A Phase I Multiple Ascending Dose Study of BMS-754807 in Combination With Paclitaxel and Carboplatin in Subjects 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
- 21
- 试验地点
- 1
- 主要终点
- Safety: Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
研究概览
简要总结
A Phase I dose escalation study to determine the safety, tolerability, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in combination with chemotherapy drugs, paclitaxel and carboplatin, in patients with advanced or metastatic solid tumors. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 in combination with paclitaxel and carboplatin for Phase 2 studies
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with advanced or metastatic solid tumors for whom carboplatin and paclitaxel is considered an appropriate therapy
- •ECOG performance status 0-1
- •At least 4 weeks between surgery or last dose prior anti-cancer therapy
排除标准
- •Symptomatic brain metastases
- •Any disorder or dysregulation of glucose homeostasis {e.g. diabetes)
- •Uncontrolled or significant cardiovascular disease
- •Inadequate bone marrow, liver or kidney function
- •Evidence of > Grade 1 peripheral neuropathy
研究组 & 干预措施
Sequential allocation of patients in two dosing schedules
干预措施: BMS-754807 (Drug)
Sequential allocation of patients in two dosing schedules
干预措施: Paclitaxel (Drug)
Sequential allocation of patients in two dosing schedules
干预措施: Carboplatin (Drug)
结局指标
主要结局
Safety: Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
时间窗: Continuous assessment throughout the duration of the trial: starting with dosing on Day 1 until after 30 day follow-up following the last dose
次要结局
- Pharmacodynamics: Biochemical parameters of drug action in serum(assessed every 6 weeks of the study)
- Metabolic measures: Effects of the drug on parameters of glucose homeostasis(assessed every 6 weeks of the study)
- Efficacy Measures: PET scans and tumor assessments by CT/MRI(a total of 3 PET scans at screening and during the first 3 weeks. CT/MRI assessed every 6 weeks)
- Pharmacokinetic Measures: Blood samples will be collected during pre-specified times(Day 2, 8 and 15 of Cycle 1 and on Day 1 or Cycle 2 (for Arm A subjects only))