NCT00479583已完成1 期
A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With FOLFIRI and FOLFOX in Subjects With Advanced Metastatic Solid Tumors
Bristol-Myers Squibb3 个研究点 分布在 2 个国家目标入组 25 人开始时间: 2007年9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
- 25
- 试验地点
- 3
- 主要终点
- Safety assessment
研究概览
简要总结
The purpose of this research study is to determine the highest dose of BMS-690514 that can be safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to patients with advanced cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible for FOLFIRI or FOLFOX therapy
- •ECOG performance status score 0-1
- •At least 4 weeks since the last chemotherapy, immunotherapy or radiotherapy with:
- •At least 4 weeks since anti-cancer hormonal therapy OR targeted therapy (for instance tamoxifen or Tarceva)
- •No maximum age for Study Arm A (FOLFOX)
- •18-65 years of age for Study Arm B (FOLFIRI)
排除标准
- •Treatment with other TKIs within the past 4 weeks
- •Active inflammatory bowel disease
- •Major gastrointestinal surgery which may affect absorption of the drug, any surgery within the last 4 weeks
- •History of thromboembolism
- •Severe unmanageable diarrhea
- •Uncontrolled or significant cardiovascular disease
研究组 & 干预措施
A
Active Comparator
干预措施: BMS-690514 / FOLFIRI (Drug)
B
Active Comparator
干预措施: BMS-690514 / FOLFOX (Drug)
结局指标
主要结局
Safety assessment
时间窗: throughout the study
dose-limiting toxicity (DLT)
时间窗: assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified
determination of maximum tolerated dose (MTD)
时间窗: during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified
次要结局
- Describe anti-tumor of combination therapy(Every 8 weeks throughout the study)
- Describe effects of combination therapy on markers of therapeutic activity. e.g. blood, plasma and biopsy samples(throughtout the study)
研究者
研究点 (3)
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