NCT00169533已完成1 期
An Open Label, Phase 1b Rollover Study to Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- To determine the long-term safety and tolerability of lapatinib as monotherapy or in combination regimen
研究概览
简要总结
The EGF19060 study is a rollover study to evaluate the long term safety of lapatinib and to provide lapatinib to patients who had a positive response in previous lapatinib studies until lapatinib is available pending FDA approval.
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
- •Currently receiving clinical benefit as defined by CR, PR or SD from treatment with lapatinib through participation in a Phase I study of lapatinib either as monotherapy or as part of a combination regimen.
- •Ability to understand and provide written informed consent to participate in this trial.
- •Is male or female.
- •Female and male subjects agree to the protocol specific birth control measures
排除标准
- •Permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure.
- •Is a pregnant or lactating female.
- •Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.
- •Currently receiving treatment with any medications listed on the prohibited medication list (see Section 7.2).
- •Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- •Has a left ventricular ejection fraction (LVEF) < 40% based on MUGA or ECHO.
研究组 & 干预措施
Arm 1
Experimental
Lapatinib either 750, 1000, 1250 or 1500 mgs
干预措施: GW572016 oral tablets (Drug)
结局指标
主要结局
To determine the long-term safety and tolerability of lapatinib as monotherapy or in combination regimen
时间窗: Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites.
次要结局
- Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients, Overall survival(Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites.)
研究者
研究点 (1)
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