A Phase II, Multi-centre, Open-Label, Parallel Group, Randomised Study To Compare the Efficacy of AZD6244 vs Temozolomide in Patients With Unresectable AJCC Stage 3 or 4 Malignant Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Diagnosed with late stage malignant melanoma
- •Aged 18 or over
- •Female patients must be post-menopausal or with negative urine pregnancy test if pre-menopausal
排除标准
- •Any previous radiotherapy or chemotherapy (palliative radiotherapy is acceptable)
- •Participation in any other trial with an investigational product within the previous 30 days
研究组 & 干预措施
1
Temozolomide
干预措施: Temozolomide (Drug)
2
AZD6244
干预措施: AZD6244 (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: RECIST data collected as per institutional standard practise
To compare the efficacy of AZD6244 vs temozolomide in patients with unresectable AJCC stage 3 or 4 malignant melanoma by assessing progression free survival (PFS)
时间窗: From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)
Time to death
时间窗: From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest)
Duration of response
时间窗: RECIST data collected as per institutional standard practise
次要结局
- Assessment of the safety and tolerability of AZD6244(Assessed at all visits)
- Investigation of the pharmacokinetics of AZD6244(Day 1 & 8 (for patients on AZD6244))
- Assessment of the efficacy of AZD6244 versus temozolomide in patients who are BRAF and BRAF and /or NRAS mutation positive(From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest))