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    Summary
    EudraCT Number:2008-001087-36
    Sponsor's Protocol Code Number:Bay 43-9006/12414
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-06
    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 ConcernedGreece - EOF
    A.2EudraCT number2008-001087-36
    A.3Full title of the trial
    A Phase III randomized, double-blind, placebo-controlled study of sorafenib as adjuvant treatment for hepatocellular carcinoma after surgical resection or local ablation.
    A.3.2Name or abbreviated title of the trial where available
    STORM
    A.4.1Sponsor's protocol code numberBay 43-9006/12414
    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 SponsorBayer Healthcare AG
    B.1.3.4CountryUnited Kingdom
    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 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 Health Care 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/06/364
    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.3.9.1CAS number 28844-1-73-1
    D.3.9.2Current sponsor codeBAY 43-9006
    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
    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
    To evaluate clinical benefits of sorafenib vs placebo as adujuvant treatment in subjects with HCC who received potentially curative treatment (surgical resection or local ablation).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10019830
    E.1.2Term Hepatocellular carcinoma resectable
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The Primary efficacy objective is to compare Recurrence Free Survival (RFS) in the patients treated with sorafenib vs placebo after receiving potentially curative treatment with surgical resection or local ablation.
    E.2.2Secondary objectives of the trial
    The secondary objectives are Time to Recurrence (TTR) and overall survival (OS).

    Other objectives are Patient-Reported Outcome (PRO) as assessed by FACT-Hep and EQ 5D questionnaire, and evaluation of biomarkers and pharmacokinetics.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Informed consent
    • Confirmation of diagnosis of HCC:
    • for subjects undergoing surgical resection histological confirmation is mandatory (a post surgery pathology report is required for both histological confirmation and risk stratification).
    • for subjects undergoing local ablation either histological confirmation or clinical diagnosis by AASLD criteria in cirrhotic subjects is required. For subjects without cirrhosis histological confirmation is mandatory.
    Prior to curative treatment, confirmation of a maximum tumor load of:
    • single lesion any size for surgical resection, or
    single lesion ≤ 5cm (largest diameter, unidimensional measurement) for local ablation
    • 2-3 lesions, each ≤ 3 cm in size (largest diameter, unidimensional measurement)
    • Subjects who have undergone surgical resection or local ablation (PEI or percutaneous or intraoperative RFA) for treatment of HCC with curative intent within 4 months from staging to potentially curative treatment. A maximum of 2 local ablation courses may be administered during this time period.
    • 4 weeks (28 days ± 7 days) from resection or last local ablation course, to CT/MRI scan date
    • Male or female subjects ≥ 18 years of age
    • Confirmation of CR (absence of residual tumor after curative treatment), on the eligibility scan by independent radiological review.
    • For subjects undergoing surgical resection pathology proven complete removal of tumor.
    • Intermediate or High Risk of recurrence as assessed by tumor characteristics.
    • Child-Pugh score 5 -7 points. A Child-Pugh score of 7 points is allowed only in the absence of ascites.
    • ECOG Performance Status of 0.
    • Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples approximately 14 days prior to randomization:
    • Alpha fetoprotein < 400 ng/mL
    • Women of childbearing potential must have a negative serum pregnancy test performed within 14 days prior to the start of treatment (assessed centrally).
    • Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
    • No more than 4 weeks (28 days ± 7 days) from the eligibility scan date (CT or MRI) to randomization.
    E.4Principal exclusion criteria
    • Recurrent HCC
    • Child-Pugh score 7 points with presence of ascites.
    • The following tumor characteristics:
    a) Low risk of recurrence after curative treatment defined as any of the following:
     for local ablation patients: single lesions < 2 cm
     for surgical resection patients: single lesions < 2 cm without microscopic vascular invasion, without tumor satellites and histologically well differentiated.
    b) > 3 lesions or 2-3 lesions of which any are > 3 cm in size (largest diameter, unidimensional measurement) prior curative treatment (surgical resection or local ablation)
    c) single lesion > 5 cm (largest diameter, unidimensional measurement) in size prior local ablation.
    d) Macrovascular invasion
    e) Extrahepatic spread (including regional lymph nodes and invasion into adjacent structures)
    • History of cardiovascular disease:
    • History of HIV infection
    • Active clinically serious infections (> grade 2 NCI-CTCAE version 3.0)
    • Subjects with seizure disorder requiring medication (such as steroids or anti-epileptics)
    • History of organ allograft
    • Subjects with evidence or history of bleeding diathesis
    • Subjects undergoing renal dialysis
    • 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.
    • Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
    • Encephalopathy
    • History of GI bleeding within 30 days.
    • Subjects with a history of esophageal varices bleeding which has not been followed by effective therapy and/or treatment to prevent bleeding recurrence.
    • Prior anti cancer therapy for treatment of HCC (including sorafenib or any other molecular therapy) is excluded.
    • Major surgery within 4 weeks of start of study, except for surgical resection or local ablation of HCC.
    • Autologous bone marrow transplant or stem cell rescue within 4 months of study
    • Use of biologic response modifiers, such as G-CSF, within 3 week of study entry.
    • Investigational drug therapy outside of this trial during or within 4 weeks of study entry
    • Pregnant or breast-feeding subjects.
    • Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results
    • Known or suspected allergy to sorafenib.
    • Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study
    • Subjects unable to swallow oral medications. This applies to subjects with severe obstruction of the upper GI tract that require gavage.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy objective: Recurrence Free Survival (RFS)
    Secondary efficacy objectives: Time to Recurrence (TTR).
    Overall Survival (OS)


    Other objectives:
    • Patient-Reported Outcome (PRO) as assessed by FACT-Hep and EQ-5D questionnaire.
    • Evaluation of biomarkers.
    • Evaluation of pharmacokinetics.

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    patient reported outcomes
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of study for regulatory purposes is defined as the date the last subject completes the end of study visit.
    Patients will be continued to be followed up for long term survival information follwoing completion of the end of study visit and will be contacted by telephone on a 3 monthly basis by the investigator or research nurse. This is for information only and does not involve any study related intervention.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 1100
    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 Decision2009-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-28
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