跳至主要内容
临床试验/NCT02185560
NCT02185560进行中(未招募)不适用

Drug Use Investigation of Sorafenib/ NEXAVAR® for Unresectable Differentiated Thyroid Carcinoma (DTC)

Bayer1 个研究点 分布在 1 个国家目标入组 453 人开始时间: 2014年6月27日最近更新:
适应症
干预措施
相关药物

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

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)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验