EUCTR2010-023526-21-HU进行中（未招募）1 期
An open-label, multicenter expanded access study of RO5185426 in patients with metastatic melanoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Adult patients, >/= 18 years of age
- •- Histologically confirmed metastatic melanoma with BRAF V600 mutation determined by Cobas 4800 BRAF Mutation Test
- •- Disease Progression after at least one prior systemic treatment for metastatic melanoma
- •- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •- Adequate hematologic, renal and liver function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Evidence of symptomatic CNS lesions
- •- Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
- •- Concurrent administration of any anti-cancer therapies other than those administered in the study
- •- Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
- •- Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption
研究者
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