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    Summary
    EudraCT Number:2008-003789-24
    Sponsor's Protocol Code Number:SHH4489g
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-17
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-003789-24
    A.3Full title of the trial
    A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL EVALUATING THE EFFICACY AND SAFETY OF GDC-0449 AS MAINTENANCE THERAPY IN PATIENTS WITH OVARIAN CANCER IN A SECOND OR THIRD COMPLETE REMISSION.
    A.4.1Sponsor's protocol code numberSHH4489g
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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-0449
    D.3.2Product code GDC-0449
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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-0449
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboCapsule*
    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
    OVARIAN CANCER (SECOND OR THIRD COMPLETE REMISSION)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10066697
    E.1.2Term Ovarian cancer recurrent
    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 for this study is as follows:
    • To estimate the clinical benefit of the addition of GDC-0449 as maintenance therapy for patients
    with ovarian cancer in a second or third complete remission, as measured by
    investigator-determined PFS by radiographic assessment
    E.2.2Secondary objectives of the trial
    Secondary objectives for this study are as follows:
    • To make a preliminary assessment of the safety and tolerability of GDC-0449 in this population
    • To evaluate the relationship between detectable Hh expression in archival tumor tissue and
    clinical benefit of GDC-0449 in patients as measured by PFS
    • To make a preliminary assessment of the efficacy of GDC-0449 as measured by overall survival

    Exploratory objectives for this study are as follows:
    • To explore the effect of Hh expression in archival tumor tissue on
    secondary endpoints
    • To explore the effect of Hh pathway signaling on primary and secondary
    endpoints
    • To explore the effect of GDC-0449 on PFS as assessed by a combination of
    CA-125 and radiographic criteria
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Study Title: DNA REPOSITORY SUBSTUDY IN ASSOCIATION WITH GDC-0449 STUDY SHH4489g

    Protocol Date and Version: SHH4489g dated 09 June 2008

    The primary objective of this study is to perform exploratory analyses to generate hypotheses identifying genes associated with treatment response, toxicity, or disease risk. If such genetic hypotheses are identified, they may be tested in future clinical studies within this therapeutic area.
    E.3Principal inclusion criteria
    Patients must meet the following inclusion criteria to be eligible for study entry:
    • Age ≥ 18 years
    • Histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma
    • Must be in second or third complete remission, have received chemotherapy
    (platinum-based and/or non−platinum-based) for recurrent disease, and have achieved a complete remission after their most recent chemotherapy regimen
    Complete remission is defined as no symptoms suggestive of persistent
    cancer, CT scan of the chest/abdomen/pelvis without evidence of ovarian
    cancer within 4 weeks of randomization, and normal CA-125 (measured
    within 2 weeks of randomization) following completion of prior chemotherapy.
    • Patients must have completed their most recent cytotoxic chemotherapy
    regimen (platinum-based or non-platinum based) no less than 3 weeks and
    no more than 12 weeks prior to screening.
    • Archival tissue must be available and requested.
    The tissue must consist of representative tumor specimens in paraffin
    blocks (preferred) or at least 15 unstained slides, with an associated
    pathology report, obtained at any time prior to entry of study.
    • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
    (see Appendix D)
    • Adequate hematopoietic capacity, as defined by the following:
    Hemoglobin > 8.5 g/dL, not transfusion-dependent
    Granulocyte count ≥ 1200/μL
    Platelets ≥ 75,000/μL
    • Adequate hepatic function, as defined by the following:
    AST and ALT ≤ 3 × the upper limit of normal (ULN)
    Total bilirubin ≤ 1.5 × ULN or within 3 × ULN for patients with Gilbert’s disease
    • Adequate renal function, as defined by the following:
    Serum creatinine ≤ 2.0 mg/dL or measured creatinine clearance
    > 50 mL/minute
    • Negative pregnancy test on Day 1
    • For women of childbearing potential: Use of two effective methods of barrier
    contraception, including one barrier method (See Appendix C for
    unacceptable methods of contraception.)
    • Signed informed consent
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from study entry:
    • Pregnancy or lactation
    For women of childbearing potential: use of two effective methods of
    barrier contraception, including one barrier method, during the study and
    for 12 months after discontinuing study drug (see Appendix C for
    unacceptable methods of contraception).
    • Patients whose ovarian cancer is in first remission
    • Patients must not have experienced more than two prior recurrences
    of disease
    • Concurrent non−protocol-specified anti-tumor therapy, either approved or
    unapproved (e.g., chemotherapy, hormonal therapy, other targeted therapy,
    radiation therapy, surgery, herbal therapy)
    • Current, recent (within 4 weeks of Day 1), or planned participation in an
    experimental drug study while enrolled in this study
    • History of other malignancies within 3 years of Day 1, except for tumors with
    a negligible risk for metastasis or death, such as adequately treated BCC or
    squamous-cell carcinoma of the skin; ductal carcinoma in situ of the breast;
    or carcinoma in situ of the cervix
    • Uncontrolled medical illnesses such as infection requiring IV antibiotics
    • Life expectancy < 12 weeks
    • History of other disease, metabolic dysfunction, physical examination finding,
    or clinical laboratory finding giving reasonable suspicion of a disease or
    condition that contraindicates use of an investigational drug or that might
    affect interpretation of the results of the study or render the patient at high
    risk from treatment complications.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint in this study is the hazard ratio (HR) of PFS using the
    stratified Cox model. PFS will be defined as the time from randomization until the
    first occurrence of radiographic progression or death from any cause, determined
    by the investigator (see Primary Efficacy Outcome Measures, Section 3.3.1, for a
    definition of radiographic progression). Patients who do not meet the criteria for
    disease progression, but who die, will be treated as having progressed for the PFS analysis. Patients who do not meet the criteria for disease progression and
    who do not die will be censored at the time of last tumor assessment.
    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 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.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 Yes
    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.8.3 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 EEA15
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Treatment will continue until evidence of radiographic progression, until the patient experiences intolerable toxicities most probably attributable to GDC-0449, or until the patient withdraws from the study.

    Patients who discontinue study treatment will be followed for survival approximately every 3 months until death, loss to follow-up, or study termination by Genentech.
    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 months7
    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 months7
    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.1.3Elderly (>=65 years) Yes
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 100
    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 Decision2008-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-09-23
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