NCT02143999已完成不适用
An Observational Study of BRAF Inhibitors Effectiveness in Patients With Newly Diagnosed Metastatic Melanoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 403
- 试验地点
- 24
- 主要终点
- Overall survival
研究概览
简要总结
This observational study will evaluate the effectiveness of BRAF inhibitors and current therapies in patients with newly diagnosed metastatic melanoma with or without BRAF V600 mutation. Patients will be treated per the locally approved therapeutic options in clinical practice. The observation period for each patient will be up to 24 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients, >/= 18 years of age at diagnosis
- •Histologically confirmed new diagnosis of unresectable or metastatic melanoma
- •Patients with tumor samples available for assessment of BRAF V600 mutation
排除标准
- •Prior systemic therapy for metastatic disease
- •Participation in interventional clinical trials
结局指标
主要结局
Overall survival
时间窗: 2 years
次要结局
- Duration of response(2 years)
- Progression-free survival(2 years)
- ECOG performance status(2 years)
- Safety: Incidence of adverse events(2 years)
- Best Overall Response Rate (BORR)(2 years)
- Time to response(2 years)
研究者
研究点 (24)
Loading locations...
相似试验
尚未招募
不适用
Observational Study of BRAF Inhibitor Combination Therapy for BRAF mutant Metastatic Colorectal Cancer including Biomarker Research: BEETS trial(JACCRO CC-18)Colorectal CancerJPRN-UMIN000045530JACCRO200
进行中（未招募）
2 期
Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive CraniopharyngiomaBRAF V600E Mutation PresentPapillary CraniopharyngiomaNCT03224767Alliance for Clinical Trials in Oncology24
已完成
2 期
BRAF Inhibitor, Vemurafenib, in Patients With Relapsed or Refractory Hairy Cell LeukemiaHairy Cell LeukemiaNCT01711632Memorial Sloan Kettering Cancer Center36
尚未招募
不适用
Therapeutic Drug Monitoring of BRAF- and MEK-inhibitors in a *Real Life* Cohort of Melanoma Patientsmalignancy10040900cancerNL-OMON38707Antoni van Leeuwenhoek Ziekenhuis120
已完成
2 期
BRF113928: A Phase II study of the BRAF inhibitor dabrafenib as a single agent and in combination with the MEK inhibitor trametinib in subjects with BRAF V600E mutation positive metastatic (stage IV) non-small cell lung cancer10029107non-small cell lung cancerlung cancerNL-OMON47910ovartis20