Clinical Trials Register

Summary
EudraCT Number:	2019-000974-44
Sponsor's Protocol Code Number:	D910CC00001
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2019-08-09
Trial results	View 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

Spain - AEMPS

A.2

EudraCT number

2019-000974-44

A.3

Full title of the trial

A Phase 1b/2, Open-label, Multicenter Study of Novel Oncology Therapies in Combination with Chemotherapy and Bevacizumab as First-line Therapy in Metastatic Microsatellite-stable Colorectal Cancer (COLUMBIA-1)

Estudio en fase Ib/II, multicéntrico y abierto para evaluar tratamientos oncológicos novedosos en combinación con quimioterapia y bevacizumab como tratamiento de primera línea en el cáncer colorrectal metastásico con microsatélites estables (COLUMBIA-1)

A.3.1

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

A Study of Novel Oncology Therapies in Combination with FOLFOX and Bevacizumab in Metastatic Microsatellite-Stable Colorectal Cancer

Estudio de tratamientos oncológicos novedosos en combinación con FOLFOX y bevacizumab en cáncer colorrectal con estabilidad de microsatélites metastásico

A.3.2

Name or abbreviated title of the trial where available

COLUMBIA-1

A.4.1

Sponsor's protocol code number

D910CC00001

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	AstraZeneca AB
B.1.3.4	Country	Sweden
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	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca AB
B.5.2	Functional name of contact point	Clinical Trial Transparency
B.5.3	Address:
B.5.3.1	Street Address	..
B.5.3.2	Town/ city	Södertälje
B.5.3.3	Post code	151 85
B.5.3.4	Country	Sweden
B.5.6	E-mail	ClinicalTrialTransparency@astrazeneca.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	durvalumab
D.3.2	Product code	MEDI4736
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	durvalumab
D.3.9.1	CAS number	1428935-60-7
D.3.9.2	Current sponsor code	MEDI4736
D.3.9.3	Other descriptive name	Human immunoglobulin G1 (IgG1) kappa monoclonal antibody (mAb)
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	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	Yes
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	oleclumab
D.3.2	Product code	MEDI9447
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	oleclumab
D.3.9.1	CAS number	1803176-05-7
D.3.9.2	Current sponsor code	MEDI9447
D.3.9.3	Other descriptive name	Human immunoglobulin G1 (IgG1) lambda monoclonal antibody (mAb)
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	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	Yes
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 Microsatellite-Stable Colorectal Cancer

Cáncer colorrectal con microsatélites estables metastásico

E.1.1.1

Medical condition in easily understood language

Metastatic Colorectal Cancer

Cáncer colorrectal metastásico

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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10052362
E.1.2	Term	Metastatic colorectal cancer
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Part 1: To evaluate the safety and tolerability profile of FOLFOX + bevacizumab + novel oncology therapy combinations

Part 2: To compare the efficacy of FOLFOX + bevacizumab + novel oncology therapy combinations versus FOLFOX + bevacizumab

Parte 1: Evaluar el perfil de seguridad y tolerabilidad de FOLFOX + bevacizumab + combinaciones de tratamientos oncológicos novedosos

Parte 2: Comparar la eficacia de FOLFOX + bevacizumab + combinaciones de tratamientos oncológicos novedosos frente a FOLFOX + bevacizumab

E.2.2

Secondary objectives of the trial

Part 1 & 2:
To investigate the preliminary antitumor activity of FOLFOX + bevacizumab+ novel oncology therapy combinations

To describe the PK of novel agents when used in combination with FOLFOX + bevacizumab. To describe the PK of bevacizumab when used in combination with FOLFOX + novel oncology therapy combinations

To assess the immunogenicity of applicable novel agents when used in combination with FOLFOX + bevacizumab. To assess the immunogenicity of bevacizumab when used in combination with FOLFOX + novel oncology therapy combinations

Part 2:
To evaluate the safety and tolerability profile of FOLFOX + bevacizumab + novel oncology therapy combinations

Partes 1 y 2:
Investigar la actividad antitumoral preliminar de FOLFOX + bevacizumab + combinaciones de tratamientos oncológicos novedosos

Describir la FC de los agentes novedosos cuando se usan en combinación con FOLFOX + bevacizumab. Describir la FC de bevacizumab cuando se usa en combinación con FOLFOX + combinaciones de tratamientos oncológicos novedosos

Evaluar la inmunogenicidad de los agentes novedosos correspondientes cuando se usan en combinación con FOLFOX + bevacizumab. Evaluar la inmunogenicidad de bevacizumab cuando se usa en combinación con FOLFOX + combinaciones de tratamientos oncológicos novedosos

Parte 2:
Evaluar el perfil de seguridad y tolerabilidad de FOLFOX + bevacizumab + combinaciones de tratamientos oncológicos novedosos

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
• Age ≥ 18 years at the time of screening.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patients must have histologic documentation of advanced or metastatic colorectal cancer and:
- A documented mutation test during screening and confirmed tumor locations from disease assessment for enrollment.
- Patients must NOT have defective DNA mismatch repair (microsatellite instability) as documented by testing.
- Patients must not have received any prior systemic therapy for recurrent/metastatic disease (prior adjuvant chemotherapy or radio-chemotherapy is acceptable so long as progression was not within 6 months of completing the adjuvant regimen).
• Patients must have at least one lesion that is measurable by RECIST v1.1 (Eisenhauer et al, 2009).
• Patients must have adequate organ function.
• Patients with medical conditions requiring systemic anticoagulation (eg, atrial fibrillation) are eligible provided that both of the following criteria are met:
- The patient has an in-range international normalized ratio (INR) on a stable dose of oral anticoagulant or be on a stable dose of low molecular weight heparin.
- The patient has no active bleeding or pathological condition that carries a high risk of bleeding.
• Body weight > 35 kg.
• Adequate method of contraception per protocol.

•Consentimiento informado por escrito, así como cualquier autorización local requerida, obtenidos de parte del paciente/representante legal antes de la realización de todo procedimiento relacionado con el protocolo, incluidas las evaluaciones para la selección.
•Edad ≥18 años en el momento de la selección.
•Estado funcional del Grupo oncológico cooperativo del este (ECOG) de 0 o 1.
•Los pacientes deben tener documentación histológica del cáncer colorrectal en estadio avanzado o metastásico y:
-Una prueba de mutación documentada durante la selección y localizaciones tumorales confirmadas de la evaluación de la enfermedad para el reclutamiento.
-Los pacientes NO deben tener defectos en la reparación de los errores de emparejamiento del ADN (inestabilidad de microsatélites) documentada mediante análisis.
-Los pacientes no deben haber recibido ningún tratamiento sistémico previo para la enfermedad recurrente/metastásica (la quimioterapia adyuvante o la quimiorradioterapia son aceptables siempre que la progresión no se produjera en los 6 meses posteriores a la finalización de la pauta de tratamiento adyuvante).
•Los pacientes deben tener al menos una lesión medible según los criterios RECIST v1.1 (Eisenhauer et al., 2009).
•Los pacientes deben tener una función orgánica adecuada.
•Los pacientes con afecciones médicas que requieran anticoagulación sistémica (p. ej., fibrilación auricular) son elegibles siempre que se cumplan los siguientes criterios:
-El paciente presenta un índice internacional normalizado (INR) dentro del intervalo con una dosis estable de anticoagulante oral o recibe una dosis estable de heparina de bajo peso molecular.
-El paciente no presenta hemorragia activa ni una afección patológica que implique un alto riesgo de hemorragia.
•Peso corporal >35 kg.
•Método anticonceptivo adecuado de acuerdo con el protocolo.

E.4

Principal exclusion criteria

• History of allogeneic organ transplantation.
• Active or prior documented autoimmune disorders within the past 5 years
• History of venous thrombosis within the past 3 months
• Cardiovascular criteria:
- Presence of acute coronary syndrome including myocardial infarction or unstable angina pectoris, other arterial thrombotic event including cerebrovascular accident or transient ischemic attack or stroke within the past 6 months.
- New York Heart Association (NYHA) class II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or uncontrolled hypertension.
- History of hypertensive crisis/hypertensive encephalopathy within the past 6 months
• Mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) ≥ 470 ms
• No significant history of bleeding events or gastrointestinal perforation
• Uncontrolled intercurrent illness
• History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥ 5 years of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
• History of active primary immunodeficiency
• Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
• Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
• Any unresolved toxicity NCI CTCAE Grade > 1 from previous anticancer therapy.
• History of leptomeningeal disease or cord compression.
• Untreated central nervous system (CNS) metastases
• Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
• Known dihydropyrimidine dehydrogenase (DPD) deficiency.
• Prior immunotherapy or anti-angiogenics.
• Receipt of live attenuated vaccine within the past 30 days.
• Major surgical procedure, open biopsy, or significant traumatic injury within the past 28 days.
• Current or prior use of immunosuppressive medication within the past 14 days, with exceptions per protocol.

•Antecedentes de alotrasplante de órganos.
•Trastornos autoinmunitarios activos o previos documentados en los últimos 5 años.
•Antecedentes de flebotrombosis en los últimos 3 meses.
•Criterios cardiovasculares:
-Presencia de síndrome coronario agudo, incluidos infarto de miocardio o angina de pecho inestable, otros acontecimientos trombóticos arteriales, incluidos accidente cerebrovascular o accidente isquémico transitorio o ictus dentro de los últimos 6 meses.
-Insuficiencia cardíaca congestiva de clase II o superior de la New York Heart Association (NYHA), arritmia cardíaca grave que requiera medicación, o hipertensión no controlada.
-Antecedentes de crisis hipertensivas o encefalopatía hipertensiva en los últimos 6 meses.
•Media del intervalo QT corregido para la frecuencia cardíaca utilizando la fórmula de Fridericia (QTcF) ≥470 ms.
•Sin antecedentes significativos de acontecimientos hemorrágicos o perforación gastrointestinal.
•Enfermedad intercurrente no controlada.
•Antecedentes de otra neoplasia maligna primaria, excepto:
-Neoplasia maligna tratada con intención curativa y sin enfermedad activa conocida ≥5 años de bajo riesgo de recurrencia.
-Cáncer de piel distinto de melanoma tratado adecuadamente o lentigo maligno sin evidencia de enfermedad.
-Carcinoma localizado tratado adecuadamente y sin evidencia de enfermedad.
•Antecedentes de inmunodeficiencia primaria activa.
•Infección activa, incluidos tuberculosis, hepatitis B, hepatitis C o virus de la inmunodeficiencia humana.
•Alergia o hipersensibilidad conocida a cualquiera de los fármacos del estudio o cualquiera de los excipientes del fármaco del estudio.
•Cualquier toxicidad no resuelta de grado >1 según los CTCAE del NCI del anterior tratamiento antineoplásico.
•Antecedentes de carcinomatosis leptomeníngea o compresión medular.
•Metástasis del sistema nervioso central (SNC) no tratadas.
•Falta de integridad física de la parte superior del tubo digestivo, síndrome de mala absorción, o incapacidad para tomar medicación oral.
•Deficiencia conocida de dihidropirimidina deshidrogenasa (DPD).
•Uso previo de inmunoterapia o de antiangiogénicos.
•Recepción de una vacuna atenuada en los últimos 30 días.
•Procedimiento quirúrgico mayor, biopsia abierta o lesión traumática significativa en los 28 días anteriores.
•Uso actual o previo de medicación inmunodepresora en los últimos 14 días, con excepciones al protocolo.

E.5 End points

E.5.1

Primary end point(s)

Part 1: Incidence of adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), laboratory findings, and vital signs

Part 2: Objective response (OR) per RECIST v1.1

Parte 1: Incidencia de acontecimientos adversos (AA) y acontecimientos adversos graves (AAG), toxicidades limitantes de dosis (TLD), hallazgos de laboratorio, y constantes vitales

Parte 2: Respuesta objetiva (RO) según RECIST v1.1.

E.5.1.1

Timepoint(s) of evaluation of this end point

Safety observed from informed consent through 90 days after the last dose of investigational product.

Dose-limiting toxicities will be evaluated during the safety run-in phase (Part 1). The DLT evaluation period is defined as 28 days from the first dose of investigational product (novel therapy).

Efficacy will be assessed every 8 weeks through 1 year then every 12 weeks.

Evaluación de la seguridad desde el momento de la obtención del consentimiento informado hasta 90 días después de la última dosis del producto en investigación.

Las toxicidades limitantes de la dosis se evaluarán durante la fase de preinclusión de seguridad (Parte 1). El periodo de evaluación de TLD se define como 28 días desde la primera dosis del producto en investigación (nuevo tratamiento).

La eficacia se evaluará cada 8 semanas durante el primer año y, a continuación, cada 12 semanas.

E.5.2

Secondary end point(s)

Part 1: Objective response (OR), best overall response (BOR), duration of response (DoR), disease control (DC), progression-free survival-12 (PFS-12), progression-free survival (PFS) per RECIST v1.1, and overall survival (OS)

Part 1 & 2: PK (drug concentration) and incidence of antidrug antibodies (ADA)

Part 2: Incidence of adverse events (AEs), serious adverse events (SAEs), laboratory findings, and vital signs

Part 2: BOR, DoR, DC, PFS-12 and PFS per RECIST v1.1,and overall survival (OS)

Parte 1: Respuesta objetiva (RO), mejor respuesta global (MRG), duración de la respuesta (DdR), control de la enfermedad (CE), supervivencia sin progresión-12 (SSP-12), supervivencia sin progresión (SSP) según los criterios RECIST v1.1, y supervivencia global (SG)

Partes 1 y 2: FC (concentración del fármaco) e incidencia de anticuerpos antifármaco (AAF)

Parte 2: Incidencia de acontecimientos adversos (AA), acontecimientos adversos graves (AAG), hallazgos de laboratorio y constantes vitales
Parte 2: MRG, DdR, CE, SSP-12 y SSP según los criterios RECIST v1.1 y supervivencia global (SG)

E.5.2.1

Timepoint(s) of evaluation of this end point

Efficacy endpoints assessed from screening until 18 months post last dose, then every 6 months.

PK from Day 1 until Week 53.

ADA from Day 1 until 90 days post last dose.

Criterios de valoración de la eficacia evaluados desde la selección hasta 18 meses después de la última dosis, posteriormente, cada 6 meses.

FC desde el día 1 hasta la semana 53.

AAF desde el día 1 hasta 90 días después de la última dosis.

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity

Inmunogenia

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Phase 1b

Fase 1b

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

Yes

E.8.1.7.1

Other trial design description

Estudio de plataforma

Platform study

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

France

Spain

United States

E.8.7

Trial has a data monitoring committee

E.8.8

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

The end of the study (“study completion”) is defined as the date of the last protocol-specified visit/assessment (including telephone contact) for the last subject in the study (ie, last subject last visit). The end of the study occurs after the last subject has discontinued study treatment and completed any applicable follow-up visit per the schedule of study procedures (see Section 4.2 of the protocol), or the date the study is closed by the sponsor, whichever occurs first.

El FdE (“finalización del estudio”) se define como la fecha de la última visita o evaluación especificada en el protocolo (incluidos contactos telefónicos) del último sujeto del estudio (es decir, LPLV). El FdE se produce después de que el LP haya interrumpido el tratamiento del estudio y completado cualquier visita de seguimiento aplicable de acuerdo con el calendario de los procedimientos del estudio (ver S. 4.2 del prot) o la fecha en que el promotor cierre el estudio, lo que ocurra primero.

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Written informed consent and any locally required authorization obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations.

CI por escrito, así como cualquier autorización local requerida, obtenidos de parte del sujeto/representante legal antes de la realización de todo procedimiento relacionado con el protocolo, incluidas las evaluaciones para la selección.

F.3.3.7

Others

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Nonsterilized male subjects using contraception

Pacientes varones no esterilizados que usen anticonceptivos

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

114

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)

At the conclusion of the study, subjects who continue to demonstrate clinical benefit will be eligible to receive investigational product(s) via the options listed in section 3.1.7 "Post-study Access to Investigational Product (s)" of the protocol.

En el momento de la conclusión del estudio, los sujetos que sigan presentando beneficio clínico serán aptos para recibir el producto en investigación a través de las opciones que figuran en la sección 3.1.7 “Acceso al producto en investigación posterior al estudio” del protocolo.

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

2019-10-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-10-08

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-03-11

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