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    Summary
    EudraCT Number:2011-003574-84
    Sponsor's Protocol Code Number:NP27884
    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:2011-11-18
    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 number2011-003574-84
    A.3Full title of the trial
    A Randomized, Placebo-controlled, Double-blind,
    Multicenter Phase II Trial of Intravenous GC33 at 1600 mg
    Q2W in Previously Treated Patients with Unresectable
    Advanced or Metastatic Hepatocellular Carcinoma (HCC).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of intravenous GC33 treatment in patients with liver cancer that cannot be resected or has metastatized and that has not responded to currently available treatment(s).
    A.4.1Sponsor's protocol code numberNP27884
    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 SponsorF. Hoffmann-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. 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.5.4Telephone number+4161 688 1111
    B.5.5Fax number+4161 691 9319
    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 Information not present in EudraCT
    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.3.2Product code Ro 513-7382/F02
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeRO5137382
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400 mg
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) 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 Yes
    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 typeMonoclonal antibody
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Second-line treatment for adult patient with unresectable
    advanced or metastatic hepatocellular cancer.
    E.1.1.1Medical condition in easily understood language
    The disease under investigation is advanced liver cancer (hepatocellular carcinoma) that cannot be resected, or liver cancer (hepatocellular carcinoma) that has metastatized.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10019828
    E.1.2Term Hepatocellular carcinoma non-resectable
    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
    To evaluate efficacy of GC33 vs. placebo through investigator-assessed progression-free survival (PFS) in patients with unresectable advanced or metastatic hepatocellular carcinoma (HCC) previously treated with at least 1 systemic agent, with documented progressive disease, or documented adverse event(s) resulting in discontinuance of that (those) agents, stratified by level of GPC-3 expression (IHC score)
    E.2.2Secondary objectives of the trial
    1. To compare treatment effect of GC33 vs. placebo on overall survival (OS)
    2. To compare treatment effect of GC33 vs. placebo on disease control rate
    3. To evaluate the tolerability and safety of GC33 when given as monotherapy in comparison to placebo using the NCI-CTCAE version 4.0
    4. To further characterize the pharmacokinetic (PK) profile of GC33
    5. To validate the GPC-3 immunohistochemistry(IHC) assay for analysis of GPC-3 expression
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female ≥18 years old
    2. Life expectancy of at least 12 weeks
    3. ECOG Performance Status of 0 or 1
    4. Histologically confirmed unresectable advanced or metastatic hepatocellular carcinoma (without fibrolamellar subtype) patients who are not candidate for or progressed on loco-regional therapy
    5. Prior treatment with at least 1 systemic agent, (such as Sorafenib or other experimental agents), with documented progressive disease after systemic agent(s), or documented adverse event(s) associated with prior systemic agent(s) that resulted in discontinuance of that(those) agent(s)
    6. Not a candidate for curative treatments (e.g. resection, transplantation)
    7. Child-Pugh A ( score of 5-6)
    8. Adequate hematologic function: Platelet count ≥ 50x 109/L, Absolute Neutrophil Count ≥ 1,500/μL, Hemoglobin ≥ 8.0 g /dL
    9. Adequate hepatic function: ALT (SGPT), AST (SGOT) ≤ 5 x ULN, Bilirubin ≤ 2 mg/ dL
    10. Adequate renal function: Serum Creatinine ≤ 2 x ULN or calculated Creatinine Clearance ≥ 60 ml/min using Cockcroft and Gault formula
    11. Ability to provide, for central review, a tumor tissue sample containing at least 5 % tumor cells to determine the level of GPC-3 expression by IHC. Determination of GPC-3 expression level is required prior to study entry.
    12. Patients must have recovered from effects of any major surgery or significant traumatic injury at least 14 days before the first dose of study treatment
    13. Measurable disease (by RECIST 1.1) prior to the administration of study treatment
    14. Negative serum pregnancy test
    E.4Principal exclusion criteria
    1. Child-Pugh B or C
    2. Known HCC with fibro-lamellar histology
    3. Known brain or leptomeningeal metastases
    4. Patients with a previous malignancy within the past 5 years are excluded(patients who had curatively treated basal cell carcinoma of the skin,early gastrointestinal cancer by endoscopic resection, and/or insitu carcinoma of the cervix and other malignancies which were considered cured and deemed by the PI to have no impact on the PFS and OS are allowed after discussion with the study medical monitor)
    5. Active infectious diseases requiring treatment except for hepatitis B and C
    6. NCI CTCAE version 4.0 grade 3 hemorrhage within 4 weeks of starting the study treatment
    7. History of organ allograft including liver transplant
    8. Anticipated or ongoing administration of anti-cancer therapies other than those administered in this study
    9. Patient who have had any anticancer treatment within 2 weeks prior to entering the study
    10. Patients who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies
    11. Patients receiving Interferon therapy
    12. Patients with baseline QTc > 470 ms, or patients with baseline resting bradycardia <45 beats per minutes.
    13. Patients who received anticoagulation or thrombolytic agents for therapeutic purposes (except for low-dose administration for catheter clearance or for prophylactic purposes) within 2 weeks prior to Day 1
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    When PFS data mature (about 24 months from FPFV)
    E.5.2Secondary end point(s)
    Overall survival
    Time to progression
    Disease control rate
    E.5.2.1Timepoint(s) of evaluation of this end point
    Planned at the same time as primary endpoint
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 No
    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 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.8.2.4Number of treatment arms in the trial2
    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 EEA30
    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
    Belgium
    France
    Germany
    Hong Kong
    Italy
    Japan
    Korea, Republic of
    Netherlands
    New Zealand
    Singapore
    Spain
    Taiwan
    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
    The study will continue until 1) the last data point from the last patient (OS) is received; or 2) 12 months after the last patient
    was enrolled, and all patients completed the 28-day follow-up visit, whichever comes first.

    Patients may continue on study treatment until the development of progressive disease, unacceptable toxicity, and/or consent withdrawal.
    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 months8
    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 months8
    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: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 86
    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 No
    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 2011-11-18. 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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    F.4.2.2In the whole clinical trial 171
    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)
    A subject who has ended his/her participation in the trial will be followed for 28 days for safety and every 8 weeks thereafter for survival and collection of information on his/her subsequent anti-cancer therapy(ies).
    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 Decision2011-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-08-20
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