EUCTR2010-023526-21-DE进行中（未招募）1 期
An open-label, multicenter study to assess the safety of RO5185426 in patients with metastatic melanoma
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,300
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
- •- Male or female patients = 16 years of age
- •- Histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with BRAF V600 mutation determined by Cobas 4800 BRAF Mutation Test
- •- Patients may or may not have received prior therapy for metastatic melanoma
- •- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •- Adequate hematologic, renal and liver function.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 13
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2381
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 914
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
- •- Known hypersensitivity to RO5185426 or another BRAF inhibitor
- •- 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
- •- Evidence of symptomatic CNS lesions as determined by investigator, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of RO5185426
研究者
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