跳至主要内容
临床试验/NCT00388076
NCT00388076已完成1 期

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

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2006年4月28日最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Part 1

Experimental

pazopanib and paclitaxel

干预措施: Pazopanib (Drug)

Part 1

Experimental

pazopanib and paclitaxel

干预措施: paclitaxel (Drug)

Part 2

Experimental

pazopanib, paclitaxel, and carboplatin

干预措施: Pazopanib (Drug)

Part 2

Experimental

pazopanib, paclitaxel, and carboplatin

干预措施: paclitaxel (Drug)

Part 2

Experimental

pazopanib, paclitaxel, and carboplatin

干预措施: carboplatin (Drug)

Part 3

Experimental

pazopanib, paclitaxel, and lapatinib

干预措施: Pazopanib (Drug)

Part 3

Experimental

pazopanib, paclitaxel, and lapatinib

干预措施: Lapatinib (Drug)

Part 3

Experimental

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).)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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