JPRN-jRCT2080223012已完成1 期
Phase 1 study of KHK2375 in subjects with advanced or recurrent breast cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
In the DLT evaluation of KHK2375 in patients with progressed / relapse Japanese breast cancer, tolerabilitythe was confirmed in dose range was 3 to 10 mg for a single oral administration, and 5 mg for daily oral administration in combination with exemestane 25 mg. Tolerability was also confirmed in continuous oral administration of exemestane 25 mg daily and in combination after the end of the DLT observation period.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 74age old（—）
- 性别
- Female
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
研究者
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