临床试验/NCT00515866

NCT00515866已完成1 期

A Phase I, Open Label, Study of the Safety and Tolerability of KU-0059436 in Combination With Gemcitabine in the Treatment of Patients With Advanced Solid Tumours

AstraZeneca1 个研究点分布在 1 个国家目标入组 68 人开始时间: 2007年8月最近更新: 2013年12月20日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: AstraZeneca
入组人数: 68
试验地点: 1
主要终点: To establish the maximum tolerated dose (MTD) or a tolerable and effective dose of KU 0059436 in combination with gemcitabine

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 this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with gemcitabine chemotherapy for the treatment of pancreatic cancer.

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

•Histologically or cytologically confirmed adenocarcinoma of pancreas
•Locally advanced or metastatic unresectable disease

排除标准

•No prior anti cancer chemotherapy, radiotherapy (except palliative >4 weeks prior to entry, endocrine or immunotherapy or use of other investigational agents;

研究组 & 干预措施

1

Experimental

Gemcitabine + KU-0059436

干预措施: KU-0059436 (AZD2281)(PARP inhibitor) (Drug)

1

Experimental

Gemcitabine + KU-0059436

干预措施: Gemcitabine (Drug)

结局指标

主要结局

To establish the maximum tolerated dose (MTD) or a tolerable and effective dose of KU 0059436 in combination with gemcitabine

时间窗: assessed at each visit

次要结局

To identify the dose-limiting toxicity of the combination therapy(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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