NCT01990248已完成不适用
ZeSS: A Prospective Observational Safety Study of Patients With BRAF-V600 Mutation-positive Unresectable or Metastatic Melanoma Treated With Vemurafenib (Zelboraf®)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 339
- 试验地点
- 80
- 主要终点
- Incidence of non-cutaneous squamous cell carcinoma
研究概览
简要总结
This multi-center, prospective, observational safety study will evaluate the safety and effectiveness of Zelboraf (vemurafenib) in a real world setting. Data from Zelboraf-treated patients with BRAF-V600 mutation-positive unresectable or metastatic melanoma will be collected for 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients of the age of 18 years or older
- •Diagnosis of BRAF-V600 mutation-positive unresectable or metastatic melanoma confirmed by a validated test and being treated with vemurafenib
- •Vemurafenib treatment must have been initiated at the time of enrollment or no more than one month prior to enrollment
- •Patient (or legally acceptable representative) has personally signed and dated the informed consent document indicating that he or she has been informed of all pertinent aspects of the study, if applicable
- •Patient is willing to provide information on at least one alternate contact person for study staff to contact regarding the patient's whereabouts, should the patient become lost to follow-up during the course of the study
排除标准
- •Patient was treated with vemurafenib as part of a clinical trial or expanded access program
- •Patient has participated in any studies involving any investigational study drug within one month prior to initiating vemurafenib treatment
- •Patient has any significant history of disease of medical condition (except metastatic melanoma) which in the judgment of the investigator has the potential to impact participation on the study
结局指标
主要结局
Incidence of non-cutaneous squamous cell carcinoma
时间窗: 2 years
Incidence of cutaneous squamous cell carcinoma
时间窗: 2 years
Incidence of QT prolongation (defined as QTc >500 ms or an increase in QTc >60 ms)
时间窗: 2 years
Incidence of abnormal liver function
时间窗: 2 years
次要结局
- Incidence of a second (or subsequent) primary melanoma(2 years)
- Incidence of gastrointestinal polyps(2 years)
- Incidence of adverse events(2 years)
研究者
研究点 (80)
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