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    Summary
    EudraCT Number:2008-008715-26
    Sponsor's Protocol Code Number:CA182037
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-04-23
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-008715-26
    A.3Full title of the trial
    A Randomized, Double-blind, Multicenter Phase III Study of Brivanib versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients with
    Unresectable Hepatocellular Carcinoma: The BRISK TA Study

    Pharmacogenetics Blood Sample Amendment Number 01 (v1.0, dated 16-Dec-2008)

    Estudio fase III aleatorizado, doble ciego, multicéntrico, de brivanib frente a placebo como tratamiento adyuvante a la quimioembolización transarterial (TACE) en pacientes con carcinoma hepatocelular irresecable: Estudio BRISK TA

    Enmienda número 01 de muestras de sangre para farmacogenética (versión 01, de fecha 16-Dec-2008)
    A.3.2Name or abbreviated title of the trial where available
    The BRISK TA Study
    A.4.1Sponsor's protocol code numberCA182037
    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 SponsorBristol Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 No
    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 nameBrivanib Alaninate
    D.3.2Product code BMS-582664-02
    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 INNBrivanib Alaninate
    D.3.9.1CAS number 649735-63-7
    D.3.9.3Other descriptive nameVEGFR2
    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
    intermediate stage hepatocellular carcinoma (HCC)

    Carcinoma hepatocelular (CHC) en estadio intermedio
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10019828
    E.1.2Term Hepatocellular carcinoma non-resectable
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.
    E.2.2Secondary objectives of the trial
    ? To compare the Time-To-Disease Progression (TTDP) of patients receiving brivanib
    with TACE therapy to that of patients receiving placebo with TACE therapy.
    ? To compare the time to extrahepatic spread or vascular invasion in the brivanib and
    placebo arms.
    ? To determine the total number of TACE sessions in the brivanib and placebo arms.
    ? To compare the rate of TACE sessions in the brivanib and placebo arms.
    ? To compare the Time-to-Progression (tumor) after the first TACE session in the
    brivanib and placebo arms.
    ? To evaluate the safety of brivanib in combination with TACE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed Written Informed Consent
    a) Voluntary signed and dated written informed consent form in accordance with
    regulatory and institutional guidelines obtained before the performance of any protocol-related procedures not part of normal patient care.
    2) Target Population
    a) Patients with diagnosis of hepatocellular carcinoma (HCC) meeting the criteria
    below:
    i) Biopsy-proven HCC (histology or cytology), OR
    ii) Radiological evidence of HCC showing lesion arterial hypervascularity and venous phase washout by either dynamic (triple-phase), contrast-enhanced computed tomography of the abdomen OR dynamic (triple-phase) contrast (gadolinium)-enhanced MRI, AND
    (1) Serology positive for hepatitis B or C, AND
    (2) Alpha fetoprotein > 400 ?g/L at the time of diagnosis
    b) One lesion that is ? 5 cm, OR multinodular disease with 4 or more lesions (at
    least one of which has a diameter > 3 cm)
    c) Cirrhotic status of Child-Pugh Class A or B with a score of 7
    d) ECOG performance status of 0 or 1
    e) Life expectancy of at least 12 weeks
    f) Ability to comply with visits/procedures required by protocol
    3) Physical and Laboratory Test Findings
    a) Adequate hematologic function with absolute neutrophil counts ? 1,500/mm3,
    platelet count ? 60 x 10E9/L, and hemoglobin ? 8.5 g/dL
    b) Adequate hepatic function with serum total bilirubin ? 3 mg/dL, serum albumin ?
    2.8 g/dL, and ALT and AST ? 5 times the institutional upper limits of normal (ULN)
    c) Amylase and lipase < 1.5 times the institutional upper limit of normal
    d) Adequate renal function with serum creatinine ? 2.0 mg/dL
    e) Prothrombin time (PT): International normalized ratio (INR) < 1.7 or PT < 4 seconds above control
    f) Left ventricular ejection fraction (LVEF) ? 50% as measured by 2-D Electrocardiogram
    g) All laboratory test finding should be stable within the range listed in a) - f)
    without continuous supportive treatment, such as blood transfusion, coagulation
    factors and/or platelet infusion, red/white blood cell growth factor administration,
    albumin infusion, ursodeoxycholic acid, or drug treatment for lowering liver enzyme/bilirubin, etc.
    4) Age and Sex
    a) Men and women, ages 18 or older
    Women of childbearing potential (WOCBP) must be using an adequate method of
    contraception to avoid pregnancy throughout the study and for up to 12 weeks
    after the last dose of investigational product in such a manner that the risk of
    pregnancy is minimized.
    E.4Principal exclusion criteria
    1) Sex and Reproductive Status
    a) WOCBP who are unwilling or unable to use an acceptable method to avoid
    pregnancy for the entire study period and for up to 12 weeks after the last dose of
    investigational product.
    b) Women who are pregnant or breastfeeding.
    c) Women with a positive pregnancy test on enrollment or prior to investigational
    product administration.
    d) Sexually active fertile men not using effective birth control if their partners are
    WOCBP.
    2) Target Disease Exceptions
    a) Diffuse pattern of disease on CT/MRI
    b) Presence of extra-hepatic lesions
    c) Main portal vein or vena cava thrombosis or occlusion
    d) Intrahepatic or portal-caval shunts
    e) Any previous TACE procedure for HCC
    f) Prior use of systemic treatment for HCC
    g) Prior history of or current ascites or encephalopathy
    3) Medical History and Concurrent Diseases
    a) Previous or concurrent cancer that is distinct in primary site or histology from
    HCC, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 5 years prior to entry is permitted.
    b) History of cardiac disease:
    i) Uncontrolled hypertension which defined as systolic blood pressure greater
    than 150 mmHg or diastolic pressure greater than 90 mmHg despite optimal medical management.
    ii) Congestive heart failure NYHA (New York Heart Association) class III and IV
    iii) Active coronary artery disease, unstable or newly diagnosed angina or myocardial infarction less than 12 months prior to study entry
    iv) Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
    v) Valvular heart disease ? CTCAE Grade 2
    c) QTc (Fridericia) > 450 msec on two consecutive ECGs (baseline ECG should be
    repeated if QTc is found to be > 450 msec)
    d) Thrombotic or embolic events within the past 6 months, such as a cerebrovascular
    accident (including transient ischemic attacks), pulmonary embolism
    e) Hemorrhage/bleeding event ? CTCAE Grade 3 within 4 weeks prior to study entry
    f) Prior history of gastrointestinal bleeding within the past year or presence of
    gastro-duodenal ulcers or gastro-esophageal varices documented by gastroscopy
    g) History of non-healing wounds or ulcers, or bone fractures within 3 months of
    fracture
    h) Major surgical procedure, open biopsy, or significant traumatic injury less than 3
    weeks or those who receive minor surgical procedures (e.g., core biopsy or fine
    needle aspiration) within 1 week
    i) History of organ allograft or on an allograft waiting list
    j) Inability to swallow tablets or untreated malabsorption syndrome
    k) Pre-existing thyroid abnormality of thyroid function that cannot be maintained in
    the normal range with medication
    l) History of human immunodeficiency virus (HIV) infection
    m) Active infection, less than 7 days after completing systemic antibiotic therapy
    n) Active, untreated hepatitis
    o) Substance abuse, medical, psychological or social conditions that may interfere
    with the patient?s compliance with study requirements and participation in the study or evaluation of the study results.
    p) Any medical condition that is unstable or which could jeopardize the safety of the
    patient and his/her compliance in the study.
    4) Physical and Laboratory Test Findings
    a) Positive pregnancy test
    b) Hyponatremia with sodium < 130 mmol/L
    c) Baseline serum potassium < 3.5 mmol/L (potassium supplementation may be
    given to restore the serum potassium above this level prior to study entry)
    5) Allergies and Adverse Drug Reactions
    a) Known or suspected history of allergy to brivanib or any agents given in association with this trial
    6) Prohibited Treatments and/or Therapies
    a) Prior use of any systemic anti-cancer chemotherapy, immunotherapy, investigational or molecular targeted agents for HCC
    b) Prior immunotherapy for HCC
    c) Concomitant treatment with rifampin (and its analogues), or St John?s Wort
    d) Patients requiring anticoagulation therapy with an agent such as warfarin or
    heparin
    e) Patients requiring chronic anti-platelet therapy (aspirin at dose > 300 mg/day,
    clopidogrel at dose > 75 mg/day)
    f) Radiotherapy within 4 weeks prior to start of study drug
    7) Other Exclusion Criteria
    a) Prisoners or patients who are involuntarily incarcerated
    b) Patients who are compulsorily detained for treatment of either a psychiatric or
    physical (e.g., infectious disease) illness
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is Overall Survival (OS).
    OS will be defined as the time from the date of randomization to the date of death. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    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 months1
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days15
    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 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 1740
    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 Decision2009-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-26
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