NCT01596530终止1 期
A Randomised Double-Blind Placebo-controlled Multicentre Phase I Study to Assess the Biological Activity of AZD8931 in Patients With Early Breast Cancer Who Are Ineligible for Treatment With Trastuzumab as Defined by IHC Status
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Comparison of the effects of AZD8931 versus placebo on cytoplasmic p-MAPK after 7 days or more days of treatment
研究概览
简要总结
To compare the activity of AZD8931 against placebo on the cell markers in cancer tumours
详细描述
A Randomised Double-Blind Placebo-controlled Multicentre Phase I Study to Assess the Biological Activity of AZD8931 in Patients with Early Breast Cancer who are Ineligible for Treatment with trastuzumab as defined by IHC status
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 18 or older Early stage breast cancer and planned surgery
- •Ineligible for Trastuzumab (Herceptin) treatment as per local guidelines
- •World health Organisation performance status of 0 to 1 Tumour size amenable to obtaining adequate biopsies pre dosing.
排除标准
- •Eligible for Trastuzumab (Herceptin) Treatment Known sensitivity to AZD8931, its excipients or drugs in its class;
- •Including oral tyrosine kinase inhibitors History of eye conditions e.g. previous injury within 3 months or clinically significant eye disease
- •Concurrent malignancy Unable to discontinue medication or herbal supplement known to inhibit CYP3A4 or CYP2D6
研究组 & 干预措施
AZD8931
Active Comparator
AZD8931
干预措施: Drug-AZD8931 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Drug-Placebo (Drug)
结局指标
主要结局
Comparison of the effects of AZD8931 versus placebo on cytoplasmic p-MAPK after 7 days or more days of treatment
时间窗: Day 7 - Day 14
次要结局
- Establishing the baseline tumour characteristics, including but not limited to ER, PR and HER-2 status(Day -28 to Day 0)
- Comparison of the effects of AZD8931 versus placebo on p-EGFR, p-erbB2, p-erbB3 NUCLEAR p-Mapk, p-AKT and Ki67 after 7 or more days of treatment(Day 7 - Day 14)
- Assessment sof the safety and tolerability of AZD8931 as assessed by incidence of adverse events during the course of the study.(From study entry through to 30 days post treatment (Day 44 maximum))
- Assessment of the plasma PK of AZD8931(Day 1 - Day 14)
- Comparison of the effects of AZD8931 versus placebo on other biomarkers including but not limited to, erbB ligands, pER, PTEN, erbB receptor homo- and hetero- dimers, total MAPK, apoptosis markers and total AKT after 7 or more days of treatment.(Day 7 - Day 14)
- Exploration of the relationship between AZD8931 exposure (PK in plasma and tumour) and a selection of secondary biomarkers (e.g. p-EGFR, nuclear p-MAPK, Ki67 and apoptosis markers after ?7 days of treatment), if possible.(Day 1 - Day 14)
- Change from baseline in laboratory, vitals signs and ECG data(Day 1 - Day 14)
研究者
研究点 (1)
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