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    Summary
    EudraCT Number:2008-005062-31
    Sponsor's Protocol Code Number:06-41
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-08
    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 ConcernedIreland - HPRA
    A.2EudraCT number2008-005062-31
    A.3Full title of the trial
    Phase II single agent sorafenib in the treatment of relapsed oesophageal/gastric adenocarcinoma in platinum pre-treated patients
    A.3.2Name or abbreviated title of the trial where available
    Sorafenib upper GI study
    A.4.1Sponsor's protocol code number06-41
    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 SponsorICORG, the all-Ireland Co-operative Oncology Research Group
    B.1.3.4CountryIreland
    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 AuthorisationGermany
    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 namesorafenib; BAY 43-9006
    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.3.10 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
    oesophageal/gastric adenocarcinoma (which has relapsed in platinum pre-treated patients).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10062878
    E.1.2Term Gastrooesophageal cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the Disease Control rate after 4 months of treatment for each patient (complete response + partial response + stable disease) rate
    E.2.2Secondary objectives of the trial
    • Progression Free Survival
    • Overall Survival
    • Time to tumour progression
    • Objective response rate
    • Tolerability/ toxicity
    • Biomarkers of response/resistance to therapy
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Translational biomarker research sub-study:

    If consented to, in a separate sub-study research consent:
    - archived tissue (paraffin embedded tissue blocks) and fresh frozen tissues will be collected, where possible, for analysis of molecular determinants of response to treatment.
    - upper gastrointestinal tract endoscopy will be performed within 28 days prior to study dose. Other specimens will be taken at 1 month, and at time of tumour progression where possible.
    - 2x10ml blood samples (one plasma and one serum) will be taken at 28 days prior to study dose, at 1 month (before cycle 2 treatment), and at time of tumour progression where possible. Serum, plasma and white cells will be stored at site for later shipment for biomarker research analysis. Contact in St James’s Hospital is study Chief Investigator Dr Ken O’Byrne (see contacts list in appendix G of protocol).

    Objectives: For predictive and drug effect markers, comparison of pre- and post-drug values will be performed. The transcriptone and proteomic data in those patients whose disease is controlled with therapy at 4 months will be compared to the transcriptone and proteomic data in those whose tumours progress. Through this work, a number of genes and or proteins may emerge as potential biomarkers predictive of sensitivity or resistance to sorafenib therapy. The epigenomic/genomic and proteomic data will be analysed by Dr Alan Kelly, Chartered Statistician, Senior Lecturer in Biostatistics, Trinity College.
    E.3Principal inclusion criteria
    • Relapsed or progressed histologically confirmed oesophageal and/or gastric adenocarcinoma after prior platinum based chemotherapy not suitable for radical therapy.
    • Prior local radiotherapy is allowed if it is completed at least 3 weeks prior to the first dose of study drug.
    • Prior surgery is allowed if it is performed at least 4 weeks prior to the first dose of study drug.
    • Subjects with at least one uni-dimensional measurable lesion as assessed by the RECIST criteria.
    • Age > 18 years old.
    • ECOG Performance Status of 0 to 2.
    • Life expectancy of at least 2 months.
    • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:
    - Haemoglobin > or = 9.0 g/dl.
    - Absolute neutrophil count (ANC) ³ 1.5 x 10^9/L.
    - Platelet count >or = 100 x 1^09/L.
    - Total bilirubin > 1.5 times the upper limit of normal.
    - ALT and AST < or = 2.5 x upper limit of normal (< or = 5 x upper limit of normal for patients with liver involvement).
    - Alkaline Phosphatase < or = 2.5 x upper limit of normal (< or = 4 x upper limit of normal for patients with bony involvement).
    - INR (international normalised ratio) <1.5, and aPTT (activated partial thromboplastin time) within normal limits.
    - Creatinine ≤1.5 times the upper limit of normal.

    • 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 contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib.
    • Ability to understand and the willingness to sign a written informed consent, given according to ICH/GCP, and national/local regulations. A signed informed consent must be obtained prior to any study specific procedures.
    E.4Principal exclusion criteria
    • Cardiac disease: History of cardiac disease: congestive heart failure >NYHA class 2; active Coronary Artery Disease (Mycardial Infarction more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
    • Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
    • Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
    • Active clinically serious infections > or = CTCAE Grade 2.
    • Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months.
    • Pulmonary haemorrhage/bleeding event > or = CTCAE Grade 2 within 4 weeks of first dose of study drug.
    • Any other haemorrhage/bleeding event > or = CTCAE Grade 3 within 4 weeks of first dose of study drug.
    • Serious, non-healing wound, ulcer (apart from the tumour), or bone fracture.
    • Evidence or history of bleeding diathesis or coagulopathy.
    • Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug.
    • Current signs or symptoms of severe progressive or uncontrolled hepatic, haematological, renal, endocrine, pulmonary or cardiac disease.
    • Uncontrolled, symptomatic brain metastases – intracranial bleeding into metastases with tyrosine kinase inhibitors (TKI's) appears to be rare in other solid tumours and in our view should not exclude patients with well controlled disease from the study. The patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies).
    • Previous treatment with a tyrosine kinase inhibitor or anti-angiogenic agent (licensed or investigational) such as sunitinib or bevacizumab.
    • Any previous drug treatment (licensed or investigational) that targets the RAS, VEGF, VEGFR or EGFR pathway.
    • Investigational drug therapy during or within 30 days.
    • Concomitant treatment with rifampin or St. John's Wort.
    • Any cancer chemotherapy, immunotherapy, radiotherapy or hormonal treatment over the previous 4 weeks. Palliative radiotherapy to symptomatic disease sites is permitted.
    • Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except bisphosphonates.
    • Women who are pregnant, nursing, or planning pregnancy within 6 months after the last treatment (this includes men who plan to father a child within 6 months of the last treatment).
    • Therapeutic anticoagulation with vitamin K antagonists such as warfarin, or with heparins or heparinoids. Low dose warfarin (1 mg p.o. qd) is permitted if the INR is < 1.5. Low-dose aspirin is permitted.
    • 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 oesophago-gastric junction cancer excluding cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumours [Ta and Tis] or any cancer curatively treated > 3 years prior to study entry.
    • Concurrent cancer that is distinct in primary site or histology from oesophago-gastric cancer.
    • Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results.
    • Any condition that impairs patient’s ability to swallow whole pills.
    • Any malabsorption condition.
    • Patients with seizure disorder requiring medication (such as steroids or anti-epileptics).
    • History of organ allograft.
    • Patients undergoing renal dialysis.
    • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Estimates of disease control rates (partial and complete responses, and stable disease sustained for ≥4 months as per RECIST guidelines, Appendix C of protocol) and their 95% confidence intervals will be calculated.
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5.1Number of sites anticipated in the EEA1
    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
    Progression of disease, or patient withdrawal from the trial. Patient withdrawal will be: voluntarily, if per investigator it is in subject's best interests; specific Sponsor request; Progression of disease per RECIST criteria; patient death; significant study non-compliance; pregnancy; lost to follow up; illicit use of drugs or intercurrent illness which per investigator may interfere/skew study results; interuption of study drug for more than 28 days.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 54
    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)
    Toxicities will be reported until 30 days following cessation of treatment. Patients will have routine follow-up after completion of treatment as defined by supervising consultant: Evaluation of symptoms and toxicity; Full history and examination including neurological assessment.
    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 Decision2008-12-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-08
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