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    Summary
    EudraCT Number:2007-004875-21
    Sponsor's Protocol Code Number:BAY 43-9006 / 12913
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-07
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-004875-21
    A.3Full title of the trial
    A Phase II, Multi-centre, Open-label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Intrapatient Dose Escalation of Sorafenib as First Line Treatment for Metastatic Renal Cell Carcinoma
    A.4.1Sponsor's protocol code numberBAY 43-9006 / 12913
    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, D-51368 Leverkusen, Germany
    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 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/04/207
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    renal cell carcinoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10050513
    E.1.2Term Metastatic renal cell carcinoma
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of intrapatient dose escalation in previously untreated subjects with mRCC. The initial dose of sorafenib will be 400mg bid administered orally, on a continuous basis. Intrapatient dose escalation will occur as defined in the table below, providing no grade 3 or 4 toxicities (except for alopecia, nausea and vomiting) are observed.

    The primary objective is to assess the response rates (by independent assessment) observed in subjects treated with a continuous, daily dose of 400 mg bid sorafenib dose escalated up to 800mg bid.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the following:
    • Safety and tolerability
    • Pharmacokinetics
    • Progression free survival (PFS)
    • Time to progression (TTP)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age > 18 years.
    • Histological or cytological documentation of metastatic and/or unresectable clear cell RCC is required
    • Subjects with at least one uni-dimensional measurable lesion. Lesions must be measured by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumours (RECIST).
    • ECOG Performance Status of 0 or 1
    • MSKCC good or intermediate category
    • Life expectancy of at least 12 weeks.
    • 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  100,000/l
    • Total bilirubin < 1.5 times the upper limit of normal
    • ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for subjects with liver involvement of their cancer)
    • Alkaline phosphatase < 2.5 x ULN
    PT-INR/PTT < 1.5 x upper limit of normal. Subjects who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists. For subjects on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre dose, as defined by the local standard of care (exluding subjects being anticaogulated for deep vein thrombosis and/or pulmonary embolus occurring within 12 months of the start of treatment).
    • Serum creatinine < 1.5 x upper limit of normal
    • Signed informed consent must be obtained prior to any study specific procedures.
    • Subjects must have received no prior systemic anticancer therapy for the treatment of their renal cell carcinoma
    • Prior nephrectomy
    • Prior palliative radiotherapy to metastatic lesion(s) is permitted
    E.4Principal exclusion criteria
    • History of cardiac disease;
    • congestive heart failure >NYHA class 2
    • active CAD (MI more than 6 mo prior to study entry is allowed)
    • cardiac arrhythmias requiring anti-arrhythmic therapy( beta blockers or digoxin are permitted)
    • uncontrolled hypertension (defined as blood pressure >160mmHg systolic and/or > 90mmHg diastolic on medication)
    • History of HIV infection or chronic hepatitis B or C
    • Active clinically serious infections (> grade 2 NCI-CTCAE version 3.0)
    • Symptomatic metastatic brain or meningeal tumors unless the subject 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. Also the subject must not be undergoing acute steroid therapy or taper therapy (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
    • Subjects with seizure disorder requiring medication (such as steroids or anti-epileptics)
    • History of organ allograft
    • Subjects with evidence or history of bleeding diathesis
    • Deep vein thrombosis and/or pulmonary embolus within 12 months of the start of treatment.
    • Delayed healing of wounds, ulcers or bone fractures
    • Subjects with pre-existing thyroid abnormality whose thyroid function cannot be maintained within the normal range by medication
    • 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.
    • Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study
    • Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to 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 three months after the completion of trial. The investigator is requested to advise the subject how to achieve an adequate contraception.

    • Subjects unable to swallow oral medications. This applies to subjects with severe obstruction of upper GI that require gavage.
    Excluded therapies and medications, previous and concomitant:
    • Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents, experimental therapy (adjuvant or neo-adjuvant therapy including IFN-IL2-5FU is permitted).
    • Prior adjuvant sorafenib is excluded.
    • Radiotherapy during study or within 3 weeks of start of study drug
    • Major surgery within 4 weeks of start of study
    • 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. [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.] Subjects taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study.
    • Investigational drug therapy outside of this trial during or within 4 weeks of study entry
    • 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 the investigational agent or any agent given in association with this trial.
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point is to assess the response rates observed for patients treated with continuous daily dose of sorafenib escalated from 400mg to 600mg to a maximum of 800mg bid.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    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 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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 years2
    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 years2
    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) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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 Decision2008-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-01-13
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