JPRN-jRCT2080221895未知1 期
An Open label, Multi-Center, PhaseI/IIstudy of vemurafenib in patients with unresectable or Metastatic Melanoma with BRAFV600 Mutation.
试验速览
- 阶段
- 1 期
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients with histologically or cytologically confirmed unresectable or meastatic melanoma
- •-Patients must have positive BRAF V600 mutation result determined by cobas(R) 4800 BRAF V600 mutation test
- •-Measurable disease ( by RECIST criteria version 1.1) prior to the administration of study treatment
排除标准
- •-Patients with brain metastasis which lead to any clinical symptoms or need any treatments. However patients treated with surgery or stereotactic therapy are eligible if patients remains without evidence of disease progression in brain >= 3 months
- •-Patients who have been previously treated with whole-brain irradiation
- •-Patients with uncontrolled hypertension or diabetic mellitus
- •-Patients who have been previously treated with a BRAF inhibitor
研究者
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