An Open-Label, Safety, Pharmacokinetic and Pharmacodynamic Study of Multiple Doses of GW786034 and Lapatinib Concomitantly Administered in Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Labs every wk first cycle:day 1 subsequent cycles
研究概览
简要总结
This Phase I, dose finding study evaluates the safety and tolerability of lapatinib, a dual tyrosine kinase inhibitor, and GW786034, an anti-angiogenesis agent, when given together. The study first will find the best doses using safety and blood concentration data of both agents. This is done enrolling stepwise, cohorts of 3 patients each and the last patient enrolled must reach at least Day 22 of continuous daily dosing before the next cohort at an increased dose can begin. If a patient in a cohort has a dose limiting toxicity before Day 22, then 3 more patients are studied at that same dose. If 2 of 6 patients have dose limiting toxicities within the first 22 days, the next cohort receives the next lowest dose. Otherwise each cohort has an increasing dose of one of the two agents. The second stage of the study will administer the best doses of the agents to about 16 patients to further study safety and collect more blood concentration data (more blood samples in the second phase compared to the first phase). The second stage has the advantage of using the best dose (decreases chance of receiving a sub-therapeutic dose) while it collects more blood samples and requires slightly more long clinic visits.
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
- 21 Years 至 —（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
Cohort 1
Subjects will receive GW786034 500 milligrams and lapatinib 750 milligrams.
干预措施: GW786034 (Drug)
Cohort 1
Subjects will receive GW786034 500 milligrams and lapatinib 750 milligrams.
干预措施: lapatinib (Drug)
Cohort 2
Subjects will receive GW786034 250 milligrams and lapatinib 750 milligrams.
干预措施: GW786034 (Drug)
Cohort 2
Subjects will receive GW786034 250 milligrams and lapatinib 750 milligrams.
干预措施: lapatinib (Drug)
Cohort 3
Subjects will receive GW786034 250 milligrams and lapatinib 1000 milligrams.
干预措施: GW786034 (Drug)
Cohort 3
Subjects will receive GW786034 250 milligrams and lapatinib 1000 milligrams.
干预措施: lapatinib (Drug)
Cohort 4
Subjects will receive GW786034 500 milligrams and lapatinib 1000 milligrams.
干预措施: GW786034 (Drug)
Cohort 4
Subjects will receive GW786034 500 milligrams and lapatinib 1000 milligrams.
干预措施: lapatinib (Drug)
Cohort 5
Subjects will receive GW786034 250 milligrams and lapatinib 1250 milligrams.
干预措施: GW786034 (Drug)
Cohort 5
Subjects will receive GW786034 250 milligrams and lapatinib 1250 milligrams.
干预措施: lapatinib (Drug)
Cohort 6
Subjects will receive GW786034 400 milligrams and lapatinib 1250 milligrams.
干预措施: GW786034 (Drug)
Cohort 6
Subjects will receive GW786034 400 milligrams and lapatinib 1250 milligrams.
干预措施: lapatinib (Drug)
Cohort 9
Subjects will receive GW786034 400 milligrams and lapatinib 1000 milligrams.
干预措施: lapatinib (Drug)
Cohort 7
Subjects will receive GW786034 200 milligrams and lapatinib 1500 milligrams.
干预措施: GW786034 (Drug)
Cohort 7
Subjects will receive GW786034 200 milligrams and lapatinib 1500 milligrams.
干预措施: lapatinib (Drug)
Cohort 8
Subjects will receive GW786034 400 milligrams and lapatinib 1500 milligrams.
干预措施: GW786034 (Drug)
Cohort 8
Subjects will receive GW786034 400 milligrams and lapatinib 1500 milligrams.
干预措施: lapatinib (Drug)
Cohort 9
Subjects will receive GW786034 400 milligrams and lapatinib 1000 milligrams.
干预措施: GW786034 (Drug)
Cohort 10
Subjects will receive GW786034 800 milligrams and lapatinib 1500 milligrams.
干预措施: GW786034 (Drug)
Cohort 10
Subjects will receive GW786034 800 milligrams and lapatinib 1500 milligrams.
干预措施: lapatinib (Drug)
结局指标
主要结局
Labs every wk first cycle:day 1 subsequent cycles
时间窗: first cycle:day 1 subsequent cycles
Changes in pre and post treatment lab values and monitoring/reporting AES.AE's throughout study
时间窗: throughout study
次要结局
- find max conc of drugs in blood and time it occurs find out if drugs are taken up by the body, how much/for how long find out if drugs affect the size of the tumor. Blood taken day 15, 22 or 37 and tumor assessed every 8 wks(Blood taken day 15, 22 or 37 and tumor assessed every 8 wks)