A Phase I, Open-Label, Study of the Safety, Tolerability, and Pharmacokinetics of Pazopanib in Combination With Paclitaxel on a Weekly Schedule for Three Consecutive Weeks of a 28-Day Cycle, Paclitaxel and Carboplatin on an Every 21 Days Schedule and Lapatinib and Paclitaxel on a Weekly Schedule for Three Consecutive Weeks of a 28- Day Cycle
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Adverse Effects, Laboratory parameters
研究概览
简要总结
Pazopanib will be given with TAXOL in one part, in another part pazopanib will be given with TAXOL and PARAPLATIN, and in a third part pazopanib will be given with TAXOL and lapatinib (patients separated in each part). Toxicity monitoring will enable us to find the largest dose of pazopanib daily that can be safely given in combination with the chemotherapy agents TAXOL and PARAPLATIN, and with lapatinib, as well as what side effects are likely to manifest when these agents are given together and whether the combination of pazopanib with chemotherapy, helps to treat different types of cancer. Another objective is to find out how much pazopanib, TAXOL, PARAPLATIN and lapatinib are in the blood at specific times after the agents are given. Collecting the blood samples requires that the patients remain in the vicinity of the clinic overnight on 2 occasions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part 1
pazopanib and paclitaxel
干预措施: Pazopanib (Drug)
Part 1
pazopanib and paclitaxel
干预措施: paclitaxel (Drug)
Part 2
pazopanib, paclitaxel, and carboplatin
干预措施: Pazopanib (Drug)
Part 2
pazopanib, paclitaxel, and carboplatin
干预措施: paclitaxel (Drug)
Part 2
pazopanib, paclitaxel, and carboplatin
干预措施: carboplatin (Drug)
Part 3
pazopanib, paclitaxel, and lapatinib
干预措施: Pazopanib (Drug)
Part 3
pazopanib, paclitaxel, and lapatinib
干预措施: Lapatinib (Drug)
Part 3
pazopanib, paclitaxel, and lapatinib
干预措施: paclitaxel (Drug)
结局指标
主要结局
Adverse Effects, Laboratory parameters
时间窗: before and after taking the study medications.
次要结局
- Blood samples(over a 24 hour period)
- Tumors(will be measured at routine intervals throughout (e.g. by CT scan).)
