NCT00955084已完成1 期
A Maintenance Study Evaluating the Long Term Safety of XL999 Administered Intravenously to Subjects With Advanced Malignancies Previously Enrolled in Other XL999 Studies
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- The primary objective of this study is to allow rollover of the two remaining subjects from the other XL999 studies to continue to receive XL999.
研究概览
简要总结
The primary objective of this study is to allow rollover of the two remaining subjects from the other XL999 studies to continue to receive XL999.
The secondary objectives of this study are as follows:
- To evaluate tumor response after long term repeat administration of XL999 in two subjects rolled over from other XL999 studies.
- To characterize the long term safety and tolerability of XL999 after repeat administration in two subjects rolled over from other XL999 studies.
- To characterize the long term effects of XL999 on cardiac function after repeat administration in two subjects rolled over from other XL999 studies.
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
- •The subject is currently enrolled in Protocols XL999-001 or XL999-204
- •The subject has received XL999 for at least one year prior to enrollment
- •Per the respective parent XL999 protocol, the subject is eligible to continue to receive XL999 in the absence of progressive disease (PD) or unacceptable drug-related toxicity
排除标准
- •Progressive disease
- •Any development(s) that would meet the exclusion criteria from the subject's respective XL999 protocol (XL999-001 or XL999-204)
结局指标
主要结局
The primary objective of this study is to allow rollover of the two remaining subjects from the other XL999 studies to continue to receive XL999.
时间窗: Progressive disease or end of study
次要结局
- Evaluate tumor response after long term repeat administration of XL999 Characterize long term safety and tolerability of XL999 after repeat administration Characterize long term effects of XL999 on cardiac function after repeat administration(Progressive disease or end of study)
研究者
研究点 (4)
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