Clinical Trials Register

Summary
EudraCT Number:	2016-001445-61
Sponsor's Protocol Code Number:	FLO-02
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:	2016-10-26
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

2016-001445-61

A.3

Full title of the trial

Open label, multi-centre, parallel group study to compare the pharmacokinetics (PK), pharmacodynamics (PD) and safety of febuxostat between pediatric patients (>=6<18 years of age) and adults.

Estudio abierto, multicéntrico, de grupos paralelos para comparar la farmacocinética (FC), la farmacodinámica (FD) y la seguridad de febuxostat entre pacientes pediátricos (de >=6 y <18 años de edad) y adultos.

A.3.1

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

A study to compare the pharmacokinetic (Pharmacokinetic is the effect the body has on the drugs) , pharmacodynamic (pharmacodynamic is the effect that drugs have on the body) and safety of Febuxostat between paediatric patients (>=6<18 years of age) and adults.

Un estudio para comparar la farmacocinética (Farmacocinética es el efecto que ejerce el cuerpo sobre los medicamentos), farmacodinámica (Farmacodinámica es el efecto que tienen los medicamentos en el cuerpo) y la seguridad de Febusoxtat entre pacientes pediátricos (>=6 <18 años) y adultos.

A.3.2

Name or abbreviated title of the trial where available

FLORET

A.4.1

Sponsor's protocol code number

FLO-02

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/285/2015

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Menarini Ricerche S.p.A.
B.1.3.4	Country	Italy
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	Menarini Ricerche S.p.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Menarini Ricerche S.p.A.
B.5.2	Functional name of contact point	Corporate Clin Research Directorate
B.5.3	Address:
B.5.3.1	Street Address	Via Sette Santi 1
B.5.3.2	Town/ city	Florence
B.5.3.3	Post code	50131
B.5.3.4	Country	Italy
B.5.4	Telephone number	+34934628 8008266
B.5.6	E-mail	ACapriati@menarini-ricerche.it

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	Adenuric® 120 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Menarini International Operations Luxembourg S.A.
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	Febuxostat
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	FEBUXOSTAT
D.3.9.1	CAS number	144060-53-7
D.3.9.4	EV Substance Code	SUB25382
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	120
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	Adenuric® 80 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Menarini International Operations Luxembourg S.A.
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	Febuxostat
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	FEBUXOSTAT
D.3.9.1	CAS number	144060-53-7
D.3.9.4	EV Substance Code	SUB25382
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	80
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	Febuxostat 20 mg
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Yes
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	FEBUXOSTAT
D.3.9.1	CAS number	144060-53-7
D.3.9.4	EV Substance Code	SUB25382
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	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

Hematological malignancies at intermediate to high risk of Tumor Lysis Syndrome ( TLS) prevention.

Prevención de Síndrome de Lisis Tumoral (SLT) en neoplasias hematológicas con riesgo intermedio o alto.

E.1.1.1

Medical condition in easily understood language

Tumore Lysis Syndrome ( TLS) results from the rapid killing of a large quantity of tumor cells which occurs most often after the start of Chemotherapy in patients with haematologic cancer

El Síndrome de Lisis Tumoral(SLT) produce una rápida destrucción de un alto número de células tumorales que ocurre más frecuentemente al inicio de la quimioterapia en pacientes con cáncer hematológico

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	PT
E.1.2	Classification code	10045170
E.1.2	Term	Tumour lysis syndrome
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

-To assess the pharmacokinetics (PK) of febuxostat in paediatric patients (>=6<18 years of age) and in adults suffering from hematological malignancies at intermediate to high risk of TLS.
-To compare the febuxostat exposure in pediatric patients (>=6<18 years of age) with the one achieved in adults administered with a dose of 120 mg/QD.

- Evaluar la farmacocinética (FC) de febuxostat en pacientes pediátricos (de >=6 y <18 años de edad) y en adultos que padecen neoplasias malignas hematológicas con riesgo entre intermedio y alto de SLT.
- Comparar la exposición a febuxostat en pacientes pediátricos (de >=6 y <18 años de edad) con la alcanzada en adultos tratados con una dosis de 120 mg una vez al día.

E.2.2

Secondary objectives of the trial

-To compare the pharmacodynamics (PD) of febuxostat between pediatric patients (>=6<18 years of age) and adults.
-To evaluate and compare the PK/PD relationship of febuxostat in pediatric patients (>=6<18 years of age) and adults.
-To evaluate the safety of febuxostat between pediatric patients (>=6<18 years of age) and adults.
-To evaluate the occurrence of Laboratory TLS (LTLS) and Clinical TLS (CTLS) according to Cairo and Bishop Criteria
-To assess the age-appropriate formulation acceptability in children.

- Comparar la farmacodinámica (FD) de febuxostat en pacientes pediátricos (de >=6 y <18 años de edad) y adultos.
- Evaluar y comparar la relación entre la FC y la FD de febuxostat en pacientes pediátricos (de >=6 y <18 años de edad) y adultos.
- Evaluar la seguridad de febuxostat en pacientes pediátricos (de >=6 y <18 años de edad) y adultos.
- Evaluar la aparición de SLT analítico (SLTA) y SLT clínico (SLTC) conforme a los criterios de Cairo y Bishop
- Evaluar la aceptabilidad de la formulación apropiada para la edad en niños.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients meeting ALL the following criteria will be eligible to enter the study:

1.male and female children of 6 to less than 12 years of age, adolescents of 12 to less than 18 years of age, and adults:
a.scheduled for first cytotoxic chemotherapy cycle, regardless of the line of treatment, because of hematologic malignancies, and
b.at intermediate or high risk for TLS, and
c.with serum uric acid (sUA) levels < 10 mg/dL at Visit 1 (Day 1), and
d.with no access to rasburicase;

2.Karnofsky performance status (KPS) of 100 to 30 for patients aged 16 years and older; Lansky Play performance status (LPS) of 100 to 30 for patients aged less than 16 years;

3.A female of childbearing potential may be enrolled providing she:
- has a negative pregnancy test during screening period and
- is routinely using a highly effective method of birth control resulting in a failure rate of less than 1% per year when used consistently and correctly (e.g. combined [estrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only containing hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or total sexual abstinence) until 6 months from the last study drug administration. ;

4.informed consent before any study-related procedures obtained by patient for adults or by patient’s parents (one or both according to local regulation) or legal guardian for children and adolescents;

5.life expectancy >1 month.

Podrán participar en el estudio los pacientes que cumplan TODOS los criterios siguientes:

1. Niños de ambos sexos de 6 a menos de 12 años, adolescentes de 12 a menos de 18 años y adultos:
a. Primer ciclo de quimioterapia citotóxica programado, con independencia de la línea de tratamiento, por neoplasias malignas hematológicas.
b. Riesgo intermedio o alto de SLT.
c. Concentración sérica de ácido úrico (AUs) < 10 mg/dl en la visita 1 (día 1).
d. Sin acceso a rasburicasa.

2. Estado funcional de Karnofsky (EFK) de 100 a 30 para pacientes de 16 o más años de edad; estado funcional (rendimiento en el juego) de Lansky (EFL) de 100 a 30 para pacientes de menos de 16 años de edad.

3. Las mujeres en edad fértil podrán participar si:
- dan negativo en una prueba de embarazo durante el período de selección y
- utilizan de forma habitual un método anticonceptivo muy eficaz con un índice de fallos inferior al 1 % anual cuando se utiliza de forma sistemática y correcta (p. ej., anticonceptivos hormonales combinados [con estrógenos y progestágenos] asociados a la inhibición de la ovulación [orales, intravaginales, transdérmicos], anticonceptivos hormonales solo de progestágeno asociados a la inhibición de la ovulación [orales, inyectables, implantables], dispositivo intrauterino, sistema intrauterino de liberación de hormonas, ligadura de trompas bilateral, vasectomía de la pareja o abstinencia sexual total) hasta 6 meses después de la última administración del fármaco del estudio.

4. Obtención del consentimiento informado del paciente, si es adulto, o de los progenitores (uno o ambos, según la normativa local) o un tutor legal, en el caso de niños y adolescentes, antes de comenzar con los procedimientos relacionados con el estudio.

5. Esperanza de vida >1 mes.

E.4

Principal exclusion criteria

Patients will not be eligible to participate in the study if they meet ANY of the following exclusion criteria:

1.patients known to be hypersensitive to febuxostat or to any components of the formulation;
2.patients with hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactase malabsorption;
3.pregnant or breastfeeding women;
4.patients receiving febuxostat or any other urate-lowering therapy (e.g. allopurinol, rasburicase, probenecid) within 30 days prior to Visit 1 (Day 1);
5.patients receiving mercaptopurine and azathioprine within 14 days prior to Visit 1 (Day 1);
6.patients with severe renal insufficiency;
7.patients with severe hepatic insufficiency;
8.patients with diagnosis of Laboratory TLS (LTLS) or Clinical TLS (CTLS) at Visit 1 (Day 1).
9.Patients receiving any other investigational agent within 30 days prior to study Visit 1 (Day 1).

No podrán participar en el estudio los pacientes que cumplan ALGUNO de los criterios de exclusión siguientes:

1. Hipersensibilidad conocida a febuxostat o a alguno de los componentes de la formulación.
2. Problemas hereditarios de intolerancia a la galactosa, alactasia lapona o malabsorción de glucosa-galactosa.
3. Mujeres embarazadas o en período de lactancia.
4. Tratamiento con febuxostat o cualquier otro medicamento hipouricemiante (p. ej., alopurinol, rasburicasa, probenecid) en los 30 previos a la visita 1 (día 1).
5. Tratamiento con mercaptopurina y azatioprina en los 14 previos a la visita 1 (día 1).
6. Insuficiencia renal grave.
7. Insuficiencia hepática grave.
8. Diagnóstico de SLT analítico (SLTA) o SLT clínico (SLTC) en la visita 1 (día 1).
9. Tratamiento con otro fármaco en investigación en los 30 días previos a la visita 1 (día 1).

E.5 End points

E.5.1

Primary end point(s)

Pharmacokinetic endpoints derived from the study will include:
Primary PK parameters: CL/F, Vd/F and Ka.
Derived PK parameters: AUC and Cmax.

Los criterios de valoración farmacocinéticos derivados del estudio son:
Parámetros FC principales: CL/F, Vd/F y Ka.
Parámetros FC derivados: AUC y Cmáx.

E.5.1.1

Timepoint(s) of evaluation of this end point

Blood samples will be collected on Visits 2, 3, 4, 5, 6, 7 and 8 (i.e., after the first treatment administration and on each following visit until the Evaluation Visit).
Four additional blood samples are required for each patient on Visit 7 (Day 7) at the selected sampling intervals: 0.5-2 hours, 2-4 hours, 4-6 hours and 6-8 hours post study drug intake.

Las muestras de sangre se recogerán en las Visitas 2, 3, 4, 5, 6, 7 y 8 (es decir, después del la primera administración de tratamiento y en cada visita subsiguiente hasta la Visita de Evaluación).
Se requerirán 4 muestras de sangre adicionales para cada paciente en la Visita 7 (Día 7) en los siguientes intervalos: 0.5-2 horas, 2-4 horas, 4-6 horas y 6-8 horas después de la toma de medicación

E.5.2

Secondary end point(s)

Pharmacodynamic endpoint:
1. Area under the curve of sUA from baseline (Visit 1, Day 1) to the Evaluation Visit (Visit 8, Day 8) (AUC sUA 1-8) based on central laboratory results.

PK/PD endpoint:
2.The PK/PD relationship will be evaluated based on sUA levels and febuxostat exposure.

Clinical endpoints:
3. Incidence of Laboratory TLS (LTLS) from Start of Chemotherapy (Visit 3, Day 3) to the Evaluation Visit (Visit 8, Day 8), based on local laboratory results.
-Incidence and grading of Clinical TLS (CTLS) from Start of Chemotherapy (Visit 3, Day 3) to the Evaluation Visit (Visit 8, Day 8) based on local laboratory results.

Safety endpoints:
4.Incidence, severity (both through Mild/Moderate/Severe scale and NCI-CTCAE grade), seriousness and treatment causality of Treatment-Emergent Signs and Symptoms (TESS).
-Frequency of clinically significant abnormalities in physical examination, safety laboratory tests, vital signs and 12 Lead ECG.
-Change in PS according to Karnofsky/Lansky scales.

5. Acceptability assessment of the age-appropriate formulation only for children.

Criterio de valoración farmacodinámico:
1. Área bajo la curva del AUs desde el momento basal (visita 1, día 1) hasta la visita de evaluación (visita 8, día 8) (AUC AUs1-8) basado en los resultados del laboratorio central.

Criterio de valoración FC/FD:
2. Se evaluará la relación entre la FC y la FD con base en las concentraciones de AUs y la exposición a febuxostat.

Criterios de valoración clínicos:
3. Incidencia de SLT analítico (SLTA) desde el inicio de la quimioterapia (visita 3, día 3) hasta la visita de evaluación (visita 8, día 8), con base en los resultados del laboratorio local.
- Incidencia y grado de SLT clínico (SLTC) desde el inicio de la quimioterapia (visita 3, día 3) hasta la visita de evaluación (visita 8, día 8), con base en los resultados del laboratorio local.

Criterios de valoración de la seguridad:
4. Incidencia, intensidad (tanto en la escala de leve-moderado-intenso como el grado según los CTCAE del NCI), gravedad y la relación causal entre el tratamiento y los Signos y Síntomas Surgidos durante el Tratamiento (SSST).
- Frecuencia de anomalías clínicamente importantes en la exploración física, las pruebas analíticas de seguridad, las constantes vitales y el ECG de 12 derivaciones.
- Variación del EF según las escalas Karnofsky y Lansky.

5. Evaluación de la aceptabilidad de la formulación apropiada para la edad (únicamente en los niños).

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Blood samples for sUA analysis will be performed from Visits 1 to 8 (i.e., before 1st drug intake, on each following visit until the Evaluation Visit).
2. PK/PD timepoints are the same of both primary endpoint and the pharmacodynamic timepoints.
3. From start of treatment (day 1) to the end of study visit 10 (day 14±2)
4. From start of chemotherapy (day 3) to evaluation visit (day 8)
5. From start of treatment (day 1) to visit 7 (day 7 ) or 9 (day 9) based on investigator's judgment.

1. Las muestras de sangre para el análisis de UAs serán realizadas desde la Visita 1 hasta la Visita 8 (es decir, antes de la primera toma de medicación, en cada visita subsiguiente hasta la Visita de Evaluación)
2. Los Criterios de valoración FC/FD son los mismos que el del criterio de valoración primario y criterios de valoración farmacodinámicos.
3. Desde el inicio del tratamiento (día 1) hasta la visita de final del estudio, visita 10 (día 14±2)
4. Desde el inicio de la quimioterapia (día 3) hasta la visita de evaluación (día 8)
5. Desde el inicio del tratamiento (día 1) hasta la visita 7 (día 7) o 9 (día 9) basado en el juicio del investigador

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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)

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

To assess the PK and PD of febuxostat in pediatric patients (>=6<18 years of age).

Evaluar la FC y FD de febuxostat en paciente pediátricos (>=6<18 años de edad).

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

E.8.1.1

Randomised

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

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

Bulgaria

Croatia

Czech Republic

Hungary

Italy

Russian Federation

Spain

United Kingdom

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

Última Visita 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)

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

Paediatric population from 6 to less than 18 years of age.

Población pediátrica desde 6 hasta menos de 18 años de edad

F.3.3.7

Others

Information not present in EudraCT

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

100

F.4.2.2

In the whole clinical trial

120

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)

After the completetion of the trial participation, a standard TLS prevention treatment could be applied during the following
chemotherapy cycles, as per standard local clinical practice.

Después de la terminación de la participación en el estudio, se puede administrar el tratamiento de práctica habitual para la prevención del SLT tras los ciclos de quimioterapia.

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

2017-01-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-12-13

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2018-07-25

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