Clinical Trials Register

Summary
EudraCT Number:	2017-004730-28
Sponsor's Protocol Code Number:	FFCD1701
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2018-07-04
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

France - ANSM

A.2

EudraCT number

2017-004730-28

A.3

Full title of the trial

Nal-IRI/LV5-FU VERSUS PACLITAXEL AS SECOND-LINE THERAPY IN PATIENTS WITH METASTATIC OESOPHAGEAL SQUAMOUS CELL CARCINOMA

Nal-IRI/LV5FU VERSUS PACLITAXEL EN DEUXIEME LIGNE DE TRAITEMENT CHEZ LES PATIENTS ATTEINTS DE CARCINOME EPIDERMOIDE DE L’ŒSOPHAGE METASTATIQUE

A.3.1

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

clinical study for patients with metastatic oesophagus carcinoma

étude clinique pour les patients avec un cancer de l’œsophage métastatique

A.3.2

Name or abbreviated title of the trial where available

OESIRI

A.4.1

Sponsor's protocol code number

FFCD1701

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	fédération francophone de cancérologie digestive
B.1.3.4	Country	France
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	SHIRE
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	fédération francophone de cancérologie digestive
B.5.2	Functional name of contact point	clinical project manager
B.5.3	Address:
B.5.3.1	Street Address	7 boulevard jeanne d'arc
B.5.3.2	Town/ city	dijon
B.5.3.3	Post code	21079
B.5.3.4	Country	France
B.5.4	Telephone number	+33380393483
B.5.5	Fax number	+33380381841
B.5.6	E-mail	lila.gaba@u-bourgogne.fr

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	No
D.2.1.1.1	Trade name	ONIVYDE
D.2.1.1.2	Name of the Marketing Authorisation holder	SHIRE
D.2.1.2	Country which granted the Marketing Authorisation	France
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	IRINOTECAN SUCROSOFATE
D.3.9.2	Current sponsor code	Nal-IRI
D.3.9.3	Other descriptive name	IRINOTECAN SUCROSOFATE
D.3.9.4	EV Substance Code	SUB189296
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	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: 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	Fluorouracile Ebewe
D.2.1.1.2	Name of the Marketing Authorisation holder	SANDOZ
D.2.1.2	Country which granted the Marketing Authorisation	France
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	FLUOROURACIL
D.3.9.3	Other descriptive name	FLUOROURACIL
D.3.9.4	EV Substance Code	SUB07721MIG
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	No
D.2.1.1.1	Trade name	ELVORINE
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER
D.2.1.2	Country which granted the Marketing Authorisation	France
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	FOLINIC ACID
D.3.9.3	Other descriptive name	FOLINIC ACID
D.3.9.4	EV Substance Code	SUB13910MIG
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	No
D.2.1.1.1	Trade name	taxol
D.2.1.1.2	Name of the Marketing Authorisation holder	BRYSTOL-MYERS
D.2.1.2	Country which granted the Marketing Authorisation	France
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.3.1	Product name	TAXOL
D.3.4	Pharmaceutical form	Solution 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	PACLITAXEL
D.3.9.1	CAS number	33069-62-4
D.3.9.4	EV Substance Code	SUB09583MIG
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	6
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

METASTATIC OESOPHAGEAL SQUAMOUS CELL CARCINOMA

E.1.1.1

Medical condition in easily understood language

carcinome épidermoïde de l'oesophage

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	10053548
E.1.2	Term	Gastrointestinal cancer metastatic
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 survival of patients at 9 months

• Évaluer le taux de patients vivants à 9 mois

E.2.2

Secondary objectives of the trial

• Progression-free survival (PFS) (clinical and/or radiological)
• Overall survival (OS)
• Best response rate during treatment according to RECIST 1.1 criteria (according to the investigator and the centralised review committee)
• Toxicity (NCI CTC 4.0)
• Quality of life (QLQ-C30 and OES18 questionnaires of the EORTC)

• Survie sans progression (SSP) (clinique et/ou radiologique)
• Survie globale (SG)
• Taux de meilleure réponse sous traitement selon les critères RECIST 1.1 (selon l’investigateur et en relecture centralisée)
• Toxicités (NCI CTC 4.0)
• Qualité de vie (questionnaires QLQ-C30 et OES18 de l’EORTC)

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Constitutional analysis of genetic polymorphisms and circulating tumoral
DNA :
Evaluation of the prognostic role of ctDNA before and during the
treatment . The presence and the quantification of ctDNA will be tested
as a prognostic marker of oesophageal cancer overall survival.

Analyse du polymorphisme génétique constitutionnel et de l'ADN
tumoral circulant : Evaluation du rôle pronostic de l'ADN tumoral
circulant avant le début et pendant le traitement. La présence et la
quantification de l'ADNct sera testé en tant que marqueur pronostic de la
survie globale du cancer de l'oesophage.

E.3

Principal inclusion criteria

• Histologically proven metastatic oesophageal squamous cell carcinoma
• Patient in failure with 1st-line treatment with oxaliplatin or cisplatin. Patients presenting with resectable disease treated with surgery or neoadjuvant or adjuvant chemotherapy with oxaliplatin or cisplatin (with or without radiotherapy) can be included if a recurrence has occurred less than 6 months after the end of treatment
• Age ≥ 18 years
• Unresectable disease, measurable or not, according to RECIST 1.1 criteria
• WHO performance status ≤ 2
• Neutrophils ≥ 1500/mm3 (without use of haematopoietic growth factors), platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dl (blood transfusions are authorised for patients with a haemoglobin less than 9 g/dl)
• Total bilirubin ≤ 2 x ULN (biliary drainage is authorised in case of a biliary obstruction); albumin ≥ 25 g/L; AST ≤ 2.5 x ULN, and ALT ≤ 2.5 x ULN (≤ 5 x ULN in case of hepatic metastases)
• Creatinine clearance ≥ 50 ml/min according to MDRD formula
• A normal ECG or ECG with no clinically significant findings
• Patient able to understand and to sign the informed consent form (or who has a legal guardian able to do so for him/him)
• Women of childbearing potential must have a negative pregnancy blood or urine test within 7 days prior to inclusion
• Women of childbearing potential, as well as men (who have sexual relations with women of childbearing potential) must agree to use an effective method of contraception throughout this study and during the 4 months following administration of the last dose of the study medicinal product
• Patient who is a beneficiary of the Social security system
• Patient for whom regular follow-up is possible.

• Carcinome épidermoïde de l’œsophage métastatique prouvé histologiquement
• Patient en échec de traitement de 1ère ligne à base d’oxaliplatine ou de cisplatine. Les patients présentant une maladie résécable traitée par chirurgie ou chimiothérapie néoadjuvante ou adjuvante à base d’oxaliplatine ou de cisplatine (avec ou sans radiothérapie) peuvent être inclus si une récidive est survenue moins de 6 mois après la fin du traitement
• Âge ≥ 18 ans
• Maladie non résécable, mesurable ou non mesurable selon les critères RECIST 1.1
• Statut de performance OMS ≤ 2
• PNN ≥ 1500/mm3 (sans utilisation de facteurs de croissance hématopoïétiques), plaquettes ≥ 100 000/mm3, hémoglobine ≥ 9 g/dl (les transfusions sanguines sont autorisées pour les patients ayant des taux d’hémoglobine inférieurs à 9 g/dl)
• Bilirubine totale ≤ 2 x LNS (le drainage biliaire est autorisé en cas d’obstruction biliaire) ; albumine ≥ 25 g/L ; ASAT ≤ 2,5 x LNS, et ALAT ≤ 2,5 x LNS (≤ 5 x LNS si métastases hépatiques)
• Clairance de la créatinine ≥ 50 ml/min selon la formule MDRD
• ECG normal ou ECG sans aucun résultat cliniquement significatif
• Patient capable de comprendre et de signer un consentement éclairé (ou ayant un représentant légal capable de le faire)
• Les femmes en âge de procréer doivent avoir un test de grossesse sérique ou urinaire négatif dans les 7 jours précédant l’inclusion
• Les femmes en âge de procréer ainsi que les hommes (ayant des rapports sexuels avec des femmes en âge de procréer) doivent s’engager à utiliser des moyens de contraception efficaces tout au long de l’étude et au cours des 4 mois suivant l’administration de la dernière dose du médicament à l’étude
• Patient affilié à la Sécurité sociale
• Suivi régulier possible

E.4

Principal exclusion criteria

• Known brain or bone metastases
• Clinically significant gastrointestinal disorders, including hepatic, haemorrhagic, inflammatory, obstructive disorders or diarrhoea > grade 1
• non controlled History of chronic inflammatory bowel disease
• Gilbert's syndrome
• History of progressive cancer or in remission of less than 3 years duration (patients who present with a cancer in situ or basal cell or squamous cell skin cancer during the last 3 years are eligible).
• Severe arterial thromboembolic events (myocardial infarction, unstable angina, stroke) less than 3 months before inclusion
• NYHA class III or IV congestive heart failure, ventricular arrhythmia or uncontrolled blood pressure
• Significant neuropathy ≥ grade 2 according to NCI CTCAE criteria (National Cancer Institute Common Terminology Criteria for Adverse Events) v.4.0.
• Known hypersensitivity or allergy to a component of the medicinal products used in the study.
• Known DPD deficiency
• An investigational treatment administered during the 4 weeks prior to day one of chemotherapy scheduled in this study.
• Use of potent CYP3A4 enzyme inhibitors or inducers, or existence of other contraindications to irinotecan.
• Patient under guardianship and/or deprived of his/her freedom
• Pregnant women or breastfeeding mothers

• Métastases cérébrales ou osseuses connues
• Troubles gastro-intestinaux cliniquement significatifs, incluant les affections hépatiques, hémorragiques, inflammatoires, obstructives ou une diarrhée > grade 1
• Antécédent de maladies inflammatoires chroniques de l’intestin non contrôlé
• Maladie de Gilbert
• Antécédents de cancer évolutif ou en rémission datant de moins de 3 ans (les patients ayant présenté un cancer in situ ou un cancer basocellulaire ou épidermoïde de la peau au cours des 3 dernières années sont éligibles).
• Événements thromboemboliques artériels sévères (infarctus du myocarde, angor instable, AVC) moins de 3 mois avant l’inclusion.
• Insuffisance cardiaque congestive de classe NYHA III ou IV, arythmie ventriculaire ou pression artérielle non contrôlée.
• Neuropathie significative ≥ grade 2 selon les critères NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v.4.0.
• Hypersensibilité ou allergie connue à un composant des médicaments utilisés dans l’étude.
• Déficit connu en DPD (dihydropyrimidine déshydrogénase).
• Traitement expérimental administré au cours des 4 semaines précédant le premier jour de la chimiothérapie programmée dans cette étude.
• Utilisation de puissants inhibiteurs ou inducteurs du CYP3A4, ou présence de quelconques autres contre-indications à l’irinotecan.
• Patient sous tutelle ou/et privé de liberté
• Femme enceinte ou allaitante

E.5 End points

E.5.1

Primary end point(s)

The primary objective is to evaluate the percentage of patients alive 9 months after randomisation.

L’objectif principal est d’évaluer le pourcentage de patients vivants à 9 mois après randomisation

E.5.1.1

Timepoint(s) of evaluation of this end point

9 months

9 mois

E.5.2

Secondary end point(s)

Secondary evaluation end points are:
• Progression-free survival (PFS):
PFS is defined as the time interval between date of randomisation and date of first progression (clinical and/or radiological: RECIST 1.1 criteria) determined by the investigator, or date of death (whatever the cause). Patients alive without progression will be censured at date of last news.

• Overall survival (OS):
OS is defined as the time interval between date of randomisation and date of death (whatever the cause). Patients alive will be censured at date of last news.

• Best response rate:
• The best response rate is defined as the best response rate obtained during treatment. This end point will be evaluated solely in patients measurable with RECIST 1.1 criteria. This rate will be described as an objective response rate: complete response or partial response (CR, PR) according to the investigator (RECIST 1.1 criteria) and also by centralised review.

• Toxicity
It will be evaluated and graded in conformity with NCI-CTC v4.0 criteria.
• Quality of life (QLQ-C30 questionnaires of EORTC + OES18 of EORTC)

Les critères secondaires de jugement sont :
• Survie sans progression (SSP) :
La SSP est définie comme l’intervalle de temps entre la date de randomisation et la date de première progression (clinique et/ou radiologique : critères RECIST 1.1) déterminée par l’investigateur, ou la date de décès (quelle que soit la cause). Les patients vivants sans progression seront censurés à la date des dernières nouvelles.

• Survie globale (SG) :
La SG est définie comme l’intervalle de temps entre la date de randomisation et la date de décès (quelle que soit la cause). Les patients vivants seront censurés à la date des dernières nouvelles.

• Taux de meilleure réponse :
• Le taux de meilleure réponse est défini comme le taux de meilleure réponse obtenue au cours du traitement. Ce critère sera évalué uniquement chez les patients mesurables en RECIST 1.1. Ce taux sera décrit en taux de réponse objective : réponse complète ou partielle (RC, RP) selon l’investigateur (critères RECIST 1.1) et également en relecture centralisée.

• Toxicités
Elles seront évaluées et gradées conformément aux critères NCI-CTC v4.0.
• Qualité de vie (questionnaires QLQ-C30 de l’EORTC + OES18 de l’EORTC)

E.5.2.1

Timepoint(s) of evaluation of this end point

9 months

9 mois

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)

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

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)

Yes

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.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The end of the trial is the last visit of the last subject undergoing the trial

La fin de l'étude corresponds à la dernière visite du dernier patient en cours de l'étude

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.1.1.1

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

106

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)

In all cases of treatment discontinuation (progression, toxicities...), follow-up of the patient will continue according the recommendations of the "Thésaurus National de cancérologie Digestive".

En cas d'arrêt de la chimiothérapie (progression, toxicité, ...) , le traitement ultérieur sera à la discrétion de l'investigateur, selon les recommandations du thésaurus National de Cancérologie Digestive.

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

2018-08-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-09-17

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

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