AN OPEN-LABEL, SINGLE-ARM STUDY OF THE LONG-TERM SAFETY OF XALKORI (REGISTERED) IN PATIENTS FROM CHINA WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) OR ROS1 LOCUS WHO HAVE PREVIOUSLY BEEN TREATED ON A STUDY OF XALKORI (REGISTERED)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 41
- 试验地点
- 13
- 主要终点
- Number of Participants With Grade 3 or 4 Adverse Events (AEs), Grade 5 AEs, AEs Lead to Treatment Discontinuation, Serious AEs (SAEs)- All Causality: Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
研究概览
简要总结
This study is to allow access to crizotinib who were treated in previous Pfizer-sponsored studies in China.
详细描述
This study is a phase 4 study, to continually access Xalkori to Chinese patients who were recruited in previous studies of Crizotinib in China, and only collect the safety data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients who were enrolled and treated in Studies A8081005, A8081007, A8081014, A8081029, or A8081063 and are still receiving crizotinib treatment at the time of enrollment into this study. OR Patients randomized to the chemotherapy arm in Studies A8081014 or A8081029 who have experienced investigator assessed disease progression and have not yet crossed over to receive crizotinib treatment.
- •No ongoing NCI CTCAE Grade 3 or intolerable Grade 2 adverse events considered to be related to crizotinib treatment
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- •Adequate organ function as defined by the following criteria
排除标准
- •Use of any anticancer drug subsequent to crizotinib prior to study entry
- •Use of drugs or foods that are known potent Cytochrome P450 (CYP)3A4 inhibitors
- •Use of drugs that are known potent CYP3A4 inducers
- •Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices, associated with life threatening arrhythmias
研究组 & 干预措施
single arm
Crizotinib
干预措施: Crizotinib (Drug)
结局指标
主要结局
Number of Participants With Grade 3 or 4 Adverse Events (AEs), Grade 5 AEs, AEs Lead to Treatment Discontinuation, Serious AEs (SAEs)- All Causality: Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
时间窗: From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
An AE was any untoward medical occurrence in a clinical study participant associated with the use of study intervention, whether or not considered related to the study intervention. According to NCI CTCAE version 4.03: Grade 3 indicates severe AE, Grade 4 indicates life-threatening consequences and urgent intervention indicated and Grade 5 indicates death related to AE. Participants who discontinued treatment due to AEs were captured under AEs leading to treatment discontinuation. SAE was any untoward medical occurrence at any dose that resulted in death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect or that was considered as an important medical event.
Number of Participants With Grade 3 or 4 AEs, Grade 5 AEs, AEs Leading to Treatment Discontinuation and SAEs- Treatment Related: Assessed by NCI CTCAE v4.03
时间窗: From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)
An AE was any untoward medical occurrence in a clinical study participant associated with use of study intervention, whether or not considered related to study intervention. AEs that were related to treatment were evaluated in this outcome measure. Treatment relatedness was judged by investigator. According to NCI CTCAE version 4.03: Grade 3= severe AE, Grade 4= life-threatening consequences and urgent intervention indicated, Grade 5= death related to AE. Participants who discontinued treatment due to treatment related AEs were captured under AEs leading to treatment discontinuation. SAE was any untoward medical occurrence at any dose that resulted in death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect or that was considered as an important medical event.
次要结局
未报告次要终点