Clinical Trials Register

Summary
EudraCT Number:	2012-000382-20
Sponsor's Protocol Code Number:	DMPMtarget012
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:	2013-01-11
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2012-000382-20

A.3

Full title of the trial

Peritoneal Mesothelioma: Optimize Outcomes by the Integration of new Prognostic Factors and Potential Therapeutic Targets in a Individualized Treatment based on Molecular Characterization and Chemosensitivity Profile on Primary

Mesotelioma Peritoneale: Ottimizzazione dei risultati mediante l integrazione di nuovi fattori prognostici e potenziali target terapeutici in un trattamento personalizzato basato sulla caratterizzazione molecolare e sul profilo di chemiosensibilita' su colture primarie

A.3.1

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

Personalized adjuvant systemic chemotherapy of patients affected by diffuse malignant peritoneal mesothelioma using in vitro chemosensitivity assay

Trattamento chemioterapico personalizzato adiuvante del mesotelioma diffuso maligno del peritoneo sulla base dei test di chemiosensibilita' in vitro

A.3.2

Name or abbreviated title of the trial where available

DMPMtarget012

A.4.1

Sponsor's protocol code number

DMPMtarget012

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	ISTITUTO NAZIONALE PER LA CURA TUMORI
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	Ministero della Salute - Ricerca Finalizzata
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 IRCCS Istituto Nazionale Tumori di Milano
B.5.2	Functional name of contact point	Marcello Deraco
B.5.3	Address:
B.5.3.1	Street Address	Via Venezian 16
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20133
B.5.3.4	Country	Italy
B.5.4	Telephone number	02-2390-2362
B.5.5	Fax number	02-2390-2404
B.5.6	E-mail	marcello.deraco@istitutotumori.mi.it

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	CISPLATINO SANDOZ*EV 50MG 100M
D.2.1.1.2	Name of the Marketing Authorisation holder	SANDOZ 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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
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	CISPLATIN
D.3.9.1	CAS number	15663-27-1
D.3.9.4	EV Substance Code	SUB07483MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	75
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	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	ALIMTA*1FL POLV 500MG
D.2.1.1.2	Name of the Marketing Authorisation holder	ELI LILLY ITALIA 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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
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	PEMETREXED DISODIUM
D.3.9.1	CAS number	150399-23-8
D.3.9.4	EV Substance Code	SUB03669MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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	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	DOXORUBICINA SAND.*10FL 10MG5M
D.2.1.1.2	Name of the Marketing Authorisation holder	SANDOZ 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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
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	DOXORUBICIN
D.3.9.1	CAS number	23214-92-8
D.3.9.4	EV Substance Code	SUB06391MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	60
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	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	GEMCITABINA SUN*INF FL 1G
D.2.1.1.2	Name of the Marketing Authorisation holder	SUN PHARMACEUTICALS ITALIA Srl
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	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	GEMCITABINE
D.3.9.1	CAS number	95058-81-4
D.3.9.4	EV Substance Code	SUB07892MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	1000
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	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	NAVELBINE 10*IV 10MG 1ML
D.2.1.1.2	Name of the Marketing Authorisation holder	PIERRE FABRE PHARMA Srl
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	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	vinorelbina
D.3.9.1	CAS number	0071486-22-1
D.3.9.2	Current sponsor code	NVL
D.3.9.4	EV Substance Code	SUB06391MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	25
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	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

Patients affected by diffuse malignant peritoneal mesothelioma treated by cytoreductive surgery and hyperthermic intraperitoneal chemotherapy, without any factor precluding the performance of systemic adjuvant chemotherapy

Pazienti affetti da mesotelioma diffuso maligno trattati con chirurgia radicale di citoriduzione associato a chemioipertermia intraperitoneale senza controindicazione a chemioterapia sistemica adiuvante

E.1.1.1

Medical condition in easily understood language

Patients affected by diffuse malignant peritoneal mesothelioma treated by radical surgery and eligible for systemic chemotherapy

Pazienti affetti da mesotelioma diffuso maligno trattati con chirurgia radicale ed eleggibile a un trattamento chemioterapico

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	10056558
E.1.2	Term	Peritoneal mesothelioma malignant
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

progression free survival

E.2.2

Secondary objectives of the trial

overall survival toxicity identification of prognostic factors by biologic characterization of tumor regarding the expression of tyrosine kinase receptor expression and downstream effectors validation of osteopontin and mesothelin as potential diagnostic and prognostic tool

overall survival identificazione di fattori prognostici attraverso la caratterizzazione biologica del tumore per quanto riguarda l'expressione di ricettori tirosine chinasi e effettori a vale valutazione del valore diagnostico e prognostico dell'osteopontina e mesotelina

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. histological diagnosis of DMPM done or confirmed by the Pathology department of our institute according to a diagnostic protocol that includes a morphological evaluation (H&E) and immunohistochemical study (positivity to at least one of the following markers: CK-5-6, calretinine, podoplanin, WT-1 and at least one negativity among the followings: CEA, Ber-Ep4 and claudin; 2. age ≥ 18 years and < 71 years; 3. good performance status(ECOG<2); 4. patients that had undergone CRS + HIPEC with a complete cytoreduction; 5. surgical specimen obtained during the surgical treatment; 5. no metastatic disease; 6. signed informed consent form.

1. diagnosi istologica di DMPM eseguita o confermata presso il Dipartimento di Anatomia Patologica della Fondazione IRCCS Istituto Nazionale Tumori di Milano, secondo un protocollo diagnostico che preveda la valutazione morfologica (sezioni colorate con ematossilina-eosina) e studi immunoistochimici (presenza di almeno 2 test positivi tra CK-5-6, calretinina, podoplanina, WT-1 e di almeno 1 test negativo tra CEA, Ber-Ep4 e claudina); 2. eta' ≥ 18 anni e < 71 anni; 3. buone condizioni generali (ECOG<2); 4. pazienti sottoposti a chirurgia CRS e HIPEC con residuo di malattia <2.5mm; 5. pazienti in cui, al momento della CRS, sono stati eseguiti prelievi tumorali per test di preclinica farmacologica e caratterizzazione biologica. 5. assenza di metastasi a distanza alla TAC postperatoria; 6. consenso informato scritto.

E.4

Principal exclusion criteria

1. well differentiated papillary or multicystic mesothelioma; 2. other malignancies detected in the past 5 years excepting cutaneous basal cell carcinoma and in situ carcinoma of the uterine cervix; 3. previous systemic treatment of diffuse malignant peritoneal mesothelioma; 4. previous intraperitoneal chemotherapy; 5. non complete cytoreduction due to unresectable disease; 5. cardiac dysfunction with Ejection fraction <40%); 6. renal failure 7. hepatic insufficiency; 8. bone marrow insufficiency; 9. pulmonar dysfunction with FEV1 < 50% or a DLCO < 40% of normal value corrected by age; 10. viral or bacterial infection; 11. cognitive or consciousness dysfunction, drug or alcohol addiction or major psycosis.

1. diagnosi di mesotelioma di tipo multicistico o papillare ben differenziato; 2. anamnesi positiva per neoplasie negli ultimi 5 anni, ad esclusione del carcinoma basocellulare cutaneo e del carcinoma in situ della cervice uterina, trattati in modo adeguato; 3. precedente trattamento sistemico per la patologia in atto; 4. precedente trattamento di chemioterapia intra-peritoneale per la patologia in atto; 5. fallimento del tentativo di CRS e HIPEC per riscontro intraoperatorio di malattia non debulkabile. 5. alterata funzionalita' cardiaca (storia di scompenso cardiaco congestizio o FE <40%); 6. alterata funzionalita' renale (creatinina > 1.5 volte il valore normale o creatinina clearance < 60 mL/min); 7. alterata funzionalita' epatica (AST, ALT, bilirubina > 1.5 volte il valore normale); 8. alterata funzionalita' ematopoietica (leucociti < 3000/mm3; neutrofili < 1500/mm3; piastrine < 100000/mm3); 9. alterata funzionalita' polmonare (presenza di BPCO or altri deficit restrittivi polmonari con FEV1 < 50% or a DLCO < 40% del valore normale per eta'; 10. infezione batterica, virale o fungina non controllata; 11. alterazioni dello stadio di coscienza, dipendenza da alcol o sostanze psicotrope o psicosi maggiori.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint of the study is to evaluated in patients affected by diffuse malignant peritoneal mesothelioma treated by cytoreductive surgery and hyperthermic intraperitoneal chemotherapy the progression free survival associated with personalized adjuvant systemic chemotherapy directed on the basis of in vitro chemosensitivity assay

End point primario di questo studio e' la valutazione della sopravvivenza libera da progressione di malattia di un gruppo sperimentale di 40 pazienti affetti da DMPM sottoposti al trattamento convenzionale di CRS + HIPEC a cui si associa una sCT, basata sul profilo di chemio sensibilita' su colture primarie di cellule tumorali prelevate al momento dell’intervento chirurgico.

E.5.1.1

Timepoint(s) of evaluation of this end point

the study consists of a accrual period of 3 years and 2 years of follow-up

lo studio prevede un periodo di reclutamento di 3 anni seguito da 2 anni di follow-up

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

OS: calculated from the begining of chemotherapy to the end of follow-up; toxicity: during the study; biological study: at the end of accrual; prognostic value of osteopontin and mesothelin: before the chemotherapy

OS: calcolato dall'inizio della chemioterapia alla fine del follow-up; tossicita': durante lo studio; studio di caratterizzazione biologica del tumore: alla fine del reclutamento; valore prognostico della osteopontin e mesothelin: prima della chemioterapia

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

Yes

E.6.13.1

Other scope of the trial description

evaluation of tyrosine kinase receptors and downstream effectors

valutazione di ricettori tirosin chinasi e degli effettori a vale

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

E.8.1.1

Randomised

E.8.1.2

Open

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)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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

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

LVLS

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

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:

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

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 2013-01-11.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

Yes

F.3.3.4

Nursing women

Yes

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

foreigners with language difficulties

stranieri con barriere linguistiche

F.4 Planned number of subjects to be included

F.4.1

In the member state

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)

follow-up with clinical examination, CT scan of chest, abdomen and pelvis with and without contrast medium, serum tumor markers every 4 months in the first 2 years and every 6 months from the second to 5th year

Follow-up con esame obiettivo, TAC torace addome e pelvi con e senza mdc e markers tumorali sierici (CEA, CA19.9, Ca125, Ca15-3) ogni 4 mesi nei primi 2 anni e ogni 6 mesi dal secondo al quinto anno.

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

2012-04-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-04-24

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

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