Clinical Trials Register

Summary
EudraCT Number:	2015-001633-24
Sponsor's Protocol Code Number:	D419BC00001
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2015-11-23
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

Spain - AEMPS

A.2

EudraCT number

2015-001633-24

A.3

Full title of the trial

A Phase III, Randomized, Open-label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 Monotherapy and MEDI4736 in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Unresectable Stage IV Urothelial Bladder Cancer

Ensayo fase III, aleatorizado, abierto, controlado, multicéntrico,
internacional, de MEDI4736 en monoterapia y MEDI4736 en combinación
con tremelimumab frente a tratamiento de referencia con quimioterapia
como primera línea en pacientes con cáncer de vejiga urotelial irresecable en estadio IV.

A.3.1

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

Study of First Line MEDI4736 with or without Tremelimumab versus Standard of Care Chemotherapy in Advanced Unresectable Urothelial Bladder Cancer

Estudio de MEDI4736 en monoterapia y MEDI4736 en combinación
con tremelimumab frente a tratamiento de referencia con quimioterapia
como primera línea en pacientes con cáncer de vejiga urotelial irresecable.

A.4.1

Sponsor's protocol code number

D419BC00001

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	AstraZenenca 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 Farmacéutica Spain, S.A.
B.5.2	Functional name of contact point	Unidad de Investigación Clínica
B.5.3	Address:
B.5.3.1	Street Address	C/ Serrano Galvache, 56; Parque Norte
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28033
B.5.3.4	Country	Spain
B.5.4	Telephone number	900200444
B.5.6	E-mail	informacionEECC-Spain@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	MEDI4736
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.3.10	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	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.2.1.1.1	Trade name	Gemcitabine
D.2.1.1.2	Name of the Marketing Authorisation holder	Activis Group PTC ehf.
D.2.1.2	Country which granted the Marketing Authorisation	Iceland
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	g gram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.2 to 2
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	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.2.1.1.1	Trade name	Cisplatin
D.2.1.1.2	Name of the Marketing Authorisation holder	Hospira UK 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	Cisplatin
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	CISPLATIN
D.3.9.3	Other descriptive name	CISPLATIN
D.3.9.4	EV Substance Code	SUB07483MIG
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	1
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.2.1.1.1	Trade name	Carboplatin
D.2.1.1.2	Name of the Marketing Authorisation holder	Hospira UK 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	Carboplatin
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	CARBOPLATIN
D.3.9.2	Current sponsor code	41575-94-4
D.3.9.3	Other descriptive name	CARBOPLATIN
D.3.9.4	EV Substance Code	SUB06614MIG
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	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	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	Tremelimumab
D.3.2	Product code	MEDI1123
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	Tremelimumab
D.3.9.1	CAS number	745013-19-6
D.3.9.2	Current sponsor code	MEDI1123
D.3.9.3	Other descriptive name	MEDI1123
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	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

Adult patients (age > o = 18 years) with histologically or cytologically documented transitional cell carcinoma (transitional cell and mixed transitional/non transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra), unresectable Stage IV (ie, ?T4bN0M0 for bladder), and who are chemotherapy-naïve.

Pacientes adultos (edad > o = 18 años) con carcinoma de células transicionales (histologías de células transicionales o mixtas de células transicionales/no transicionales) documentado histológicamente o citológicamente, irresecable, en estadio IV (esto es, T4b, cualquier N; o
cualquier T, N2-N3; o M1) del urotelio (incluidos la pelvis renal, los uréteres, la vejiga urinaria y la uretra), que no han sido tratados previamente con quimioterapia de primera línea.

E.1.1.1

Medical condition in easily understood language

Urothelial Bladder Cancer

Cáncer de vejiga

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	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10022880
E.1.2	Term	Invasive bladder cancer stage IV
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

To assess PFS of MEDI4736 in combination with tremelimumab to standard of care (SoC) chemotherapy

Evaluar la eficacia del tratamiento de combinación de MEDI4736 + tremelimumab en comparación con el TdR en términos de
SLP en pacientes con CVU

E.2.2

Secondary objectives of the trial

1, To assess PFS of MEDI4736+tremelimumab to SoC chemotherapy, and to monotherapy in patients with PD-L1-negative. 2, To assess OS of MEDI4736 + tremelimumab to SoC chemotherapy. 3, To assess PFS of MEDI4736 monotherapy to SoC chemotherapy. 4. To further assess ORR of MEDI4736 + tremelimumab to SoC chemotherapy. 5, To assess disease-related symptoms in terms of FACT-BL. 6, To assess the PK of MEDI4736 monotherapy and MEDI4736 + tremelimumab. 7, To investigate the immunogenicity of monotherapy and MEDI4736+tremelimumab. 8, To assess the safety and tolerability in terms of AEs.

1. Evaluar la eficacia del tto. de combinación de MEDI4736 + treme. en comparación con MEDI4736 en monot. en términos de SLP en pac. con CVU negativo para PD-L1
2. Evaluar la eficacia del tto. de comb. de MEDI4736 + treme. en comp. con el TdR en términos de SG en pac. con CVU.
3. Evaluar la eficacia de MEDI4736 en monot. en comp. con el TdR en términos de SLP en pacientes con CVU
4. Evaluar la eficacia de MEDI4736 en monot. en comp. con el TdR en términos de SLP en pac. con CVU.
5. Evaluar los síntomas relacionados con la enf. y la CdVRS en pac. con CVU tratados con MEDI4736 en monot.a y con tto. de comb. de MEDI4736 + treme. en comp. con el TdR y entre sí usando el cuestionario FACT-BL
6. Evaluar la FC de MEDI4736 en monot. y el tto. de comb. de MEDI4736 + treme.
7. Investigar la inmunog. de MEDI4736 en monot. y del tto. de comb. de MEDI4736 + treme.
8. Evaluar el perfil de seg.y tolerab. de MEDI4736 en monot. y del tto. de comb. de MEDI4736 + treme. en comparación con el TdR

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1, Patients with histologically or cytologically documented, unresectable, Stage IV transitional cell carcinoma of the urothelium who have not been previously treated with first-line chemotherapy.
2, Patients eligible or ineligible for cisplatin-based chemotherapy. Cisplatin ineligibility is defined as meeting 1 of the following criteria: ? Creatinine clearance (calculated or measured) <60 mL/min ? Common Terminology Criteria for Adverse Events (CTCAE) Grade ?2 audiometric hearing loss ? CTCAE Grade 2 peripheral neuropathy ? New York Heart Association Class III heart failure.
3, Tumor PD-L1 status, with IHC assay confirmed by a reference laboratory, must be known prior to randomization.

1. Pacientes con carcinoma de células transicionales (histologías de células transicionales y mixta de células transicionales/no transicionales) documentado histológicamente o citológicamente, irresecable, en estadio IV del urotelio, que no han recibido tratamiento previo con quimioterapia de primera línea.
2. Pacientes elegibles o inelegibles para quimioterapia basada en cisplatino. La inelegibilidad para el cisplatino se define como el cumplimiento de 1 de los criterios siguientes: - Aclaramiento de creatinina (calculado o medido) <60 ml/min. - Pérdida auditiva audiométrica de grado > o =2 de los Criterios de Terminología
Común para Acontecimientos Adversos (CTCAE).
- Neuropatía periférica de grado 2 de los CTCAE. - Insuficiencia cardíaca de clase III de la New York Heart Association.
3. Debe conocerse el estado de PD-L1 en el tumor, con ensayo de IHQ confirmado por un laboratorio de referencia, antes de la aleatorización.

E.4

Principal exclusion criteria

1, Prior exposure to immune-mediated therapy, including but not limited to, other anti CTLA 4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, including therapeutic anticancer vaccines.
2, History of allogenic organ transplantation that requires use of immunosuppressive agents.
3, Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment. The following are exceptions to this criterion: ? Patients with vitiligo or alopecia ? Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement of psoriasis not requiring systemic treatment.
4, Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have a CT/ MRI of the brain prior to study entry.
5, Active infection including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
6, Current or prior use of immunosuppressive medication within 14 days before the first dose of MEDI4736 or tremelimumab. The following are exceptions to this criterion: ? Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection), ? Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent, ? Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
7, Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IP.

1. Exposición previa a tratamiento mediado por el sistema inmunitario (a excepción del bacilo de Calmette Guerin, BCG), incluidos, entre otros, anticuerpos anti-CTLA-4, anti-PD-1, anti-PD-L1 o anti-PD-L2 y vacunas oncológicas terapéuticas.
2. Antecedentes de trasplante alogénico de órganos que requiere el uso de agentes inmunosupresores.
3. Trastornos autoinmunitarios o inflamatorios documentados, activos o previos dentro de los 3 últimos años antes del comienzo del tratamiento. Lo siguiente son excepciones a este criterio:
- Pacientes con vitíligo o alopecia.
- Pacientes con hipotiroidismo (p. ej., posterior a síndrome de Hashimoto) estable con sustitución hormonal o psoriasis que no precise tratamiento sistémico.
4. Metástasis cerebrales o compresión de la médula espinal. Los pacientes con sospecha de metástasis cerebrales en la selección deben someterse a TC/RM del cerebro antes de la entrada en el ensayo.
5. Infección activa, incluidas infección por hepatitis B, hepatitis C o el virus de la inmunodeficiencia humana (VIH).
6. Uso actual o previo de medicamentos inmunosupresores dentro de los 14 días previos a la primera dosis de MEDI4736 o tremelimumab. Lo siguiente son excepciones a este criterio:
- Esteroides intranasales, inhalados o tópicos o inyecciones locales de esteroides (p. ej., inyección intraarticular)
- Corticosteroides sistémicos a dosis fisiológicas que no superen los 10 mg/día de prednisona o su equivalente
- Esteroides como premedicación para reacciones de hipersensibilidad (p. ej., premedicación para TC)
7. Recepción de una vacuna atenuada viva dentro de los 30 días previos a la primera dosis del PI. Nota: los pacientes, si son reclutados, no deben recibir vacunas vivas durante el ensayo y hasta 30 días después de la última dosis del PI.

E.5 End points

E.5.1

Primary end point(s)

Progression-free survival

Supervivencia libre de progresión

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to 3 years

Hasta los 3 años

E.5.2

Secondary end point(s)

1, Overall survival. 2, OS24. 3, Proportion of patients alive and progression-free at 12 months. 4, Objective response rate. 5, Duration of response. 6, Disease control rate. 7, Best objective response.

1. Supervivencia global
2.SG24
3. Proporción de pacientes vivos y libres de progresión a los 12 meses desde la aleatorización
4. Tasa de respuesta objetiva
5. Duración de la respuesta
6. Tasa de control de la enfermedad
7. Mejor respuesta objetiva

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline to the end of treatment

Desde el incio hasta el final del tratamiento.

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

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

Belgium

Brazil

Canada

Denmark

France

Germany

Israel

Italy

Japan

Korea, Republic of

Mexico

Netherlands

Poland

Russian Federation

Spain

Taiwan

Turkey

United Kingdom

United States

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

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

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:

300

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

225

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

239

F.4.2.2

In the whole clinical trial

525

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 end of treatment with study drug, patients should be managed according to local standard of care.

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

2015-11-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-11-10

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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