Clinical Trials Register

Summary
EudraCT Number:	2004-001810-16
Sponsor's Protocol Code Number:	IntergroupStudy(EORTC62024)
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:	2005-11-11
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

2004-001810-16

A.3

Full title of the trial

Intermediate and high risk localized, completely resected, gastrointestinal stromal tumors (GIST) expressing KIT receptor: a controlled randomized trial on adjuvant Imatinib mesylate (Glivec) versus no furthrer therapy complete surgery.

Tumori stromali del tratto gastrointestinale (GIST), localizzati, completamente asportati che esprimono recettore Kit: uno studio clinico controllato, randomizzato, con terapia adiuvante con Imatinib mesylate (Glivec) versus nessuna ulteriore terapia dopo chirurgia radicale.

A.3.2

Name or abbreviated title of the trial where available

EORTC 62024

A.4.1

Sponsor's protocol code number

IntergroupStudy(EORTC62024)

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	ITALIAN SARCOMA GROUP
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	GLIVEC*120CPS 100MG
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVARTIS FARMA SpA *
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	UE/3/01/061
D.3 Description of the IMP
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	Imatinib
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
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	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	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	Yes
D.3.11.13.1	Other medicinal product type	Non Applicabile

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

intermediate and high risk localized Gastrointestinal stromal tumors (GIST) patients

pazienti affetti da Tumore stromale gastrointestinale (GIST) localizzato a rischio intermedio e alto

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	PT
E.1.2	Classification code	10051066
E.1.2	Term	Gastrointestinal stromal tumour
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

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

to assess whether there is a difference in overall survival between intermediate and high risk localized GIST patients undergoing complete surgery alone and those undergoing complete surgery plus Imatinib mesylate + 400mg daily for 2 years

Stimare se Imatinib mesylate e' efficace, in termini di sopravvivenza complessiva, nei GIST localizzati, impiegato in terapia adiuvante, dopo intervento chirurgico radicale, rispetto alla sola chirurgia.

E.2.2

Secondary objectives of the trial

to assess whether there is a difference in relapse free survival and relapse free interval between intermediate and high risk localized GIST patients undergoing complete surgery alone and those undergoing complete surgery plus Imatinib mesylate + 400mg daily for 2 years. Safety of Imatinib mesylate

Stimare se Imatinib mesylate e' efficace,in termini di intervallo libero da progressione,rispetto ai pazienti non trattati.verificare se l'effetto di Imatinib mesylate,in termini di sopravvivenza libera da progressione,si differenzia nei gruppi di pazienti con GIST localizzato a rischio intermedio e alto.Studuare il profilo di tossicita' di Imatinib mesylate.

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

ALTRI SOTTOSTUDI:
Ricerca Translazionale opzionale, con l'intento di identificare nuovi marcatori molecolari nei GIST

E.3

Principal inclusion criteria

Histologically proven diagnosis of GIST-Intermediate-high risk of relapse- Surgery performed from 2 weeks to 3 months before randomization- Non evidence of residual macroscopic disease after surgery-No prior radiation therapy, no prior chemotherapy for GIST, no prior Imatinib mesylate or any molecolar targeted or biological therapy-Absence of distant metastases including absence of any peritoneal lesion not contiguous to the primary tumor-Age >/= 18- WHO PS =0-2-No class 3/4 cardiac problems- No severe/uncontrolled concurrent medical desease-No prior or ongoing other malignancy, exept adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or adequately treated cancer with eradicative intent for which the patient has been continuously disease free for at least 5 years- Adequated liver function (serum bilirubin ≤ 1.5xIULN,AST or ALT ≤ 2.5IULN)-Adequated renal function (serum creatinin < 1.5 xIULN-ANC >/=1.5 x109/l-platelet count >/=100x109/l-baseline Hemoglobin >/=9g/dl-Written informed consent

Diagnosi istologica di GIST-Elevato o intermedio rischio di ricaduta-Pazienti sottoposti a chirurgia da due settimane a tre mesi prima della randomizzazione-Nessuna evidenza di malattia residua dopo chirurgia- Assenza di precedente radioterapia o chemioterapia o altre terapie molecolar targeted o biologiche per GIST o trattamento con Imatinib mesylate- Assenza di metastasi distali inclusa assenza di lesioni peritoneali non contigue al tumore primario- Eta superiore/ugale a 18 anni-WHO PS =0-2-Assenza di principali problemi cardiaci-Assenza di gravi patologie concomitanti-Assenza di altra patologia maligna precedente o concomitante ad eccezione di carcinoma in situ della cervice, basalioma o carcinoma a cellule squamose della cute adeguatamente trattati o patologie neoplastiche precedentemente trattate con intento eradicativo per le quali il paziente sia libero da malattia da almeno 5 anni -Adeguata funzione epatica:bilirubina ematica ≤ 1,5 xIULN,AST o ALT ≤ 2,5 IULN-Adeguata funzione renale: creatinina ematica < 1,5xIULN- ANC superiore/ uguale 1,5 x109/l-piastrine maggiore /uguale 100x109/l-emoglobina basale maggiore/uguale 9g/dl- Consenso Informato scritto

E.4

Principal exclusion criteria

Prior radiation therapy, prior chemotherapy for GIST, prior Imatinib mesylate or any molecolar targeted or biological therapy-Distant metastases including peritoneal lesion not contiguous to the primary tumor-severe/uncontrolled concurrent medical desease-Ongoing pregnancy or nursing-Use of coumarine derivatives at the time of treatment start-Unadequated liver or renal function- Any psychological, familial, sociological, condition potentially hampering compliance with the study protocol and follow up

Precedente radioterapia o chemioterapia o altre terapie per GIST o trattamento con Imatinib mesylate- Metastasi distali o presenza di lesioni peritoneali non contigue al tumore primario- Presenza di patologie cardiache o altre gravi patologie concomitanti-Gravidanza o allattamento- Uso di derivati cumarinici al momento dell`inizio del trattamento- Inadeguata funzione epatica o renale- Qualsiasi condizione che possa pregiudicare la partecipazione del paziente allo studio e al follow up

E.5 End points

E.5.1

Primary end point(s)

Overall survival

sopravvivenza complessiva.

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)

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

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

nessuna terapia

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

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	No
F.1.1	Number of subjects for this age range:	0
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-11-11.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	100
F.4.2	For a multinational trial
F.4.2.1	In the EEA	400
F.4.2.2	In the whole clinical trial	400

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

2005-03-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2005-01-26

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

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