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    Summary
    EudraCT Number:2007-000730-40
    Sponsor's Protocol Code Number:SOCRATES
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-05-10
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-000730-40
    A.3Full title of the trial
    Phase II study evaluating transarterial chemoembolization (TACE) in combination with sorafenib for the treatment of advanced hepatocellular carcinoma (HCC)
    A.3.2Name or abbreviated title of the trial where available
    TACE and sorafenib for HCC
    A.4.1Sponsor's protocol code numberSOCRATES
    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 SponsorHeinrich-Heine-Universität Düsseldorf
    B.1.3.4CountryGermany
    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 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 Yes
    D.2.1.1.1Trade name Nexavar
    D.2.1.1.2Name of the Marketing Authorisation holderBayer HealthCare AG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNSorafenib
    D.3.9.2Current sponsor codeSorafenib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    histologically proven advanced hepatocellular carcinoma (HCC) not suitable for resection or liver transplantation but without extrahepatic manifestations and without previous treatment for HCC
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10019828
    E.1.2Term Hepatocellular carcinoma non-resectable
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective:
    – determination of time to progression (TTP)
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    determination of
    – overall survival (OS)
    – disease control rate (DCR: CR, PR or SD as best overall response (BOR))
    – progression-free survival (PFS)
    – total number of TACE cycles
    – safety profile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    – Patients with histologically confirmed HCC not suitable for resection or liver transplantation (> 3 tumors > 3 cm; one tumor > 5 cm; vascular invasion; corresponding to intermediate stage according to the BCLC staging criteria)
    – Age >= 18 years
    –Patients with measurable disease according to RECIST
    – Performance status ECOG 0-2
    – Patients naive to treatment with respect to the HCC
    – Normal organ and bone marrow function defined as:
    – Hematopoetic: absolute neutrophil count > 1,500/mm3, platelet count > 100,000/mm3, hemoglobin > 9g/dL
    – INR < 1.5 ULN and PTT within normal limits
    – Hepatic: AST or ALT < 5 x ULN, alkaline phosphatase < 4 x ULN
    – Renal: serum creatinine < 1.5 x ULN
    – Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
    – Male or female patients with reproductive potential must use an approved contraceptive method during and for 3 months after the end of treatment with study medication (Approved methods for women are oral contraceptives with estrogen and progesterone, vaginal rings, contraceptive patches, estrogen-free ovulation inhibitors, intrauterine devices with progesterone, 3-month injections with depot progesterone, implants settting free progesterone, abstinence or sterilization (vasectomy) of the male partner. Men must use condomes.)
    – Written informed consent (including consent to data reporting)
    E.4Principal exclusion criteria
    – Patient is eligible for liver resection or liver transplantation
    – Extrahepatic tumor manifestation
    – Thrombosis of the portal vein
    – > 8 points according to Child Pugh classification
    – Prior TACE or RFTA or any other local ablative treatment
    – Prior systemic anticancer chemotherapy or radiotherapy for HCC
    – Total bilirubin > 4.5 mg/dl
    – Life expectancy of less than 12 weeks
    – Esophageal varices grade III (any) or esophageal varices grade II with increased risk for bleeding (red wale signs, cherry spots, red coloration, hematocystic spots) without prophylactic band ligation
    – Cardiac disease: congestive heart failure > class II NYHA, unstable angina or new onset of angina or myocardial infarction within the past 6 months. Cardiac ventricular arrhythmias requiring antiarrhythmic therapy
    – Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal management
    – Known or suspected hyperthyroid state
    – Known brain metastasis. Patients with symptoms should undergo CT/MRT of the brain to exclude brain metastasis
    – Patients with seizure disorder requiring medication (such as steroids or antiepileptics)
    – History of organ allograft
    – Active clinically serious infections > CTCAE grade 2
    – Thrombotic or embolic events including transient ischemic attacks within the past 6 months
    – Hemorrhage/bleeding event >= CTCAE grade 3 within 4 weeks of first dose of study drug
    – Acute variceal bleeding within the last 2 weeks
    – Serious non healing wound, ulcer or bone fracture
    – Evidence or history of bleeding diathesis or coagulopathy
    – Therapeutic anticoagulation with vitamin K antagonists such as warfarin, or with heparins or heparinoids. Low dose warfarin is permitted if INR is < 1.5. Low dose aspirin is permitted (<= 100 mg/day)
    – Chronic daily treatment with aspirin > 100 mg/day
    – Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug
    – Known or suspected allergies to sorafenib, anthracyclines (including doxorubicin) or lipiodol (containing esters of iodinated fatty acids of poppy oil) or any agent given in the course of this trial
    – Contraindications to the use of sorafenib, doxorubicin or lipiodol as mentioned in the current summary of product characteristics
    – Previous cancer that is distinct in primary site or histology from HCC except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated 3 years prior to study entry
    – Substance abuse, medical or psychological condition that may interfere with the patient´s participation in the study
    – Participation in another clinical trial with any investigational study drug (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to enrollment
    – Incapability to give valid informed consent (including patients who are dependent on the sponsor or the investigator)
    – Lactating women
    E.5 End points
    E.5.1Primary end point(s)
    Progression of HCC or patient´s death
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned10
    E.8.5The trial involves multiple Member States No
    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
    Treatment will be continued until one of the following occurs:
    - PD
    - not tolerable toxicity
    - patient´s wish
    - other reason according to which continuation of treatment is not in the patient´s best interest
    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 months6
    E.8.9.1In the Member State concerned days
    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 state72
    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)
    After the end of therapy survival information will be collected every 3 month until death and further medical treatment is discussed between the investigator and the patient taking into account known and accepted therapy options. The investigator will suggest adequate therapy.
    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 Decision2007-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-09-15
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