Proof-of-Concept Study of AZD4547 in Patients With FGFR1 or FGFR2 Amplified Tumours
试验速览
- 阶段
- 2 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To assess anti-tumour activity as change in tumour size at 8 weeks and the correlation with change in tumour ERK1/2 phosphorylation at day 10-14.
研究概览
简要总结
To assess the activity of the FGFR inhibitor AZD4547 in patients with FGFR1 or FGFR2 amplified breast, squamous lung and stomach cancer whose cancers have progressed following previous chemotherapy
详细描述
Primary endpoint
- To assess anti-tumour activity as change in tumour size at 8 weeks and the correlation with change in tumour ERK1/2 phosphorylation at day 10-14.
Secondary endpoints
- Objective response rate to AZD4547 in all patients and in each tumour group
- Safety and tolerability of AZD4547 in all patients
- Disease control rate at 8 weeks
- Progression free survival in all patients and in each tumour group
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single Treatment Arm
16-24 patients per tumour group will be treated with AZD4547 administered 80mg twice daily, 2 weeks on, 1 week off in 21 days cycles.
干预措施: AZD 4547 (Drug)
结局指标
主要结局
To assess anti-tumour activity as change in tumour size at 8 weeks and the correlation with change in tumour ERK1/2 phosphorylation at day 10-14.
时间窗: Baseline (tumour size, pERK), day 14(pERK), and week 8(tumour size)
A primary objective of the study is to collect serial research biopsies at baseline and on treatment with AZD4547, to assess the molecular changes that occur in the tumour in response to AZD4547 treatment and correlate with change in tumour size assessed at 8 weeks.
次要结局
- Progression free survival(Time measured from baseline to disease progression or death from any cause (approximately 3-9 months))
- Disease control rate at eight weeks(Disease control rate will be calculated as the proportion of patients with CR/PR/SD at eight weeks from baseline)
- Response rate(Eight weeks from treatment initiation and then every 6 weeks thereafter)
- Safety and tolerability of AZD4547(Toxicity is assessed from consent until 30 days following treatment cessation)