Clinical Trials Register

Summary
EudraCT Number:	2021-002392-20
Sponsor's Protocol Code Number:	1403-0008
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:	2022-03-03
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

2021-002392-20

A.3

Full title of the trial

Brightline-1: A Phase II/III, randomized, open-label, multi-center study of BI 907828 compared to doxorubicin as first line treatment of patients with advanced dedifferentiated liposarcoma

Brightline-1 : Étude de phase II/III, en ouverte, multicentrique et randomisée avec le BI 907828 en comparaison à la doxorubicine dans le traitement de première ligne des patients atteints de liposarcomes dédifférenciés

A.3.1

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

Brightline-1: A study to compare BI 907828 with doxorubicin in people with a type of cancer called dedifferentiated liposarcoma

Brightline-1 : Une étude visant à comparer le BI 907828 à la doxorubicine chez des personnes atteintes d'un type de cancer appelé liposarcome indifférencié.

A.3.2

Name or abbreviated title of the trial where available

Brightline-1

A.4.1

Sponsor's protocol code number

1403-0008

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	Boehringer Ingelheim France
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Boehringer Ingelheim France
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	Boehringer Ingelheim Pharma GmbH & Co. KG
B.5.2	Functional name of contact point	CT Disclosure & Data Transparency
B.5.3	Address:
B.5.3.1	Street Address	Binger Strasse 173
B.5.3.2	Town/ city	Ingelheim am Rhein
B.5.3.3	Post code	55216
B.5.3.4	Country	Germany
B.5.4	Telephone number	498002430127
B.5.5	Fax number	498008217119
B.5.6	E-mail	clintriage.rdg@boehringer-ingelheim.com

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.2.5	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	BI 907828
D.3.2	Product code	BI 907828
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	None yet
D.3.9.1	CAS number	MASKED
D.3.9.2	Current sponsor code	BI 907828
D.3.9.4	EV Substance Code	SUB193205
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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	No
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	BI 907828
D.3.2	Product code	BI 907828
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	None yet
D.3.9.1	CAS number	MASKED
D.3.9.2	Current sponsor code	BI 907828
D.3.9.4	EV Substance Code	SUB193205
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
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.2.5	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	BI 907828
D.3.2	Product code	BI 907828
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	None yet
D.3.9.1	CAS number	MASKED
D.3.9.2	Current sponsor code	BI 907828
D.3.9.4	EV Substance Code	SUB193205
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	45
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.2.1.2	Country which granted the Marketing Authorisation	Poland
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	Doxorubicin
D.3.2	Product code	Doxorubicin
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	Doxorubicin
D.3.9.1	CAS number	23214-92-8
D.3.9.3	Other descriptive name	Doxorubicin
D.3.9.4	EV Substance Code	SUB06391MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.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

advanced dedifferentiated liposarcoma

liposarcome dédifférencié avancé

E.1.1.1

Medical condition in easily understood language

liposarcoma

Liposarcomes

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	10073135
E.1.2	Term	Dedifferentiated liposarcoma
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

The trial will assess the efficacy and safety of BI 907828 compared to doxorubicin as first
line systemic therapy for advanced or metastatic DDLPS.

L'objectif principal de l’étude est de démontrer la supériorité du BI 907828 par rapport à la doxorubicine comme traitement systémique de première ligne pour les DDLPS avancés ou métastatiques.

E.2.2

Secondary objectives of the trial

The secondary objectives of the Phase II part of the trial are to select an optimal dose of BI 907828 and to evaluate prior to the Phase III part whether the expected benefits of BI 907828 as first line systemic therapy for advanced or metastatic DDLPS outweigh any risks. The secondary objectives of the Phase III part of the trial are to evaluate whether BI 907828 as first line systemic therapy for advanced or metastatic DDLPS improves the objective response rate, duration of responses, overall survival, disease control rate, tolerability and delays worsening of quality of life, compared to doxorubicin.
Safety of BI 907828 will be investigated in both parts of the trial.

Les objectifs secondaires de la phase II de l'essai sont de sélectionner une dose optimale de BI 907828 et d’évaluer, avant la phase III, si les bénéfices attendus du BI 907828 en tant que traitement systémique de première intention pour le DDLPS avancé ou métastatique l'emportent sur les risques.
Les objectifs secondaires de la phase III de l'essai sont d'évaluer si le BI 907828, en tant que traitement systémique de première intention pour le DDLPS avancé ou métastatique, améliore le taux de réponse objective, la durée des réponses, la survie globale, le taux de contrôle de la maladie, la tolérance et retarde la détérioration de la qualité de vie, par rapport à la doxorubicine.
L'innocuité du BI 907828 sera étudiée dans les deux parties de l'essai.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Provision of signed and dated, written informed consent form ICF in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses.
2. Male or female patients ≥18 years old at the time of signature of the ICF. Women of childbearing potential and men able to father a child must be ready and able to use 2 medically acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at screening, during trial participation, and until 6 months and 12 days after last dose for women and 102 days after last dose for men.
3. Histologically proven locally advanced or metastatic, unresectable (surgery morbidity
would outweigh potential benefits), progressive or recurrent DDLPS. Locally performed histopathological diagnosis will be accepted for entry into this trial but will be confirmed by independent pathological review while the patients receive treatment in this trial.
4. Written pathology report indicating the diagnosis of DDLPS with positive MDM2 immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridization or NGS must be available.
5. Formalin fixed paraffin embedded tumor blocks or slides must be available for retrospective histopathological central review.
6. Presence of at least one measurable target lesion according to RECIST version 1.1. In patients who only have one target lesion, the baseline imaging must be performed at least 2 weeks after any biopsy of the target lesion.
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
8. Patient must be willing to donate blood samples for the pharmacokinetics, pharmacodynamics, and tumor mutation analysis.
9. Patient willing to undergo a mandatory tumor biopsy at the time point specified in the flowchart unless exempt.
10. Adequate organ function

1. Formulaire de consentement éclairé écrit signé selon la réglementation ICH-GCP et réglementation locale.
2. Patients, masculin ou féminin, de plus de 18 ans. Les femmes en âge de procréer et les hommes capables d’avoir un enfant doivent accepter et être capables d’utiliser des moyens de contraception hautement efficaces conformément aux directives ICH M3 (R2), ayant un taux d’échec inférieur à 1 % par an pour une utilisation constante et correcte, pour toute la durée du traitement à l’étude et pour 6 mois et 12 jours après la dernière dose de traitement à l’étude.
3. Liposarcome dédifférencié (DDLPS), prouvé par histologie, localement avancé ou métastatique, non résécable, progressif ou récurrent. Le diagnostic histopathologique effectué localement sera accepté pour l’entrée dans cette étude, mais sera confirmé par un examen indépendant.
4. Un rapport d’anatomopathologie indiquant le diagnostic de DDLPS avec immunohistochimie MDM2 positive ou amplification MDM2 démontrée par hybridation in situ par fluorescence ou NGS (séquençage à haute débit).
5. Des blocs tumoraux (fixés à la paraffine fixée au formol) ou des lames de tissue doivent être disponibles pour un examen central histopathologique rétrospectif.
6. Présence d’au moins une lésion cible mesurable selon les critères RECIST version 1.1. Chez les patients qui n’ont qu’une seule lésion cible, l’imagerie initiale doit être effectuée au moins 2 semaines après toute biopsie de la lésion cible.
7. Indice de performance de l’Eastern Cooperative Oncology Group (ECOG) de 0 ou 1.
8. Patient d’accord pour des prélèvements d’échantillons de sang pour la pharmacocinétique, la pharmacodynamique et l’analyse des mutations tumorales.
9. Disponibilité et volonté de fournir une biopsie fraîche de tissu tumoral (voir section 5.4.2.2 du protocole)
10. Fonctionnement adéquat des organes

E.4

Principal exclusion criteria

1. Known mutation in the TP53 gene (screening for TP53 status is not required).
2. Major surgery (major according to the investigator’s assessment) performed within
4 weeks prior to randomization or planned within 6 months after screening.
3. Prior systemic therapy for liposarcoma in any setting (including adjuvant, neoadjuvant, maintenance, palliative).
4. Previous or concomitant malignancies other than DDLPS or WDLPS, treated within the previous 5 years, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ, and prostate cancer.
5. Previous treatment with anthracyclines in any setting (systemic treatment with other anticancer agents is allowed if completed at least 5 years prior to study entry with the exception of hormone therapy).
6. Patients who must or intend to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
7. Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s) or receiving other investigational treatment(s).
8. Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator’s opinion, makes the patient an unreliable trial participant).

Further criteria apply.

1. Mutation connue du gène TP53 (le dépistage du statut TP53 n’est pas nécessaire).
2. Chirurgie majeure (majeure selon l’évaluation de l’investigateur) effectuée dans les 4 semaines précédant la randomisation ou planifiée dans les 6 mois suivant la sélection.
3. Traitement systémique antérieur du liposarcome dans n’importe quel contexte (y compris adjuvant, néoadjuvant, maintenance, soins palliatifs).
4. Tumeurs malignes antérieures ou concomitantes autres que DDLPS ou WDLPS, traitées au cours des 5 années précédentes, à l’exception des cancers de la peau autres que le mélanome, du carcinome in situ du col de l’utérus, du carcinome canalaire in situ et du cancer de la prostate.
5. Traitement antérieur avec des anthracyclines dans n’importe quel contexte (un traitement systémique avec d’autres agents anticancéreux est autorisé s’il s’est terminé au moins 5 ans avant l’entrée dans l’étude, à l’exception de l’hormonothérapie).
6. Utilisation des médicaments restreints ou de tout médicament considéré comme susceptible d’interférer avec le bon déroulement de l’étude.
7. Patient déjà impliqué dans un autre essai clinique, ou moins de 30 jours après la fin d’un ou plusieurs autres essais.
8. Patients incapables ou non disposés à se conformer au protocole (ex : abus chronique d’alcool ou de drogues ou toute autre affection qui, de l’avis de l’investigateur, fait du patient un participant peu fiable pour cette étude).

D'autres critères s'appliquent

E.5 End points

E.5.1

Primary end point(s)

Progression-free survival (PFS)

Survie sans progression (SSP)

E.5.1.1

Timepoint(s) of evaluation of this end point

1) 12 and 23 months

1) 12 et 23 mois

E.5.2

Secondary end point(s)

1) Objective response (OR)
2) Duration of objective response (DOR)
3) Overall survival (OS)
4) Disease control (DC)
5) Health-Related Quality of Life (HRQoL)

1) Réponse Objective (RO)
2) Durée de la Réponse Objective (DRO)
3) Survie Global (SG)
4) Contrôle de la Maladie (CM)
5) Qualité de vie liée à la santé

E.5.2.1

Timepoint(s) of evaluation of this end point

1) 12 and 23 months
2) 12 and 23 months
3) 12 and 23 months
4) 12 and 23 months
5) 12 and 23 months

1) 12 et 23 mois
2) 12 et 23 mois
3) 12 et 23 mois
4) 12 et 23 mois
5) 12 et 23 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

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Patients sous doxo avec progression objective de la maladie, si éligible, recevront le BI 907828

doxorubicin patients with objective PD can, if eligible, switch to BI 907828

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

Yes

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Canada

China

Hong Kong

Japan

Korea, Republic of

Philippines

Russian Federation

Taiwan

Turkey

United States

Belgium

Czechia

Denmark

Finland

France

Germany

Greece

Ireland

Italy

Netherlands

Norway

Portugal

Spain

Sweden

United Kingdom

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

LVLS

Dernier Patient, Dernière visite

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:

150

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

150

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

127

F.4.2.2

In the whole clinical trial

300

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)

Patients will participate in this trial until progressive disease, which is the timepoint at which the treatment administered is no longer effective. Further treatment beyond this time point will be administered outside the trial per local standards.

Les patients participeront à cette recherche jusqu'à la progression de leur maladie, c'est-à-dire le moment où le traitement administré n'est plus efficace. Par la suite, un nouveau traitement sera administré en dehors de cette recherche selon les recommandations locales.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Oncacare ltd
G.4.3.4	Network Country	Ireland

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-05-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-03-29

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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