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    Summary
    EudraCT Number:2014-004852-77
    Sponsor's Protocol Code Number:GO29642
    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:2015-02-16
    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 number2014-004852-77
    A.3Full title of the trial
    AN OPEN-LABEL, PHASE I/IIA STUDY OF GDC-0810 IN POSTMENOPAUSAL WOMEN WITH LOCALLY ADVANCED OR METASTATIC ESTROGEN RECEPTOR POSITIVE BREAST CANCER
    ESTUDIO ABIERTO EN FASE I/IIA CON GDC 0810 EN MUJERES POSMENOPÁUSICAS CON CÁNCER DE MAMA LOCALMENTE AVANZADO O METASTÁSICO Y RECEPTORES ESTROGÉNICOS POSITIVOS.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of ARN-810 (GDC-0810) in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
    Estudio de ARN-810 (GDC-0810) en mujeres postmenopáusicas con cáncer de mama localmente avanzado o metastásico y receptores de estrógenos positivos.
    A.4.1Sponsor's protocol code numberGO29642
    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 SponsorGenentech, 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 supportGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34 91 325 73 00
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameGDC-0810
    D.3.2Product code RO705-6118/F01-01
    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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeGDC-0810 (RO7056118)
    D.3.9.3Other descriptive nameARN-810
    D.3.9.4EV Substance CodeSUB171190
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Patients with locally advanced or metastatic estrogen receptor (ER) positive breast cancer
    Pacientes con cáncer de mama localmente avanzado o metastásico y receptores estrogénicos positivos (RE+).
    E.1.1.1Medical condition in easily understood language
    Patients with locally advanced or metastatic estrogen receptor (ER) positive breast cancer
    Pacientes con cáncer de mama localmente avanzado o metastásico y receptores estrogénicos positivos (RE+).
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    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: To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) and assess the safety of GDC-0810 in postmenopausal women with locally advanced or metastatic ER+ (HER2-) breast cancer

    Phase II: To determine the anti-tumor effect (clinical benefit rate) of GDC-0810 in postmenopausal women with locally advanced or metastatic ER+ (HER2-) breast cancer
    Fase I: Determinar la dosis máxima tolerada (DMT) y/o la dosis recomendada para la Fase II (DRF2) y evaluar la seguridad de GDC 0810 en mujeres posmenopáusicas con cáncer de mama localmente avanzado o metastásico y receptores estrogénicos positivos (RE+) (HER2-).

    Fase II: Determinar la actividad antitumoral (tasa de beneficio clínico) de GDC 0810 en mujeres posmenopáusicas con cáncer de mama localmente avanzado o metastásico y RE+ (HER2-)
    E.2.2Secondary objectives of the trial
    ?To evaluate the safety of GDC-0810 when administered at the RP2D in postmenopausal women with locally advanced or metastatic ER+ (HER2-) breast cancer

    ?To evaluate the pharmacokinetics of GDC-0810 and its O-glucuronide metabolite following single and multiple dose treatments

    ?To evaluate the effect of GDC-0810 on ventricular repolarization in postmenopausal women participating in the Phase IIa portion of the study

    ?To perform exploratory evaluation of biomarkers of pharmacodynamic (PD) response with [18F]-fluoroestradiol (FES) positron emitting tomography (PET) [FES-PET]

    ?To perform exploratory evaluation of ER target genes expression

    ?To perform exploratory evaluation of mechanisms of resistance to GDC-0810.
    - Evaluar la seguridad de GDC 0810 cuando se administra en la DRF2 a mujeres posmenopáusicas con cáncer de mama localmente avanzado o metastásico y RE+ (HER2-).
    - Evaluar la farmacocinética de GDC 0810 y su metabolito O glucurónido después del tratamiento con dosis únicas y múltiples.
    - Evaluar el efecto de GDC 0810 sobre la repolarización ventricular en las mujeres posmenopáusicas que participen en la parte en Fase II del estudio.
    - Realizar una evaluación exploratoria de la respuesta farmacodinámica (FD) de biomarcadores mediante tomografía por emisión de positrones (TEP) con [18F] fluoroestradiol (FES) [TEP FES].
    - Realizar una evaluación exploratoria de la expresión de los genes diana de RE.
    - Realizar una evaluación exploratoria de los mecanismos de resistencia a GDC 0810.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease, both progressing after at least 6 months of hormonal therapy for ER+ breast cancer

    - ER-positive, HER2-negative

    - At least 2 months must have elapsed from the use of tamoxifen

    - At least 6 months must have elapsed from the use of fulvestrant

    - At least 2 weeks must have elapsed from the use of any other anticancer hormonal therapy

    - At least 3 weeks must have elapsed from the use of any chemotherapy

    - Females, 18 years of age or older

    - Postmenopausal status

    - Eastern Cooperative Oncology Group (ECOG) performance status </= 2

    - Adequate organ function



    Phase II portion - all above inclusion criteria, except:

    - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
    - At least 6 months must have elapsed from the use of fulvestrant not
    applicable

    and plus:

    - Cohort A only: Confirmed ESR1 mutation and presence of measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or evaluable bone disease

    - Cohort A1 only: no prior fulvestrant allowed; at least 2 months must have elapsed from the use of tamoxifen

    - Cohort A2 only: prior fulvestrant allowed

    - Cohort B only: disease progression following no more than 1 prior treatment with an aromatase inhibitor in the advanced/metastatic setting

    - Cohort B1 only: no prior fulvestrant allowed

    - Cohort B2 only: prior fulvestrant allowed
    - Diagnóstico de adenocarcinoma de la mama, demostrado por histología o citología, con indicios de enfermedad localmente recurrente que no sea susceptible de resección ni radioterapia con intención curativa o de enfermedad metastásica, en ambos casos, con progresión después de al menos 6 meses de tratamiento endocrino para el cáncer de mama con RE+.
    - RE positivo, Her2 negativo.
    - Intervalo de al menos 2 meses desde el uso de tamoxifeno.
    - Intervalo de al menos 6 meses desde el uso de fulvestrant.
    - Intervalo de al menos 2 semanas desde el uso de otro tratamiento hormonal contra el cáncer.
    - Intervalo de al menos 3 semanas desde el uso de cualquier quimioterapia.
    - Mujeres de 18 años o más.
    - Estado posmenopáusico.
    - Estado funcional del Eastern Cooperative Oncology Group (ECOG) </= 2.
    - Función orgánica adecuada.

    Fase II: todos los criterios de inclusión anteriores, excepto:
    - Estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 o 1.
    - Intervalo de al menos 6 meses desde el uso de fulvestrant; no aplica.

    Y además:
    - Solo en la cohorte A: Mutaciones confirmadas del dominio LBD de RE? (ESR1) y presencia de enfermedad evaluable conforme a los criterios RECIST, versión 1.1. o enfermedad ósea evaluable.

    -Solo en la cohorte A1: no se permite el uso previo de fulvestrant; deberán haber transcurrido como mínimo 2 meses desde el uso de tamoxifeno.
    - Solo en la cohorte A2: se permite el uso previo de fulvestrant.

    - Solo en la cohorte B: Progresión de la enfermedad después de no más de 1 tratamiento previo con un IA en caso de enfermedad avanzada/metastásica.
    - Solo en la cohorte B1: no se permite el uso previo de fulvestrant.
    - Solo en la cohorte B2: se permite el uso previo de fulvestrant.
    E.4Principal exclusion criteria
    - Untreated or symptomatic CNS metastases

    - Endometrial disorders

    - More than 2 prior chemotherapy in the advanced/metastatic setting (prior adjuvant chemotherapy is allowed so long as it occurred >/= 12 months prior to enrollment)

    - Current treatment with any systemic anticancer therapies for advanced disease or any systemic experimental treatment on another clinical trial

    - Any significant cardiac dysfunction within 12 months prior to enrollment

    - Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric resection

    - Known human immunodeficiency virus infection

    - Major surgery within 4 weeks prior to enrollment

    - Radiation therapy within 2 weeks prior to enrollment



    Phase II portion - all above exclusion criteria, plus:

    - Cohort A1, A2, and Cohort B2 only: > 1 prior chemotherapy in the advanced/metastatic setting

    - Cohort B1 only: prior chemotherapy in the advanced/metastatic setting
    - Metástasis en el SNC sintomáticas o no tratadas.
    - Trastornos del endometrio.
    - Más de 2 quimioterapias previas en caso de enfermedad avanzada/metastásica (se permite la quimioterapia adyuvante previa siempre que se haya administrado ? 12 meses antes de la inclusión).
    - Tratamiento actual con cualquier antineoplásico sistémico para la enfermedad avanzada o cualquier tratamiento experimental en otro ensayo clínico.
    - Cualquiera disfunción cardiaca significativa en los 12 meses anteriores a la inclusión.
    - Enfermedad inflamatoria intestinal activa o diarrea crónica, síndrome del intestino corto o cirugía digestiva superior, incluida la resección gástrica
    - Infección conocida por el virus de la inmunodeficiencia humana (VIH).
    - Intervención de cirugía mayor en las 4 semanas anteriores a la inclusión
    - Radioterapia en las 2 semanas anteriores a la inclusión

    Fase II: todos los criterios de exclusión anteriores, más:
    - Cohorte A1, A2 y cohorte B2 solo: > 1 quimioterapia previa en caso de enfermedad avanzada/metastásica
    - Cohorte B1 solo: Quimioterapia previa en caso de enfermedad avanzada/metastásica
    E.5 End points
    E.5.1Primary end point(s)
    1. Maximum tolerated dose (MTD)
    2. Incidence of adverse events
    3. Efficacy (phase II portion only):clinical benefit rate according to RECIST v1.1
    1. Dosis máxima tolerada (DMT).
    2. Incidencia de acontecimientos adversos.
    3. Eficacia (fase II solo); tasa de beneficio clínico de acuerdo a RECIST v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2. 12 months
    3. Until disease progression, unacceptable toxicity, or patient withdrawal of consent, approximately 6 months
    1-2: 12 meses.
    3. Hasta progresión de la enfermedad, toxicidad inaceptable o retirada del consentimeinto por el paciente; aproximadamente 6 meses.
    E.5.2Secondary end point(s)
    1.Pharmacokinetics of ARN-810 and its main metabolite:Maximum concentration (Cmax)
    2.Pharmacokinetics of ARN-810 and its main metabolite:Time to maximum concentration (Tmax)
    3.Pharmacokinetics of ARN-810 and its main metabolite:area under the concentration-time curve (AUC)
    4.Pharmacokinetics of ARN-810 and its main metabolite:half-life (t1/2)
    1. Farmacocinética de GDC 0810 y su principal metabolito: Concentración plasmática máxima (Cmax).
    2. Farmacocinética de GDC 0810 y su principal metabolito: Tiempo hasta la concentración plasmática máxima (Tmax).
    3. Farmacocinética de GDC 0810 y su principal metabolito: área bajo la curva de concentración plasmática frente al tiempo (AUC)
    4. Farmacocinética de GDC 0810 y su principal metabolito: semivida plasmática terminal (t1/2).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4. 12 months
    1-4. 12 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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 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 trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Korea, Republic of
    Netherlands
    Spain
    United States
    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
    The end of this study is defined as the date when the last patient, last visit (LPLV) occurs or the date at which the last data point required for statistical analysis or safety follow-up is received from the last patient, whichever occurs later.
    El final del estudio se define como la fecha de la última visita de la última paciente (UVUP) o la fecha en la que se reciba el último punto de datos necesario para el análisis estadístico o el seguimiento de la seguridad de la última paciente, lo que suceda más tarde.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 131
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 141
    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)
    The Sponsor will offer post-trial access to the study drug GDC-0810 free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product.
    El promotor ofrecerá acceso gratuito al fármaco del estudio, GDC 0810, después del ensayo a las pacientes aptas, de conformidad con la Política Mundial de Roche sobre Acceso Continuado a Productos en Investigación.
    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 Decision2015-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-13
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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