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    Summary
    EudraCT Number:2013-001110-15
    Sponsor's Protocol Code Number:1280.4
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-24
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-001110-15
    A.3Full title of the trial
    A Phase Ib/II Randomized Study of BI 836845 in Combination with Exemestane and Everolimus Versus Exemestane and Everolimus Alone in Women with Locally Advanced or Metastatic Breast Cancer
    Ensayo clínico de Fase Ib/II, aleatorizado, de BI 836845 en combinación con Exemestano y Everolimus frente a Exemestano y Everolimus en mujeres con cáncer de mama localmente avanzado o metastásico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BI 836845 in estrogen receptor positive metastatic breast cancer
    BI 836845 en cáncer de mama metastásico positivo para el receptor de estrógeno
    A.4.1Sponsor's protocol code number1280.4
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBoehringer Ingelheim España, S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBoehringer Ingelheim España. S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+1 800 243 0127
    B.5.5Fax number+1 800 821 7119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code BI 836845
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot yet assigned
    D.3.9.2Current sponsor codeBI 836845
    D.3.9.3Other descriptive nameBI 836845
    D.3.9.4EV Substance CodeSUB122634
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeFully human monoclonal antibody (HumAb) of the IgG1 isotype
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Afinitor 2,5 mg Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEverolimus
    D.3.9.1CAS number 159351-69-6
    D.3.9.3Other descriptive nameEVEROLIMUS
    D.3.9.4EV Substance CodeSUB02065MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Afinitor 5 mg Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEverolimus
    D.3.9.1CAS number 159351-69-6
    D.3.9.3Other descriptive nameEVEROLIMUS
    D.3.9.4EV Substance CodeSUB02065MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    Locally Advanced or Metastatic Breast Cancer positive for estrogen-receptor (ER) and/or progesterone receptor (PgR) and negative for HER2 which is refractory to non-steroidal aromatase inhibitor (letrozole and/or anastrozole)
    Cáncer de mama localmente avanzado o metastásico positivo para el receptor de estrógeno (ER) y/o el receptor de progesterona (PgR) y negativo para HER2 negativo que es resistente a inhibidores de la aromatasa no esteroideos (letrozol y/o anastrozol)
    E.1.1.1Medical condition in easily understood language
    advanced breast cancer overexpressing hormone receptors (like estrogen)
    Cáncer de mama avanzado en el que se sobreexpresan receptores de hormonas (como estrógeno)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor positive breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I part: To determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of BI 836845 and everolimus in combination with exemestane in women with HR+/HER2- advanced breast cancer.
    Phase II part: To evaluate the antitumor activity of BI 836845 in combination with exemestane and everolimus compared to exemestane and everolimus alone in women with HR+/HER2- advanced breast cancer.
    Fase I: Determinar la dosis máxima tolerada (MTD) y la dosis recomendada para la fase II de BI 836845 en combinación con exemestano y everolimus en mujeres con cáncer de mama localmente avanzado o metastásico HR+/HER2-.
    Fase II: Evaluar la actividad antitumoral de BI 836845 en combinación con exemestano y everolimus frente a exemestano y everolimus en mujeres con cáncer de mama localmente avanzado o metastásico HR+/HER2-.
    E.2.2Secondary objectives of the trial
    To determine the safety of BI 836845 in combination with exemestane and everolimus in HR+/HER2- advanced breast cancer patients.
    Determinar la seguridad de BI 836845 en combinación con exemestano y everolimus en pacientes con cáncer de mama avanzado HR+/HER2-.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Histologically-confirmed locally advanced (aBC) or metastatic breast cancer (mBC) not deemed amenable to curative surgery or curative radiation therapy
    -Tumors are positive for estrogen-receptor (ER) and/or progesterone receptor (PgR).
    -Tumors must be negative for HER2 per local lab testing.
    -Must have adequate archival tumor tissue from surgery or biopsy.
    - Postmenopausal women.
    -Objective evidence of recurrence or progressive disease on or after the last line of systemic therapy for breast cancer prior to study entry
    - The patient is disease refractory to non-steroidal aromatase inhibitor (letrozole and/or anastrozole)
    - Patients must have measurable lesion according to RECIST version 1.1 or bone lesions only: lytic or mixed (lytic + sclerotic) in the absence of measurable lesion as defined above
    - Eastern Cooperative Oncology Group performance score <= 2.
    - Life expectancy of >= 6 months in the opinion of the investigator
    - Fasting plasma glucose < 8.9 mmol/L (< 160 mg/dL) and HbA1c < 8.0%
    - Adequate organ function
    - Recovered from any previous therapy related toxicity to <= Grade 1 at study entry (except for stable sensory neuropathy <=Grade 2 and alopecia)
    - Written informed consent that is consistent with ICH-GCP guidelines and local regulations

    Inclusion criteria for the biopsy substudy are identical to the main study of the phase II part except for the following two inclusion criteria:
    - Fresh tumor biopsy should be taken when deemed safe and feasible by the investigator and upon informed consent by the patient. Bone lesion is not recommended for biopsy
    - Patients eligible to undergo tumor biopsy should have normal coagulation parameters (INR and PTT within normal range)
    - Cáncer de mama localmente avanzado o metastásico confirmado histológicamente y considerado no susceptible a cirugía o radioterapia curativas
    - Tumores positivos para el receptor de estrógeno (ER) y/o el receptor de progesterona (PgR);
    - Los tumores deben ser negativos para HER2 según pruebas de un laboratorio local
    - Se debe disponer de tejido tumoral archivado de una biopsia o intervención quirúrgica
    - Mujeres posmenopáusicas
    - Indicios objetivos de recidiva o de progresión de la enfermedad durante o después de un tratamiento sistémico de última línea para el cáncer de mama antes de la entrada en el estudio
    - Enfermedad resistente a inhibidores de la aromatasa no esteroideos (letrozol y/o anastrozol)
    - Las pacientes deben presentar una lesión medible de acuerdo con los criterios RECIST versión 1.1 o, en ausencia de una lesión medible, solo lesiones óseas: líticas o mixtas (líticas + escleróticas)
    - Puntuación del estado funcional según la escala ECOG (Eastern Cooperative Oncology Group, R01-0787) ? 2
    - Esperanza de vida de ? 6 meses en opinión del investigador
    - Glucosa plasmática < 8,9 mmol/l (< 160 mg/dl) y HbA1c < 8,0% determinadas en ayunas
    - Función de los órganos suficiente
    - Recuperación de cualquier toxicidad relacionada con un tratamiento previo a grado ? 1 en el momento de su entrada en el estudio (excepto en caso de neuropatía sensorial estable de grado ? 2 y alopecia)
    - Consentimiento informado por escrito conforme a las normas de BPC de la ICH y a la legislación local

    Los criterios de inclusión para el subestudio de la biopsia son los mismos que los de la fase II del estudio principal, exceptuando los dos criterios de inclusión que se indican a continuación:
    - La biopsia del tumor en fresco debe realizarse cuando se haya obtenido el consentimiento informado de la paciente y el investigador considere que es un procedimiento seguro y viable. No se recomienda biopsiar una lesión ósea
    - Las pacientes aptas para someterse a una biopsia del tumor deben presentar parámetros de coagulación normales (INR y PTT dentro del intervalo normal)
    E.4Principal exclusion criteria
    - Previous treatment with agents targeting on IGF pathway, phosphoinositide 3-kinase (PI3K) signaling pathway, protein kinase B (AKT), or mammalian target of rapamycin (mTOR) pathways
    - Prior treatment with exemestane
    - Known hypersensitivity to monoclonal antibody, mTOR inhibitors (e.g. sirolimus), or to the excipients of any study drugs
    - Ovarian suppression by ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist
    - Less than one week after receiving immunization with attenuated live vaccines prior to study treatment
    - Radiotherapy within 4 weeks prior to run-in treatment, except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to study treatment
    - Chemotherapy, biological therapy (other than bevacizumab), immunotherapy or investigational agents within 5 half-life of the drug or within two weeks prior to the start of study treatment, whichever is longer; bevacizumab treatment within 4 weeks prior to start of study treatment
    - Hormonal treatment for breast cancer within 2 weeks prior to start of study treatment
    - Major surgery in the judgement of the investigator within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
    - Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use except Topical applications, inhaled sprays, eye drops or local injections or Patients on stable low dose of corticosteroids for at least two weeks before study entry
    - Chronic hepatitis B infection, chronic hepatitis C infection and/or known HIV carrier
    - QTcF prolongation > 470 ms or QT prolongation deemed clinically relevant by the investigator
    - Disease that is considered by the investigator to be rapidly progressing or life threatening such as extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor
    - History of brain or other CNS metastases
    - Bilateral diffuse lymphangitic carcinomatosis
    - Hypokalemia of Grade >1
    - History of another primary malignancy within 5 years, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer
    - Family history of long QT syndrome
    - Any concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety and anti-tumor activity of the test drug(s)
    - Patients being treated with drugs recognized being strong or moderate CYP3A4 and/or PgP inhibitors and/or strong CYP3A4 inducers within 2 weeks prior to study entry
    - Patients received more than two lines of chemotherapy for locally advanced or metastatic breast cancer (For the Phase II: more than one line)
    - Tratamiento previo con fármacos dirigidos contra la vía de IGF, la vía de señalización de la fosfoinositol 3-quinasa (PI3K), la proteína quinasa B (AKT) o las vías de la diana de la rapamicina en mamíferos (mTOR) (sirolimus, temsirolimus, etc.)
    - Tratamiento previo con exemestano
    - Hipersensibilidad conocida a un anticuerpo monoclonal, a inhibidores de mTOR (p. ej., sirolimus) o a los excipientes de alguno de los fármacos del estudio
    - Supresión ovárica debida a radiación ovárica o al tratamiento con un agonista de la hormona liberadora de hormona luteinizante (LH-RH)
    - Vacunación con virus vivos atenuados menos de una semana antes del tratamiento del estudio
    - Radioterapia en las 4 semanas previas al tratamiento de preinclusión, excepto en el caso de radioterapia localizada con fines analgésicos o para lesiones líticas con riesgo de fractura, que se puede finalizar en las dos semanas previas al inicio del tratamiento del estudio
    - Quimioterapia, bioterapia (aparte de bevacizumab), inmunoterapia o terapia con fármacos experimentales administrada en el plazo de 5 semividas del fármaco o en las dos semanas antes del inicio del tratamiento del estudio, lo que sea más largo; tratamiento con bevacizumab en las 4 semanas previas al inicio del tratamiento del estudio
    - Tratamiento hormonal para el cáncer de mama en las 2 semanas previas al inicio del tratamiento del estudio
    - Cirugía mayor a criterio del investigador, realizada en las 4 semanas anteriores al inicio del tratamiento del estudio o intervención quirúrgica programada para llevarse a cabo dentro del periodo programado del estudio
    - Tratamiento concomitante con agentes inmunosupresores o uso crónico de corticosteroides, con excepción de aplicaciones tópicas, los aerosoles nasales, los colirios o las inyecciones locales o pacientes que han recibido dosis bajas estables de corticosteroides durante al menos dos semanas antes de la inclusión en el estudio
    - Infección crónica por hepatitis B (definida como la presencia de HBsAg y/o DNA de HBV), infección crónica por hepatitis C y/o ser portador conocido del HIV
    - Prolongación del intervalo QTcF > 470 ms o prolongación del intervalo QT que el investigador considera clínicamente relevante
    - Enfermedad que en opinión del investigador sea rápidamente progresiva o potencialmente mortal como afectación visceral extensa y sintomática, incluidas afectación hepática y diseminación pulmonar linfangítica del tumor
    - Antecedentes de metástasis cerebral u otras metástasis del SNC
    - Carcinomatosis linfangítica bilateral difusa
    - Hipopotasemia de grado > 1
    - Antecedentes de otra neoplasia maligna primaria en 5 años, con la excepción de carcinoma in situ de cuello uterino, útero, carcinoma basocelular o epidermoide o cáncer de piel no melanoma, tratados correctamente
    - Antecedentes familiares de síndrome de QT largo
    - Cualquier alteración de un sistema orgánico o enfermedad grave concomitante que, en opinión del investigador, afectaría a la seguridad del paciente o interferiría en la evaluación de la seguridad y la actividad antitumoral de los fármacos del estudio
    - Pacientes que reciban tratamiento con fármacos que son inhibidores potentes o moderados de CYP3A4 y/o la glucoproteína P (PgP) y/o inductores potentes de CYP3A4 durante las 2 semanas previas a la inclusión en el estudio
    - Pacientes que hayan recibido más de dos líneas de quimioterapia para el cáncer de mama localmente avanzado o metastásico (Para la Fase II, más de una línea)
    E.5 End points
    E.5.1Primary end point(s)
    1: Progression-free survival (PFS)

    2: occurrence of Dose Limiting Toxicity (DLT) - phase I part
    1: Supervivencia libre de progresión

    2: Aparición de toxicidad limitante de la dosis - fase I
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: up to 10,8 months

    2: up to 28 days
    1: hasta 10,8 meses

    2: hasta 28 días
    E.5.2Secondary end point(s)
    1: Time to progression (TTP), defined as the duration of time from the date of C1V1 until the date of the first objective tumor progression

    2: Objective response (OR), defined as complete response (CR) or partial response (PR) (CR + PR)

    3: Time to objective response

    4: Duration of objective response

    5: Clinical benefit (CB), defined as best overall response of complete response (CR) or partial response (PR), or stable disease (SD) >=6 months, or Non-CR/Non-PD for >=6 months (CR + PR + SD6m + Non-CR/Non-PD6m)

    6: Duration of clinical benefit
    1: El tiempo hasta la progresión (TTP) se define como el tiempo transcurrido desde la fecha de la C1V1 hasta la fecha de la primera progresión tumoral objetiva
    2: La respuesta objetiva (OR), definida como respuesta completa (CR) o respuesta parcial (PR) (CR + PR)
    3: Tiempo hasta la respuesta objetiva
    4: Duración de la respuesta objetiva
    5: El beneficio clínico (CB) se define como la mejor respuesta global de respuesta completa (CR) o respuesta parcial (PR), o enfermedad estable (SD) ? 6 meses, o ni CR/ni PD durante ? 6 meses (CR+PR+SD6m+ni CR/ni PD6m)
    6: Duración del beneficio clínico
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: up to 10,8 months

    2: up to 10,8 months

    3: up to 10,8 months

    4: up to 10,8 months

    5: up to 10,8 months

    6: up to 10,8 months
    1: hasta 10,8 meses

    2: hasta 10,8 meses

    3: hasta 10,8 meses

    4: hasta 10,8 meses

    5: hasta 10,8 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Ireland
    Netherlands
    Sweden
    Korea, Republic of
    Spain
    Taiwan
    United Kingdom
    E.8.7Trial 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 63
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 226
    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)
    any anti cancer therapy at investigators discretion
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-14
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