between Investigator and subject. Informed consent states that there will be follow up contact, and also arrangement for continuing care.

Sarà discusso tra lo Sperimentatore ed il soggetto. Il consenso informato stabilisce che verranno effettuati dei contatti di follow-up ed inoltre descrive le cure successive

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

2015-06-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-06-25

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-06-24

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