临床试验/NCT00516373

NCT00516373已完成1 期

A Phase I, Pharmacokinetic and Biological Evaluation of a Small Molecule Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP-1), KU-0059436, in Patients With Advanced Tumours.

AstraZeneca1 个研究点分布在 1 个国家目标入组 98 人开始时间: 2005年7月11日最近更新: 2024年2月22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: 98
试验地点: 1
主要终点: To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436

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

To determine the safety, tolerability, dose-limiting toxicity (DLT), pharmacokinetic-pharmacodynamic profile, and maximum tolerated dose (MTD) of KU-0059436 when administered orally to patients with advanced solid tumours. To further evaluate the safety and efficacy of KU-0059436 in an expanded cohort of BCRA-enriched population, primarily ovarian cancer patients

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 130 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Confirmed malignant advanced solid tumour refractory to standard therapy or for which no suitable effective standard therapy exists.

排除标准

•Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used).

研究组 & 干预措施

KU-0059436

Experimental

KU-0059436 administered orally twice daily

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

结局指标

主要结局

To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436

时间窗: assessed at each visit

次要结局

Objective tumour response(assessed every 8 weeks)

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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