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    Summary
    EudraCT Number:2008-005073-36
    Sponsor's Protocol Code Number:07130
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-04-11
    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 ConcernedIreland - HPRA
    A.2EudraCT number2008-005073-36
    A.3Full title of the trial
    TACE-2: A randomised placebo-controlled, double blinded, phase III trial of sorafenib in combination with transarterial chemoembolisation in hepatocellular cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TACE-2: A randomised placebo-controlled, double blinded, phase III trial of sorafenib in combination with transarterial chemoembolisation in hepatocellular cancer
    A.3.2Name or abbreviated title of the trial where available
    TACE-2
    A.4.1Sponsor's protocol code number07130
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN93375053
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01324076
    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 SponsorUniversity College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer PLC
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportBiocompatibles Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Birmingham
    B.5.2Functional name of contact pointCRUK Clinical Trials Unit, TACE-2
    B.5.3 Address:
    B.5.3.1Street AddressEdgbaston
    B.5.3.2Town/ cityBirmingham
    B.5.3.3Post codeB15 2TT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00440121 4143973
    B.5.5Fax number00440121 4142230
    B.5.6E-mailtace2@trials.bham.ac.uk
    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 Yes
    D.2.1.1.1Trade name Nexavar
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Schering Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/06/364
    D.3 Description of the IMP
    D.3.1Product nameSorafenib
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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
    Hepatocellular Carcinoma, non-resectable
    E.1.1.1Medical condition in easily understood language
    Liver cancer
    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 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principal objective is to determine whether addition of sorafenib to TransArterial ChemoEmbolisation (TACE) performed with doxorubicin eluting beads prolongs progression free survival in patients with unresectable Hepatocellular Carcinoma (HCC) compared to TACE alone. TACE is standard treatment for patients with HCC that cannot be removed by surgery. This procedure involves blocking the blood vessel that supplies the tumour with small particles and killing it by starving it of oxygen. These particles are loaded with the chemotherapy drug doxorubicin which is delivered directly to the tumour and may increase effectiveness of the procedure. Sorafenib is a relatively new anticancer treatment which is approved for use in the treatment of HCC. It works by slowing down growth of cancer cells and also slows the rate of new vessel formation on which tumour growth depends. As they work in different and complementary ways, combining the two treatments may be more effective than TACE alone.
    E.2.2Secondary objectives of the trial
    As stated, the principal objective looks specifically at progression free survival which is defined as the interval between the date of randomisation and the date of progression or death from any cause. A secondary objective of this study is to determine whether the combination therapy prolongs either the time to progression alone or the overall survival of patients. Both factors are of important significance but would require a larger sample size to form the principal objective. A realistically achievable recruitment target is crucial to a successful study and progression free survival was considered to be a suitable surrogate.
    The study will also assess whether the combination therapy has acceptable toxicity, the affect on disease response and the impact on patient Quality of Life. The study will measure whether it reduces the frequency for repeat TACE as measured by the number of TACE procedures performed in 12 months following randomisation.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The TACE-2 Quality of Life (QoL) substudy is being run alongside the main trial and details are in the main trial protocol. The QoL substudy will assess general & hepatocellular specific aspects of quality of life using EORTC QLQC30 version 3, EORTC QLQHCC18 & EuroQoL (EQ5D) questionnaire.
    E.3Principal inclusion criteria
     Histological or cytological diagnosis or meet the AASLD criteria (Appendix 1) for diagnosis of HCC and at least one uni-dimensional lesion measurable according to the RECIST criteria by CT-scan or MRI (Appendix 2)
     Not a candidate for surgical resection or liver transplant
     Aged 18 years and estimated life expectancy >3 months
     ECOG performance status 1 (Appendix 3)
     Adequate haematological function Hb 9g/L, absolute neutrophil count 1.5x109/L, platelet count 60x109/L
     Bilirubin ≤50 μmol/L, AST or ALT ≤5 x ULN, ALP <4 x ULN
     Adequate renal function; Creatinine ≤1.5 x ULN
     INR ≤1.5
     Amylase <2 x ULN
     Child-Pugh cirrhosis A (score must be ≤6) (Appendix 4)
     Left Ventricular Ejection fraction ≥45%
     Women of child-bearing potential should have a negative pregnancy test prior to study entry. Both men and women must be using an adequate contraception method, which must be continued for 3 months after completion of treatment
     Written informed consent
    E.4Principal exclusion criteria
     Extrahepatic metastasis
     Prior embolisation, systemic or radiation therapy for HCC
     Any contraindications for hepatic embolisation procedures including portosystemic shunt, hepatofugal blood flow, known severe atheromatosis
     Investigational therapy or major surgery within 4 weeks of trial entry
     Any ablative therapy (RFA or PEI) for HCC (this should not exclude patients if target lesion(s) have not been treated and occurred >6 weeks prior to study entry)
     History of bleeding within the past 4 weeks
     Child-Pugh cirrhosis C and B with score 7 (Appendix 4)
     Hepatic encephalopathy
     Ascites refractory to diuretic therapy
     Documented occlusion of the hepatic artery or main portal vein
     Hypersensitivity to intravenous contrast agents
     Active clinically serious infection > grade 2 NCI-CTC version 4 (Appendix 5)
     Pregnant or lactating women
     Known history of HIV infection
    Protocol v76.0,28th January 2013 2nd October 2012 Page 7 of 84 Cancer Research UK Clinical Trials Unit
     History of second malignancy except those treated with curative intent more than three years previously without relapse and non-melanotic skin cancer or cervical carcinoma in situ
     Evidence of severe or uncontrolled systemic diseases, cardiac arrhythmias (requiring anti-arrhythmic therapy or pace maker), uncontrolled hypertension, congestive cardiac failure >NYHA class 2 (Appendix 6), MI within 6 months, prolonged QT/QTc >450ms, or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial
     Psychiatric or other disorder likely to impact on informed consent
     Patient is unable and/or unwilling to comply with
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint assessments are performed at the ten-week assessment and then 12-weekly thereafter.
    E.5.2Secondary end point(s)
    Overall Survival
    Time to Progression
    Toxicity
    Disease Control (CR+PR+SD)
    QoL
    Number of TACE procedures performed during 12 months following randomisation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoint assessments are performed at the followin timepoints:
    the day of randomisation; assessment during 72 hours pre-TACE; follow up at seven days post-TACE; ten-week follow up assessment and six-weekly thereafter.
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 concerned1
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    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
    For regulatory and ethical purposes, the trial will be closed to recruitment when 206 patients have been recruited to
    each treatment arm. The study will continue for one year after the last patient has been recruited.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years5
    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.1.2.1Number of subjects for this age range: 206
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 206
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 412
    F.4.2.2In the whole clinical trial 412
    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)
    If patient discontinues study treatment further treatment is at discretion of clinician. Further TACE is permitted if clinically indicated but concomitant treatment with sorafenib during repeat TACE isn't recommended. Progressed patients must be unblinded, then patients receiving placebo will be offered sorafenib if clinically appropriate. Sorafenib is free of charge from clinical trial stock. If criteria in protocol are met patients on the sorafenib arm may continue treatment after progression.
    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 Decision2013-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-03-01
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