临床试验/NCT00997945

NCT00997945已完成1 期

A Phase I, Open-label, Single-arm Study to Determine the Single and Multiple Dose Pharmacokinetics of 10mg ZD4054 (Zibotentan) Administered Once Daily in Male, Elderly Chinese Patients With Advanced Solid Malignancies

AstraZeneca1 个研究点分布在 1 个国家目标入组 15 人开始时间: 2009年10月最近更新: 2011年5月19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: 15
试验地点: 1
主要终点: To assess the pharmacokinetics of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies

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 assess the pharmacokinetics of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies.

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: Basic Science
盲法: None

入排标准

年龄范围: 50 Years 至 —（Adult, Older Adult）
性别: Male
接受健康志愿者: 否

入选标准

•Provision of informed consent
•Histological and/or cytological confirmed advanced solid malignancies
•WHO performance status<2

排除标准

•History of significant gastrointestinal impairment, as judged by the investigator, that could significantly affect the absorption of ZD4054 (Zibotentan) , including the ability to swallow the tablet whole.
•ALT or AST³2.5 ´ULRR. If liver metastases are present ALT or AST more than 5times ULRR, Serum bilirubin > 1.5 x ULRR, Serum creatinine>1.5 x ULRR or creatinine clearance of <50mL/min calculated by Cockroft-Gault
•Recent (<14 days) major surgery prior to entry into the study, or a surgical incision that is not fully healed, Radical radiotherapy within the previous 4 weeks, or unresolved acute or subacute toxicities from prior radiotherapy

研究组 & 干预措施

1

Experimental

ZD4054 (Zibotentan) 10mg

干预措施: ZD4054 (Zibotentan) (Drug)

结局指标

主要结局

To assess the pharmacokinetics of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies

时间窗: PK samples will be taken until Day 16

次要结局

To assess the safety and tolerability of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies(Safety assessments to be taken until Day 16 (while patient remains on study treatment), then every 8 weeks until treatment discontinuation)

研究者

发起方

AstraZeneca

申办方类型

Industry

研究点 (1)

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