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    The EU Clinical Trials Register currently displays   37527   clinical trials with a EudraCT protocol, of which   6154   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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    EudraCT Number:2013-003076-12
    Sponsor's Protocol Code Number:673-201
    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:2014-06-02
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-003076-12
    A.3Full title of the trial
    A Phase 2, 2-Stage. 2-Cohort Study of BMN 673 Administered to Germline BRCA Mutation Subjects with Locally Advanced and/or Metastatic Breast Cancer
    Estudio de fase 2, de 2 etapas y 2 cohortes, en el que se evalúa BMN 673 en pacientes con cáncer de mama localmente avanzado y/o metastásico que presentan mutaciones en línea germinal en los genes BRCA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 Study to evaluate BMN 673 in Patients with Germline BRCA Mutations with Locally Advanced and/or Metastatic Breast Cancer
    Estudio de fase 2 para evaluar BMN 673 en pacientes con mutaciones en la linea germinal de BRCA con cancer de mama localmente avanzado y/o metastásico
    A.4.1Sponsor's protocol code number673-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02034916
    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 SponsorBioMarin Pharmaceutical Inc.
    B.1.3.4CountryUnited States
    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 supportBioMarin Pharmaceutical Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioMarin Pharmaceutical Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address105 Digital Drive
    B.5.3.2Town/ cityNovato
    B.5.3.3Post code94949
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34938002008
    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 namePoly (ADP-ribose) Polymerase Inhibitor
    D.3.2Product code BMN 673
    D.3.4Pharmaceutical form Capsule
    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 INNN/A
    D.3.9.1CAS number 1373431-65-2
    D.3.9.2Current sponsor codeBMN 673
    D.3.9.3Other descriptive nameBMN 673
    D.3.9.4EV Substance CodeSUB122393
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 and/or metastatic breast cancer with germline BRCA1 or BRCA2 mutations
    Cáncer de mama localmente avanzado y/o metastásico con mutaciones en la línea germinal BRCA1 o BRCA2
    E.1.1.1Medical condition in easily understood language
    Locally Advanced or Metastatic Breast Cancer with BRCA Mutation
    Cáncer de mama localmente avanzado o metastásico con mutaciones de BRCA
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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
    The primary objective of the study is to determine the objective response rate (ORR) for each cohort treated with BMN 673 as a single agent. The ORR will be based on confirmed responses as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
    El objetivo principal de este estudio es determinar la tasa de respuestas objetivas (TRO) para cada cohorte de pacientes tratados con BMN 673 en monoterapia. La TRO se basará en las respuestas confirmadas definidas por los Criterios de evaluación de la respuesta en tumores sólidos (RECIST).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate the following:
    - Clinical benefit response (CBR) rate as defined as CR + partial response (PR) + SD lasting ? 24 weeks
    - Duration of response (DOR) for CR and PR
    - PFS
    -Overall survival (OS)
    -Pharmacokinetics of BMN 673
    Los objetivos secundarios del estudio son determinar lo siguiente:
    - Tasa de beneficio clínico (TBC), definida como los casos de respuesta completa (RC) + respuesta parcial (RP) + enfermedad estable (EE) que se prolonguen durante ? 24 semanas.
    - Duración de la respuesta (DdR), para los casos de RC y RP.
    - Supervivencia sin progresión (SSP).
    - Supervivencia global (SG).
    - Seguridad.
    - Farmacocinética de BMN 673.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    Histologically or cytologically confirmed carcinoma of the breast.
    Locally advanced and/or metastatic disease.
    Deleterious or pathogenic germline BRCA 1 or BRCA 2 mutation.
    Prior chemotherapy: Cohort 1) PR or CR to prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or Cohort 2) > 2 prior chemotherapy regimens for metastatic disease and no prior platinum for metastatic disease.
    ECOG performance status ? 1.
    Have adequate organ function.
    Criterios de inclusión:
    Carcinoma de mama, confirmado histológica o citológicamente.
    Enfermedad localmente avanzada y/o metastásica.
    Presencia de una mutación nociva o patogénica en línea germinal en los genes BRCA1 o BRCA2.
    Quimioterapia previa: Cohorte 1) pacientes que hubieran presentado RP o RC con un tratamiento previo que incluyera platino y que se hubiera administrado para tratar la enfermedad metastásica, que hubieran experimentado progresión de la enfermedad > 8 semanas después de la última dosis de platino. Cohorte 2) > 2 tratamientos quimioterápicos previos para tratar la enfermedad metastásica, y no haber recibido platino para tratar la enfermedad metastásica.
    Categoría funcional del Eastern Cooperative Oncology Group (ECOG) ? 1.
    Tener una función orgánica adecuada.
    E.4Principal exclusion criteria
    Prior enrollment into a clinical trial of a PARP inhibitor.
    CNS metastasis except adequately treated brain metastasis documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids for management of CNS symptoms.
    Prior malignancy except for prior BRCA-associated cancer as long as there is no current evidence of the prior cancer, carcinoma in situ of the cervix or non-melanoma skin cancer, and a cancer diagnosed and definitively treated >5 years prior to study enrollment with no subsequent evidence of recurrence.
    Known to be HIV positive, active hepatitis C virus, or active hepatitis B virus.
    Known hypersensitivity to any of the components of BMN 673.
    Haber sido reclutado anteriormente en un ensayo clínico en el que se haya evaluado un inhibidor de la PARP.
    Metástasis en el SNC Excepto metástasis cerebrales que se hubieran tratado adecuadamente, documentadas en el momento basal mediante tomografía computarizada (TC) o resonancia magnética (RM), que no hayan progresado respecto a pruebas de imagen previas, y que no requieran la administración de corticosteroides para tratar los síntomas relacionados con el SNC.
    Neoplasias malignas previas, excepto en cáncer previo relacionado con los genes BRCA, sin que en la actualidad se observe ningún indicio del cáncer previo,carcinoma in situ del cuello uterino o cáncer de piel no melanomatoso, y en cáncer diagnosticado y que se haya tratado definitivamente > 5 años antes, sin posteriores indicios de recurrencia.
    Presentar infección por el virus de la inmunodeficiencia humana, infección activa por virus de la hepatitis C o por virus de la hepatitis B.
    Hipersensibilidad conocida a cualquiera de los componentes de BMN 673.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR)
    Tasa de respuestas objetivas (TRO)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Anticipated in about 24-30 months following first patient enrolled
    Previsto en 24-30 meses después del primer paciente incluido
    E.5.2Secondary end point(s)
    Clinical Benefit Response (CBR) (CR + PR + SD lasting ? 24 weeks), Duration of Response (DOR) for responding subjects (CR + PR, subset analysis) by IRF evaluation, Progression Free Survival (PFS), and Overall Survival (OS)
    Los criterios secundarios de valoración de la eficacia son la Tasa de Beneficio clínico,TBC (RC + RP + EE que se prolongue ? 24 semanas), Duración de la respuesta (DdR) para los pacientes que respondan (RC + RP, subconjunto de análisis) de acuerdo con la evaluación realizada por el CRI, la Supervivencia sin progresión (SSP) y la Supervivencia global (SG).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Primary efficacy analysis will be performed after the last subject has had the opportunity to be confirmed as a responder if the subject responds within 18 weeks
    El análisis principal de la eficacia se realizará una vez que se haya tenido la oportunidad de confirmar la condición de respondedor del último paciente, si el paciente responde en el transcurso de 18 semanas.
    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 No
    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. 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 No
    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) No
    E.8.2.2Placebo No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    United Kingdom
    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
    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 months6
    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 months6
    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: 140
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 140
    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)
    Expected normal treatment of the condition
    Tratamiento normal esperado para la enfermedad
    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 TRIO EURL
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-10-31
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