NCT01898585已完成4 期
An Open-Label, Single-Arm, Multicenter Study To Assess The Safety Of Vemurafenib In Patients With Braf V600 Mutation Positive Metastatic Melanoma In South Africa.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This open-label, single-arm, multicenter study will assess the safety and efficacy of Zelboraf (vemurafenib) in patients with Braf V600 mutation positive metastatic melanoma. Patients will receive Zelboraf 960 mg twice a day until progressive disease, unacceptable toxicity, consent withdrawal, death, reasons deemed by the treating physician or study termination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults patients >= 18 years of age
- •Patients with histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with documented BRAF V600 mutation determined by the cobas® BRAF V600 Mutation Test prior to administration of vemurafenib. Unresectable stage IIIC disease must have confirmation from a surgical oncologist
- •Patients with either measurable or non-measurable disease (RECIST Version 1.1)
- •Patients may or may not have received prior systemic therapy for metastatic melanoma
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- •Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma
- •Adequate hematological, renal, and liver function
- •Negative serum pregnancy test at screening
- •Fertile men and women must use an effective form of contraception during the study and for at least 6 months after completion of the study
排除标准
- •Evidence of symptomatic CNS lesions as determined by the investigator, use of steroid or anti-seizure medication for treatment of brain metastases prior to the first administration of vemurafenib
- •Patients with previous malignancies (other than melanoma) within the past 2 years except patients with treated and controlled basal or squamous cell carcinoma (SCC) of the skin or carcinoma in-situ of the cervix.
- •Concurrent administration of any anti-cancer therapies (e.g. chemotherapy, other targeted therapy, experimental drug, etc.) other than those administered in this study
- •Known hypersensitivity to vemurafenib or another BRAF inhibitor
- •Pregnant or lactating women
- •Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption.
- •Any of the following within the 6 months prior to the first vemurafenib administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischaemic attack, pulmonary embolism, hypertension not adequately controlled by current medications.
研究组 & 干预措施
Zelboraf Arm
Experimental
干预措施: Zelboraf (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: 12 months
次要结局
- Overall response rate according to Response evaluation criteria in solid tumors (RECIST v1.1)(12 months)
- Progression free survival(12 months)
研究者
研究点 (8)
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