跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/EUCTR2008-005084-34-ES
EUCTR2008-005084-34-ES进行中（未招募）1 期

A Randomized, Double-blind, Multi-center Phase III Study of Brivanib plus BestSupportive Care (BSC) versus Placebo plus BSC in Subjects with Advanced Hepatocellular Carcinoma (HCC) who have Failed or are Intolerant to Sorafenib: The BRISK PS Study.Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (v1.0, dated 12-Sep-2008)/// Estudio fase III, aleatorizado, doble ciego, multicéntrico, de brivanib más mejor tratamiento de soporte (BSC) frente a placebo más BSC en sujetos con carcinoma hepatocelular (CHC) avanzado con fracaso o intolerancia a sorafenib: estudio BRISK PSEnmienda número 01 - sobre muestras de sangre para farmacogenética - Específica de centro - BRISK PS study

Bristol Myers Squibb International Corporation0 个研究点目标入组 680 人开始时间: 2009年1月20日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
680
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.
  • •b) Advanced disease defined as:
  • •i) disease not eligible for surgical or loco-regional therapy or
  • •ii) disease progressive after surgical or loco-regional therapy
  • •c) Patient has failed ? 14 days of sorafenib treatment:
  • •i) Documented radiographic progression
  • •ii) Documented symptomatic progression
  • •iii) Documented intolerance to sorafenib
  • •d) Cirrhotic status of Child-Pugh Class A or B with a score of 7.
  • •e) ECOG performance status 0, 1, 2.
  • •f) Subjects who have a life expectancy of at least 8 weeks.
  • •g) Accessible for treatment and follow-up.
  • •h) Locoregional therapy must be completed at least 3 weeks prior to the baseline
  • •scan; previously treated lesions are not selected as index lesions.
  • •i) At lease one measurable untreated lesion. All subjects must have at least one
  • •previously un-irradiated, bi-dimensionally measurable lesion by CT or MRI scan
  • •? 20mm. Index lesions that are previously un-irradiated and are bi-dimensionally
  • •measurable by spiral CT scan to be ? 10mm will be permitted.
  • •i) The lesion can be accurately measured bidimensionally according to WHO criteria.
  • •ii) The lesion has not been previously treated with surgery, radiation therapy,
  • •radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
  • •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.
  • •4) Age and Sex
  • •a) Male or female subjects ? 18 years of age.
  • •b) Women of childbearing potential (WOCBP) must be using an adequate method
  • •of contraception to avoid pregnancy throughout the study and up to 12 weeks
  • •after the last dose of investigational product in such a manner that the risk of
  • •pregnancy is minimized.
  • •WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation,
  • •or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined
  • •? Amenorrhea ? 12 consecutive months without another cause or
  • •? For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level ? 35 mIU/mL.
  • •Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential.
  • •WOCBP must have a negative

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 if their partners are
  • •2) Target Disease Exceptions
  • •a) Brain metastasis or evidence of leptomeningeal disease.
  • •b) Known fibrolamellar HCC or mixed cholangiocarcinoma and HCC.
  • •c) Any encephalopathy.
  • •d) Any ascites.
  • •e) Bleeding esophageal or gastric varices within 2 months prior to inclusion.
  • •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 is defined as systolic blood pressure greater than 150 mmHg or diastolic pressure greater than 90 mmHg despite optimal medical management. Subjects with a history of persistent hypertension who are receiving treatment with calcium channel blockers that are CYP3A4 substrates should be changed to an alternative antihypertensive medication.
  • •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) Any other hemorrhage/bleeding event > CTC AE Grade 3 within 4 weeks except
  • •for esophageal or gastric varices (see 4.2.2 Target disease Exceptions).
  • •f) Active infection, less than 7 days after completing systemic antibiotic therapy.
  • •g) Psychiatric illness/social situations that would limit compliance with study requirements.
  • •h) History of non-healing wounds or ulcers, or bone fractures within 3 months of
  • •i) Major surgical procedure, open biopsy, or significant traumatic injury less than 3
  • •weeks or those who receive minor surgical procedures (eg core biopsy or fine needle aspiration) within 1 week.
  • •j) History of organ allograft or on an allograft waiting list.
  • •k) Vena cava thrombosis or occlusion.
  • •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 patient and his/her compliance in the study.
  • •r) Active, untreated hepatitis B.
  • •4) Physical and Laboratory Test Findings
  • •a) Positive pregnancy test.
  • •b) Hyponatremia with sod

研究者

相似试验

已完成
3 期
BRISK - F
CTRI/2009/091/000276Bristol Myers Squibb India Pvt Ltd1,714
进行中（未招募）
不适用
Phase III, First Line Advanced Hepatocellular Carcinoma (HCC)advanced hepatocellular carcinomaMedDRA version: 14.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2008-003533-24-DEBristol-Myers Squibb International Corporation1,800
进行中（未招募）
1 期
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) - BRISK FL Study
EUCTR2008-003533-24-FRBristol Myers Squibb International Corporation1,665
已完成
不适用
Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC) GRANITE-1-C160 CardiaCardiaC160
PER-105-09OVARTIS BIOSCIENSES PERU S.A.,11
进行中（未招募）
不适用
A Randomized, Double-blind, Multi-center Phase III Study of Brivanib versus Sorafenib as First-line Treatment in Patients with Advanced Hepatocellular Carcinoma. - BRISK FL StudyHepatocellular carcinoma non-resectableMedDRA version: 12.0Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectable
EUCTR2008-003533-24-ITBristol Myers Squibb International Corporation1,800