NCT00412412已完成1 期
A Ph1 Open-Label,Dose-Escalation,Safety,PK & PD Study of CNF2024 as a Single-Agent Treatment in Subjects w/HER2- Adv Breast Cancer or in Combo w/Trastuzumab in Subjects w/HER2+ Advanced Breast Cancer
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
- Biogen
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Clinical and laboratory safety assessments
研究概览
简要总结
The goal of this clinical research study is to study the drug CNF2024 as a single agent or in combination with trastuzumab in patients with advanced breast cancer and to:
- find the highest dose of the drug CNF2024 as a single agent or in combination with trastuzumab that can be given safely
- measure levels of CNF2024 as a single agent or in combination with trastuzumab in blood
- determine if CNF2024 as a single agent or in combination with trastuzumab can stop breast cancer cells from growing
详细描述
A Phase 1 Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CNF2024 as a Single-Agent Treatment in Subjects with HER2- Advanced Breast Cancer or in Combination with Trastuzumab in Subjects with HER2+ Advanced Breast 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A
Experimental
Patients with HER2- Breast Cancer
干预措施: CNF2024 (Drug)
B
Experimental
Patients with HER2+ Breast Cancer
干预措施: CNF2024 + trastuzumab (Drug)
结局指标
主要结局
Clinical and laboratory safety assessments
时间窗: 30 days after discontinuation of CNF2024 or until drug-related toxicites have returned to less than Grade 1
次要结局
未报告次要终点
研究者
研究点 (2)
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