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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41228   clinical trials with a EudraCT protocol, of which   6756   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Summary
    EudraCT Number:2008-008232-87
    Sponsor's Protocol Code Number:SOCS-B
    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:2009-03-09
    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 number2008-008232-87
    A.3Full title of the trial
    Open-label phase II study of sorafenib in patients with advanced hepatocellular carcinoma (HCC) and Child Pugh score B with special analysis of patients 65 years or older
    A.3.2Name or abbreviated title of the trial where available
    Sorafenib in Child Pugh Score B patients
    A.4.1Sponsor's protocol code numberSOCS-B
    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 SponsorCharite Universitätsmedizin Berlin- Campus Virchow-Klinikum
    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.3.10 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
    hepatocellular carcinoma and Child Pugh score B
    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
    To determine the rate of patients with drug-related toxicity with NCI CTCAE grade ≥ 3
    E.2.2Secondary objectives of the trial
    – Time to progression (TTP)
    – progression-free survival (PFS)
    – response rate (EASL/RECIST)
    – disease control rate (DCR: CR, PR or SD ≥ 8 weeks as best overall response (BOR)) – EASL/RECIST
    – Overall Survival (OS)
    – Cumulative dose
    – Average Daily Dose
    – Quality of Life
    – Safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects with proven HCC not suitable for loco-regional treatment options, resection or liver transplantation. Diagnosis of HCC can be made either histologically or according to EASL criteria.
    2. Child-Pugh stage B
    3. Age > 18 years
    4. ECOG Performance Status of 0 to 2
    5. Life expectancy of at least 12 weeks
    6. Subjects with at least one uni-dimensional (for RECIST) measurable lesion. Lesions must be measured by MRI or CT
    7. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
    - Hemoglobin > 9.0 g/dl
    - Absolute neutrophil count (ANC) >1,500/mm3
    - Platelet count  50,000/μl
    - Total bilirubin < 3 times the upper limit of normal
    - 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
    - Serum creatinine < 1.5 x upper limit of normal, creatinine clearance > 60 ml/min
    8. Signed and dated informed consent before the start of specific protocol procedures
    E.4Principal exclusion criteria
    Excluded medical conditions:
    1. Child-Pugh stages A and C
    2. Patients eligible for loco-regional treatment options, resection or transplantation
    3. Patients with portal vein thrombosis exceeding thrombosis of a single intrahepatic branch
    4. Patients with esophageal varices grade II (with high risk signs) or grade III without prior prophylactic band ligation
    5. Acute variceal bleeding within the last 4 weeks
    6. Ascites not adequately controlled by diuretic therapy
    7. Encephalopathy > grade I
    8. Uncontrolled arterial hypertension with systolic blood pressure >160 mmHg or diastolic blood pressure > 90 mm Hg despite optimal treatment
    9. History of cardiac disease:
    a) congestive heart failure > NYHA class 2;
    b) active CAD (MI more than 6 mo prior to study entry is allowed);
    c) cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted), or
    d) uncontrolled hypertension (defined as blood pressure ≥ 160 mmHg systolic and/or ≥ 90 mmHg diastolic on medication)
    10. History of HIV infection
    11. Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
    12. 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)
    13. Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
    14. History of organ allograft.
    15. Patients with evidence or history of bleeding diathesis
    16. Serious non-healing wound, fracture, or ulcer
    17. Major surgery within the last 4 weeks
    18. Thrombotic or embolic events within the last 6 months
    19. Patients undergoing renal dialysis
    20. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
    21. Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial (and men for at least 3 months after last administration of study medication).
    22. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
    23. Known severe hypersensitivity to sorafenib or any of the excipients
    24. Patients unable to swallow oral medications.
    25. Participation in another clinical study within 30 days of enrollment
    26. Patients unable to give written informed consent
    27. Patients that are placed in institutions by the order of a judge or other regulatory authority.

    Excluded therapies and medications, previous and concomitant:
    1. Anticancer chemotherapy or immunotherapy or targeted therapy (except study medication) during the study or within 4 weeks of study entry.
    2. Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed).
    3. Major surgery within 4 weeks of start of study
    4. Autologous bone marrow transplant or stem cell rescue within 4 months of study
    5. 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]
    6. Patients receiving anticoagulation therapy, such as warfarin, phenprocoumon or heparin, or ASS >100 mg/d
    7. Investigational drug therapy outside of this trial during or within 4 weeks of study entry
    8. Prior exposure to the study drug.
    9. Any St. John’s wort containing remedy
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with drug-related toxicity with NCI CTCAE grade ≥ 3 will be derived with the 95% confidence interval.
    Furthermore all treatment-emergent and drug-related adverse events and serious AEs as well as safety laboratory parameters will be summarized by CTC grade
    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 concerned15
    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
    After discontinuation of treatment with study medication, each patient will be followed every 3 months until death. Follow-up stops 3 months after LPLV.
    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 months3
    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 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 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 state112
    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 completion of study therapy patients will be followed for survival status and it is assured that adequate medical treatment will be provided. The mode of subsequent treatment is at the discretion of the investigator.
    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 Decision2009-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-07-30
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