Clinical Trials Register

Summary
EudraCT Number:	2017-004500-22
Sponsor's Protocol Code Number:	GOIRC-01-2017
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:	2018-03-21
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

2017-004500-22

A.3

Full title of the trial

Phase II multicentre trial of perioperative chemotherapy in operable patients with gastric cancer (PERISCOPE trial)

PERISCOPE: studio di fase II multicentrico di chemioterapia perioperatoria nel cancro gastrico operabile

A.3.1

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

Study of chemotherapy in operable patients with cancer of the stomach

Studio di chemioterapia nei pazienti operabili con tumore dello stomaco

A.3.2

Name or abbreviated title of the trial where available

Ph II CT of perioperative chemotherapy in operable patients with gastric cancer

Studio di fase II di chemioterapia perioperatoria nei pazienti con adenocarcinoma gastrico operabile

A.4.1

Sponsor's protocol code number

GOIRC-01-2017

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN00000000

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00000000

A.5.3

WHO Universal Trial Reference Number (UTRN)

U0000-0000-0000

A.5.4

Other Identifiers

Name:

Periscope trial

Number:

Acronimo

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	GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)
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	Medac
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ASST di Cremona
B.5.2	Functional name of contact point	S. C. Oncologia
B.5.3	Address:
B.5.3.1	Street Address	Viale Concordia 1
B.5.3.2	Town/ city	Cremona
B.5.3.3	Post code	26100
B.5.3.4	Country	Italy
B.5.4	Telephone number	0372405248
B.5.5	Fax number	0372405702
B.5.6	E-mail	segreteria.oncologiao@asst-cremona.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	ELOXATIN - 5 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO DA 40 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS 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.3.4	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	OXALIPLATINO
D.3.9.1	CAS number	61825-94-3
D.3.9.2	Current sponsor code	NA
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	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: 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	IRINOTECAN ACTAVIS - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 5 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	ACTAVIS ITALY 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.3.4	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	IRINOTECAN CLORIDRATO TRIIDRATO
D.3.9.1	CAS number	136572-09-3
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB45873
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	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	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	SODIO LEVOFOLINATO MEDAC - 50 MG/ML SOLUZIONE INIETTABILE O PER INFUSIONE 5 FLACONCINI IN VETRO DA 9 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH
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 injection
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	Sodio Levofolinato
D.3.9.2	Current sponsor code	NA
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	50
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	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	FLUOROURACILE TEVA - 5 G/100 ML SOLUZIONE PER INFUSIONE 1 FLACONCINO DA 100 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	TEVA ITALIA S.R.L.
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	51-21-8
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB07721MIG
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	50
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

Gastric Cancer

Carcinoma gastrico

E.1.1.1

Medical condition in easily understood language

Tumor of the stomach

Tumore dello stomaco

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	10001150
E.1.2	Term	Adenocarcinoma 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 evaluate the pCR rate of a new chemotherapy regimen (modified FOLFOXIRI) for operable castric cancer using sodium folinate instead of calcium folinate

Valutare il tasso di risposte patologiche complete (pCR) di un nuovo schema chemioterapico a base di 5-fluororuracile, oxaliplatino ed irinotecan (FOLFOXIRI modificato) per i carcinomi dello stomaco operabili utilizzando il sodio levofolinato in sostituzione del calcio levofolinato, comunemente utilizzato

E.2.2

Secondary objectives of the trial

- To evaluate additional efficacy parameters;
- To evaluatesurvival relapse free survival at 1 year after surgery;
- To evaluate the effect of the treatment on patients' quality of life;
-To evaluate the safety and tolerability of the perioperative regimen.

- Valutare ulteriori parametri di efficacia;
- Valutare la sopravvivenza libera da ricadute ad un anno dall'intervento chirurgico;
- Valutare l'impatto del trattamento sulla qualit¿ della vita dei pazienti;
- Valutare la tollerabilit¿ e il profilo di sicurezza del trattamento prioperatorio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Males or females = 18 years old;
2. Written, signed consent for trial participation;
3. Patients should consent to optional provision of a sample of blood (30 ml) and urine (10 ml) at basal time and every month during neoadjuvant, before surgery, one month after surgery, at the end of adjuvant treatment and every 4 months during follow-up (in order that specific correlative marker assays could be performed);
4. Patients should also consent to optional provision of available histological tissue (e.g. bioptic and surgical tissue) in order that correlative marker assays could be performed;
5. Histological or cytological diagnosis of GC;
6. Clinical staging of GC cT2-4/cN-any/cM0 or cT-any/cN+/cM0 (according to the 8th edition of the UICC TNM classification performed with thoraco-abdominal CT scan, ecoendoscopy and esophagogastroduodenoscopy performed within 4 weeks prior to randomization;
7. No prior treatments (chemo or radiotherapy);
8. Measurable disease, defined in accordance with RECIST (Response Evaluation Criteria in Solid Tumors) criteria version 1.1, evaluated with ecoendoscopy, esophagogastroduodenoscopy and thoraco-abdominal CT scan;
9. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
10. Adequate organ function assessed within 4 weeks prior to randomization including:
a. Hematologic: absolute neutrophil count (ANC) = 1.5 x 109/L, platelets = 100 x 109/L, haemoglobin = 9.0 g/dL;
b. Hepatic: bilirubin = 1.5 times upper limits of normal (ULN), alanine transaminase (ALT) = 3 times ULN;
c. Renal: Serum creatinine =1.5 times ULN.

1. Maschi o femmine di età = 18 anni;
2. Consenso informato scritto prima dell’esecuzione di qualsiasi procedura di protocollo;
3. I pazienti dovrebbero acconsentire alla fornitura opzionale di un campione di sangue (30 ml) e urine (10 ml) al basale, ogni mese durante la terapia neoadiuvante, prima della chirurgia, un mese dopo la chirurgia, al termine della terapia adiuvante ed ogni 4 mesi durante il follow-up;
4. I pazienti dovrebbero acconsentire alla fornitura opzionale del tessuto istologico disponibile (per esempio bioptico e chirurgico);
5. Diagnosi istologica o citologica di carcinoma gastrico;
6. Stadio clinico di carcinoma gastrico cT2-4/cN-/cM0 or cT (qualsiasi)/cN+/cM0 (in accordo all’ottava edizione della classificazione UICC TNM) ottenuto con l’esecuzione di TAC torace-addome, ecoendoscopia ed esofagogastroduodenoscopia eseguita entro le quattro settimane precedenti alla randomizzazione;
7. Nessun trattamento precedente (chemio o radioterapia);
8. Malattia misurabile per criteri RECIST (Response Evaluation Criteria in Solid Tumors) versione 1.1 (Eisenhower et al. 2009), valutata con TAC torace-addome ed ecoendoscopia;
9. Performance status (PS) ECOG di 0 o 1;
10. Adeguata funzionalità d’organo nelle quattro settimane precedenti la randomizzazione e comprendenti i seguenti parametri:
a. Ematologici: conta assoluta dei neutrofili (ANC) = 1.5 x 109/L, piastrine = 100 x 109/L, emoglobina = 9.0 g/dL;
b. Epatici: bilirubina = 1.5 valori superiori di norma (ULN), alanina amino-transferasi (ALT) = 3 volte ULN;
c. Renali: creatinina sierica =1.5 volte ULN.

E.4

Principal exclusion criteria

1. ECOG PS > 1;
2. Metastatic Gastric Cancer;
3. Previous chemo or radiotherapy;
4. Current active infection;
5. Serious pre-existing medical conditions or serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator (for example, unstable angina pectoris, or a clinically significant history of cardiac disease or renal disease, neurological disease or condition of peripheral neuropathy);
6. Females who are pregnant or lactating;
7. Patients with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for > 3 years;
8. Patients unable to undergo medical test for geographical, social or psychological reason;
9. Known dihydropyrimidine dehydrogenase (DPD) deficiency.

1. ECOG PS > 1;
2. Carcinoma gastrico metastatico;
3. Chemio o radioterapia precedente;
4. Infezione attiva;
5. Condizioni mediche pre-esistenti severe o disordini sistemici concomitanti e severi che potrebbero compromettere la sicurezza del paziente e la sua capacità di terminare lo studio, a discrezione dello sperimentatore (esempio: angina pectoris instabile, storia clinica significativa di malattia cardiaca o renale, malattia neurologica o neuropatia periferica);
6. Donne in gravidanza o allattamento;
7. Pazienti con storia di neoplasia eccetto: tumore della pelle adeguatamente trattato, tumore della cervice adeguatamente curato ed in sede, altri tumori solidi curati e non recidivati da un periodo di tempo > 3 anni;
8. Pazienti non in grado di eseguire i test medici richiesti per ragioni geografiche, sociali o psicologiche;
9. Noto deficit di diidropirimidina deidrogenasi (DPD).

E.5 End points

E.5.1

Primary end point(s)

Pathologic coplete responseafter neoadjuvant treatment

Risposta patologica copleta dopo terapia neoadiuvante

E.5.1.1

Timepoint(s) of evaluation of this end point

At the end of neoadjuvant treatment

Alla fine della terapia adiuvante

E.5.2

Secondary end point(s)

ORR before surgery;
; Tumor regression rate; Rate of radical resection; Median relapse free survival; Evaluation of quality of life; Safety and tolerability of chemotherapy regimen (Neoadjuvant and adjuvant)

Risposta globale prima della chirurgia; Grado di regressione tumorale; Rate di resezioni radicali; Mediana della sopravvivenza libera da recidiva; Valutazione della qualit¿ della vita; Sicurezza e tollerabilit¿ del regime chemioterapico (neoadiuvante e adiuvante)

E.5.2.1

Timepoint(s) of evaluation of this end point

After cycle 4 of neoadjuvant treatment; At the end of neoadjuvant treatment; At surgery; One year from surgery; At enrolment, at the end of neoadjuvant regiment, before surgery and at the end of treatment visit; From Informed consent signature to the end of treatment visit

Dopo il ciclo 4 del trattamento neoadiuvante; Alla fine del trattamento neoadiuvante; Al momento della chirurgia; A un anno dalla chirurgia; All'arruolamento, alla fine della terapia neoadiuvante, prima della chirurgia e alla visita di fine trattamento; Dalla firma del consenso informato alla visita di fine trattamento

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

Biomarkers analysis

Analisi di biomarcatori

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

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

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.8.5.1

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

Information not present in EudraCT

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

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:

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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 the condition

Terapia

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

2018-03-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-12-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2024-08-30

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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