NCT02439411已完成不适用
Retrospective Analysis of Dabrafenib +/- Trametinib Compassionate Use Experience in Spain
Grupo Español Multidisciplinar de Melanoma29 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2015年3月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 29
- 主要终点
- Best Overall Response
研究概览
简要总结
The purpose of this study is to analyze whether Dabrafenib +/- Trametinib are effective in overall survival, response rates and toxicity in both programs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients who have received at least one dose of dabrafenib or combination with trametinib as part of a compassionate use for the treatment of metastatic melanoma, with deadline the start of treatment the April 30, 2014.
排除标准
- •Patients with a history not available.
研究组 & 干预措施
Dabrafenib plus Trametinib
Patients treated with Dabrafenib plus Trametinib
干预措施: Trametinib (Drug)
结局指标
主要结局
Best Overall Response
时间窗: Up to 18 months
Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Adverse Event Rates
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Percentage of patients developing an Adverse Event through follow-up
次要结局
- Overall Survival(Participants will be followed for the duration of hospital stay, an expected average of 18 months.)
- Resectability of tumor(Participants will be followed for the duration of hospital stay, an expected average of 18 months.)
- Adherence to treatment(Participants will be followed for the duration of hospital stay, an expected average of 18 months.)
研究者
研究点 (29)
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