Clinical Trials Register

Summary
EudraCT Number:	2014-002517-39
Sponsor's Protocol Code Number:	PRODIGE34
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2018-06-28
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

Belgium - FPS Health-DGM

A.2

EudraCT number

2014-002517-39

A.3

Full title of the trial

Randomised phase III trial evaluating adjuvant chemotherapy after the stage III colon adenocarcinoma resection for patient of 70 year old or more

ETUDE DE PHASE III RANDOMISEE EVALUANT LA CHIMIOTHERAPIE ADJUVANTE APRES RESECTION D’UN ADENOCARCINOME COLIQUE DE STADE III CHEZ LES PATIENTS DE 70 ANS ET PLUS

A.3.1

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

Randomised phase III trial evaluating adjuvant chemotherapy after the stage III colon adenocarcinoma resection for patient of 70 year old or more

ETUDE DE PHASE III RANDOMISEE EVALUANT LA CHIMIOTHERAPIE ADJUVANTE APRES RESECTION D’UN ADENOCARCINOME COLIQUE DE STADE III CHEZ LES PATIENTS DE 70 ANS ET PLUS

A.3.2

Name or abbreviated title of the trial where available

PRODIGE 34 - ADAGE

A.4.1

Sponsor's protocol code number

PRODIGE34

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 (FFCD)
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	FFCD itself
B.4.2	Country	France
B.4.1	Name of organisation providing support	Belgian Group Digestive Oncology( BGDO)
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Belgian Group Digestive Oncology( BGDO)
B.5.2	Functional name of contact point	Micheline Stempin
B.5.3	Address:
B.5.3.1	Street Address	Leuvensesteenweg 643
B.5.3.2	Town/ city	Zaventem
B.5.3.3	Post code	1930
B.5.3.4	Country	Belgium
B.5.4	Telephone number	32474074584
B.5.6	E-mail	clinicaltrials@bdgo.org

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	Fluorouracil Accord Healthcare 50 mg/ml, solution pour injection ou perfusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Accord Healthcare Limited
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
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 bolus use (Noncurrent)
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: 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	Fluorouracil Accord Healthcare 50 mg/ml, solution pour injection ou perfusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Accord Healthcare Limited
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
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	Yes
D.2.1.1.1	Trade name	Elvorine 25 mg/2,5 ml solution injectable Elvorine 50 mg/5 ml solution injectable
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer SA, Bruxelles
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
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	ELVORINE
D.3.9.3	Other descriptive name	CALCIUM LEVOFOLINATE
D.3.9.4	EV Substance Code	SUB06054MIG
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 150 mg comprimés pelliculés. Xeloda 500 mg comprimés pelliculés.
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CAPECITABINE
D.3.9.3	Other descriptive name	CAPECITABINE
D.3.9.4	EV Substance Code	SUB12474MIG
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.2.1.1.1	Trade name	ELOXATIN 5 mg/ml solution à diluer pour perfusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Belgium
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
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	61825-94-3
D.3.9.4	EV Substance Code	SUB09490MIG
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

Adjuvant treatment in stage III adenocarcinoma of the colon fully resected for patient of 70 years and over

Traitement adjuvant d'un adénocarcinome colique de stade III totalement réséqué chez les patients de 70 ans et plus

E.1.1.1

Medical condition in easily understood language

Adjuvant treatment in stage III adenocarcinoma of the colon fully resected for patient of 70 years and over

Traitement adjuvant d'un adénocarcinome colique de stade III totalement réséqué chez les patients de 70 ans et plus

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The study population will be dichotomized into two groups (group 1 and group 2) according to the investigator's choice, after a multidisciplinary assessment involving geriatric settings.
The main objective is to compare recurrence-free survival (RFS) at 3 years for 2 therapeutic strategies in each group of patients of 70 years or more, after resection of the stage III colon cancer.
Group 1 (fit to receive a bi-chemotherapy): we expect an improvement of 7% of the RFS in the arm with oxaliplatin compared to 5FU or capecitabin arm
Group 2 (unfit to receive bi-chemotherapy): we expect an improvement of 15% of the RFS in the arm with chemotherapy (5-FU or capecitabin) compared with observation alone arm.

La population âgée de l’étude sera dichotomisée en deux groupes (groupe 1 et groupe 2) selon le choix de l’investigateur, après une évaluation multidisciplinaire, impliquant des paramètres gériatriques.
L'objectif principal est de comparer la survie sans récidive (SSR) à 3 ans de 2 stratégies thérapeutiques dans chaque groupe de patients âgés de 70 ans ou plus, après résection d’un cancer du côlon de stade III.
Groupe 1 (aptes à recevoir une bi-chimiothérapie) : on attend une amélioration de 7% de la SSR dans le bras avec oxaliplatine comparé au bras avec 5FU ou capécitabine.
Groupe 2 (inaptes à recevoir une bi-chimiothérapie): on attend une amélioration de 15% de la SSR dans le bras avec chimiothérapie (5FU ou capécitabine) comparé au bras avec observation seule.

E.2.2

Secondary objectives of the trial

The secondary objectives are:
- Dose intensity
- Safety (NCI CTC 4.0)
- Time to recurrence,
- Overall survival,
- Time to degradation of autonomy,
- Time to deterioration of the quality of life.

Les objectifs secondaires sont:
- dose intensité,
- tolérance (NCI CTC 4.0),
- temps jusqu’à récidive,
- survie globale,
- temps jusqu’à dégradation de l’autonomie,
- temps jusqu’à détérioration de la qualité de vie.

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

As part of this study, an ancillary biological study will be realized on the tumor sample (removed at the time of the R0 surgery, before inclusion in this study).
The objective of this biological study is to search predictive and prognostic factors . These will mainly include:
- An assessment of the prognostic and predictive value of microsatellite instability and tumor V600E BRAF mutation.
- An assessment of the prognostic value of tumor PI3K mutations in patients treated with aspirin / acetylsalicylic acid taken daily and continuously.

Dans le cadre de cette étude, il sera réalisé une étude ancillaire biologique sur le prélèvement tumoral (réséqué au moment de la chirurgie R0, avant inclusion dans cette étude).
Cette étude biologique a pour objectif de rechercher sur ce prélèvement des facteurs prédictifs et pronostics. Il y aura notamment:

- une évaluation de la valeur pronostique et prédictive de l’instabilité microsatellitaire et de la mutation tumorale V600E de BRAF.
- une évaluation de la valeur pronostique des mutations de PI3K tumorale chez les patients traités par aspirine/ acide acétyl-salicylique en prise quotidienne et continue.

E.3

Principal inclusion criteria

- Age ≥ 70 years
- Patient considered enough fit to receive chemotherapy according to the multidiciplinary committee
- Lee score completed and faxed to the CRGA
- Stage III colonic adenocarcinoma or upper rectum
- R0 resection of the primary tumor
- Adjuvant chemotherapy can start within 12 weeks after surgery
- No prior chemotherapy for colon cancer
- Self-administered (patient) geriatric questionnaire completed and faxed to the CRGA
- Team geriatric questionnaire completed and faxed to the CRGA
- Effective contraception for male patients during treatment and for at least 6 months after discontinuation of oxaliplatin
- Signed informed consent

- Age ≥ 70 ans
- Patient jugé apte à recevoir une chimiothérapie par la RCP
- Score de Lee détaillé, faxé au CRGA
- Adénocarcinome colique de stade III et haut rectum
- Résection R0 de la tumeur primitive
- Début de la chimiothérapie adjuvante possible dans les 12 semaines après la chirurgie
- Absence de chimiothérapie antérieure pour le cancer colique
- Auto-questionnaire gériatrique « patient » complété, faxé au CRGA
- Questionnaire gériatrique « équipe » complété, faxé au CRGA
- Contraception efficace pour les patients hommes, pendant toute le traitement et au moins 6 mois après l’arrêt du traitement par oxaliplatine
- Consentement(s) éclairé(s) signé(s).

E.4

Principal exclusion criteria

- Other progressive malignant tumor (cancer not stabilized for less than 2 years )
- Rectal cancer (located within 15 cm from the anal verge by endoscopy or below the peritoneal reflection )
- PNN < 2 000/mm3 for group 1 and PNN <1 500/mm3 for group 2, platelets <100000/mm3 or hemoglobin <9 g / dL
- Neuropathy for patients in group 1
- Known deficit of dihydropyrimidine dehydrogenase (DPD)
- Patients with severe hepatic impairment
- Any contra-indications for the drugs used in the study
- Geographical, sociological or psychological conditions that would not permit the patient to complete the medical study follow-up visits

- Autre tumeur maligne évolutive (cancer non stabilisé depuis moins de 2 ans)
- Cancer rectal (localisé à moins de 15 cm de la marge anale en endoscopie ou sous péritonéal)
- PNN < 2 000/mm3 pour le groupe 1 et PNN <1 500/mm3 pour le groupe 2, plaquettes < 100000/mm3 ou hémoglobine < 9 g/dL
- Neuropathie pour les patients du groupe 1
- Déficit connu à la dihydropyrimidine déshydrogénase (DPD)
- Patient présentant une insuffisance hépatique sévère
- Toute contre-indication aux médicaments utilisés dans l’étude
- Impossibilité de se soumettre au suivi médical de l’essai pour des raisons géographiques, sociales ou psychiques.

E.5 End points

E.5.1

Primary end point(s)

The main objective is to compare recurrence-free survival (RFS) at 3 years for 2 therapeutic strategies in each group of elderly patients, after resection of stage III colon cancer.
Group 1 (fit to receive a bi-chemotherapy): we expect a 7% improvement in recurrence-free survival in the arm with oxaliplatin compared to 5FU or capecitabin arm.
Group 2 (unfit to receive bi-chemotherapy): we expect a 15% improvement in recurrence-free survival in the chemotherapy arm compared with observation alone arm.

L’objectif principal est de comparer la survie sans récidive (SSR) à 3 ans de 2 stratégies thérapeutiques dans chaque groupe de patients âgés, après résection d’un cancer du côlon de stade III.
Groupe 1 (aptes à recevoir une bi-chimiothérapie) : on attend une amélioration de 7% de la survie sans récidive dans le bras avec oxaliplatine comparé au bras avec 5FU ou capécitabine.
Groupe 2 (inaptes à recevoir une bi-chimiothérapieCT) : on attend une amélioration de 15% de la survie sans récidive dans le bras avec chimiothérapie comparé au bras avec observation seule.

E.5.1.1

Timepoint(s) of evaluation of this end point

The recurrence-free survival (RFS) is estimated at 3 years after the last patient is randomised

La survie sans récidive (SSR) est estimée à 3 ans après que le dernier patient soit randomisé.

E.5.2

Secondary end point(s)

The secondary objectives are to compare for the two treatment strategies for each group:
- The dose intensity
- Safety (NCI CTC 4.0)
- Time to recurrence
- Overall survival
- The time to deterioration of autonomy
- The time to deterioration in quality of life

Exploratory analyses: reserach of geriatric prognostic factors for the primary endpoint.

Les objectifs secondaires : Comparer pour les 2 stratégies de traitement, pour chaque groupe :
- La dose intensité
- La tolérance (NCI CTC 4.0)
- Le temps jusqu’à récidive
- La survie globale
- Le temps jusqu’à dégradation de l’autonomie
- Le temps jusqu’à détérioration de la qualité de vie

Evaluation exploratoire : rechercher les facteurs pronostiques gériatriques pour le critère de jugement principal.

E.5.2.1

Timepoint(s) of evaluation of this end point

All these endoints will be evaluated at 3 years after the last patient is randomised. Overall survival can be re-evaluated later.

Tout ces critères seront évalués 3 ans après que le dernier patient soit randomisé. La survie globale pourra être réévaluée plus tard.

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

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 correspond à la dernière visite du dernier patient selon 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

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)

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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.4.2.2

In the whole clinical trial

982

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)

it is not different from the expected normal treatment of that condition

il n'est pas différent du traitement que le patient aurait hors protocole

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

2018-07-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-10-15

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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