TREATMENT ACCESS PROTOCOL FOR PATIENTS PREVIOUSLY TREATED WITH DACOMITINIB ON A CLINICAL TRIAL IN JAPAN
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 7
- 试验地点
- 6
- 主要终点
- Number of Participants Who Were Previously Treated With Dacomitinib on the Parent Study in Japan and Who Got Access to Dacomitinib in This Extension Study
研究概览
简要总结
The purpose of this study to permit continued access to dacomitinib for patients who participated in other dacomitinib monotherapy treatment protocols in Japan and have the potential to derive clinical benefit without unacceptable toxicity from continued dacomitinib treatment.
详细描述
The intention of the study is to allow continued use of dacomitinib in Japan for patients on closed dacomitinib clinical trials and who continue to experience clinical benefit.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received dacomitinib on another clinical trial in Japan
- •Evidence of a personally signed and dated informed consent document
排除标准
- •Patients who meet one or more study withdrawal criteria on the prior study
- •Participation in other studies involving other investigational drug(s) during study participation
研究组 & 干预措施
Dacomitinib
3 dose strengths (45 mg, 30 mg, and 15 mg), continuous oral daily dosing
干预措施: Dacomitinib (Drug)
结局指标
主要结局
Number of Participants Who Were Previously Treated With Dacomitinib on the Parent Study in Japan and Who Got Access to Dacomitinib in This Extension Study
时间窗: 4 years
To allow access to dacomitinib for participants who received dacomitinib on prior studies (A7471009 \[NCT01360554\] and A7471050 \[NCT01774721\]) in Japan and who had the potential to derive continued clinical benefit from single-agent dacomitinib treatment without unacceptable toxicity based upon the investigator's judgment.
次要结局
- Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks)