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    The EU Clinical Trials Register currently displays   36377   clinical trials with a EudraCT protocol, of which   5992   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-012007-25
    Sponsor's Protocol Code Number:BAY 43-9006 / 14295
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-15
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2009-012007-25
    A.3Full title of the trial
    A Double-Blind, Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
    A.4.1Sponsor's protocol code numberBAY 43-9006 / 14295
    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 States
    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 Schering Pharma
    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 284461-73-0
    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
    Differentiated thyroid cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10016935
    E.1.2Term Follicular thyroid cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10033701
    E.1.2Term Papillary thyroid cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10055107
    E.1.2Term Thyroid cancer metastatic
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10066136
    E.1.2Term Huerthle 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 primary objective of this phase III study in subjects with differentiated thyroid cancer (papillary, follicular, Hurthle cell carcinoma) who are refractory to radioactive iodine treatment is to compare the treatment groups in terms of progression free survival (PFS) evaluated by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare the sorafenib and placebo treatment groups in terms of:
    •Overall Survival (OS)
    •Time to Progression (TTP)
    •Disease Control Rate (DCR)
    •Response Rate (RR)
    •Duration of response
    •Safety, which will include assessment of adverse events and abnormalities in laboratory parameters
    •Exposure of sorafenib AUC(0-12) by population pharmacokinetic methods
    Exploratory:
    • Health Utility Values
    • Health-Related Quality of Life (HRQoL)
    • Biomarker analysis
    • Progression-Free Survival after unblinding until further disease progression in subjects who had received sorafenib and continue sorafenib treatment
    • Progression-Free Survival after unblinding until further disease progression in subjects who had received placebo and crossover to sorafenib treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular and Hurthle cell)
    •Progression within 14 months (RECIST should be used as a basis for the assessment of disease progression)
    •RAI refractory: patients will be deemed to be refractory to radioactive iodine (RAI) if they have a known tumor lesion that qualifies as a target lesion per the protocol RECIST criteria, and that target lesion has no iodine uptake on a post-radioactive-iodine scan performed under conditions of a low iodine diet and adequate TSH elevation or rhTSH stimulation.
    Certain patients whose tumors have iodine uptake may also be eligible for participation. They include the following categories of patients:
    Patients who have some iodine uptake, who have had a radioactive iodine treatment (≥100 mCi) within the last 16 months, and who have had progression (by RECIST) of their target lesion(s) despite that RAI treatment (which was performed under conditions of a low iodine diet and adequate TSH elevation or rhTSH stimulation);
    OR
    Patients who have some iodine uptake, who have had multiple RAI treatments, whose last RAI treatment was >16 months ago, and who had progression after each of two RAI treatments (≥100 mCi each) that were done within 16 months of each other (and which were each performed under conditions of a low iodine diet and adequate TSH elevation or rhTSH stimulation);
    OR
    Any individual patient who has received RAI treatments with a cumulative RAI dose of ≥600 mCi.
    •Not a candidate for surgery or radiotherapy with curative intent
    •Subjects with at least one measurable lesion. Lesions must be measured by CT-scan or MRI (Magnetic Resonance Imaging) according to Response Evaluation Criteria in Solid Tumors [RECIST Criteria (v1.0), see Appendix 10.6].
    For this study, bone lesions are considered to be measurable and eligible as target lesions if they are lytic lesions or mixed lytic-blastic lesions, with identifiable soft tissue components, that can be evaluated by CT or MRI and the soft tissue component meets the definition of measurability according to RECIST (vs. 1.0).
    •Availability of histological material for central review of the diagnosis of differentiated thyroid cancer
    •Adequate TSH-suppression (< 0.5 mU/l)
    •Age > 18 years
    •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to randomization:
    Hemoglobin > 9.0 g/dl
    Absolute neutrophil count (ANC) >1,500/mm3
    Platelet count ≥ 100,000/mm3
    Total bilirubin < 1.5 times the upper limit of normal
    Alanine aminotransaminase (ALT) and Aspartate aminotransferase (AST) < 2.5 x upper limit of normal
    Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)
    Serum creatinine < 1.5 x ULN.
    •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
    •Life expectancy of at least 12 weeks.
    •Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
    •Women and men of childbearing potential must agree to use adequate contraception (barrier method of birth control) since signing of the informed consent form until at least 30 days after the last study drug administration.
    •Subjects must be able to understand and willing to sign a written informed consent. A signed informed consent must be appropriately obtained prior to any study specific procedures.
    •Subjects must be able to swallow and retain oral medication.
    E.4Principal exclusion criteria
    •Histologic subtypes of thyroid cancer other than differentiated (i.e. like anaplastic and medullary carcinoma, lymphoma or sarcoma).
    •Prior anticancer treatment with tyrosine kinase inhibitors, monoclonal antibodies (licensed or investigational) that target VEGF or VEGF Receptors or other targeted agents.
    •Prior anti-cancer treatment for thyroid cancer with use of chemotherapy (low dose chemotherapy for radiosensitization is allowed) or Thalidomide or any of its derivatives.
    •Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization.
    •Non-healing wound, ulcer, or bone fracture.
    •Evidence or history of bleeding diathesis or coagulopathy disorder.
    •Subjects with tracheal, bronchial or esophageal infiltration with significant risk of bleeding but without having received local treatment prior to enrollment in the study.
    •Clinically significant cardiac disease including congestive heart failure > class II New York Heart Association (NYHA) (see Appendix 10.5), unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months) or myocardial infarction within the past 6 months prior to randomization.
    •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg) despite optimal medical management.
    •Thrombotic or embolic venous or arterial events, such as a cerebrovascular accident, including transient ischemic attacks, arterial thrombosis, deep vein thrombosis and pulmonary embolism within the past 6 months.
    •Hemorrhage/bleeding event  National Cancer Institute NCI-Common Terminology Criteria for Adverse Events (CTCAE) greater than or equal to Grade 3 within 3 months of randomization.
    •Infection > NCI-CTCAE (version 3) Grade 2.
    •Known human immunodeficiency virus infection or infection with hepatitis B or C.
    •Previous or concurrent cancer that is distinct in primary site or histology from thyroid cancer within 5 years prior to randomization EXCEPT cervical cancer in situ, treated basal cell carcinoma and superficial bladder tumors [Ta (Non invasive tumor), Tis (Carcinoma in situ) and T1 (Tumor invades lamina propria)].
    •Known or suspected allergy to sorafenib or hypersensitivity to sorafenib or any agent given in the course of this trial.
    •Subjects with seizure disorder requiring medication (such as steroids or anti-epileptics).
    •Subjects undergoing renal dialysis.
    •Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results.
    •Unresolved toxicity (i.e. neurotoxicity) attributed to any prior therapy higher than NCI-CTCAE (version 3) Grade 2 (excluding cases of alopecia).
    •Any malabsorption condition.
    •Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.
    History of brain metastases: allowed, provided definitive therapy (surgery and/or radiation) has been administered before randomization , no further treatment of brain metastases is planned, the subject is clinically stable for at least 2 weeks before study treatment (Prior and ongoing corticosteroid treatment is allowed, provided the dose is not high, stable and no dose adjustments are needed after randomization).
    Pregnant or breast-feeding subjects: Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. All subjects of child-bearing potential must use adequate birth control measures during the course of the trial (barrier method of birth control).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is Progression-Free Survival (PFS)
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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 study will end when the data for the primary endpoint are mature (i.e. after approximately 267 PFS events have been reached).
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 190
    F.4.2.2In the whole clinical trial 380
    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)
    If at the time of study endpoint there are still subjects on the study who are continuing to benefit from treatment, they will be allowed to continue treatment either through commercial supply or through an extension program.
    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 Decision2009-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-01
    P. End of Trial
    P.End of Trial StatusCompleted
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