Clinical Trials Register

Summary
EudraCT Number:	2011-004997-27
Sponsor's Protocol Code Number:	OBELICS
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:	2012-03-08
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-004997-27

A.3

Full title of the trial

Randomized phase 3 study on the optimization of the combination of bevacizumab with FOLFOX/OXXEL in the treatment of patients with metastatic colorectal cancer

Studio randomizzato di fase III sull'ottimizzazione della combinazione di bevacizumab con FOLFOX/OXXEL nel trattamento dei pazienti affetti da carcinoma del colon-retto metastatico

A.3.1

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

Randomized phase 3 study on the optimization of the combination of bevacizumab with FOLFOX/OXXEL in the treatment of patients with metastatic colorectal cancer

Studio randomizzato di fase III sull’ottimizzazione della combinazione di bevacizumab con FOLFOX/OXXEL nel trattamento dei pazienti affetti da carcinoma del colon-retto metastatico

A.3.2

Name or abbreviated title of the trial where available

OBELICS

A.4.1

Sponsor's protocol code number

OBELICS

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 LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
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 Salute
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	Istituto Nazionale Tumori di Napoli
B.5.2	Functional name of contact point	Unita' Sperimentazioni Cliniche
B.5.3	Address:
B.5.3.1	Street Address	Via Mariano Semmola
B.5.3.2	Town/ city	Napoli
B.5.3.3	Post code	80313
B.5.3.4	Country	Italy
B.5.4	Telephone number	081 5903 571
B.5.5	Fax number	081 7702938
B.5.6	E-mail	segreteria@usc-intnapoli.net

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	AVASTIN*INFUS 1FL 400MG 16ML
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE 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	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	BEVACIZUMAB
D.3.9.1	CAS number	216974-75-3
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB16402MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	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	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	NA
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
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	85
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	LEVOFOLENE*INIET 1FL 100MG
D.2.1.1.2	Name of the Marketing Authorisation holder	BAYER 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	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	levofolene
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	na
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	200
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	XELODA*120CPR RIV 500MG
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE 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	Coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oromucosal 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	NA
D.3.9.2	Current sponsor code	xeloda
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
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	2000
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	fluorouracile
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	5-FU
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
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	2400
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 with metastatic colorectal cancer

pazienti affetti da carcinoma del colon-retto metastatico

E.1.1.1

Medical condition in easily understood language

patients with metastatic colorectal cancer

pazienti affetti da carcinoma del colon-retto 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	PT
E.1.2	Classification code	10010035
E.1.2	Term	Colorectal cancer stage IV
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 assess whether an experimental schedule of bevacizumab, given in sequence instead of in combination with oxaliplatin regimen (mFOLFOX/mOXXEL), can improve treatment activity (in terms of objective response rate) in patients with metastatic colorectal cancer

• Valutare se una schedula sperimentale con bevacizumab somministrato in sequenza, invece che in combinazione con un regime di chemioterapia contenente oxaliplatino (mFOLFOX-6/mOXXEL), sia in grado di migliorare l’attività del trattamento (in termini di tasso di risposte obiettive) nei pazienti affetti da cancro del colon-retto metastatico.

E.2.2

Secondary objectives of the trial

• To evaluate the impact of the experimental schedule on:

- Progression free survival (PFS)
- Overall survival (OS).
- Toxicity.
- Quality of life.

• To evaluate prognostic and predictive value of :
- Circulating endothelial cells (CEC) and Circulating endothelial precursor cells (CEP) count on patient blood samples.
- Cytokine and circulating angiogenic factors plasma levels on patient blood samples.
- Single nucleotide polymorphisms (SNPs) of VEGF on patient blood samples.
- WBC counts at 24 hours after the 1st administration of bevacizumab on patient blood samples.
- microRNAs (miRNAs) on patient blood samples.

Valutare l’impatto della schedula sperimentale su:
-Sopravvivenza libera da progressione (PFS)
-Sopravvivenza globale (OS)
-Tossicità
-Qualità di vita

Valutare il ruolo prognostico e predittivo di:
-Conta delle cellule endoteliali circolanti (CEC) e cellule progenitrici delle cellule endoteliali (CEP) su campioni di sangue dei pazienti
-Livelli plasmatici di citochine e fattori angiogenetici circolanti su campioni di sangue dei pazienti
-Polimorfismi di singoli nucleotidi (SNP) del VEGF su campioni di sangue dei pazienti
-Conta dei Leucociti 24 ore dopo la prima somministrazione di bevacizumab su campioni di sangue dei pazienti
-miRNA su campioni di sangue dei pazienti

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

 Histological diagnosis of adenocarcinoma of the colon or rectum
 Stage IV of disease
 Presence at least one measurable target lesion (according to the RECIST criteria) not previously treated with radiotherapy.
 Ages > 18 and < 75 years
 ECOG performance status 0 or 1 at study entry
 Life expectancy > 3 months
 Adequate recovery from recent surgery (at least 28 days after a major surgery or a biopsy).
 Effective contraception both for male and female patients, if the risk of conception exists.
 Signed informed consent.

 Diagnosi istologica di adenocarcinoma del colon o del retto.
 Stadio IV di malattia.
 Presenza di almeno una lesione target misurabile (sec. criteri RECIST) non precedentemente irradiata.
 Età > 18 e < 75 anni.
 Performance status 0-1 secondo ECOG al momento di entrare nello studio.
 Aspettativa di vita >3 mesi.
 Adeguato recupero da un precedente intervento chirurgico. Devono essere trascorsi almeno 28 giorni da un intervento chirurgico o dall’effettuazione di una biopsia per l’inserimento nello studio.
Metodi contraccettivi efficaci adottati sia dagli uomini che dalle donne nei casi in cui esiste la possibilità di un concepimento.
 Consenso informato scritto

E.4

Principal exclusion criteria

 More than one line of treatment for metastatic disease.
 Previous treatment with bevacizumab or oxaliplatin (a previous treatment with fluoropirymidines, folic acid, irinotecan or cetuximab is allowed).
 Presence of primary colorectal cancer that produces stenosis or full-thickness wall infiltration.
 Regular use of NSAID or aspirin (more than 325 mg/die).
 Bleeding diathesis or pre-existing coagulopathy.
 Use of anticoagulants at therapeutic dose.
 Known or suspected brain metastases ( determined exclusively in the presence of at least one clinical symptom)
 Neutrophils < 2000/mm3 or platelets < 100.000/ mm3 or haemoglobin <9 gr/dl.
 Creatinine >1.5 time the upper normal limit (UNL).
 GOT and/or GPT > 2.5 time the UNL and/or bilirubin >1.5 time the UNL in absence of liver metastasis.
 GOT and/or GPT > 5 time the UNL and/or bilirubin > 3 time the UNL in presence of liver metastasis
 Any concurrent malignancy other than non-melanomatous 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.
 Congestive heart failure, recent ischemic coronary disease (in the last 12 months), uncontrolled arrhythmia.
 Uncontrolled hypertension.
 Active or uncontrolled infection.
 A serious uncontrolled medical disorder that in the opinion of the investigator would impair the ability of the subject to receive protocol therapy.
 Pregnancy (absence to be confirmed by B-HCG test) or lactation period.
 History or current evidence on physical examination of central nervous system disease or Peripheral Neuropathy > Grade 1 (CTCAE v. 4.0)
 Unable to comply with follow-up

 Più di una precedente linea di trattamento per la malattia metastatica.
 Precedente trattamento con bevacizumab o oxaliplatino (consentiti invece precedenti trattamenti con irinotecano, cetuximab, fluoro pirimidine, acido folico).
 Presenza di tumore primitivo stenosante e/o infiltrante a tutto spessore la parete intestinale.
 Regolare uso di FANS o aspirina (più di 325 mg /die).
 Diatesi emorragica o coagulopatia pre-esistente.
 Terapia in corso con dicumarolici.
 Metastasi cerebrali note o sospette (da verificare esclusivamente in presenza di almeno un sintomo clinico).
 Neutrofili < 2000/mm³ o piastrine < 100.000/mm³ o emoglobina <9 g/dl.
 Creatinina > 1.5 volte il limite superiore di normalità.
 GOT e/o GPT > 2.5 volte il limite superiore di normalità e/o bilirubina >1.5 volte il limite superiore di normalità, in assenza di metastasi epatiche.
 GOT e/o GPT >5 volte il limite superiore di normalità e/o bilirubina >3 volte il limite superiore di normalità, in presenza di metastasi epatiche.
 Altre neoplasie concomitanti ad eccezione dei tumori della pelle, tranne il melanoma, o del carcinoma in situ della cervice. I pazienti con una precedente diagnosi di neoplasia maligna ma senza evidenza di malattia per 5 anni possono partecipare allo studio.
 Insufficienza cardiaca congestizia, recente malattia ischemica coronarica (negli ultimi 12 mesi), aritmia incontrollata.
 Ipertensione arteriosa non controllata.
 Infezione attiva o non controllata.
 Qualsiasi patologia concomitante che a giudizio dell’investigatore controindichi l’utilizzo dei farmaci in studio.
 Gravidanza (l’assenza deve essere confermata con il test della beta-HCG) o allattamento.
 Malattie del sistema nervoso centrale o neuropatie periferiche di grado > 1 (CTCAE v. 4.0).
 Impossibilità a garantire la partecipazione al follow-up.

E.5 End points

E.5.1

Primary end point(s)

Primary end point is objective response rate (RR) according to RECIST criteria

percentuale di risposte obiettive, misurate secondo i criteri RECIST

E.5.1.1

Timepoint(s) of evaluation of this end point

at week 12 and 24

12 e 24 settimane

E.5.2

Secondary end point(s)

- Progression free survival (PFS)
- Overall survival (OS).
- Toxicity.
- Quality of life

- Sopravvivenza libera da progressione(PFS)
- Sopravvivenza globale (OS)
- Tossicità
- Qualità di vita

E.5.2.1

Timepoint(s) of evaluation of this end point

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

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

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

differenze schedula di somministrazione - Stesso farmaco ad altro dosaggio

na - 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

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:

150

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

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

230

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)

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

2011-11-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-11-16

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials