NCT00454090已完成1 期
A Phase I, Open-Label, Multi-centre Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of AZD8330 in Patients With Advanced Malignancies
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 83
- 试验地点
- 3
- 主要终点
- To assess safety and tolerability of AZD8330 in patient with advanced malignancies.
研究概览
简要总结
The primary purpose of this protocol is to investigate the safety and tolerability of AZD8330 (ARRY-424704) in patients with Advanced Malignancies
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Cancer which is refractory to standard therapies, or no therapies exist;
排除标准
- •Participated in radiotherapy, biological or chemotherapy within 21 days prior to study start;
- •Hasn't participated in investigation drug study within 30 days;
- •Brain metastases/spinal cord compression unless treated and stable,
- •Off steroids/anticonvulsants.
结局指标
主要结局
To assess safety and tolerability of AZD8330 in patient with advanced malignancies.
Outcome variables: Adverse Events, Clinical Chemistry, Haematology, Urinalysis, Vital signs, MUGA scans/echocardiography, ECGs, Ophthalmologic examination, O2 saturation
次要结局
- To determine the PK of AZD8330.
- To investigate possible PD/PK relationships
- To investigate effect of AZD8330 on pERK in PBMCs
研究者
研究点 (3)
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