A Phase I/II Multicenter, Open-Label Study of YM155 Plus Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Occurrence of dose limiting toxicities (Part 2: Subjects with other solid tumors)
研究概览
简要总结
To determine the feasibility and safety of administering YM155 in combination with docetaxel
详细描述
This clinical trial is designed to include two parts:
Part 1: Assessment of feasibility and safety of administering YM155 in combination with docetaxel and prednisone in subjects with hormone refractory prostate cancer (HRPC) [ ENROLLMENT COMPLETED ]
Part 2: Assessment of feasibility and safety of administering YM155 in combination with docetaxel in subjects with solid tumors (except HRPC).
This registration has been updated to reflect the design requirements of PART 2.
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
- •Male subjects with histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.
- •Subjects with histologically and cytologically confirmed solid tumors with measurable disease (except HRPC).
排除标准
- •Radiation therapy within 4 weeks of the start of study drug
研究组 & 干预措施
1. HRPC
干预措施: Docetaxel (Drug)
1. HRPC
干预措施: YM 155 (Drug)
1. HRPC
干预措施: Prednisone (Drug)
2. Solid Tumors
干预措施: YM 155 (Drug)
2. Solid Tumors
干预措施: Docetaxel (Drug)
结局指标
主要结局
Occurrence of dose limiting toxicities (Part 2: Subjects with other solid tumors)
时间窗: 1 cycle
Occurrence of dose limiting toxicities (Part 1: Subjects with HRPC)
时间窗: 2 cycles
次要结局
- Assessment of pharmacokinetics(Part 1 only)
- Assessment of safety and efficacy(10 cycles)