Repotrectinib Post-Marketing Surveillance in Pediatric Patients (Age 4 to < 18) With NTRK Fusion-Positive Advanced/Recurrent Solid Tumors in Japan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events (AEs) leading to treatment modification (interruption, dose reduction, or discontinuation)
研究概览
简要总结
This study will collect safety information during routine medical care for children and adolescents in Japan who have been diagnosed with NTRK fusion-positive advanced or recurrent solid tumors who start treatment with repotrectinib. The study will describe how often side effects occur during treatment, with special attention to central nervous system disorders, interstitial lung disease, and fractures.
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
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All pediatric NTRK fusion-positive, advanced or recurrent solid tumors patients (age 4 to < 18) who received Repotrectinib for the approved indications at medical institutions in Japan during enrollment period (for 6 years after approval for this application) will be enrolled in this Post-Marketing Study.
排除标准
- •Participants receiving repotrectinib for an off-label indication
研究组 & 干预措施
Group 1
Pediatric participants with NTRK fusion-positive advanced or recurrent solid tumors treated with repotrectinib
干预措施: Repotrectinib (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs) leading to treatment modification (interruption, dose reduction, or discontinuation)
时间窗: Up to week 104
Number of participants with 1 or more adverse events (AEs)
时间窗: Up to week 104
Number of participants with 1 or more serious adverse events (SAEs)
时间窗: Up to week 104
Number of participants with adverse events by system organ class (including central nervous system disorders, interstitial lung disease, and fractures)
时间窗: Up to week 104
Number of participants with each adverse event outcome category (resolved, resolving, not resolved, resolved with sequelae, death, unknown)
时间窗: Up to week 104
次要结局
未报告次要终点