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    Summary
    EudraCT Number:2008-000566-23
    Sponsor's Protocol Code Number:GK-001-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-03-25
    Trial 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 number2008-000566-23
    A.3Full title of the trial
    A randomized phase 2 double-blind, placebo-controlled study of GK-001 in hepatocellular carcinoma (HCC) in chronic hepatitis C patients after prior curative HCC treatment

    Estudio aleatorizado de fase 2, doble ciego, controlado con placebo sobre GK-001 en pacientes con carcinoma hepatocelular (CHC) y hepatitis C crónica tras tratamiento curativo para el CHC
    A.4.1Sponsor's protocol code numberGK-001-01
    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 SponsorGeneCare Research Institute Co., Ltd.
    B.1.3.4CountryJapan
    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 nameGK-001
    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 codeGK-001
    D.3.9.3Other descriptive name(2S,12Z,14E,16S,17S,18R,19R,20R,21S,22R,23S,24E)-1,2-dihydro-5,6,9,17,19- pentahydroxy-23-methoxy-2,
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeSemisynthetic derivative of rifampicin antibiotics
    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
    hepatocellular carcinoma (HCC) in chronic hepatitis C patients after prior curative HCC treatment

    carcinoma hepatocelular (CHC) en pacientes con hepatitis C crónica tras tratamiento curativo para el CHC
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10019830
    E.1.2Term Hepatocellular carcinoma resectable
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of GK-001 in chronic hepatitis C patients who have undergone prior curative HCC treatment (percutaneous ethanol injection [PEI], radiofrequency ablation [RFA], surgical resection)
    E.2.2Secondary objectives of the trial
    To characterize efficacy parameters in placebo treated patients, for use in formulation of hypotheses in future trials

    To characterize the safety profile of GK-001 in HCC patients with chronic hepatitis C
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed informed consent obtained prior to initiation of any study-specific procedures
    • Previous HCC diagnosis (according to AASLD 2005 Guidelines) for which the patient has undergone 1-2 potentially curative treatments (PEI, RFA, surgical resection)
    • T2N0M0 or T3N0M0 HCC diagnosis prior to curative treatment
    • A dynamic CT-scan showing no evidence of HCC with proof of cancer-free margins within 30 days of randomization; scan must be performed 1-3 months after curative treatment
    • Diagnosis of chronic hepatitis C
    • Age ≥ 18 years
    • ECOG Performance Status (PS): 0-1
    • Liver function: total bilirubin: <35 µM; ALT & AST <10 x Upper Limit of Normal (ULN); Child-Pugh A
    • Patients of childbearing potential must use an approved form of contraception (barrier method or abstinence - hormonal contraception is not considered adequate) during the study
    • Ability and willingness to comply with the protocol and follow-up
    E.4Principal exclusion criteria
    • Diseases other than hepatitis which can influence ALT values (e.g. polymyositis, cholelithiasis)
    • Dialysis patients
    • Co-infection with HCV-HBV
    • Evidence of residual tumor
    • History of allergic reactions to compounds of similar chemical or biological composition to GK-001
    • Concurrent radiotherapy or chemotherapy; concurrent immunotherapy with IFN is permitted
    • Systemic chemotherapy, radiotherapy or immunotherapy for HCC during the 6 weeks prior to randomization
    • Administration of an investigational agent during the 4 weeks prior to randomization
    • Use of GK-001 in the 12 months prior to randomization
    • Concurrent anti-HIV drugs, tuberculostatic drugs other than Rifampicin
    • Alcohol consumption >30 g/day for males and >20 g/day for females
    • Planned initiation of treatment with liver-supporting medications, e.g. UDCA; patients receiving UDCA prior to study screening must continue at the same dose
    • Pregnant or breast-feeding women
    • Presence of porphyrinuria, methicillin-resistant Staphylococcus (MRSA) infection, tuberculosis, autoimmune hepatitis, drug-associated hepatitis, diabetes treated with hypoglycemic oral agents
    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, HIV, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any other psychiatric disorder or social situations which could hamper compliance
    E.5 End points
    E.5.1Primary end point(s)
    Disease-free survival (DFS): defined as the time from randomization to the first recurrence or occurrence of HCC
    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 EEA17
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 102
    F.4.2.2In the whole clinical trial 102
    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 Decision2008-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-09
    P. End of Trial
    P.End of Trial StatusOngoing
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