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    Summary
    EudraCT Number:2011-004126-10
    Sponsor's Protocol Code Number:GO27983
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-11
    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 ConcernedGreece - EOF
    A.2EudraCT number2011-004126-10
    A.3Full title of the trial
    A PHASE Ib/II STUDY OF GDC-0068 OR GDC-0980 WITH ABIRATERONE ACETATE VERSUS ABIRATERONE ACETATE IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH DOCETAXEL-BASED CHEMOTHERAPY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of GDC-0068 Or GDC-0980 With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy
    A.4.1Sponsor's protocol code numberGO27983
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01485861
    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.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech Inc
    B.5.2Functional name of contact pointCraig Talluto,Sr Clinical Leader
    B.5.3 Address:
    B.5.3.1Street Address1 DNA WAY
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post code94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 650 467-3543
    B.5.5Fax number01 650 319 81390
    B.5.6E-mailtallutc1@gene.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 nameNot Applicable
    D.3.2Product code GDC-0068
    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.3.9.2Current sponsor codeGDC-0068
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 nameNot Applicable
    D.3.2Product code GDC-0980
    D.3.4Pharmaceutical form Film-coated 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.3.9.2Current sponsor codeGDC-0980
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Castration-Resistant
    Prostate Cancer
    E.1.1.1Medical condition in easily understood language
    prostate cancer that is resistant to medical or surgical treatments that lower testosterone
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    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
    The primary objective of the Phase II portion of the study is to estimate the efficacy of two combination regimens, as measured by composite progression-free survival based on modified Prostate Cancer Working Group 2 criteria (see Section 3.1.3 and Appendix C of study protocol):
    • GDC-0068 + abiraterone and prednisone versus placebo + abiraterone
    and prednisone
    • GDC-0980 + abiraterone and prednisone versus placebo + abiraterone
    and prednisone

    Efficacy will be measured in all patients and in patients with PTEN loss.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the Phase II portion of the study:

    • To estimate the clinical activity, as measured by overall survival, of
    GDC-0068 + abiraterone and prednisone and GDC-0980 + abiraterone and
    prednisone versus placebo + abiraterone and prednisone in all patients and
    in patients with PTEN loss

    • To estimate the clinical activity, as measured by PSA response rate,
    confirmed objective tumor response rate, and duration of confirmed objective
    tumor response, of GDC-0068 + abiraterone and prednisone and
    GDC-0980 + abiraterone and prednisone versus placebo + abiraterone and
    prednisone in all patients and in patients with PTEN loss


    • To evaluate the pharmacokinetics of GDC-0068, GDC-0980, and abiraterone when administered in combination at the recommended Phase II dose

    (Please see section 2.2.2 of study protocol for other secondary endpoints)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all the following criteria to be eligible for study entry:
    • Signed Informed Consent Form(s)
    • Histologically or cytologically confirmed metastatic or advanced prostate
    adenocarcinoma that has been previously treated with docetaxel and has progressed during treatment of at least one hormonal therapy (luteinizing hormone−releasing hormone, bicalutamide, etc.)
    • Availability at the site of a representative formalin-fixed, paraffin-embedded
    tumor specimen that enabled the definitive diagnosis of prostate cancer, accompanied by an associated pathology report (required prior to randomization)
    The specimen must contain adequate viable tumor cells (≥ 20% for excisional
    biopsy and ≥ 50% if sample is a core biopsy).
    Specimen may consist of a tissue block (preferred) or 15−20 unstained, serial
    slides. Cytologic or fine-needle aspiration samples are not acceptable.
    If archival tissue is either insufficient or unavailable, the patient may still be
    eligible, upon discussion with the Medical Monitor, assuming the patient
    Can provide ≥ 5 unstained, serial slides
    or
    Is willing to consent to and undergo a pretreatment core or excisional biopsy of the tumor. Cytologic or fine-needle aspiration samples are
    not acceptable.
    • Two rising PSA levels ≥ 2 ng/mL measured ≥ 1 week apart that meet the
    PCWG2 criteria for progression prior to initiation of study treatment or
    radiographic evidence of disease progression in soft tissue or bone, with or
    without disease progression on the basis of the PSA value
    • Ongoing androgen deprivation, with serum testosterone < 50 ng/dL (< 2.0 nM/L)
    • ECOG performance status of 0, 1, or 2 at screening
    • Adequate hematologic and organ function within 14 days before the first study treatment, defined by the following (hematologic parameters must be
    assessed ≥ 14 days after a prior transfusion, if any):
    Neutrophils (ANC ≥ 1500/μL)
    Hemoglobin ≥ 9 g/dL
    Platelet count ≥ 100,000/μL
    Total bilirubin ≤ 1.5 × ULN with the following exception:
    Patients with known Gilbert’s disease who have serum bilirubin ≤ 3 × ULN may be enrolled.
    AST and ALT ≤ 2.5 × ULN, with the following exceptions:
    Patients with documented liver metastases may have AST and/or
    ALT ≤ 5 × ULN.
    Serum albumin ≥ 3 g/dL
    Serum creatinine ≤ 1.5 × ULN or creatinine clearance of > 50 mL/min
    based on a 24-hour urine collection
    Fasting total serum glucose ≤ 150 mg/dL
    • Documented willingness to use an effective means of contraception
    (e.g., abstinence, hormonal or double barrier method, surgically sterilized partner) while participating in the study
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from study entry:
    • Small cell or neuroendocrine prostate carcinoma
    • History of Type I or Type II diabetes mellitus requiring insulin Patients who are on a stable dose of oral diabetes medication ≥ 4 weeks prior to initiation of study treatment may be eligible for enrollment.
    • Inability or unwillingness to swallow pills
    • Malabsorption syndrome or other condition that would interfere with
    enteral absorption
    • Congenital long QT syndrome or QTc > 500 msec
    • NYHA Class III or IV heart failure or LVEF < 50% or ventricular arrhythmia
    requiring medication
    • Any requirement for supplemental oxygen therapy to perform activities of daily living
    • Current unstable angina or history of myocardial infarction within 6 months
    prior to Day 1
    • Active infection requiring IV antibiotics
    • Active autoimmune disease that is not controlled by nonsteroidal
    anti-inflammatory drugs or active inflammatory disease, including small or
    large intestine inflammation such as Crohn’s disease or ulcerative colitis,
    which requires immunosuppressive therapy
    • Clinically significant history of liver disease consistent with Child-Pugh Class B or C, including viral or other hepatitis, current alcohol abuse, or cirrhosis
    • History of adrenal insufficiency or hyperaldosteronism
    • Known HIV infection
    • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patients at high risk from treatment complications
    • Significant traumatic injury within 4 weeks prior to initiation of study treatment
    (all wounds must be fully healed)
    • Major surgical procedure within 4 weeks prior to initiation of study treatment
    • Treatment with chemotherapy, hormonal therapy (except GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as
    cancer therapy within 2 weeks prior to initiation of study treatment
    • Previous therapy for prostate cancer with CYP17 inhibitors, including abiraterone and ketoconazole, or previous treatment with MDV3100
    • Previous treatment for prostate cancer with Akt, PI3K, and/or mTOR inhibitors
    • Need for chronic corticosteroid therapy of ≥ 20 mg of prednisone per day or an equivalent dose of other anti inflammatory corticosteroids or immunosuppressant
    • Treatment with an investigational agent within 4 weeks prior to initiation of study treatment
    • Malignancies other than prostate cancer within 5 years prior to initiation of study treatment, except for adequately treated basal or squamous cell skin
    cancer and non−muscle-invasive bladder cancer
    • Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy
    • Inability to comply with study and follow-up procedures
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the composite PFS, defined as the time from study treatment initiation (Day 1 of Cycle 1) to the first occurrence of disease progression, as determined by investigator review of tumor assessments using modified PCWG2 criteria (see Section 3.1.3 and Appendix C of study protocol), or death on study
    (≤ 30 days after the last dose of study treatment) from any cause, whichever
    occurs first.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 of Cycle 1 or
    ≤ 30 days after the last dose of study treatment
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints include overall survival, PSA response rate,
    time to disease progression by modified PCWG2 criteria, confirmed tumor response rate by modified RECIST v1.1, duration of confirmed tumor response by modified RECIST v1.1, and change in number of CTCs and its correlation with
    efficacy assessments for all patients and for PTEN loss patients.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PSA after ≥ 4 weeks
    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 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) Yes
    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 trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Czech Republic
    France
    Greece
    Italy
    Netherlands
    Romania
    Spain
    United Kingdom
    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
    last patient last visit
    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 months2
    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 months2
    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: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 193
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 258
    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)
    Following study completion or termination, patients who continue to benefit from study treatment may be given the opportunity to continue treatment as part of an extension study provided the study drugs are available.

    Genentech will work closely with the site to assess each patient’s eligibility on a case-by-case basis. Depending on the reasons for study termination, however, the study drug may not be offered after study termination. Continued access to the study drug is not guaranteed.
    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 Decision2012-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-08-31
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