An Open-label, Multi-center Rollover Protocol for Patients Who Have Participated in a Novartis-sponsored Ribociclib (LEE011) Study and Are Continuing to Benefit From Ribociclib as Single Agent or in Combination With Other Investigational Treatments
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 13
- 主要终点
- Number of Patients enrolled and received LEE011
研究概览
简要总结
This study is to allow continued use of ribociclib (LEE011) as single agent or in combination with other investigational treatments in patients benefitting from treatment in an eligible Novartis-sponsored ribociclib (LEE011) study that has reached its primary objective(s) or has been halted for other reasons.
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
- 0 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is currently enrolled in an eligible Novartis-sponsored study and receiving ribociclib (LEE011) as single agent or in combination with other investigational treatment.
- •Patient is currently deriving clinical benefit from the study treatment, as determined by the investigator.
排除标准
- •Patient has been permanently discontinued from ribociclib (LEE011) in the parent protocol for any reason.
- •Patients who do not meet parent protocol criteria to continue study treatment.
研究组 & 干预措施
LEE011
All patients in all combinations with LEE011 will be entered in one arm.
干预措施: LEE011 (Drug)
结局指标
主要结局
Number of Patients enrolled and received LEE011
时间窗: up to 5 years (study duration)
Continued access to study treatment as a single agent or in combination with other investigational treatments until patients discontinue study
Length of time receiving study treatment
时间窗: up to 5 years (study duration)
Assessed by duration in days from start of study treatment until study treatment discontinuation
次要结局
- Frequency and nature of adverse events (AEs), serious adverse events (SAEs), non-fatal SAEs and liver function assays.(up to 5 years (study duration))