POST-MARKETING SURVEILLANCE STUDY TO OBSERVE INLYTA (REGISTERED) TREATMENT DOSING PATTERN, SAFETY AND EFFECTIVENESS IN TAIWAN REAL WORLD ROUTINE PRACTICE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 13
- 主要终点
- Mean Daily Dose of Axitinib
研究概览
简要总结
This is a post-marketing Surveillance study to observe INLYTA® treatment dosing pattern, safety and effectiveness in Taiwan real world routine practice. The primary objective of this registry is to monitor the dose adjustment of INLYTA® in real world routine practice. The secondary objectives include safety profile, objective response rate, and progression-free rate in real world routine practice.
详细描述
This is a multi-center chart review registry on mRCC patients treated with axitinib. Primary objective is the dose adjustment. Secondary objectives are safety profile, objective response rate and progression free survival. Efficacy assessment will be based on investigators' judgment. Patients treated with 1st dose of axitinib between May 7, 2013 and June 30, 2015 will be enrolled. The follow-up time is 12 months. Prior therapies should include sunitinib or interferon alpha.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as advanced RCC by histology or cytology
- •Patients using axitinib as therapy after failure of sunitinib or cytokine
- •Patients received axitinib treatment and follow up in the health care center participating present registry
- •Patients agree to participate and signed inform consent or IRB waiving of signed informed consent document is available
排除标准
- •Patients with first dose of axitinib earlier than 7th May 2013
- •Patients with first dose of axitinib later than 30th June
- •Patients participating in clinical research involving axitinib
- •Patients with hypersensitivity to axitinib or to any other component of axitinib
- •Patients under 18-year of age
- •Pregnant women.
结局指标
主要结局
Mean Daily Dose of Axitinib
时间窗: From initiation of axitinib treatment up to the end of the study (up to 40 months)
Duration of Axitinib Treatment
时间窗: From initiation of axitinib treatment up to the end of the study (up to 40 months)
次要结局
- Number of Participants Discontinued Due to Adverse Events (AEs)(From initiation of axitinib treatment up to end of the study (up to 40 months))
- Objective Response Rate (ORR)(From initiation of axitinib treatment until PD or death from any cause (up to 40 months))
- Duration of Response(From initiation of axitinib treatment until PD or death from any cause (up to 40 months))
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(From initiation of axitinib treatment up to end of the study (up to 40 months))
- Number of Participants With Treatment-Related Adverse Events (AEs)(From initiation of axitinib treatment up to end of the study (up to 40 months))
- Progression-Free Survival (PFS)(From initiation of axitinib treatment until PD or death from any cause (up to 40 months))
- Number of Participants With Adverse Events (AEs) by Severity(From initiation of axitinib treatment up to end of the study (up to 40 months))