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    Summary
    EudraCT Number:2010-022338-10
    Sponsor's Protocol Code Number:H9H-MC-JBAK
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-16
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-022338-10
    A.3Full title of the trial
    Randomized Phase 2 Study of LY2157299 in Patients with Hepatocellular Carcinoma who Have Had Disease
    Progression on Sorafenib or Are Not Eligible to Receive Sorafenib
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberH9H-MC-JBAK
    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 SponsorEli Lilly and Company
    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 nameLY2157299
    D.3.2Product code LY2157299
    D.3.4Pharmaceutical form Tablet
    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 codeLY2157299
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hepatocellular Carcinoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10019829
    E.1.2Term Hepatocellular carcinoma recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to characterize and compare both the time-toprogression
    (TTP) distributions and the effect on transforming growth factor beta (TGF--associated
    serum biomarkers (for example, TGF-, alpha-fetoprotein (AFP), E-cadherin) of 2 doses of LY2157299
    in patients with hepatocellular carcinoma (HCC).
    E.2.2Secondary objectives of the trial
    To evaluate the safety of LY2157299 in HCC patients
    - To evaluate the population pharmacokinetics (PK) of LY2157299
    - To determine E-cadherin, pSMAD, beta-integrin presence in the original diagnostic tumor tissue and optional
    posttreatment tumor tissue and the correlation of this with both clinical efficacy endpoints and biomarker
    response.
    - To recommend which dose to use in future trials recruiting HCC patients
    - To characterize other time-to-event distributions, such as progression-free survival, overall survival
    - To estimate antitumor efficacy using response rate
    - To assess patient-reported outcome (PRO) measures of disease-specific symptoms and healthrelated quality of
    life.
    - To explore the utility of exploratory imaging techniques to assess treatment effect with LY2157299 when
    possible
    - Explore fibrosis-related biomarkers, such as Fibrotest
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Have histological evidence of a diagnosis of HCC not amenable to curative surgery
    [2] Child-Pugh Stage A
    [3] Serum AFP ≥1.5 upper limit of normal (ULN)
    [4] Have the presence of measurable disease as defined by the RECIST 1.1 (Eisenhauer et al. 2009; . A lesion that has been previously treated by local therapy will
    qualify as a measurable or evaluable lesion if there was demonstrable progression following
    locoregional therapy.
    [5] Age >18 years
    [6] Have given written informed consent prior to any study-specific procedures
    [7] Have adequate organ function including:
    - Hematologic: absolute neutrophil count (ANC) >1.5 x 109/L, platelets >75 x 109/L, and hemoglobin >8 g/dL
    - Hepatic: bilirubin ≤2.5 times ULN); alanine aminotransaminase (ALT) and aspartate aminotransaminase (AST) <5ULN. Prothrombin time international normalized ratio, <2.3; or
    prothrombin time, <6 seconds above control).
    - Renal: Serum creatinine <1.5 times ULN or calculated creatinine clearance >45 mL/min
    [8] Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale
    [9] Have either:
    - received sorafenib and have progressed or were intolerant to sorafenib, or
    - are ineligible for sorafenib treatment (at the investigator’s discretion)
    E.4Principal exclusion criteria
    Are currently enrolled in, or discontinued within the last 28 days from a clinical trial involving an
    investigational drug or device or not approved use of a drug or device, or concurrently enrolled in any
    other type of medical research judged not to be scientifically or medically compatible with this study
    [16] Known HCC with fibro-lamellar or mixed histology
    [17] Presence of clinically relevant ascites
    [18] History of liver transplant
    [19] Have received >1 line of systemic treatment
    [20] Have moderate or severe cardiac disease: (see Section 8.2)
    [21] Have serious preexisting medical conditions that, in the opinion of the investigator, cannot be
    adequately controlled with appropriate therapy or would preclude participation in this study
    [22] Females who are pregnant or lactating.
    [23] Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the
    cervix) unless in complete remission and off all therapy for that disease for a minimum of 3 years
    [24] Have active infection that would interfere with the study objectives or influence study compliance
    E.5 End points
    E.5.1Primary end point(s)
    Tempo di progressione
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    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.8.2.3.1Comparator description
    - same IMP used at different dosage
    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 EEA21
    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
    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 months0
    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 months0
    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 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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-05-16. Yes
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 128
    F.4.2.2In the whole clinical trial 183
    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 Decision2011-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-17
    P. End of Trial
    P.End of Trial StatusCompleted
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