Post-Approval Safety Monitoring Program to Assess the Safety and Efficacy Profile of TUKYSA in Usual Practice
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Pfizer
- 入组人数
- 600
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The objectives of the re-examination system in Korea is to re-confirm the clinical usefulness of the product through collecting, reviewing, identifying and verifying the safety and efficacy information about the product in general practice in Korea.
This surveillance is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws, the Regulations on Safety of Pharmaceuticals, etc. and the Re-examination Regulation for New Drugs and Others.
详细描述
The purpose of this study is to understand the safety of Tukysa (Tucatinib hemiethanolate) once it is out in the Korean market. Tukysa will be given to participants aged 18 or over in Republic of Korea.
Surveillance Design Patients with the approved indication who are treated with TUKYSA within the local label will be enrolled.
Adverse Events (AEs) will be collected in the usual practice during administration and for 28 days following cessation of TUKYSA, and ORR will be evaluated through radiographic imaging in the usual practice. The total follow-up period will not exceed 1 year.
Safety
Through the evaluation the safety profile of TUKYSA including important identified risks, Important potential risks, missing information, which are defined about TUKYSA in table2, will be examined. Drug safety is evaluated through the following items:
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From Day 1 through Day 7 after administration. Administration and for 28 days following. The total follow-up period will not exceed 1 year.
The BOR from the start of treatment until progressive disease (PD)/recurrence will be recorded in the electronic Case Report Form as CR, PR, stable disease (SD), PD or Not Evaluable (NE). The BOR will be defined the best overall response recorded from the start of treatment until PD/recurrence.
次要结局
未报告次要终点