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    Summary
    EudraCT Number:2006-006566-42
    Sponsor's Protocol Code Number:SIRN
    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:2007-08-14
    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 number2006-006566-42
    A.3Full title of the trial
    Sorafenib in Resected NSCLC (SIRN) - A Phase II Study to Investigate the Efficacy and Safety of Sorafenib as Adjuvant Treatment following Resection of Non-small Cell Lung Carcinoma (NSCLC) in Patients not eligible for Cisplatin-based Adjuvant Chemotherapy
    A.3.2Name or abbreviated title of the trial where available
    SIRN
    A.4.1Sponsor's protocol code numberSIRN
    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 SponsorUniversität Mainz, III. Medizinische Klinik
    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 200mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderBayer HealthCare AG, D-51368 Leverkusen, Deutschland
    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.3.9.1CAS number 4750207-59-1
    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
    Patients with histologically confirmed diagnosis of NSCLC pathological stages I, II or III A.
    Patients must have completely resected disease and may not be treated with prior chemotherapy. Patients must have fully recovered from surgery prior to initiation of study treatment.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029517
    E.1.2Term Non-small cell lung cancer stage I
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029518
    E.1.2Term Non-small cell lung cancer stage II
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029520
    E.1.2Term Non-small cell lung cancer stage IIIA
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the 2 year progression-free survival (PFS) in patients with NSCLC (UICC stages I to III A) treated with Sorafenib following potentially curative surgery of NSCLC.
    E.2.2Secondary objectives of the trial
    Secondary objectives are
    - To determine PFS at 3 and 4 years following surgery
    - To determine overall survival (assessed after 3 and 4 years)
    - To assess the safety and tolerability of Sorafenib adjuvant treatment when administered following surgery for NSCLC,
    - To assess biomarkers relevant to Sorafenib response and disease state, and their correlation to clinical outcome
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with histologically confirmed diagnosis of NSCLC UICC stages I, II or III A.
    • Patients must have completely resected disease (pathological R0 resection) and may not be treated with prior chemotherapy. Patients must have fully recovered from surgery prior to initiation of study treatment.
    • Adjuvant radiotherapy for stage III A disease is permitted given that the patient has recovered from all radiation-induced toxicities. In those patients, a complete restaging will be performed prior to enrolment into the trial.
    • Patients with completely resected NSCLC stage II or III A, who for medical reasons are not eligible for standard adjuvant chemotherapy consisting of a regimen of 4 cycles cisplatin/vinorelbine.
    • Patients with completely resected NSCLC stage II or III A, who are not willing to undergo standard adjuvant chemotherapy with 4 cycles of cisplatin/vinorelbine, are also eligible.
    • Age ≥ 18 years.
    • ECOG performance status 0, 1 or 2.
    • Normal organ and marrow function defined as:
    a. Hematopoetic: absolute neutrophil count >1,500/mm3, platelet count > 100,000/mm3, hemoglobin > 9 g/dL
    b. INR < 1.5 ULN and PTT within normal limits
    c. Hepatic: total bilirubin < 1.5 x ULN, AST or ALT < 2.5 x ULN
    d. Renal: 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.
    • Women of childbearing potential and men must agree to use adequate birth contraception prior to study entry and for the duration of study participation (i.e. contraception with a failure ratio of < 1%/year are implants, injection preparations, combined oral contraceptiva, intrauterine device (e.g. hormone spiral), surgical sterilisation or vasectomy). Men should use adequate birth control for at least 3 months after the last administration of Sorafenib.
    • Ability to understand the nature and scope of the trial and willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
    E.4Principal exclusion criteria
    • Any other histology (e.g. carcinoid tumors) or disease stages other than I to III A.
    • Patients who are eligible and willing to undergo standard adjuvant chemotherapy (4 cycles of cisplatin/vinorelbine).
    • Any prior systemic anticancer therapy including chemotherapy, targeted agents, experimental therapy or biological therapy for NSCLC.
    • Cardiac disease: congestive heart failure > class II NYHA, patients must not have unstable angina pectoris or new onset of angina pectoris or myocardial infarction within the past 6 months, or cardiac ventricular arrhythmias requiring antiarrhythmic therapy.
    • Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal therapy.
    • Known brain metastasis. Patients with symptoms should undergo CT scan/MRI of the brain to exclude brain metastasis.
    • Active clinically serious infections > NCI-CTCAE Grade 2.
    • Thrombotic or embolic events including transient ischemic attacks within the past 6 months.
    • Pulmonary hemorrhage/bleeding event > NCI-CTCAE Grade 2 within 4 weeks before first dose of study drug.
    • Hemorrhage/bleeding event ≥ NCI-CTCAE Grade 3 within 4 weeks before first dose of study drug.
    • 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/phenprocoumon, or with heparins or heparinoids. Low dose warfarin/phenprocoumon is permitted if INR is < 1.5. Low dose aspirin (300mg/d) is permitted.
    • Use of St John’s Wort or rifampicin.
    • Major surgery, open biopsy or significant traumatic injury within 4 weeks before first dose of study drug.
    • Known or suspected allergy to Sorafenib or any agent given in the course of this trial.
    • Previous cancer that is distinct in primary site or histology from NSCLC except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated ≤ 3 years prior to study entry.
    • Concurrent cancer that is distinct in primary site or histology from NSCLC.
    • Substance abuse, medical or psychological condition that may interfere with the patient´s participation in the study.
    • Any condition that impairs patient’s ability to swallow whole pills
    • Any malabsorption condition
    • Use of Bevacizumab or any other any drugs (licensed or investigational) that target VEGF or VEGF Receptors.
    • Systemic treatment for lung cancer, including the use of investigational agents.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival at 2 years (PFS, time until disease progression or death from any cause)
    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
    Biomarker analysis
    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 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 Yes
    E.8.1.7.1Other trial design description
    Historical control group
    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
    NSCLC patients treated with surgery alone or surgery followed by adjuvant radiotherapy
    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 concerned6
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months66
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months66
    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 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 2007-08-14. 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 state134
    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 Decision2007-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-07-15
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