NCT00633789已完成2 期
A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors
Bristol-Myers Squibb7 个研究点 分布在 2 个国家目标入组 597 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 597
- 试验地点
- 7
- 主要终点
- Radiographic imaging and clinical evaluation will be used for tumor assessment
研究概览
简要总结
The purpose of this study is to determine if gastric/esophageal, lung, pancreatic, bladder and sarcoma patients show benefit from brivanib treatment. Patients who clearly do, stay on treatment. Those in which it is unclear will be randomized to continue or withdraw treatment to determine whether that benefit is related to brivanib
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Life expectancy at least 3 months
- •Diagnosis of a solid tumor which is unresectable in which no approved effective therapy exists or for subjects who are intolerable to such therapy. The initial enrollment will focus on non-small cell lung, gastric/esophageal adenocarcinoma, soft tissue sarcoma, transitional cell carcinoma, and pancreatic cancer including ampulla of Vater tumors
- •Adequate tumor sample
- •Adequate recovery (baseline or Grade 1) from recent therapy. At least 1 week must have elapsed from the time of a minor surgery, and at least 8 weeks for major surgery or radiation therapy
排除标准
- •Subjects with known brain metastasis.
- •Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by CT or MRI
- •Medical History and Concurrent Diseases:
- •History of thrombo-embolic disease within the last six months requiring therapeutic anticoagulation
- •Subjects with history of poor wound healing or non healing ulcers
- •Uncontrolled or significant cardiovascular disease
- •Allergies and Adverse Drug Reactions:
- •History of allergy to brivanib its drug class, or related compounds
- •Prohibited Treatments and/or Therapies:
- •Exposure to any investigational drug within 4 weeks of enrollment
- •Other concurrent chemotherapy, hormonal therapy, immunotherapy regimens or radiotherapy, standard or investigational. Subjects may continue to receive hormone replacement therapy
- •Prior exposure to brivanib
研究组 & 干预措施
1
Experimental
干预措施: brivanib (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Radiographic imaging and clinical evaluation will be used for tumor assessment
时间窗: every 6 weeks
次要结局
- Disease control rate(determined June 2010)
- Biomarkers(determined June 2010)
- Disease response rate(determined June 2010)
- Pharmacodynamics(determined June 2010)
- Safety profiles(ongoing throughout trial)
- Pharmacokinetics(determined June 2010)
研究者
研究点 (7)
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