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    Summary
    EudraCT Number:2005-002524-34
    Sponsor's Protocol Code Number:011941
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-09-02
    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 number2005-002524-34
    A.3Full title of the trial
    An Open Label, Non Comparative, Phase III Study of the Raf Kinase Inhibitor BAY 43-9006 as a Subsequent to First Line Therapy in Patients with Advanced Renal Cell Carcinoma
    A.4.1Sponsor's protocol code number011941
    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.1.3.4CountryGermany
    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 Information not present in EudraCT
    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.3.1Product namesorafenib
    D.3.2Product code 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.3.8INN - 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Advanced Renal Cell Carcinoma
    MedDRA Classification
    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 make BAY 43-9006 available for patients with advanced RCC, who failed prior systemic therapy for advanced disease (i. e., require second line treatment), and who do not have access to or are not eligible for other clinical trials with BAY 43-9006.
    E.2.2Secondary objectives of the trial
    In addition, safety data and limited efficacy data will be collected for BAY 43-9006 in the treatment of patients with advanced RCC, who failed prior systemic therapy for advanced disease (i. e., require second line treatment). All Drug Related Adverse Events, all Adverse Events NCI CTCAE Version 3.0 Grade 3 or higher, and all Serious Adverse Events regardless of causal relationship to study drug will be recorded in this study.
    It is expected that, according to the oncological standards, radiological and other procedures will have been performed prior to enrolment of any patient, and, similarly, that the Investigator will be performing appropriate radiological and other procedures according to the local standard of care, although these procedures are not specifically defined within this study protocol.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.The patient must provide written informed consent prior to receiving BAY 43-9006.
    2.The male or female patient must be at least 18 years of age.
    3.The patient must have advanced Renal Cell Carcinoma.
    4.The patient must have failed at least one prior systemic established therapy for advanced RCC (e. g., IL-2, IFN-alpha), or must have been unable to tolerate systemic therapy for advanced RCC, or is deemed by the Investigator to be unsuited for systemic therapy for advanced RCC.
    5.A patient, who has received prior systemic and local therapies, must have completely recovered from acute toxicity (i. e., resolved back to CTCAE Grade 1 or less, or is considered as not going to resolve), if any, prior to study entry.
    6.The patient must be, in the Investigator’s opinion, reasonably likely to benefit from treatment with BAY 43-9006 as a single agent.
    7.The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
    8.The patient will not require other systemic anti-cancer chemotherapy, immunotherapy (including monoclonal antibodies), signal transduction inhibitors or hormonal therapy, except for bisphosphonates, while taking BAY 43-9006.
    9.Both male and female patients must use adequate barrier birth control methods (oral contraceptives, injectable contraceptives, intrauterine devices, condoms, sterilization) during their participation in the protocol. The birth control methods must be used for 4 weeks for female patients and for 3 months for male patients after discontinuation of treatment with BAY 43-9006.
    10.For patients, who have had major surgery, the wound must be completely healed prior to receiving BAY 43-9006 treatment (4 weeks).
    11.Patients with metastatic brain disease which is active or progressive despite previous radiation, radiosurgical, or surgical therapy (including gamma knife) are eligible for this protocol, provided they have recovered from any treatment-related toxicity. Patients whose metastatic brain lesions have been surgically removed are also eligible for this protocol. Patients with brain metastases should be observed carefully for any central nervous system symptoms or signs of worsening. Brain metastases are excluded as target lesions for RECIST unless they are the only lesions being followed for the patient.
    E.4Principal exclusion criteria
    1.Patients who have previously been enrolled in any other BAY 43 9006 clinical trial are not eligible for enrolment in this protocol. However, patients, who are being treated with BAY 43-9006 in another trial can be enrolled in this study if the trial they are currently participating in is being discontinued, and if the patient has not already experienced progressive disease on sorafenib treatment.
    2.Patients, who are eligible for or do have access to any other BAY 43-9006 clinical trial as to the knowledge of the Investigator.
    3.Patients who have a life expectancy of less than 2 months.
    5.Patients are excluded who require any of the following:
    a. Investigational drug therapy during the treatment with BAY 43-9006 or
    within 30 days prior to their first dose of BAY 43-9006 with the exception of patients, who are currently enrolled in or have previously participated in other sorafenib trials.
    Warfarin is allowed; however, for patients receiving concomitant warfarin
    therapy close monitoring of Prothrombin Time (PT) should be performed
    (please note that no laboratory data are collected in this study).
    6.Women who are pregnant or breast feeding. Women of childbearing potential must have a negative pregnancy test performed within seven days of the start of study drug (please note that no laboratory data are collected in this study).
    7.Patients with congestive heart failure greater than NYHA functional class II (symptomatic during ordinary activity)
    8.Patients with cardiac arrhythmias greater than Grade 1 NCI CTCAE, Version 3.0 (conduction abnormality and supraventricular arrhythmia present but patient is asymptomatic; intervention not indicated, palpitations present and QTc > 0.45 - 0.47 second).
    9.Patients with active coronary artery disease or ischemia.
    10.Patients with Child Pugh class C hepatic impairment.
    11.Patients with severe renal impairment (calculated creatinine clearance of < 30 ml/min) or who require dialysis.
    12.Patients with active uncontrolled hypertension.
    13.Patients with recent or active bleeding diathesis.
    14.Patients with any medical condition which could jeopardize their safety while taking an investigational drug.
    15.severe hypersensitivity to sorafenib or any of the excipients.
    E.5 End points
    E.5.1Primary end point(s)
    Not applicable
    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 Information not present in EudraCT
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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) 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    It is the intention of the Sponsor to continue the protocol until BAY 43-9006 is approved by the EMEA, i. e. the recruitment of patients will be stopped after approval of the study drug.
    The protocol may be discontinued at any time if, for example, data become available from ongoing clinical trials which changes the risk/benefit assessment.
    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 months15
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months15
    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 Information not present in EudraCT
    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 2005-09-02. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 1500
    F.4.2.2In the whole clinical trial 1500
    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 Decision2005-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-05
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