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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2013-000288-10
    Sponsor's Protocol Code Number:CL2-80881-001
    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:2013-10-21
    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 number2013-000288-10
    A.3Full title of the trial
    An open, 3-cohort, phase II trial testing oral administration of lucitanib in patients with FGFR1-amplified or non-amplified estrogen receptor positive metastatic breast cancer.
    Estudio abierto de fase II, con 3 cohortes, de evaluación de la administración oral de lucitanib en pacientes con cáncer de mama metastásico y receptor estrogénico positivo con FGFR1 amplificado o no.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open, 3-cohort, phase II trial testing oral administration of lucitanib in patients with FGFR1-amplified or non-amplified estrogen receptor positive metastatic breast cancer.
    Estudio abierto de fase II, con 3 cohortes, de evaluación de la administración oral de lucitanib en pacientes con cáncer de mama metastásico y receptor estrogénico positivo con FGFR1 amplificado o no.
    A.3.2Name or abbreviated title of the trial where available
    FINESSE
    A.4.1Sponsor's protocol code numberCL2-80881-001
    A.5.4Other Identifiers
    Name:BIGNumber:BIG 2-13
    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 SponsorLaboratorios Servier S.L.
    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 supportADIR
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recherches Internationales Servier
    B.5.2Functional name of contact pointValérie
    B.5.3 Address:
    B.5.3.1Street AddressFautrier
    B.5.3.2Town/ citySuresnes cedex
    B.5.3.3Post code92284
    B.5.3.4CountryFrance
    B.5.4Telephone number3315572 70 63
    B.5.5Fax number3315572 54 12
    B.5.6E-mailvalerie.fautrier@fr.netgrs.com
    B.Sponsor: 2
    B.1.1Name of SponsorInstitut de Recherches Internationales de Servier
    B.1.3.4CountryFrance
    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 supportLaboratorios Servier S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorios Servier S.L.
    B.5.2Functional name of contact pointMaria DE QUINTANA
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de los Madroños 33
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28043
    B.5.3.4CountrySpain
    B.5.4Telephone number3491748 96 70
    B.5.5Fax number3491300 32 49
    B.5.6E-mailmaria.dequintana@es.netgrs.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.3.1Product nameS80881
    D.3.2Product code S80881
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLucitanib
    D.3.9.1CAS number 1058137-23-7
    D.3.9.2Current sponsor codeS80881-2
    D.3.9.3Other descriptive nameE-3810
    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.IMP: 2
    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.3.1Product nameS80881
    D.3.2Product code S80881
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLucitanib
    D.3.9.1CAS number 1058137-23-7
    D.3.9.2Current sponsor codeS80881-2
    D.3.9.3Other descriptive nameE-3810
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    FGFR1-amplified or non-amplified estrogen receptor positive metastatic breast cancer
    Cáncer de mama metastásico y receptor estrogénico positivo con FGFR1 amplificado o no
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    Cáncer de mama
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor positive breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -To evaluate the objective response rate (ORR) of single agent lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non-amplified with 11q amplification, or FGFR1-non-amplified without 11q amplification.
    -Evaluar la tasa de respuesta objetiva (TRO) de lucitanib como único agente en pacientes con cáncer de mama metastásico con FGFR1- amplificado, FGFR1- no amplificado con amplificación del 11q, o FGFR1- no amplificado sin amplificación del 11q.
    E.2.2Secondary objectives of the trial
    -To determine the clinical benefit rate (CBR) of single agent lucitanib.
    -To evaluate the progression-free survival (PFS).
    -To evaluate the duration of response.
    -To evaluate the safety of lucitanib.
    -To evaluate the pharmacokinetics of lucitanib.
    -To measure pharmacogenomics and proteomic biomarkers.
    -Determinar la tasa de beneficio clínico (TBC) de lucitanib como único agente .
    -Evaluar la supervivencia libre de progresión (SLP).
    -Evaluar la duración de la respuesta.
    -Evaluar la seguridad de lucitanib.
    -Evaluar la farmacocinética de lucitanib.
    -Medir biomarcadores farmacogenómicos y proteómicos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Histologically confirmed breast adenocarcinoma.
    -Prior first-line hormonal therapy in the metastatic setting.
    -Demonstrated progression of disease by radiological or clinical
    assessment.
    -Female patient, aged ?18 years old.
    -Estimated life expectancy >3 months.
    -Normal Left ventricular function
    -Adequate haematological, hepatic and renal functions.
    -For women with childbearing potential, a negative pregnancy test prior to initiation of the study drug and use an effective contraception.
    -Ability to swallow oral capsules.
    -Adenocarcinoma de mama confirmado histológicamente.
    -Terapia hormonal de primera línea previa para enfermedad metastásica.
    -Progresión de la enfermedad demostrada por radiología o mediante evaluación clínica.
    -Mujer, edad ? 18 años.
    -Esperanza de vida > 3 meses.
    -Función ventricular izquierda normal.
    -Valores renales, hepáticos y hematológicos adecuados.
    -Para las mujeres en edad fértil, una prueba de embarazo negativa previas al inicio de la medicación del estudio y disposición para utilizar un método anticonceptivo eficaz.
    -Capacidad para tragar las cápsulas orales.
    E.4Principal exclusion criteria
    -More than two lines of chemotherapy and two lines of hormonal therapy
    with or without targeted therapy in the metastatic setting.
    -Previous treatment with bevacizumab within 3 months of first dose of
    IMP.
    -Active central nervous system metastases, cerebral oedema, and/or
    progressive growth.
    -Patients with impaired cardiac function.
    -Uncontrolled hypothyroidism.
    -Pregnant or breastfeeding women.
    -Más de dos líneas de quimioterapia y dos líneas de terapia hormonal con o sin terapia dirigida para el cáncer metastásico.
    -Tratamiento previo con bevacizumab en los 3 meses previos a la primera dosis del MEI.
    -Metástasis activa en el sistema nervioso central, evidenciada por síntomas clínicos, edema cerebral, y/o crecimiento progresivo.
    -Pacientes con función cardiaca dañada.
    -Hipotiroidismo no controlado.
    -Mujeres embarazadas o en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    -Objective response rate (ORR).
    -Tasa de respuesta objetiva (TRO)
    E.5.1.1Timepoint(s) of evaluation of this end point
    -at baseline and every 8 weeks.
    -al inicio y cada 8 semanas
    E.5.2Secondary end point(s)
    -Clinical benefit rate (CBR).
    -Progression-free survival (PFS).
    -Duration of response.
    -Safety profile of lucitanib.
    -PK profile of lucitanib.
    -Tasa de beneficio clínico (TBC).
    -Supervivencia libre de progresión (SLP).
    -Duración de la respuesta.
    -Perfil de seguridad de lucitanib.
    -Farmacocinética de lucitanib.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -CBP, SLP, Duration of response: over the study
    -Safety evaluation: D1, D14, D28, D56, and every 4 weeks
    -PK evaluation: D14, D56.
    -TBC, PFS, duración de respuesta: durante el estudio
    -Evaluación de seguridad: D1, D14, D28, D56, y cada 4 semanas
    -Evaluación PK: D14, D56.
    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 No
    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 No
    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 No
    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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Australia
    Belgium
    Canada
    France
    Germany
    Italy
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    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.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 49
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 74
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 123
    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 discontinuation of the study treatment, the participant will receive a treatment and/or have access to other appropriate care by her doctor, which will be at the investigator?s discretion. As the study drug is not licensed yet at this time, it will not be available on the market.
    Después de la interrupción del medicamento en investigación, la participante recibirá un tratamiento y/o los cuidados médicos apropiados según el criterio de su médico. El medicamento en investigación todavía no tiene autorización de comercialización por lo que no está disponible en el mercado.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Breast International Group (BIG)-asbl
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-28
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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