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    Summary
    EudraCT Number:2014-004852-77
    Sponsor's Protocol Code Number:GO29642
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-03-02
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-004852-77
    A.3Full title of the trial
    AN OPEN-LABEL, PHASE Ia/Ib/IIa STUDY OF GDC-0810 SINGLE AGENT OR
    IN COMBINATION WITH PALBOCICLIB AND/OR AN LHRH AGONIST IN
    WOMEN WITH LOCALLY ADVANCED OR METASTATIC ESTROGEN RECEPTOR
    POSITIVE BREAST CANCER
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of ARN-810 (GDC-0810) Single Agent or in Combination With
    Palbociclib and/or an LHRH Agonist in Women With Locally Advanced or
    Metastatic Estrogen Receptor Positive Breast Cancer
    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.5.6E-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 code GDC-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
    E.1.1.1Medical condition in easily understood language
    Patients with locally advanced or metastatic estrogen receptor (ER) positive breast cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    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 Ia: To determine the maximum tolerated dose (MTD) and/or
    recommended Phase II dose (RP2D) and assess the safety of single
    agent GDC-0810 in postmenopausal women with locally advanced or
    metastatic ER+ (HER2-) breast cancer

    Phase IIa: To determine the anti-tumor activity of single agent of GDC0810
    in postmenopausal women with locally advanced or metastatic ER+
    (HER2-) breast cancer
    E.2.2Secondary objectives of the trial
    •To evaluate the safety of GDC-0810 single agent when administered at the RP2D in postmenopausal women with locally advanced or metastatic ER+ (HER2-) breast cancer

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

    •To evaluate the effect of GDC-0810 single agent 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] in Phase Ia and Phase IIa

    •To perform exploratory evaluation of ER target genes

    •To perform exploratory evaluation of mechanisms of resistance to GDC-0810.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General 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 general above inclusion criteria, plus:

    - 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
    E.4Principal exclusion criteria
    General exclusion criteria:
    - Untreated or symptomatic CNS metastases

    - Patients with a history of endometrial polyps, endometrial cancer,
    atypical endometrial hyperplasia, or other significant endometrial
    disorders should be excluded unless they have undergone total
    hysterectomy and there is no evidence of active disease.

    - 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 IIa portion - all general 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
    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
    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
    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)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4. 12 months
    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 concerned2
    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, GDC 0810 drug supply is exhausted, or when Sponsor decides to stop the study.
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 62
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 152
    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.
    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 Decision2015-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-03-13
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