Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- Safety assessment
研究概览
简要总结
This is a Phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of progressive advanced or metastatic (tumor that has spread) solid tumors
- •No tumor spread to the brain
- •Feeling well other than cancer diagnosis (i.e. lab work, no infection, etc.)
- •Available tumor tissue sample from prior surgery
- •4-6 weeks since prior therapy and recovered from prior therapy
- •Men and women, ages 18 and above
- •Women must not be pregnant or breastfeeding
- •Diagnosis of advanced or metastatic (tumor that has spread) colorectal, hepatocellular (liver) or renal (kidney) cancer
- •Measurable disease on scans (at least one)
排除标准
- 未提供
研究组 & 干预措施
1
干预措施: Brivanib (Drug)
2
干预措施: Brivanib (Drug)
3
干预措施: Brivanib (Drug)
4
干预措施: Brivanib (Drug)
5
干预措施: Brivanib (Drug)
6
干预措施: Brivanab (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
- Efficacy based on duration of response and time to progression based on assessment(measured every 8 weeks throughout the study)