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    Summary
    EudraCT Number:2014-004796-23
    Sponsor's Protocol Code Number:REP0114
    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:2015-05-08
    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 number2014-004796-23
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled phase 2 study of paclitaxel in combination with reparixin compared to paclitaxel alone as front-line therapy for Metastatic Triple-Negative Breast Cancer (FRIDA)
    Estudio de fase II aleatorizado, con doble ciego y controlado con placebo, acerca del uso de paclitaxel combinado con reparixina comparado con paclitaxel solo, como tratamiento de primera línea para el cáncer de mama triple negativo metastásico (FRIDA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Reparixin combined with paclitaxel compared to paclitaxel alone in patients with metastatic Triple-negative breast cancer
    Estudio de Reparixin combinado con paclitaxel comparado con paclitaxel solo en pacientes con cancer de mama triple negativo metastasico
    A.3.2Name or abbreviated title of the trial where available
    FRIDA
    FRIDA
    A.4.1Sponsor's protocol code numberREP0114
    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 SponsorDompé Farmaceutici s.p.a.
    B.1.3.4CountryItaly
    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 supportDompé Farmaceutici s.p.a.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDompé Farmaceutici s.p.a.
    B.5.2Functional name of contact pointclinical trial information REP0114
    B.5.3 Address:
    B.5.3.1Street AddressVia Santa Lucia, 6
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number900 811 335
    B.5.6E-mailcti.rep0114@dompe.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 nameReparixin
    D.3.2Product code Reparixin
    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 INNReparixin
    D.3.9.1CAS number 266359-83-5
    D.3.9.2Current sponsor codeDF 1681Y
    D.3.9.3Other descriptive nameREPARIXIN
    D.3.9.4EV Substance CodeSUB130481
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic triple negative Breast Cancer
    Cancer de mama triple negativo metastasico
    E.1.1.1Medical condition in easily understood language
    Metastatic triple negative Breast Cancer
    Cancer de mama triple negativo metastasico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic 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
    Progression Free Survival (PFS)
    supervivencia sin progresión (SSP)
    E.2.2Secondary objectives of the trial
    To determine the median PFS (mPFS)
    To determine Overall Survival (OS).
    To evaluate Objective Response Rates (ORR)
    To assess the safety of the combination of paclitaxel and orally administered reparixin.
    Determinar la mediana de la SSP (mSSP)
    Determinar la supervivencia total (OS).
    Evaluar las tasas de respuesta objetiva (ORR)
    Evaluar la seguridad de la combinación de paclitaxel y reparixina administrada por vía oral.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    evaluation of CD24-CD44+CSC, ALDH+CSC.
    evaluacion de CD24-CD44+CSC,ALDH+CSC
    E.3Principal inclusion criteria
    1.Female aged >= 18 years.
    2.Patients with pathologically documented metastatic triple negative breast cancer (TNBC), eligible for treatment with paclitaxel. Paraffin-embedded tissue must be available from metastatic sites, if reasonably accessible, or from the primary tumor, to confirm the diagnosis of TNBC and for correlative studies (only on metastatic tissue). Fifteen slides can be obtained if the full block is not available to be sent or released.
    TNBC will be defined as breast cancer with <1% ER+ and <1% PgR+ cells, and HER2 immunohistochemistry score of 0 or 1+ and/or in situ hybridization (ISH) with HER2 gene copy number <4 or a ratio of less than 2 between HER2 gene copy number and centromere of chromosome 17. Patients whose metastatic disease is TNBC are eligible even when their primary tumor expressed hormone receptors and/or HER2.
    3.Patients must have relapsed following a prior (neo)adjuvant chemotherapy regimen. If a taxane (i.e., paclitaxel or docetaxel) was administered as part of the (neo)adjuvant regimen, PD must have occurred > 12 months from the end of previous (neo)adjuvant treatment. For non-taxane (neo)adjuvant regimen, PD must have occurred > 6 months from the end of previous (neo)adjuvant treatment
    4.Patients with at least one baseline measurable lesion according to RECIST criteria version 1.1.
    5.Zubrod (Eastern Co-operative Oncology Group [ECOG]) Performance Status (PS) of 0 1.
    6.Life expectancy of at least three months.
    7.Patients must be able to swallow and retain oral medication (intact tablet).
    8.Able to undergo all screening assessments outlined in the protocol.
    9.Adequate organ function (defined by the following parameters):
    a)Serum creatinine < 140 µmol/L (< 1.6 mg/dL) or creatinine clearance > 60 mL/min.
    b)Serum hemoglobin >= 9 g/dL; absolute neutrophil count >= 1.5 x 109/L; platelets >= 100 x 109/L.
    c)Serum bilirubin <= 1.5 x upper normal limit (UNL) except patients with Gilberts syndrome
    d)Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) <= 2.5 x UNL but <= 5.0 x UNL in case of liver metastases; alkaline phosphatase (ALP) <= UNL but <= 2.5 x ULN in case of liver metastases; albumin within normal limits.
    10.No history or evidence by CT scan or MRI, of brain metastases or leptomeningeal disease.
    11.No known hepatitis B virus (not due to immunization), hepatitis C virus, human immunodeficiency virus I and II positive status.
    12.Dated and signed IEC/IRB-approved informed consent.
    1.Mujer >= 18 años.
    2.Pacientes con cáncer de mama triple negativo (CMTN) metastásico, confirmado anatomopatológicamente y que resultan aptos para recibir el tratamiento con paclitaxel. Se debe disponer de tejido contenido en parafina proveniente de zonas metastásicas, si se puede acceder a ellas de manera razonable, o del tumor principal, para confirmar el diagnóstico de CMTN y para estudios correlativos (solo en tejido metastásico). Se pueden obtener quince cortes seriados si el bloque completo no está disponible para enviarlo o trasladarlo.
    El CMTN se definirá como un cáncer de mama con <1 % de células ER+ y <1 % de células RPg+, además de una puntuación inmunohistoquímica HER2 de 0 o 1+ y/o una hibridación in situ (HIS) con un número de copias del gen HER2 < 4 o una relación inferior a 2 entre el número de copias del gen HER2 y el centrómero del cromosoma 17. Los pacientes cuya enfermedad metastásica sea CMTN serán aptos para el estudio, incluso si su tumor principal ha expresado receptores hormonales y/o HER2.
    3.Los pacientes deben haber sufrido una recaída tras un tratamiento anterior con quimioterapia (neo)adyuvante. Si se había administrado un taxano (por ejemplo, paclitaxel o docetaxel) como parte del tratamiento (neo)adyuvante, se debe haber producido la progresión de la enfermedad (PE) > 12 meses desde el fin del tratamiento (neo)adyuvante anterior. En regímenes neoadyuvantes sin taxano, se debe haber producido la progresión de la enfermedad (PE) > 6 meses desde el fin del tratamiento neoadyuvante anterior
    4.Pacientes con al menos una lesión medible de referencia según la versión 1.1 de los criterios RECIST.
    5.Estado funcional (EF) según Zubrod (Grupo oncológico de cooperación del este [ECOG]) de entre 0 y 1.
    6.Esperanza de vida de al menos tres meses.
    7.Los pacientes deben ser capaces de tragar y retener medicación administrada por vía oral (comprimidos intactos).
    8.Deben ser capaces de someterse a todas las evaluaciones de selección definidas en el protocolo.
    9.Funcionamiento adecuado de los órganos (definido por los siguientes parámetros):
    a)Creatinina en suero < 140 µmol/l (< 1,6 mg/dl) o depuración de creatinina > 60 ml/min.
    b)Hemoglobina sérica >= 9 g/dL; recuento absoluto de neutrófilos >= 1,5 x 109/L; plaquetas >= 100 x 109/L.
    c)Bilirrubina sérica <= 1,5 x límite superior de la normalidad (LSN) excepto en pacientes con síndrome de Gilbert.
    d)Alanina aminotransferasa sérica (ALT), aspartato aminotransferasa (AST) <=2,5 x LSN, pero <= 5,0 x LSN en caso de metástasis hepática; fosfatasa alcalina (FA) <= LSN, pero <= 2,5 x LSN en caso de metástasis hepática; albúmina dentro de los límites normales.
    10.Sin historia ni evidencia mediante TC o RMN de metástasis cerebrales ni enfermedades leptomeníngeas.
    11.Sin resultado positivo conocido para el virus de la hepatitis B (no debido a inmunización), virus de la hepatitis C y el virus de la inmunodeficiencia humana I y II.
    12.Consentimiento informado aprobado por el CEI/JRI con fecha y firma.
    E.4Principal exclusion criteria
    1.Newly diagnosed metastatic TNBC and TNBC not previously treated with (neo)adjuvant chemotherapy
    2.Prior therapy for metastatic TNBC (chemotherapy, hormone therapy or biological therapy), Patients may receive bisphosphonates and other therapies to treat bone metastases, however if used, bone lesions will not be considered as measurable disease.
    3.Less than four weeks since last radiotherapy (excluding palliative radiotherapy).
    4.Pregnancy or lactation or unwillingness to use adequate method of birth control.
    5.Neurological or psychiatric disorders which may influence understanding of study and informed consent procedures.
    6.Active or uncontrolled infection.
    7.Malabsorption syndrome, disease significantly affecting gastrointestinal function.
    8.G>1 pre-existing peripheral neuropathy
    9.Any other invasive malignancy from which the patient has been disease-free for less than 5 years with the exception of curatively treated basal or squamous cell skin cancer
    10.Hypersensitivity to:
    a)paclitaxel
    b)ibuprofen or to more than one non-steroidal anti-inflammatory drug.
    c)more than one medication belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib; hypersensitivity to sulphanilamide antibiotics alone (e.g.sulfamethoxazole) does not qualify for exclusion.
    1.CMTN de nuevo diagnóstico y CMTN que no hayan sido tratados previamente con quimioterapia (neo)adyuvante
    2.Antes del tratamiento para el CMTN metastásico (quimioterapia, tratamiento hormonal y tratamiento biológico), los pacientes pueden recibir bisfosfonatos y otros tratamientos para la metástasis ósea; sin embargo, si se utilizan, las lesiones óseas no se considerarán enfermedades medibles.
    3.Si han pasado menos de cuatro semanas desde la última radioterapia en el paciente (excluida la radioterapia paliativa).
    4.Embarazo, lactancia o la negativa a utilizar métodos anticonceptivos adecuados.
    5.Trastornos neurológicos o psiquiátricos que pudieran influir en la comprensión del estudio y de los procedimientos del consentimiento informado por parte del paciente.
    6.Infección activa o no controlada.
    7.Síndrome de hipoabsorción, enfermedad que perjudica considerablemente la función gastrointestinal.
    8.G>1 neuropatía periférica preexistente
    9.Cualquier otra neoplasia infiltrante que haya sufrido el paciente y que haya desaparecido durante menos de 5 años, a excepción del cáncer de piel de células escamosas o basales sometido a tratamiento curativo.
    10.Hipersensibilidad a:
    a)paclitaxel
    b)ibuprofeno o más de un fármaco antiinflamatorio no esteroide.
    c)Más de un medicamento que pertenecen al grupo de las sulfonamidas, como sulfametacina, sulfametoxazol, sulfasalacina , pimesulida o celecoxib; hipersensibilidad a antibióticos sulfonilamidas solos (por ejemplo, sulfametoxazol), no califica como exclusión.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS) defined as the interval (days) between randomization and the date of progression or death from any cause, whichever occurs first, as assessed by Independent Radiology Review)
    La supervivencia sin progresión (SSP) de la enfermedad, definida como el intervalo (días) entre la aleatorización y la fecha de progresión o fallecimiento por cualquier motivo, lo que ocurra primero, tal y como lo evalúe una revisión radiológica independiente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    disease progression or death from any cause, whichever occurs first
    Progresion de la enfermedad o muerte por cualqueir causa, lo que ocurra primero
    E.5.2Secondary end point(s)
    1)median PFS (mPFS)defined as the number of days between the date of randomization and the date of clinical disease progression (PD) according to RECIST criteria version 1.1, or death for any cause, whichever occurs first
    2)overall Survival defined as the interval (days) between randomization and death from any cause.
    3)objective response rates (ORR) defined as the percentage of the patients reaching complete remission (CR), partial remission (PR) or stable disease (SD) according to RECIST criteria version 1.1.
    CR rate
    PR rate
    SD rate
    PD rate
    4)safety of the combination treatment
    1)la mediana de SSP (mSSP) definida como el número de días entre la fecha de aleatorización y la fecha de progresión clínica de la enfermedad (PE) según la versión 1.1 de los criterios RECIST, o el fallecimiento por cualquier causa, lo que ocurra primero
    2)la supervivencia total, definida como el intervalo (días) entre la aleatorización y el fallecimiento por cualquier causa.
    3)las tasas de respuesta objetiva (ORR), definido como el porcentaje de los pacientes que alcancen la remisión completa (CR), remisión parcial (PR) o estabilización de la enfermedad (EE) según la versión 1.1 de los criterios RECIST.
    La respuesta de la enfermedad (estado de la enfermedad hasta la progresión de la enfermedad [PE]) en el preestudio (referencia) y cada ocho semanas hasta el final del estudio:
    Tasa de CR
    Tasa de PR
    Tasa de EE
    Tasa de PE
    4)seguridad del tratamiento combinado
    E.5.2.1Timepoint(s) of evaluation of this end point
    1)at disease progression or death
    2)death
    3)every eight weeks until disease progresion or death wichever occurs first
    4)throughout the study
    1)En el momento de la progresion de la enfermedad o muerte
    2)Muerte
    3)ocho semanas hasta la progresion de la enfermedad o muerte, lo que ocurra primero
    4)A través del estudio
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Czech Republic
    France
    Italy
    Poland
    Spain
    United States
    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
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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: 127
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 126
    F.4.2.2In the whole clinical trial 190
    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 End of treatment the patients will return to their normal SOC medication.
    Despues de la finalizacion del tratamiento los pacientes volveran a recibir la medicacion standar
    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 Decision2015-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-05
    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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