A Phase 1, Open Label Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2171 and Selected Chemotherapy Regimens When Given in Combination to Patients With Advanced Solid Tumors

AstraZeneca3 个研究点分布在 1 个国家目标入组 104 人开始时间: 2005年1月最近更新: 2011年7月27日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: AstraZeneca
入组人数: 104
试验地点: 3
主要终点: Determine the safety and tolerability of once daily oral doses of AZD2171 when given in combination with one of these anticancer regimens; FOLFOX, Pemetrexed, Irinotecan, Docetaxel

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A multicentre, 2-part study to assess the safety and tolerability of once daily oral doses of AZD2171 when administered with various anticancer regimens (part A) and to confirm the tolerability of its combination with FOLFOX (part B).

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

•histologically confirmed metastatic cancer that is not amenable to surgery or radiation therapy with curative intent
•measurable lesion by CT or other techniques according to RECIST

排除标准

•Inadequate bone marrow reserve
•history of poorly controlled hypertension

结局指标

主要结局

Determine the safety and tolerability of once daily oral doses of AZD2171 when given in combination with one of these anticancer regimens; FOLFOX, Pemetrexed, Irinotecan, Docetaxel

时间窗: After 5 weeks of treatment

次要结局

Examine the PK interaction of AZD2171 with one of the 4 different chemotherapeutic regimens. Make a preliminary evaluation of clinical response as measured by objective response rate.(Assessed at each visit)

研究者

发起方

AstraZeneca

申办方类型

Industry

研究点 (3)

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