NCT01046864已完成1 期
A Phase Ib Multiple Ascending Dose Study to Evaluate the Safety of Brivanib in Combination With 5-Fluorouracil/Leucovorin (5FU/LV) and Brivanib in Combination With 5-Fluorouracil/Leucovorin/Irinotecan (FOLFIRI) in Subjects With Advanced or Metastatic Gastrointestinal Malignancies
Bristol-Myers Squibb4 个研究点 分布在 2 个国家目标入组 49 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- Safety-Toxicity, evaluated according to NCI Common Terminology Criteria for Adverse Events v3.0. Assessments based on medical review of adverse events, results of vital signs, ECGs, echocardiography, physical examinations, and clinical laboratory tests
研究概览
简要总结
The purpose of this study is to determine a safe and maximum tolerable dose of Brivanib when combined with standard dose 5FU/LV and FOLFIRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological/cytological confirmed diagnosis of Gastrointestinal malignancy, except pancreatic cancer
- •Eligible for 5FU/LV or FOLFIRI chemotherapy
- •Able to swallow and tolerate tablets
- •Life expectancy of 3 months
排除标准
- •Unwilling to use acceptable method to avoid pregnancy of partner/self for the entire study period and up to 4 weeks after last dose
- •Women who are pregnant or breastfeeding
- •Pancreatic cancer
- •Known brain metastasis, evidence of leptomeningeal disease
- •History of thrombo-embolic disease
- •Hemorrhage/bleeding events
- •Uncontrolled or significant cardiovascular disease
- •Any 3 or more of the following risk factors: arterial thrombosis , smoking, hypercholesterolemia, hypertension, obesity (BMS>30) and diabetes
- •Pre-existing thyroid abnormality, not maintained with medication
- •QTC (Fridericia) >450 msec on two consecutive ECG's
- •Subjects with concomitant second malignancies ( except adequately treated non-melanoma skin, in situ carcinoma of bladder, cervix or breast, early prostate cancer)
- •Any major surgery within 4 weeks of study drug administration
- •Increased levels of both D-Dimer and Prothrombin fragment 1 +2
- •Arm B and C only-positive UGT1A1 genotype of TA7/TA7
- •History of allergy of brivanib or drug class
- •History of severe reactions to fluoropyrimidine therapy or irinotecan
- •Prior therapy with brivanib
研究组 & 干预措施
Arm 1
Experimental
干预措施: 5-FU (Drug)
Arm 1
Experimental
干预措施: Leucovorin (Drug)
Arm 1
Experimental
干预措施: Brivanib (Drug)
Arm 2
Experimental
干预措施: 5-FU (Drug)
Arm 2
Experimental
干预措施: Leucovorin (Drug)
Arm 2
Experimental
干预措施: Irinotecan (Drug)
Arm 2
Experimental
干预措施: Brivanib (Drug)
Arm 3
Experimental
Japanese Population
干预措施: 5-FU (Drug)
Arm 3
Experimental
Japanese Population
干预措施: Leucovorin (Drug)
Arm 3
Experimental
Japanese Population
干预措施: Irinotecan (Drug)
Arm 3
Experimental
Japanese Population
干预措施: Brivanib (Drug)
结局指标
主要结局
Safety-Toxicity, evaluated according to NCI Common Terminology Criteria for Adverse Events v3.0. Assessments based on medical review of adverse events, results of vital signs, ECGs, echocardiography, physical examinations, and clinical laboratory tests
时间窗: Cycle 4, Day 1
次要结局
- Exploratory Measures (Biomarkers for Predictive Analysis): Potential predictive markers, including activity of FGF, VEGF and related pathways as well as K-RAS mutation status, will be evaluated based on blood or tumor samples(Cycle 1, Cycle 2, every other cycle)
- Pharmacokinetics (Cmax, Tmax, AUC (TAU), T-HALF) plasma concentration vs time for brivanib given alone and in combination with FOLFIRI. Individual concentrations (C) of 5FU will be calculated from samples on Day 2 in the presence and absence of Brivanib(Cycle 2, Day 2)
- Efficacy-Tumor BOR determined for treated subjects by radiological responses assessed by CT scan or MRI, by RECIST criteria (v1.1). Radiological tumor assessments to evaluate response & progression will be done every 8 wks or more frequently if indicated(Every 8 weeks)
研究者
研究点 (4)
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