临床试验/NCT00514761

NCT00514761已完成2 期

A Phase II, Open, Randomized Study to Assess the Efficacy and Safety of AZD6244 vs Capecitabine (Xeloda) in Patients With Colorectal Cancer Who Have Failed One or Two Prior Chemotherapeutic Regimens.

AstraZeneca1 个研究点分布在 1 个国家目标入组 64 人开始时间: 2006年9月最近更新: 2014年8月13日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: AstraZeneca
入组人数: 64
试验地点: 1
主要终点: Progression event count

研究概览研究设计入排标准研究组 & 干预措施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

The purpose of the study is to assess if there is benefit when using AZD6244 in the treatment if metastatic colorectal cancer in comparison with another treatment called capecitabine. This study will also assess how safe and well tolerated AZD6244 is.

研究设计

研究类型: Interventional
分配方式: 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

•colorectal cancer
•require treatment but have failed one or two previous chemotherapeutic regimens that must have included oxaliplatin and/or irinotecan
•have World Health Organisation (WHO) performance status 0-2 and life expectancy > 12 weeks

排除标准

•previous therapy with EGFR inhibitor, MEK inhibitor or capecitabine
•any recent surgery, unhealed surgical incision or severe concomitant condition which makes it undesirable for the patient to participate in the study
•nausea and vomiting, chronic gastrointestinal disease or significant bowel resection that would preclude adequate absorption

研究组 & 干预措施

1

Active Comparator

Xeloda

干预措施: Capecitabine (Drug)

2

Experimental

AZD6244

干预措施: AZD6244 (Drug)

结局指标

主要结局

Progression event count

时间窗: assessed after each visit

次要结局

safety and tolerability(assessed at each visit)

研究者

发起方

AstraZeneca

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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