Clinical Trials Register

Summary
EudraCT Number:	2011-005537-39
Sponsor's Protocol Code Number:	LEGA
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2012-07-23
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

2011-005537-39

A.3

Full title of the trial

A Randomized Phase III Study Of Low-Docetaxel Oxaliplatin, Capecitabine (Low-Tox) Vs Epirubicin, Oxaliplatin And Capecitabine (Eox) In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer

Studio randomizzato di fase III di Docetaxel, Oxaliplatino, Capecitabina (low-TOX) verso Epirubicina, Oxaliplatino e Capecitabina (EOX) in pazienti con carcinoma gastrico localmente avanzato non operabile o metastatico.

A.3.1

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

Comparison between the combination Low-Docetaxel, Oxaliplatin, Capecitabine (Low-Tox) Vs Epirubicin, Oxaliplatin and Capecitabine (Eox) in patients with stomach tumor

Studio di confronto tra la combinazione Docetaxel, Oxaliplatino, Capecitabina (low-TOX) e la combinazione Epirubicina, Oxaliplatino e Capecitabina (EOX) in pazienti con tumore dello stomaco

A.4.1

Sponsor's protocol code number

LEGA

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	GISCAD
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	Regione Lombardia
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 Giscad
B.5.2	Functional name of contact point	Luciano Frontini
B.5.3	Address:
B.5.3.1	Street Address	Via Vittorio Alfieri, 45
B.5.3.2	Town/ city	Parabiago (MI)
B.5.3.3	Post code	20015
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 0331 490052
B.5.5	Fax number	0331-553720
B.5.6	E-mail	frontini44@yahoo.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.2.1.2	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	DOCETAXEL TRIHYDRATE
D.3.9.1	CAS number	148408-66-6
D.3.9.4	EV Substance Code	SUB21602
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	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.2.1.2	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	OXALIPLATIN
D.3.9.1	CAS number	61825-94-3
D.3.9.4	EV Substance Code	SUB09490MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/l milligram(s)/litre
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	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.2.1.2	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	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CAPECITABINE
D.3.9.1	CAS number	154361-50-9
D.3.9.4	EV Substance Code	SUB12474MIG
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	150
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.2.1.2	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	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CAPECITABINE
D.3.9.1	CAS number	154361-50-9
D.3.9.4	EV Substance Code	SUB12474MIG
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	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: 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.2.1.2	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	EPIRUBICIN HYDROCHLORIDE
D.3.9.1	CAS number	56390-09-1
D.3.9.4	EV Substance Code	SUB01915MIG
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	2
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

Locally advanced unresectable or metastatic gastric cancer.

Carcinoma gastrico localmente avanzato non operabile o metastatico.

E.1.1.1

Medical condition in easily understood language

Locally advanced unresectable or metastatic stomac cancer.

Tumore dello stomaco in stadio localmente avanzato (non operabile) o metastatico.

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	LLT
E.1.2	Classification code	10007350
E.1.2	Term	Carcinoma gastric
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

To compare the therapeutic efficacy of Docetaxel, Oxaliplatin and Capecitabine (low-TOX) vs. Epirubicin, Oxaliplatin and Capecitabine (EOX) as measured by the duration of overall survival (OS) in patient with locally advanced/metastatic gastric cancer.

Confrontare l'efficacia terapeutica di docetaxel, oxaliplatino e capecitabina (low-TOX) verso epirubicina, oxaliplatino e capecitabina (EOX) in termini di durata della sopravvivenza globale (OS) in pazienti affetti da tumore gastrico localmente avanzato/metastatico.

E.2.2

Secondary objectives of the trial

To evaluate additional measures of tumor control to further characterize the efficacy of the low-TOX regimen vs. EOX regimen. Evaluation of the safety profile of the 2 combinations tested.

Valutare misure addizionali di controllo della malattia per meglio caratterizzare l'efficacia del regime low-TOX verso il regime EOX.Valutare il profilo di tossicità delle due combinazioni.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed written informed consent prior to beginning protocol specific procedures. 2. Male or female <70 years of age. 3. Histologically proven diagnosis of adenocarcinoma of the stomach. 4. HER2 negative tumor or HER2+ tumors not qualifying for herceptin therapy. 5. Locally advanced (non resectable) or metastatic gastric cancer. 6. Presence of measurable disease with at least one measurable lesion by means of CT scan or MRI in not previously irradiated area(s) (according to RECIST criteria (version 1.1). 7. Life expectancy of >/= 3 months. 8. ECOG performance status of 0-1 at study entry. 9. Neutrophils >/= 2.0 x 1000000000/L, platelets >/= 100 x 1000000000/L, and hemoglobin >/= 10 g/dL. 10. Bilirubin level either normal or </= 1.5 x ULN. 11. AST and ALT </= 2.5 X UNL (</= 5 x ULN if liver metastasis are present). 12. Alkaline phosphatase (ALP) </= 2.5 X ULN; patients with alkaline phosphatase > 2.5x ULN and AST and ALT </= 1.5 x ULN are equally eligible. 13. Serum creatinine < 1.5 x ULN. In presence border-line values, the calculated creatinine clearance should be >/= 60 mL/min. 14. Negative pregnancy test (if female in reproductive years). 15. Effective contraception prior to study entry and for the duration of the study participation, for both male and female patients of child producing potential. 16. Able and willing to comply with scheduled visits, therapy plans and laboratory tests required in this protocol.

1. Consenso informato scritto firmato dal paziente prima di iniziare le procedure specifiche dello studio. 2. Maschio o femmina <70 anni. 3.Diagnosi di adenocarcinoma dello stomaco, istologicamente confermata. 4. Tumore HER2 negativo o HER2 positivo non qualificabile per la terapia con herceptin. 5. Tumore gastrico localmente avanzato (non operabile) o metastatico. 6. Presenza di almeno una lesione misurabile mediante TAC o risonanza magnetica, in un'area non precedentemente irradiata (in accordo ai criteri RECIST 1.1 - versione 1.1). 7. Aspettativa di vita di almeno 3 mesi. 8. ECOG performance status 0 o 1 all’inizio dello studio. 9. Neutrofili >/= 2.0 x 1000000000/L, piastrine >/= 100 x 1000000000/L, e emoglobina >/= 10 g/dL. 10. Livello di bilirubina normale o </= 1.5 x ULN. 11. AST e ALT </= 2.5 X UNL (</= 5 x ULN in presenza di metastasi epatiche). 12. ALP </= 2.5 x ULN; pazienti con ALP > 2.5x ULN e AST e ALT </= 1.5 x ULN sono ugualmente eleggibili. 13. Creatinina < 1.5 x ULN. In presenza di valori border-line, la creatinina clearance calcolata deve essere >/= 60 mL/min. 14. Test di gravidanza negativo (se donna in età riproduttiva). 15. Uso di sistemi efficaci di contraccezione prima dell'entrata in studio e durante la partecipazione allo studio, sia per i maschi, sia per le femmine potenzialmente fertili. 16. Capacità e volontà di seguire la pianificazione delle visite, il piano terapeutico e gli esami richiesti dal protocollo.

E.4

Principal exclusion criteria

1. Previous chemotherapy, except adjuvant treatment administered at least 1 year before study entry. 2. Concurrent chronic systemic immune therapy. 3. Any investigational agent(s) 4 weeks prior to entry. 4. Clinically relevant coronary artery disease or a history of a myocardial infarction or a history of hypertension not controlled by therapy within the last 12 months. 5. Known hypersensitivity to study drugs. Known grade 3 or 4 allergic reaction to any of the components of the treatment. 6. Known drug abuse/ alcohol abuse. 7. Acute or subacute intestinal occlusion and any other significant chronic gastrointestinal disease that might interfere with absorption of oral treatment. 8. History of clinically relevant psychiatric disability precluding informed consent. 9. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. 10. Pregnant or breastfeeding women. 11. Active uncontrolled infection(s). 12. Positive for HIV serology and/or viral hepatitis B or C. 13. Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial).

1. Precedente chemioterapia, eccetto terapia adiuvante somministrata almeno un anno prima l'entrata nello studio. 2. Terapia immunologica sistemica cronica concomitante. 3. Assunzione di qualsiasi farmaco sperimentale fino a 4 settimane prima dell'entrata nello studio. 4. Malattie clinicamente rilevanti a carico del sistema cardio-vascolare o precedente infarto del miocardio o nota ipertensione non controllata da terapia negli ultimi 12 mesi. 5. Nota ipersensibilità ai farmaci in studio. Allergia di grado 3 o 4 nota per qualsiasi eccipiente del farmaco di studio. 6. Abuso di farmaci e/o alcool noti. 7. Occlusione intestinale acuta o subacuta a qualsiasi altro disturbo gastrointestinale cronico significativo che potrebbe interferire con l'assorbimento del farmaco orale. 8. Nota disabilità psichica clinicamente rilevante che possa precludere la possibilità di dare il consenso scritto alla partecipazione allo studio. 9. Presenza di qualsiasi condizione psicologica, familiare, sociale o geografica che possa potenzialmente interferire con l'adeguato svolgimento dello studio e l'esecuzione delle visite pianificate. 10. Donne in gravidanza o in allattamento. 11. Infezioni attive non controllate. 12. Positività per HIV e/o epatite B o C. 13. Qualsiasi tumore concomitante ad eccezione della neoplasia cutanea non-melanoma (NMSC), o del carcinoma della cervice. (Pazienti con un prededente tumore ma senza evidenza di malattia negli ultimi 5 anni sono ammessi nello studio).

E.5 End points

E.5.1

Primary end point(s)

Overall Survival (OS), defined for each patient as the time from randomization to the date of death from any cause.

Sopravvivenza globale (OS), definita, per ciascun paziente, come il tempo dalla data di randomizzazione alla data di morte, per qualsiasi causa.

E.5.1.1

Timepoint(s) of evaluation of this end point

At patient's death.

Al decesso del paziente.

E.5.2

Secondary end point(s)

1. Progression Free Survival (PFS), defined as the time from randomization to the date of local or regional progression, distant metastasis, second primary malignancy or death from any cause, whichever comes first. 2. Objective Response Rate (CR + PR) according to RECIST 1.1 guideline. 3. Disease control rate: CR + PR + SD lasting > 12 weeks. 4. Tolerability of the treatments evaluated in term of occurrence of: side effects graded according to the NCI-CTCAE scale (version 4.0); serious adverse reactions, expected and unexpected.

1. Sopravvivenza libera da malattia (PFS), definita, come il tempo dalla data di randomizzazione alla data di documentata progressione (locale, regionale, metastatica), o alla data di insorgenza di un nuovo tumore primario o alla data di morte per qualsiasi causa, qualsiasi di questi eventi accada per primo. 2. Tasso di risposta obiettiva (ORR) (CR + PR)in accordo alle linee guida RECIST 1.1. 3. Tasso di controllo della malattia: CR + PR + SD per più di 12 settimane. 4. Tollerabilità dei trattamenti valutata in termini di frequenza degli eventi avversi, classificati secondo la scala NCI-CTCAE (versione 4.0): eventi avversi seri, attesi e inattesi.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. At the date of progression, second primary malignancy or death. 2, 3, 4. All study period, including follow up.

1. Al momento della progressione della malattia o alla data di insorgenza di un nuovo tumore o alla data di morte del paziente. 2, 3, 4. Lungo tutta la durata dello studio, follow up compreso.

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

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

Yes

E.8.2.3.1

Comparator description

- Stesso farmaco ad altro dosaggio

- same IMP used at different dosage

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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 including follow up contacts.

LVLS inclusi i contatti durante il 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

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:

362

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

462

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)

Standard medical care for that condition.

Terapie per la patologia secondo la pratica clinica.

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

2012-04-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-04-13

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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IMP with orphan designation in the indication
Orphan Designation Number:
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