2024-511125-61-00招募中2 期
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
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of patients receiving ribociclib as single agent or in combination with other investigational treatments under the rollover study, duration of exposure
研究概览
简要总结
To allow patients enrolled in a ribociclib (LEE011) Novartis-sponsored study continued access to study treatment after the study has reached its primary objective(s) or the study has been terminated for other reasons.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patient is currently enrolled in an eligible Novartis-sponsored ribociclib (LEE011) study and is receiving ribociclib as single agent or in combination with other investigational treatments.
- •Patient is currently deriving clinical benefit from the study treatment, as determined by the investigator.
- •Patient has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.
排除标准
- •Patients who have permanently discontinued from ribociclib (LEE011) in the parent protocol for any reason
- •Patients who do not meet parent protocol criteria to continue study treatment.
结局指标
主要结局
Number of patients receiving ribociclib as single agent or in combination with other investigational treatments under the rollover study, duration of exposure
Number of patients receiving ribociclib as single agent or in combination with other investigational treatments under the rollover study, duration of exposure
次要结局
- Frequency and nature of adverse events (AEs), serious adverse events (SAE) and liver function tests
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (1)
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