Drug Use Investigation of Sorafenib/ NEXAVAR® for Unresectable Differentiated Thyroid Carcinoma (DTC)
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 453
- 试验地点
- 1
- 主要终点
- Number of participants with Serious adverse events as a measure of safety and tolerability.
研究概览
简要总结
This is a non-interventional, multi center post-authorization safety study that includes all patients diagnosed as Unresectable Differentiated Thyroid Carcinoma (DTC) and treated with Sorafenib within a certain period. The investigator should have made the choice of treatment (NEXAVAR) according with the Japanese Package Insert prior to enrolling the patient in this study.
The enrollment period is of 9 months. The observation period for each patient starts when the therapy with NEXAVAR is initiated. Patients will be followed for 9 months or until it is no longer possible (e.g. lost to follow-up); this will be considered the standard observation period. Those patients, to whom a total of 24 month follow up is possible, information on effectiveness including treatment duration and survival status of the patient and of keratoacanthoma and/or squamous cell cancer development will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who start NEXAVAR treatment for radioactive iodine-refractory unresectable Differentiated Thyroid Carcinoma (DTC)
排除标准
- •Patients who have already received NEXAVAR treatment
研究组 & 干预措施
BAY43-9006
NEXAVAR treatment group
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
结局指标
主要结局
Number of participants with Serious adverse events as a measure of safety and tolerability.
时间窗: Up to 9 months
Number of participants with Adverse drug reaction as a measure of safety and tolerability.
时间窗: Up to 9 months
Number of participants with Serious adverse drug reaction as a measure of safety and tolerability
时间窗: Up to 9 months
次要结局
- 2-year survival(At 24 months)
- Time of treatment failure (TTF)(Up to 24 months)
