Treatment Registry of Alecensa in Korean Patients With Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 355
- 试验地点
- 36
- 主要终点
- Percentage of Participants with Adverse Events (AEs)
研究概览
简要总结
Alectinib was approved by the Ministry of Food and Drug Safety (MFDS) in Korea in Oct 2016. The purpose of this registry is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and effectiveness of the new drug so that the regulatory authority can manage the marketing approval properly.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are administered alectinib at physician's discretion and fall into the approved indication in Korea.
排除标准
- •Hypersensitivity to alectinib or any ingredient of alectinib;
- •Pregnant or lactating women;
- •Pediatric subjects (age </=18 years);
- •Due to the presence of lactose, subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take alectinib.
研究组 & 干预措施
Alectinib
Participants with ALK-positive, locally advanced or metastatic non-small cell lung cancer, who are treated with alectinib in accordance with local clinical practice and local labeling, are observed in this study.
干预措施: Alectinib (Drug)
结局指标
主要结局
Percentage of Participants with Adverse Events (AEs)
时间窗: Up to approximately 3 years
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. All AE events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
次要结局
- Complete Response (CR)(Up to approximately 3 years)
- Overall Response Rate (ORR)(Up to approximately 3 years)
- Percentage of Participants with Stable Disease (SD)(Up to approximately 3 years)
- Percentage of Participants with Partial Response (PR)(Up to approximately 3 years)
- Percentage of Participants with Progressive Disease (PD)(Up to approximately 3 years)