Clinical Trials Register

Summary
EudraCT Number:	2018-004243-23
Sponsor's Protocol Code Number:	J1S-MC-JV02
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:	2020-01-17
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

2018-004243-23

A.3

Full title of the trial

A Randomized, Open-Label Phase I/II Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with relapsed, Recurrent, or Refractory Synovial Sarcoma.

Estudio de fase 1/2, aleatorizado, sin enmascaramiento, en el que se evalúa ramucirumab en pacientes menores de edad y en adultos jóvenes con sarcoma sinovial recidivante, recurrente o resistente al tratamiento

A.3.1

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

A Study Evaluating Ramucirumab in Children and Young Adults with Synovial Sarcoma.

Estudio en el que se evalúa ramucirumab en niños y adultos jóvenes con sarcoma sinovial.

A.4.1

Sponsor's protocol code number

J1S-MC-JV02

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	Lilly S.A.
B.1.3.4	Country	Spain
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	Eli Lilly and Company
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Eli Lilly Cork Ltd
B.5.2	Functional name of contact point	Clinical Trial Registry Office
B.5.3	Address:
B.5.3.1	Street Address	• Clinical Trial Registry Office
B.5.3.2	Town/ city	Co. Cork
B.5.3.3	Post code	T45 KD39
B.5.3.4	Country	Isle of Man
B.5.4	Telephone number	3491836 29 58
B.5.6	E-mail	ensayosclinicos@lilly.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	Yes
D.2.1.1.1	Trade name	Cyramza 10 mg/ml concentrate for solution for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederland B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Ramucirumab
D.3.2	Product code	LY3009806
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	RAMUCIRUMAB
D.3.9.1	CAS number	947687-13-0
D.3.9.3	Other descriptive name	RAMUCIRUMAB
D.3.9.4	EV Substance Code	SUB32795
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	10
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	Yes
D.2.1.1.1	Trade name	Gemzar
D.2.1.1.2	Name of the Marketing Authorisation holder	Lilly France S.A.S.
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	Gemcitabine
D.3.4	Pharmaceutical form	Powder 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	GEMCITABINE
D.3.9.1	CAS number	95058-81-4
D.3.9.4	EV Substance Code	SUB07892MIG
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	1000
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	Docetaxel Accord 20 mg/ml concentrate
D.2.1.1.2	Name of the Marketing Authorisation holder	Accord Healthcare Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	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	DOCETAXEL
D.3.9.3	Other descriptive name	DOCETAXEL
D.3.9.4	EV Substance Code	SUB12492MIG
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	20
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	Docetaxel-ratiopharm 20 mg/ml Concentrate for Solution for Infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	ratiopharm GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	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	DOCETAXEL
D.3.9.3	Other descriptive name	DOCETAXEL
D.3.9.4	EV Substance Code	SUB12492MIG
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	20
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

Synovial Sarcoma

Sarcoma sinovial

E.1.1.1

Medical condition in easily understood language

Synovial Sarcoma

Sarcoma sinovial

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	10042863
E.1.2	Term	Synovial sarcoma
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

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of ramucirumab in combination with gemcitabine and docetaxel compared with gemcitabine and docetaxel in pediatric and young adult patients with SS (SS = synovial sarcoma).

Comparar la eficacia de ramucirumab en combinación con gemcitabina y docetaxel con la de gemcitabina y docetaxel en el tratamiento de pacientes menores de edad y adultos jóvenes con SS (sarcoma sinovial).

E.2.2

Secondary objectives of the trial

- To evaluate the safety and tolerability of ramucirumab in combination with gemcitabine and docetaxel compared with gemcitabine and docetaxel in pediatric and young adult patients with SS.
- To characterize the PK of ramucirumab when co-administered with gemcitabine and docetaxel in pediatric and young adult patients with SS.
- To assess the immunogenicity of ramucirumab when co-administered with gemcitabine and docetaxel in pediatric and young adult patients with SS.

Comparar la seguridad y la tolerabilidad de ramucirumab en combinación con gemcitabina y docetaxel con la de gemcitabina y docetaxel en el tratamiento de pacientes menores de edad y adultos jóvenes con SS.
- Caracterizar la FC de ramucirumab cuando se administra de forma concomitante con gemcitabina y docetaxel a pacientes menores de edad y adultos jóvenes con SS.
- Evaluar la inmunogenia de ramucirumab cuando se administra de forma concomitante con gemcitabina y docetaxel a pacientes menores de edad y adultos jóvenes con SS.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patients with either relapsed, recurrent, or refractory SS.
- Patients must be >11 kg at the time of study enrollment.
- The patient has a Lansky (<16 years of age; Lansky et al. 1987) or Karnofsky (≥16 years of age; Karnofsky et al. 1948) performance score of at least 50.
- Patients must be 36 months to ≤29 years of age at the time of study enrolment.
- Patients must
•have measurable disease by RECIST 1.1
•have received at least one prior line of systemic treatment (including neoadjuvant and adjuvant chemotherapy) that contains ifosfamide and/or doxorubicin, and any approved therapies for which they are eligible, unless the patient is not a suitable candidate for the approved therapy.
•not be eligible for surgical resection at time of enrollment
- Patients must not have received prior exposure to ramucirumab.
- Patient with adequate laboratory values and hematologic, coagulation, liver, cardiac, renal and bladder function, and adequate blood pressure (BP) control as per protocol.

- Sufrir SS recidivante, recurrente o resistente al tratamiento.
- Los pacientes deben pesar más de 11 kg en el momento del reclutamiento en el estudio.
- Tener una puntuación del estado funcional de al menos 50 en la escala de Lansky (<16 años; Lansky et al. 1987) o en la de Karnofsky (≥16 años; Karnofsky et al. 1948).
- Tener entre 36 meses y ≤29 años de edad en el momento del reclutamiento en el estudio.
- Los pacientes deben:
• presentar enfermedad mensurable de acuerdo con los criterios RECIST 1.1.
• haber recibido al menos una línea previa de tratamiento sistémico (se contabiliza también la quimioterapia neoadyuvante y adyuvante) que incluyera ifosfamida y/o doxorubicina, así como cualquier terapia aprobada para la que el paciente sea tributario, a menos que este no sea un candidato idóneo para la terapia aprobada.
• no ser tributario de una intervención de resección quirúrgica en el momento del reclutamiento.
- Los pacientes no deben haber recibido anteriormente ramucirumab.
- Tener una función hematológica, hepática, cardiaca y renal suficientes, así como una coagulación y un control de la tensión arterial (TA) aceptables, de acuerdo con el protocolo.

E.4

Principal exclusion criteria

- Patients who have had allogeneic bone marrow or solid organ transplant are excluded.
- Patients who have active infections requiring therapy.
- Patients who have a history of fistula, gastrointestinal (GI) ulcer or perforation, or intra-abdominal abscess within 3 months of study enrolment are not eligible.
- Patients with a bowel obstruction, extensive intestinal resection or history or presence of inflammatory enteropathy or other GI pathology as per protocol.
- Patients with a history of hepatorenal syndrome.
- Patients with a known hypersensitivity to ramucirumab , gemcitabine,
docetaxel or agents formulated with Polysorbate 80.
- Patients with evidence of active bleeding or a history of significant (≥
Grade 3) bleeding event, deep vein thrombosis requiring medical
intervention (including pulmonary embolism), hemoptysis or other signs
of pulmonary haemorrhage, or esophageal varices within 3 months of
enrollment are not eligible.
- Patients with a bleeding diathesis or vasculitis are not eligible.
- Patients with a history of central nervous system (CNS) arterial/venous thromboembolic events (VTEs) including transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 6 months of study enrolment are not eligible.
- Patients with myocardial infarction or unstable angina within the prior 6 months.
- Patients with significant vascular disease or peripheral vascular disease.
- Patients with a history of hypertensive crisis or hypertensive encephalopathy within 6 months of study enrolment are not eligible.
- Patients who have non-healing wound, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrolment are not eligible.
- Patients previously treated and progressed on combination gemcitabine or docetaxel. (Patients who received combination as maintenance therapy, without progression, would be eligible.)
- Patients who have previously received any exposure to ramucirumab are not eligible.
- Patients with clinical or radiologic findings consistent with interstitial pneumonia or pulmonary fibrosis.
- Patients with CNS involvement are ineligible.

Se excluirá a los pacientes que hayan recibido un alotrasplante de médula ósea o un trasplante de víscera maciza.
- Pacientes que presenten infecciones activas que requieran tratamiento.
- No se considerarán idóneos los pacientes con antecedentes de fístulas, úlceras o perforaciones gastrointestinales (GI) o abscesos intraabdominales en el transcurso de los 3 meses anteriores al reclutamiento en el estudio.
- Pacientes con obstrucción intestinal, amplia resección intestinal o antecedentes o presencia de enteropatía inflamatoria u otras patologías gastrointestinales, de conformidad con el protocolo.
- Pacientes con antecedentes de síndrome hepatorrenal.
- Pacientes con hipersensibilidad a gemcitabina, docetaxel o a medicamentos que incluyan polisorbato 80.

- No se considerarán idóneos los pacientes con signos de hemorragia activa o antecedentes de episodios hemorrágicos importantes (grado ≥3), trombosis venosa profunda que requiera una intervención médica (incluidos los casos de embolia pulmonar), hemoptisis u otros signos de hemorragia pulmonar o varices esofágicas en el transcurso de los 3 meses anteriores al reclutamiento.
- No se considerarán idóneos los pacientes con diátesis hemorrágica o vasculitis.
- No se considerarán idóneos los pacientes con antecedentes de episodios tromboembólicos venosos/arteriales (ETV/ETA) en el sistema nervioso central, incluidos los casos de accidente isquémico transitorio (AIT) o de accidente cerebrovascular (ACV) en el transcurso de los 6 meses anteriores al reclutamiento en el estudio.
- Pacientes que hayan sufrido un infarto de miocardio o angina de pecho inestable en el transcurso de los 6 meses anteriores.
- Pacientes con vasculopatía o vasculopatía periférica importante.
- No se considerarán idóneos los pacientes con antecedentes de crisis hipertensiva o encefalopatía hipertensiva en el transcurso de los 6 meses anteriores al reclutamiento en el estudio.
- No se considerarán idóneos los pacientes que en el momento del reclutamiento presenten heridas tórpidas, fracturas sin consolidar o consolidadas parcialmente, o fracturas óseas abiertas.
- Pacientes que anteriormente hayan recibido tratamiento politerápico con gemcitabina o doctaxel y hayan sufrido progresión de la enfermedad durante este tratamiento (se considerarán idóneos para participar los pacientes que hayan recibido esta politerapia como tratamiento de mantenimiento y no hayan presentado progresión de la enfermedad).
- No se considerarán idóneos los pacientes que anteriormente hayan recibido ramucirumab.
- Pacientes con manifestaciones clínicas o resultados en las pruebas radiográficas compatibles con neumonía intersticial o fibrosis pulmonar.
- Los pacientes que presenten afectación en el SNC no se considerarán idóneos.

E.5 End points

E.5.1

Primary end point(s)

progression-free survival (PFS)

Supervivencia sin progresión (SSP)

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary analysis will be triggered when PFS events have occurred for approximately 80% of the enrolled patients.

El análisis principal se realizará cuando se hayan observado eventos de SSP aproximadamente en el 80 % de los pacientes reclutados.

E.5.2

Secondary end point(s)

Serious adverse event, Adverse event, Safety laboratory assessments, Vital signs, overall response rate, Duration of response, Complete response, Cmax (maximum concentration), Cmin (minimum concentration) and Incidence of immunogenicity

Acontecimientos adversos graves, acontecimientos adversos, parámetros analíticos de seguridad, constantes vitales, tasa global de respuesta, duración de la respuesta, respuesta completa, Cmáx (concentración máxima) y Cmín (concentración mínima) e incidencia de casos de inmunogenia.

E.5.2.1

Timepoint(s) of evaluation of this end point

Throughout study.

A lo largo del estudio.

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

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)

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

Therapeutic exploratory

Exploratorio terapeutico

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

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

Belgium

France

Germany

Italy

Japan

Netherlands

Spain

United Kingdom

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

LVLS - Last visit or last scheduled procedure for the last patient.

UVUP: última visita o último procedimiento programado del último paciente.

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

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)

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

The patient's parent/guardian, has given written informed consent (and assent, as applicable) and authorization for release of health/information for research prior to any study specific procedures being performed.

El padre o tutor del paciente ha dado su consentimiento informado por escrito (y el asentimiento, si procede) y ha autorizado la divulgación de información médica o para investigación antes de realizar ninguno de los procedimientos del estudio.

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

F.4.2.2

In the whole clinical trial

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)

None

Ninguno

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	The Experimental Cancer Medicine Centres
G.4.3.4	Network Country	United Kingdom
G.4 Investigator Network to be involved in the Trial: 2
G.4.1	Name of Organisation	Children's Oncology Group Operations Center
G.4.3.4	Network Country	United States
G.4 Investigator Network to be involved in the Trial: 3
G.4.1	Name of Organisation	The ECMC Network aims to act as an efficient and effective network that will assist in the delivery of early phase cance

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-12-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-11-22

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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