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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-011904-47
    Sponsor's Protocol Code Number:SoraDox2009
    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:2010-07-13
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-011904-47
    A.3Full title of the trial
    Sorafenib plus doxorubicin versus sorafenib alone for the treatment of advanced hepatocellular carcinoma: a randomized phase II trial
    A.3.2Name or abbreviated title of the trial where available
    SoraDox 2009
    A.4.1Sponsor's protocol code numberSoraDox2009
    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 SponsorEthik-Kommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
    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 RoleComparator
    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.3.1Product nameNexavar
    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.3.9.1CAS number 284461-73-0
    D.3.9.2Current sponsor codeBAY 43-9006
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number to 200
    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.IMP: 2
    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 Doxo-Cell
    D.2.1.1.2Name of the Marketing Authorisation holderCell Pharm GmbH (Bad Vilbel, Germany)
    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.3.1Product namedoxorubicin
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOXORUBICIN
    D.3.9.1CAS number 23214-92-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number to 50
    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 Yes
    D.3.11.13.1Other medicinal product typedoxorubicin is a fermentation product of fungus and belongs to the group of Anthracyclinantibiotika with anticancer properties
    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
    Advanced hepatocellular carcinoma (HCC) stage C (or better) according to BCLC classification restricted to Child-Pugh class A/B (5-7 points).
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Time to progression (TTP) according to RECIST 1.1 criteria
    E.2.2Secondary objectives of the trial
    • Assessment of overall survival (OS)
    • Assessment of disease control rate (CR, PR, SD) according to RECIST 1.1 criteria
    • Assessment of disease control rate (CR, PR, SD) according to EASL criteria
    • Assessment of safety
    • Assessment of quality of life (FACT-Hep)
    • Assessment of the potential of biomarkers (AFP, VEGF, PDGF serum/plasma; vascular invasion, markers of stem cells and multi-drug resistance in biopsies) to predict tumor response
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    9.3 TRANSLATIONAL RESEARCH PROGRAM
    The translational research program will focus on signal transduction pathways relevant for (1) the efficacy of the anti-tumor medication and (2) the secondary resistance of the tumor to the medication characterized by progressive disease (PD) after an initial tumor response. The efficacy of the medication will be investigated for both drugs: signal transduction pathways responsible for the effect of sorafenib are related to VEGF and PDGF, pathways responsible for the effect of doxorubicin to the multi-drug resistance of hepatocytes, i.e. the MAP kinase pathway. The secondary resistance of the tumor is potentially related to the recruitment of (mesenchymal) stem cells to the tumor stroma with either oncogenic or immunosuppressive properties. Preliminary data associate growth hormones such as HGF and EGF with progressive disease following sorafenib treatment. In addition to the analysis of the signal transduction pathways of these growth hormones biopsies of the tumor and the tumor stroma will be assessed histologically for the recruitment and the properties of stem cells. The above delineated investigations require the following samples from patients if separate informed consent has been given: A blood sample (10 mL EDTA blood and 10 mL serum) will be taken and stored (-20°C). The samples will be taken before the administration of the study treatment, at week 6, 12 and 24, and at the end of treatment. Additionally, 10 paraffin-embedded slides of all liver biopsies will be collected and part of the liver biopsy will be frozen and stored (-20°C), if a new biopsy is performed. At week 12 a second liver biopsy will be taken and one part paraffin-embedded, the other frozen and stored (-20°C). All samples should be shipped to the prescribed condition (courier, frozen) to the core center at regular intervals after consulting the core center (Susanne Behl, University of Halle-Wittenberg, Tel.: +49 345 557 2668, e-mail: Susanne.behl@medizin.uni-halle.de). Labels for all samples will be provided by the core center. Patients will need to consent to the collection of blood and tissue samples for this translational research program.
    E.3Principal inclusion criteria
    Inclusion Criteria:
    Patients may be included in the study only if they meet all the following criteria:
    1. Non-resectable locally advanced or metastasized HCC
    2. Subjects must have at least one tumor lesion that meets the following criteria:
    - the lesion can be accurately measured in at least one dimension according to RECIST 1.1
    3. Subjects who have received local therapy (such as surgery, radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation) are eligible, provided that they have a target lesion which shows progress of the disease despite treatment.. Local therapy must be completed at least 4 weeks prior to the baseline scan.
    4. Confirmation of disease by histology
    5. Liver function: Child Pugh stage A/B (5-7 points) only
    6. Tumor stage: BCLC stage C (or better)
    7. ECOG performance status 0-2
    8. Life expectancy of at least 12 weeks
    9. Age ≥ 18 years
    10. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening and within 4 weeks before start of treatment:
    - Hemoglobin ≥ 9.0 g/dl
    - Absolute neutrophil count (ANC) ≥1.500/mm3
    - Platelet count ≥ 70.000/μl
    - Total bilirubin ≤ 3 mg/dl
    - ALT and AST ≤ 5 x upper limit of normal
    - Alkaline phosphatase < 4 x upper limit of normal
    - PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as warfarin, phenprocoumon or heparin will NOT be allowed to participate]
    - Serum creatinine ≤ 1.5 x upper limit of normal
    11. Signed and dated informed consent before start of any study specific procedure
    E.4Principal exclusion criteria
    Exclusion Criteria:
    Patients will be excluded from the study for any of the following reasons:
    1. Patients eligible for resection or transplantation
    2. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study. However cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1) or any cancer curatively treated > 3 years prior to entry is permitted
    3. Serious myocardial dysfunction: defined as absolute left ventricular ejection fraction (LVEF) < 50%, instable coronaropathy (MI more than 6 mo prior to study entry is allowed), cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
    4. Inadequately controlled hepatic complications (varices, encephalopathy)
    5. Untreated active Hepatitis B including HBs-Ag carriers; patients should be started on (prophylactic) anti-viral medication even without current viral replication
    6. Concomitant therapy with interferon (e.g. Hepatitis B/C) during study phase
    7. Uncontrolled arterial hypertension with systolic blood pressure >160 mmHg or diastolic blood pressure > 90 mm Hg despite optimal treatment
    8. Known history of HIV infection
    9. Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
    10. Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
    11. Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
    12. History of organ allograft
    13. Patients with evidence or history of bleeding diathesis
    14. Thrombotic or embolic events within the last 6 months
    15. Serious non-healing wound, fracture, or ulcer
    16. Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Women enrolled in this trial must use adequate barrier birth control measures during the course of the trial for at least 6 months after last administration of doxorubicin and 2 months after the last administration of sorafenib.
    17. Severe concomitant disease or psychiatric disorders
    18. Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
    19. Known severe hypersensitivity to sorafenib, doxorubicin or any of the excipients
    20. Patients unable to swallow oral medications
    21. Incompliance / contraindications against study medication
    Excluded therapies and medications, previous and concomitant:
    22. Previous systemic therapy for HCC
    23. Anticancer chemotherapy or immunotherapy or targeted therapy (except study medication) during the study or within 4 weeks of study entry.
    24. Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed). Major surgery within 4 weeks of start of study
    25. Autologous bone marrow transplant or stem cell rescue within 4 months of study
    26. Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]
    27. Patients receiving anticoagulation therapy or ASS >100 mg/d
    28. Investigational drug therapy outside of this trial during or within 4 weeks of study entry
    29. Prior exposure to the study drug.
    30. Any St. John’s wort containing remedy
    E.5 End points
    E.5.1Primary end point(s)
    • Time to progression (TTP) according to RECIST 1.1 Creteria
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard-of-care: sorafenib/Nexavar
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    The study will continue until the statistical endpoint of the study (127 events) has been met, but not later than 12 months after enrolment of the last patient.
    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 2010-07-13. 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 state170
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 170
    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 Decision2010-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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