An Extension Study of Linifanib in Subjects With Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 主要终点
- Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.
研究概览
简要总结
An extension study of linifanib in subjects with advanced or metastatic solid tumors.
详细描述
This study is designed to evaluate the safety of linifanib in subjects with advanced or metastatic solid tumors.
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
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years(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
linifanib
干预措施: linifanib (Drug)
结局指标
主要结局
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.
时间窗: All adverse events occuring through the Final Visit will be reported.
The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study. The investigators will question each subject regarding any adverse effects that they have experienced and record any events on the care report forms. All adverse events will be followed to a satisfactory clinical resolution.
Safety: Clinical Lab Tests will be performed for each participant as a safety measure.
时间窗: Change from baseline to Day 1 of Weeks 1, 2, 3, 6, 9 and 12 and on Week 24 then Day 1 of every 12 weeks and Final Visit
Chemistry, hematology, urinalysis lab tests will be measured and recorded on the case report forms. All clinically significant values will be followed by the investigator to a satisfactory clinical resolution.
Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety.
时间窗: Change from baseline to Day 1 of Weeks 1, 2, 3, 6, 9 and 12 and on Week 24 then Day 1 of every 12 weeks and Final Visit.
Physical exam, blood pressure, pulse, body temperature will be measured and recorded on the case report forms.
Safety: Multiple Gated Acquisition (MUGA) will be assessed at specified time points as a measure of safety.
时间窗: Change from baseline to every 12 weeks
MUGA
次要结局
- There are no secondary outcome measures specified for this study.(There are no secondary outcome measures specified for this study.)
