An open-label, multicenter expanded access study of RO5185426 in patients with metastatic melanoma

F. Hoffmann-La Roche Ltd.0 个研究点目标入组 900 人开始时间: 2011年1月11日最近更新: 2016年11月28日

适应症

试验速览

暂无简介。

•- 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

•- 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

发起方