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临床试验/EUCTR2008-003533-24-DE
EUCTR2008-003533-24-DE进行中（未招募）不适用

A Randomized, Double-blind, Multi-center Phase III Study of Brivanib versus Sorafenibas First-line Treatment in Patients with Advanced Hepatocellular Carcinoma (The BRISK FL Study)Pharmacogenetics Blood Sample Amendment 1 (v1.0, dated 10-Dec-2008)Revised Protocol Number 02 incorporating Protocol Amendment 08 (dated 15-Oct-2010) - BRISK FL Study

Bristol-Myers Squibb International Corporation0 个研究点目标入组 1,800 人开始时间: 2009年4月8日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
1,800
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •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) Histologic or cytologic confirmed diagnosis of HCC prior to the start of investigational product administration.
  • •b) Advanced HCC
  • •i) disease not eligible for surgical and / or locoregional therapies
  • •ii) progressive disease after surgical and / or locoregional therapies
  • •c) Child-Pugh Class A
  • •d) ECOG performance status 0-1 Life expectancy of at least 12 weeks
  • •f) Accessible for treatment and follow-up
  • •g) Locoregional therapy must be completed at least 3 weeks prior to the baseline
  • •h) At lease one measurable untreated lesion. All subjects must have at least one
  • •previously un-treated, uni-dimensionally measurable lesion by MRI scan =
  • •20mm or by spiral CT scan = 10mm.
  • •i) The lesion can be accurately measured uni-dimensionally according to mRECIST for HCC criteria
  • •ii) The lesion has not been previously treated with surgery, radiotherapy, and /or
  • •locoregional therapy (eg: radiofrequency ablation (RFA), percutaneous ethanol or acetic acid injection (PEI / PAI), transcatheter arterial chemoembolization (TACE) or cryoablation, etc.)
  • •iii) Bone metastases are not considered measurable lesions.
  • •3) Physical and Laboratory Test Finding
  • •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
  • •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) International normalized ratio (INR) = 2.3 or Prothrombin time (PT) = 6 seconds
  • •above control
  • •f) Left ventricular ejection fraction (LVEF) = 50% as measured by 2-D Echocardiogram
  • •g) All laboratory test finding should be stable within the range listed in 3a) - 3f)
  • •without continuous supportive treatment, such as blood transfusion, coagulation
  • •factors and / or platelet infusion, red / white blood cell growth factor administration, or albumin infusion etc.
  • •4) Age and Sex
  • •a) Men and women, ages 18 or older
  • •b) Women of childbearing potential (WOCBP). WOCBP whose male partners receive study drug and male subjects 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.
  • •In the case of urine pregnancy testing, a serum sample for pregnancy testing must
  • •also be obtained within 72 hours prior to start of investigational product to
  • •confirm the urine results. Investigational product may be initiated prior to the
  • •confirmatory serum pregnancy test results being available.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •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 up to 12 weeks after the last dose of investigational product if their partners are WOCBP.
  • •2) Target Disease Exceptions
  • •a) Brain metastasis or evidence of leptomeningeal disease
  • •b) Known fibrolamellar HCC or mixed cholangiocarcinoma and HCC
  • •c) History of encephalopathy
  • •d) Any ascites that is considered clinically significant, defined as: i) Any ascites detected by physical exam at screening or ii) Any prior or current ascites that required treatment
  • •e) Evidence of portal hypertension with bleeding esophageal or gastric varices
  • •within the past 6 months
  • •f) Main portal vein or vena cava occlusion caused by HCC.
  • •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 active 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 3 and 4
  • •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 (except HCC tumor thrombus) within the past 6 months, such as a cerebrovascular accident (including transient ischemic attacks), pulmonary embolism
  • •e) Any other hemorrhage/bleeding event = CTCAE Grade 3 within 8 weeks except for esophageal or gastric varices
  • •f) Active infection, less than 7 days after completing systemic antibiotic therapy
  • •g) Active, untreated hepatitis B
  • •h) Psychiatric illness/social situations that would limit compliance with study requirements
  • •i) History of non-healing wounds or ulcers, or bone fractures within 3 months
  • •j) Major surgical procedure, open biopsy, or significant traumatic injury less than 3
  • •weeks prior to the start of investigational product administration or those who receive minor surgical procedures (eg core biopsy or fine needle aspiration) within 1 week
  • •k) History of organ allograft or on an allograft waiting list
  • •l) Portal-caval shunts
  • •m) Inability to swallow tablets or untreated malabsorption syndrome
  • •n) Pre-existing thyroid abnormality with thyroid function that cannot be maintained
  • •in the normal range with medication
  • •o) History of human immunodeficiency virus (HIV) infection
  • •p) Substance abuse, medical, psychological or social conditions that may interfere
  • •with the patient’s participation in the study or evaluation of the study results.
  • •q) Any medical condition that is unstable or which could jeopardize the safety of the

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