NCT00788333已完成1 期
A Phase I/II Trial of BMS-754807 in Combination With Trastuzumab (Herceptin®) in Subjects With Advanced or Metastatic Her-2-positive Breast Cancer
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年7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
- 40
- 试验地点
- 1
- 主要终点
- The dose escalation portion will determine the MTD and recommended Phase 2 dose or dose range of BMS-754807 when administered orally on a daily schedule in combination with trastuzumab administered at standard doses IV on a weekly basis
研究概览
简要总结
This is a Phase I/II study to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics following daily oral doses of 50 to 200 mg of BMS-754807 in combination with trastuzumab (Herceptin®) in subjects with advanced or metastatic Her-2-positive breast cancer. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 in combination with trastuzumab for Phase II studies and provide preliminary evidence of anti-tumor activity in Her-2-positive breast cancer subjects after trastuzumab failure
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects with locally advanced or metastatic Her-2-positive breast cancer who have failed at least one trastuzumab containing regimen. Prior treatment with other Her-2-targeted agents (e.g. lapatinib, pertuzumab, trastuzumab DM-1 etc.) is allowed
- •Histologic or cytologic diagnosis of Her-2-positive breast cancer
- •ECOG status 0 - 1
排除标准
- •Symptomatic brain metastasis
- •Any condition requiring chronic use of steroids
- •Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2 Diabetes Mellitus or prediabetic symptoms
- •History of glucose intolerance
- •Women of child-bearing potential unwilling or unable to use acceptable contraception methods
研究组 & 干预措施
A
Experimental
Combination
干预措施: BMS-754807 (Drug)
A
Experimental
Combination
干预措施: trastuzumab (Herceptin®) (Drug)
结局指标
主要结局
The dose escalation portion will determine the MTD and recommended Phase 2 dose or dose range of BMS-754807 when administered orally on a daily schedule in combination with trastuzumab administered at standard doses IV on a weekly basis
时间窗: Every 30 days until MTD is reached
次要结局
- Assess anti-tumor activity of combination at MTD of BMS-754807 (dose expansion cohort)(Every 8 weeks)
- Evaluate safety and tolerability of the combination regimen(Ongoing)
- Assess effect of combination therapy on glucose metabolism(At 30 days, then every 8 weeks)
- Explore whether co-medication with oral anti-hyperglycemic agent can enable adequate tolerability of the combination therapy if BMS-754807 induces hyperglycemia(Ongoing)
- Obtain BMS-754807 plasma concentrations vs time data for future population PK analysis(Days, 1,8,15,22)
研究者
研究点 (1)
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