Clinical Trials Register

Summary
EudraCT Number:	2014-004281-25
Sponsor's Protocol Code Number:	MLN1117-1501
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:	2015-06-15
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

2014-004281-25

A.3

Full title of the trial

A Phase 1b/Adaptive Phase 2 Study of Docetaxel With or Without MLN1117 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Estudio fase Ib/adaptativo de fase II, de docetaxel con o sin MLN1117 en pacientes con cáncer de pulmón no microcítico localmente avanzado o metastásico

A.3.1

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

A Phase 1b/Adaptive Phase 2 Study of Docetaxel With or Without MLN1117 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Estudio fase Ib/adaptativo de fase II, de docetaxel con o sin MLN1117 en pacientes con cáncer de pulmón no microcítico localmente avanzado o metastásico

A.4.1

Sponsor's protocol code number

MLN1117-1501

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02393209

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	Millennium Pharmaceuticals, Inc.
B.1.3.4	Country	United States
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	Millennium Pharmaceuticals, Inc.
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	Millennium Pharmaceuticals, Inc.
B.5.2	Functional name of contact point	Hess Sue
B.5.3	Address:
B.5.3.1	Street Address	40 Landsdowne Street
B.5.3.2	Town/ city	Cambridge
B.5.3.3	Post code	02139
B.5.3.4	Country	United States
B.5.4	Telephone number	-
B.5.6	E-mail	HaeSuk.Suh@takeda.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	MLN1117
D.3.2	Product code	MLN1117
D.3.4	Pharmaceutical form	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	MLN1117
D.3.9.2	Current sponsor code	MLN1117
D.3.9.3	Other descriptive name	MLN1117
D.3.9.4	EV Substance Code	SUB126088
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	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	MLN1117
D.3.2	Product code	MLN1117
D.3.4	Pharmaceutical form	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	MLN1117
D.3.9.2	Current sponsor code	MLN1117
D.3.9.3	Other descriptive name	MLN1117
D.3.9.4	EV Substance Code	SUB126088
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	300
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	Docetaxel-Actavis
D.2.1.1.2	Name of the Marketing Authorisation holder	Actavis 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	docetaxel
D.3.2	Product code	docetaxel
D.3.4	Pharmaceutical form	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.3.9.1	CAS number	1268454-23-4
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

non-small cell lung cancer (NSCLC)

cáncer de pulmón no microcítico (CPNM)

E.1.1.1

Medical condition in easily understood language

non-small cell lung cancer (NSCLC)

cáncer de pulmón no microcítico (CPNM)

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	18.0
E.1.2	Level	PT
E.1.2	Classification code	10059515
E.1.2	Term	Non-small cell lung cancer metastatic
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Phase 2: To evaluate progression-free survival (PFS) as the primary efficacy measure of MLN1117 plus docetaxel versus docetaxel alone in patients with advanced NSCLC

? Evaluar la supervivencia sin progresión (SSP) como criterio principal de valoración de la eficacia de MLN1117 más docetaxel en comparación con docetaxel en monoterapia en pacientes con CPNM avanzado

E.2.2

Secondary objectives of the trial

PHASE 2:
- To evaluate the safety and tolerability of MLN1117 plus docetaxel administered to patients with NSCLC
- To evaluate the PK of MLN1117 when administered with docetaxel
- To evaluate additional efficacy measures, such as response rate (RR), disease control rate, response duration, time to progression (TTP), and OS, of MLN1117 plus docetaxel versus docetaxel alone in patients with NSCLC
- To evaluate PFS and additional efficacy measures of MLN1117 plus docetaxel versus docetaxel alone in different populations of patients with NSCLC, such as patients with squamous NSCLC versus nonsquamous NSCLC, and patients with
squamous NSCLC with or without PIK3CA mutation and/or amplification (MUT/AMP)

FASE 2:
? Evaluar la seguridad y la tolerabilidad de MLN1117 más docetaxel administrado a pacientes con CPNM
? Evaluar la farmacocinética (FC) de MLN1117 cuando se administra con docetaxel
? Evaluar criterios de valoración de la eficacia adicionales tales como la tasa de respuesta, la tasa de control de la enfermedad, la duración de la respuesta, el tiempo hasta la progresión y la supervivencia general (SG) de MLN1117 más docetaxel en comparación con docetaxel en monoterapia en pacientes con CPNM
? Evaluar la SSP y los criterios de valoración de la eficacia adicionales de MLN1117 más docetaxel en comparación con docetaxel en monoterapia en distintas poblaciones de pacientes con CPNM, tales como pacientes con CPNM escamoso en comparación con pacientes con CPNM no escamoso y pacientes con CPNM escamoso con o sin mutación y/o amplificación de PIK3CA (MUT/AMP)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

?Has a histologically and/or cytologically confirmed diagnosis of NSCLC (squamous or nonsquamous).
?For Phase 2, has a diagnosis of mixed squamous and nonsquamous (or adenosquamous) NSLC.
?Has locally advanced or metastatic disease (Stage IIIb or Stage IV) with radiographically or clinically evaluable lesions.
?Has experienced failure of at least 1 prior chemotherapy regimen.
?For Phase 2, has received 1 prior platinum-based chemotherapy regimen (excluding a docetaxel-containing regimen) for advanced or metastatic (Stage IIIb or Stage IV) disease followed by documented progressive disease.
?For Phase 1b, has experienced failure of multiple lines of prior chemotherapy.
?For Phase 2, has archived or fresh tumor biopsy samples obtained during screening sufficient for genotyping.
?Has adequate organ function, before the first dose of study drug.
?Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
?Female participants who are postmenopausal for at least 1 year before the screening visit or are surgically sterile, or are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or agree to practice true abstinence.
?Male participants agree to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of study drug, or agree to practice true abstinence.
?Has suitable venous access for the study-required blood sampling.
?Has recovered (ie, <= Grade 1 toxicity or eligibility per this protocol is met) from the reversible effects of prior anticancer therapy.

? Los pacientes deben presentar un diagnóstico confirmado histológica y/o citológicamente de CPNM (escamoso o no escamoso).
? Para la Fase 2 o Se aceptará a pacientes con diagnóstico de CPNM mixto escamoso y no escamoso (o adenoescamoso).
? Los pacientes deben presentar enfermedad localmente avanzada o metastásica (estadio IIIb o IV) con lesiones evaluables radiográfica o clínicamente
? Los pacientes deben haber experimentado el fracaso de 1 pauta anterior de quimioterapia como mínimo
? Para la Fase 2 Los pacientes deben haber recibido 1 pauta anterior de quimioterapia basada en platino (excluyendo aquellas con docetaxel) para tratar la enfermedad avanzada o metastásica (estadio IIIB o IV), seguida de PE documentada
? Para la Fase 1b Los pacientes que hayan experimentado un fracaso de varias líneas de quimioterapias anteriores son aptos
? Para la Fase 2 El paciente debe disponer de muestras de biopsia tumoral recién obtenida o de archivo obtenidas durante la selección y suficientes para la genotipificación
? Los pacientes deben tener una funcionalidad orgánica adecuada antes de la primera dosis del fármaco del estudio
? Estado general según la escala del Grupo Oncológico Cooperativo del Este (ECOG) de 0 o 1
? Las mujeres participantes que lleven siendo posmenopáusicas al menos desde 1 año antes de la visita de selección o que hayan sido esterilizadas quirúrgicamente o si tienen capacidad reproductiva, que acepten el uso de 2 métodos anticonceptivos eficaces al mismo tiempo desde el momento de firmar el formulario de consentimiento informado y hasta 30 días después de la administración de la última dosis del fármaco del estudio o acepten la práctica de una abstinencia verdadera
? Para participantes varones que acepten utilizar métodos anticonceptivos eficaces de barrera durante todo el periodo de tratamiento del estudio y durante los 30 días posteriores a la última dosis del fármaco del estudio o acepten la práctica de una abstinencia verdadera
? Acceso venoso adecuado para la toma de muestras de sangre necesarias para el estudio
? Recuperado (es decir, ?toxicidad de grado 1 o cumplir con los criterios de aptitud de este protocolo) de los efectos reversibles de tratamientos antineoplásicos anteriores

E.4

Principal exclusion criteria

?Previous treatment with a PI3K or AKT inhibitor.
?Prior cancer therapy or other investigational therapy within 2 weeks before the first administration of study drug or failed to recover from the reversible effects of prior anticancer therapies. For prior therapies with a half-life longer than 3 days, the interval must be at least 28 days before the first administration of study drug, and the patient must have documented progressive disease.
?Has poorly controlled diabetes mellitus defined as HbA1c > 6.5%.
?Has taken strong inhibitors or strong inducers of CYP3A4 within 14 days before the first dose of study drug.
?Has taken histamine-H2 receptor antagonists and/or neutralizing antacids within 24 hours before the first administration of study drug.
?Has taken proton pump inhibitors within 7 days before the first administration of study drug.
?Has any clinically significant co-morbidities.
?Has acute myocardial infarction within 6 months before starting study drug, current or history of New York Heart Association Class III or IV heart failure, Evidence of current uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or ECG evidence of acute ischemia or active conduction system abnormalities, Fridericia's corrected QT interval > 475 milliseconds (msec) (males) or > 450 msec (females) on a 12-lead ECG during the Screening period, or abnormalities on 12-lead ECG including, but not limited to, changes in rhythm and intervals that in the opinion of the investigator are considered to be clinically significant.
?Has known, previously diagnosed human immunodeficiency virus infection or active chronic hepatitis B or C.
?Has brain metastasis, except for those patients who have completed definitive therapy, are not on steroids, have a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids, and do not have neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
?Has active secondary malignancy that requires treatment.
?Has any serious medical or psychiatric illness, including drug or alcohol abuse.
?Male participants who intend to donate sperm during the course of this study or 12 weeks after receiving their last dose of study drug.
?Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before administration of the first dose of study drug

? Tratamiento anterior con algún inhibidor de PI3K o AKT.
? Tratamiento antineoplásico anterior u otro tratamiento en investigación en las 2 semanas anteriores a la primera administración del fármaco del estudio, o fracaso en la recuperación de los efectos reversibles de tratamientos antineoplásicos anteriores. En el caso de los tratamientos anteriores con una semivida superior a los 3 días, el intervalo debe ser de un mínimo de 28 días antes de la primera administración del fármaco del estudio y el paciente debe tener PE documentada.
? Diabetes mellitus mal controlada, definida por HbA1c > 6,5 %
? El paciente ha tomado inhibidores potentes o inductores potentes del CYP3A4 en los 14 días anteriores a la primera dosis del fármaco del estudio (consultar el apartado 14.3).
? El paciente ha tomado antagonistas de receptores H2 de histaminas y/o antiácidos neutralizantes en las 24 horas anteriores a la primera administración del fármaco del estudio.
? El paciente ha tomado inhibidores de la bomba de protones en los 7 días anteriores a la primera administración del fármaco del estudio.
? El paciente presenta comorbilidades clínicamente significativas
? Los pacientes con alguna de las afecciones cardiovasculares en los 6 meses anteriores al comienzo con el fármaco del estudio. Historial actual o antecedentes de insuficiencia cardíaca de clase III o IV según la Asociación Cardiológica de Nueva York Indicio de afecciones cardiovasculares actuales no controladas, lo que incluye arritmias cardíacas, angina de pecho, hipertensión pulmonar o indicio electrocardiográfico de isquemia aguda o anomalías activas del sistema de conducción. Intervalo QT corregido de Fridericia > 475 milisegundos (ms) (hombres) o > 450 ms (mujeres) en un ECG de 12 derivaciones durante el periodo de selección. Anomalías en los ECG de 12 derivaciones, incluidas, entre otras, cambios en ritmo e intervalos, que en opinión del investigador se consideren clínicamente significativas.
? Infección por el virus de la inmunodeficiencia humana conocida y diagnosticada anteriormente o hepatitis B o C crónica activa
? El paciente sufre metástasis cerebral, salvo aquellos pacientes que han finalizado un tratamiento definitivo; no toma esteroides; tiene un estado neurológico estable durante al menos 2 semanas después de la finalización del tratamiento definitivo y la toma de esteroides, y no padece una disfunción neurológica que pueda llevar a confusión en la evaluación de los AA neurológicos y otros AA
? Pacientes con una alguna otra enfermedad que requiera tratamiento
? Cualquier enfermedad clínica o psiquiátrica grave, alcoholismo y drogadicción incluidos
? Pacientes masculinos que tengan la intención de donar esperma durante el transcurso del estudio o 12 semanas después de recibir su última dosis del fármaco del estudio
? Pacientes de sexo femenino que estén en periodo de lactancia materna, que den positivo en una prueba de embarazo en suero durante el periodo de selección o en una prueba de embarazo en orina en el día 1 antes de la administración de la primera dosis del fármaco del estudio

E.5 End points

E.5.1

Primary end point(s)

Progress-Free Survival

Surpervivencia sin progresión

E.5.1.1

Timepoint(s) of evaluation of this end point

DLTs, MTD, and RP2D may occur at any time.
PFS data will be collected during the posttreatment follow-up period of up to 6 months after the last dose of study drug

TLD, DMT y DRF2 pueden ocurrir en cualquier momento
Los datos de SSP serán recogidos durante el periodo de 6 meses de seguimiento post-tratamiento después de la última doses de la medicación en estudio

E.5.2

Secondary end point(s)

Endpoints for phase 2

- Safety:
o Vital signs
o Physical examination findings
o 12-lead ECG
o Clinical laboratory test results
o AEs and SAEs
- Response rate (complete response [CR] + partial response [PR]), disease control rate (CR + PR + stable disease [SD]), duration of response (DOR), and TTP
- Overall Survival
- MLN1117 plasma concentrations when administered 1 day after docetaxel
- Exploratory endpoints
o Correlation between PIK3CA and/or other mutations detected in circulating tumor DNA and tumor tissue DNA
o Correlation between the amount of and allelic frequencies of PIK3CA and/or othermutations detected in circulating tumor DNA and clinical response
o Genetic polymorphisms in genes encoding drug metabolizing enzymes and/or transporters on the PK of MLN1117 and/or in genes related to clinical response and/or study drug-related toxicity
o HRQOL, physical functioning, and other effects of the disease and/or therapy as measured by the PRO instruments the EORTC QLQ-C30(1, 2) and the EORTC QLQLC-13(3)

- Seguridad:
Signos vitales
Hallazgos de la exploración física
ECG de 12 derivaciones
Resultados de las pruebas de laboratorio clínico
AA y AAG
Tasa de control de la enfermedad tasa de respuesta (respuesta completa [RC] + respuesta parcial [PR]), (CR + PR + enfermedad estable [DE]), duración de la respuesta (DOR) y TTP
Supervivencia global
concentraciones plasmáticas MLN1117 cuando se administra 1 día después de docetaxel
criterios de valoración exploratorios
Correlación entre PIK3CA y / o otras mutaciones detectadas en la circulación de ADN del tumor y ADN de tejido tumoral
Correlación entre la cantidad de frecuencias alélicas y de PIK3CA y / o othermutations detectado en la circulación de ADN tumoral y la respuesta clínica
Polimorfismos genéticos en genes que codifican enzimas que metabolizan las drogas y / o transportistas en el PK de MLN1117 y / o en los genes relacionados con la respuesta clínica y / o estudiar la toxicidad relacionada con las drogas
La CVRS, el funcionamiento físico y otros efectos de la enfermedad y / o terapia como medidos por los instrumentos PRO la EORTC QLQ-C30 (1, 2) y el EORTC QLQLC-13 (3)

E.5.2.1

Timepoint(s) of evaluation of this end point

Any time during phase II of the study

En cualquier momento durante la fase II 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

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

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

Yes

E.6.13.1

Other scope of the trial description

Genetic testing

Pruebas genéticas

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

Italy

Netherlands

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

The study will be terminated 6 months after the last patient completes an EOT study visit

El estudio finalizará 6 meses despues de que el último paciente complete la visita de Fin de Tratamiento del estudio

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:

130

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-06-15.

Yes

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

F.4.2.2

In the whole clinical trial

155

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

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-08-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-07-13

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

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