NCT02623751已完成1 期
Phase 1 Study of KHK2375 in Subjects With Advanced or Recurrent 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
- 入组人数
- 15
- 主要终点
- Number and percentage of subjects with treatment-emergent adverse events including dose-limiting toxicities and serious adverse events
研究概览
简要总结
The primary objective of the open-label, dose-escalation study is to investigate the safety of single-dose monotherapy and repeated-dose of KHK2375 combined with exemestane in female subjects with advanced or recurrent breast cancer. The secondary objective is to investigate the pharmacokinetics and efficacy.
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
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women aged ≥ 20 and < 75 years at the time of consent;
- •Estrogen receptor positive and/or progesterone receptors positive;
- •HER2-negative
- •Nonresectable advanced or recurrent breast cancer previously treated with nonsteroidal aromatase inhibitor (AI), and planning to be treated with exemestane
排除标准
- •Radiation therapy or immuno therapy within 14 days before the first dose of investigational product;
- •Chemotherapy, biological medicines, other pharmacotherapy or major surgery within 21 days before the first dose of the investigational product;
- •Prior chemotherapies of ≥ 3 regimens for advanced or recurrent breast cancer;
- •Ongoing treatment with other investigational product
研究组 & 干预措施
KHK2375 PO and Exemestane PO
Experimental
KHK2375 and Exemestane
干预措施: KHK2375 (Drug)
KHK2375 PO and Exemestane PO
Experimental
KHK2375 and Exemestane
干预措施: Exemestane (Drug)
结局指标
主要结局
Number and percentage of subjects with treatment-emergent adverse events including dose-limiting toxicities and serious adverse events
时间窗: Assessed up to 28 days after study discontinuation
次要结局
- Pharmacokinetics of KHK2375 [maximum concentration (Cmax)](Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1)
- Pharmacokinetics of KHK2375 [Area under the curve (AUC)](Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1)
- Pharmacokinetics of KHK2375 [Half-life (t1/2)](Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1)
研究者
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