A post-trial access roll-over study to allow access to ribociclib (LEE011) for patients who are on ribociclib treatment in Novartis-sponsored study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- occurrence of adverse events of ribociclib
研究概览
简要总结
The purpose of this study is to assess the long-term safety of ribociclib (LEE011) in combination with other drugs and provide post-trial access (PTA) to participants who are currently receiving treatment with ribociclib in combination with other drugs in a Novartis sponsored global study that has reached its primary objective(s). Participants who are currently receiving treatment with ribociclib in combination with other drugs within a Novartis sponsored global study, that has fulfilled the requirements for its primary objective(s), and who, in the opinion of the Investigator, would benefit from continued treatment but are unable to access the study treatments outside of this study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants who are currently receiving treatment with ribociclib in combination with other drugs within a Novartis sponsored global study, that has fulfilled the requirements for its primary objective(s), and who, in the opinion of the Investigator, would benefit from continued treatment but are unable to access the study treatments outside of this study.
排除标准
- •Permanent discontinuation of ribociclib in the parent study due to toxicity or disease progression, non-compliance to study procedures, withdrawal of consent or any other reason as stipulated in parent protocol.
- •Participant currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study (participants meeting all other eligbility criteria may be enrolled once toxicities have resolved to allow ribociclib dosing to resume).
- •Local access to commercially available ribociclib and reimbursed (except for US enrolled participants from parent protocol CLEE011A2404 meeting all other eligibility criteria).
- •Women of child-bearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment and for 21 days after stopping the treatment.
- •Highly effective contraception methods include: a) Total abstinence b) Female sterilization c) Male partner sterilization d) Placement of an intrauterine device (IUD).
结局指标
主要结局
occurrence of adverse events of ribociclib
时间窗: Week 1 Day 1, Every 24 wks, Continuous up to 30 days after the last dose of study treatment
次要结局
- To evaluate clinical benefit as assessed by the Investigator.(Week 1 Day 1, Every 24 wks untill no benefit seen.)
研究者
Murugananthan K
Novartis Healthcare Private Limited