Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Combination With Full Dose Erbitux in Patients With Advanced Gastrointestinal Malignancies Who Have Failed Prior Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 6
- 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 combination with full dose erbitux in patients with advanced colorectal cancer who have received no more than 2 prior regimens for metastatic colorectal cancer.
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 advanced or metastatic (tumor has spread) gastrointestinal malignancy
- •Feeling well other than cancer diagnosis (ie lab work, no infection, etc)
- •Available tumor tissue sample from prior surgery
- •Measurable disease on scans
- •4-6 weeks since prior therapy and recovered from the effects of prior therapy
- •Men and women, ages 18 and above
- •Women must not be pregnant or breastfeeding
排除标准
- 未提供
研究组 & 干预措施
1
干预措施: Brivanib + Cetuximab (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 maximu 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)