Clinical Trials Register

Summary
EudraCT Number:	2020-000770-21
Sponsor's Protocol Code Number:	GORTEC2019-01
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2020-03-25
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

France - ANSM

A.2

EudraCT number

2020-000770-21

A.3

Full title of the trial

A phase II randomized trial, non comparative, evaluating chemotherapy associated cisplatin, 5-fluorouracil and docetaxel at adapted doses in patients with locally advanced squamous cell carcinoma

Etude de Phase II randomisée non comparative, évaluant une chimiothérapie d’induction associant le cisplatine, le 5-Fluorouracile et le docétaxel à doses adaptées (TPFm) chez des patients avec un cancer épidermoïde ORL localement avancé

A.3.1

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

Randomized trial evaluating adapted chemotherapy in patients with squamous carcinoma

Essai randomisé évaluant une chimiothérapie adpatée pour le traitement du cancer ORL

A.3.2

Name or abbreviated title of the trial where available

TPFmORL

A.4.1

Sponsor's protocol code number

GORTEC2019-01

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	GORTEC
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	GORTEC
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	GORTEC
B.5.2	Functional name of contact point	Martial BINDZI
B.5.3	Address:
B.5.3.1	Street Address	CHRU de Tours - Hôpital Bretonneau, 2 Bd Tonnellé
B.5.3.2	Town/ city	TOUTRS
B.5.3.3	Post code	37004
B.5.3.4	Country	France
B.5.4	Telephone number	+33(0)2 42 06 01 87
B.5.5	Fax number	+33(0)2 42 06 01 76
B.5.6	E-mail	martial.bindzi@gortec.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	Yes
D.2.1.1.1	Trade name	cisplatine accord
D.2.1.1.2	Name of the Marketing Authorisation holder	ACCORD HEALTHCARE FRANCE SAS
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	cisplatine
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	CISPLATIN
D.3.9.4	EV Substance Code	SUB07483MIG
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	docetaxel hospira
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER HOLDING FRANCE
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	docetaxel
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	DOCETAXEL
D.3.9.4	EV Substance Code	SUB12492MIG
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	fluorouracile Accord
D.2.1.1.2	Name of the Marketing Authorisation holder	ACCORD HEALTHCARE France SAS
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	fluorouracile
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.3.9.3	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: 4
D.1.2 and D.1.3	IMP Role	Comparator
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	cisplatine accord
D.2.1.1.2	Name of the Marketing Authorisation holder	ACCORD HEALTHCARE FRANCE SAS
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	cisplatine
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.3.11 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	Comparator
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	docetaxel
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER HOLDING FRANCE
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	docetaxel
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.3.11 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: 6
D.1.2 and D.1.3	IMP Role	Comparator
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
D.2.1.1.2	Name of the Marketing Authorisation holder	ACCORD HEALTHCARE FRANCE SAS
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	fluorouracile
D.3.2	Product code	L01BC02
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.3.11 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

Carcinome épidermoïde de la cavité buccale, de l’oropharynx, de l’hypopharynx ou du larynx, histologiquement prouvé, adénopathies sans porte d’entrée

E.1.1.1

Medical condition in easily understood language

cancer ORL localement avancé

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	PT
E.1.2	Classification code	10060121
E.1.2	Term	Squamous cell carcinoma of head and neck
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

Evaluer l’efficacité de l'association cisplatine-5FU-docetaxel à doses adaptées (TPFm) en terme de réponse au traitement sans toxicité.

E.2.2

Secondary objectives of the trial

• Survie globale
• Survie sans progression
• Contrôle local et/ou locorégional
• Préservation laryngée
• Métastases à distance (incidence et survie)
• Toxicités du traitement complémentaire au traitement d’induction
• Compliance au traitement d’induction
• Hospitalisation ou prolongation d’hospitalisation pour toxicité du traitement
• Durée d'hospitalisation pendant le traitement d’induction
• Evaluation de la qualité de vie

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Carcinome épidermoïde de la cavité buccale, de l’oropharynx, de l’hypopharynx ou du larynx, histologiquement prouvé (plusieurs localisations ORL sont autorisées), adénopathies sans porte d’entrée
2) Tumeur considérée comme inopérable ou dont la chirurgie serait mutilante. Les critères de non-opérabilité sont :
 Résection techniquement impossible : fixation/invasion de la tumeur à la base du crâne ou aux vertèbres cervicales, nasopharynx impliqué, ganglions
 Sélection médicale basée sur une faible curabilité chirurgicale. Cette catégorie inclut tous les T3-T4 et tous les N2-N3 (AJCC 8ème édition, Juin 2018)
 Sélection médicale basée sur une stratégie de préservation d'organe

3) Patient non traité antérieurement un cancer ORL

4) Age > 18 ans et < 75 ans
5) PS 0 ou 1 selon l’OMS
6) Au moins une lésion mesurable selon les critères RECIST 1.1
7) Patient pouvant recevoir du TPF selon les critères suivants :
 Fonction hématologique adéquate : polynucléaires neutrophiles * 1.5 x 109/l, plaquettes * 100 x 109/l, hémoglobine * 10 g/dl (ou 6,2 mmol/l)
 Fonction rénale adéquate : clairance de la créatinine calculée (Cockroft & Gault) ou mesurée * 60 ml/min.
 Fonction hépatique adéquate : bilirubine totale normale ; ASAT et ALAT * 1,5 * LNS; PAL * 2,5 * LNS
 Neuropathie périphérique de grade < 2 selon NCI CTCAE v5.0
 Pas d’atteinte clinique de la fonction auditive
 Pour les patients âgés de 71 à 74 ans, PS à 0 et considérés non fragiles gériatriquement (Questionnaire G8 et évaluations multidimensionnelles proposées par le groupe GERICO (échelle ADL, MMSE, GDS, nutrition, motricité et équilibre, situation géographique et personnelle et évaluations thymiques))
8) Espérance de vie estimée supérieure ou égale à 3 mois
9) Perte de poids inférieure à 10 % au cours des 3 mois avant randomisation
10) Patient comprenant le français et capable de compléter les questionnaires de qualité de vie
11) Patient ayant donné son consentement écrit avant toute procédure spécifique du protocole
12) Affiliation à un régime de sécurité sociale ou bénéficiaire d’un tel régime

E.4

Principal exclusion criteria

1) T3 trans-glottique avec infiltration massive de l’hémilarynx ou T4 avec lyse cartilagineuse massive ou tumeur de la région rétro-cricoarythénoïdenne ou de la paroi hypopharyngée postérieure
2) Vaccination contre la fièvre jaune récente ou prévue
3) Déficit connu à la dihydropyrimidine deshydrogénase (DPD) ou déterminé par le dosage de l’uricémie.
4) Antécédents d'autre cancer sauf le cancer in situ du col utérin ou carcinome basocellulaire contrôlé. Les patients en rémission d’un cancer traité il y a plus de 3 ans sont éligibles. Les patients traités par chirurgie seule pour un cancer ORL dans les 3 années précédentes sont éligibles.
5) Traitement antérieur d’un cancer ORL par chimiothérapie ou radiothérapie Les patients traités par chirurgie seule pour un cancer ORL dans les 3 années précédentes sont éligibles).
6) Présence de métastase à distance.
7) Participation à un essai thérapeutique dans les 30 jours précédant la randomisation
8) Traitement anticancéreux concomitant
9) Patient sous traitement chronique (* 3 mois) par corticoïde dont la posologie journalière est * 20 mg/jour de méthylprednisolone ou équivalent
10) Autres pathologies médicales sérieuses existantes (liste non exhaustive) :
 Pathologie cardiaque non contrôlée malgré un traitement adéquat
 Infarctus de myocarde dans les 6 mois précédant la randomisation
 Antécédents neurologiques ou psychiatriques tels que démence, convulsions
 Infection active
 Anomalies gastro-intestinales significatives, y compris celles qui nécessitent une nutrition parentérale, ulcère gastroduodénal évolutif et antécédents d’interventions chirurgicales affectant l’absorption
 Broncho-pneumopathie obstructive ayant nécessité une hospitalisation dans l'année précédant la randomisation
 Diabète de type II non contrôlé ou autres contre-indications aux corticostéroïdes.
 Eczéma modéré ou sévère
11) Hypersensibilité connue au docetaxel, au cisplatine au 5FU ou à l’un de leurs excipients.
12) Utilisation concomitante prévue de phénytoïne, carbamazépine, barbituriques ou rifampicine
13) Présence, à la sélection, de facteurs d’ordre psychologique, familial, social ou géographique susceptibles d’influencer l’observance du patient au protocole à l’étude et au suivi.
14) Femme enceinte ou allaitante
15) Patient (homme ou femme) en âge de procréer ne pouvant ou n’acceptant pas de prendre des mesures contraception adéquates pendant le traitement et jusqu’à 6 mois après l’administration du dernier traitement.
16) Personnes privées de liberté, sous tutelle ou curatelle

E.5 End points

E.5.1

Primary end point(s)

Le critère principal est défini comme le taux de patient en succès à 8 semaines. Un succès est défini comme un patient en réponse objective complète ou partielle selon les critères RECIST 1.1 et sans toxicité ayant entraîné le report ou l’arrêt définitif du traitement

E.5.1.1

Timepoint(s) of evaluation of this end point

Une évaluation clinique et tumorale sera réalisée à 8 semaines

E.5.2

Secondary end point(s)

• Survie globale définie par le délai entre la date de randomisation et la date du décès, quelle qu'en soit la cause. En absence de notification de décès, les données de survie seront censurées à la date de dernières nouvelles sans progression.
• Survie sans progression définie par le délai entre la date de randomisation et la date de première mise en évidence d'une progression, la date de décès quelle qu'en soit la cause ou la date de dernières nouvelles sans progression.
• Taux de patients en contrôle local et/ou locorégional de la maladie à la semaine 8 ± 3 jours.
• Taux de patients avec préservation du larynx. Est considérée comme événement la laryngectomie totale.
• Survie sans métastase définie par le délai entre la date de randomisation et la date de première mise en évidence d'une progression métastatique, ou la date de décès, quelle qu'en soit la cause.
• Toxicités du traitement complémentaire au traitement d’induction.
Taux de patients ayant reçu la totalité du traitement complémentaire.
• Hospitalisation ou prolongation d’hospitalisation pour toxicité liée aux traitements à l’étude.
• Qualité de vie selon les questionnaires EORTC QLQ-C30 et EORTC-H&N35

E.5.2.1

Timepoint(s) of evaluation of this end point

Une évaluation tumorale sera faite tous les 3 mois pendant 2 ans puis tous les 6 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

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

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

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

dernière visite du dernier patient participant à l'essai

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	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.2.1	Number of subjects for this age range:	60
F.1.3	Elderly (>=65 years)	Yes
F.1.3.1	Number of subjects for this age range:	39
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	99
F.4.2	For a multinational trial
F.4.2.1	In the EEA	99
F.4.2.2	In the whole clinical trial	99

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

2020-04-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-05-25

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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