2024-514891-41-00招募中4 期
A post-trial access roll-over study to allow access to ribociclib (LEE011) for patients who are on ribociclib treatment in Novartis-sponsored study
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 7
- 试验地点
- 7
- 主要终点
- Frequency and severity of AEs/SAEs
研究概览
简要总结
To evaluate long-term safety as assessed by occurrence of adverse events of ribociclib as part of a combination regimen
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participant is currently participating in a Novartis sponsored global study (parent study), receiving treatment with ribociclib in combination with other drugs, and the parent study has fulfilled its primary objective(s).
- •Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
- •Participant must have been receiving treatment with ribociclib for at least 6 cycles in the parent study.
- •Participant must have evidence of clinical benefit as determined by the Investigator.
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.
- •Participants currently have unresolved toxicities for which ribociclib dosing has been interrupted in the parent study (participants meeting all other eligibility 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)
研究组 & 干预措施
LEE011
Test
干预措施: LEE011 (Drug)
GOSERELIN ACETATE
Test
干预措施: GOSERELIN ACETATE (Drug)
LETROZOLE
Test
干预措施: LETROZOLE (Drug)
RIBOCICLIB
Test
干预措施: RIBOCICLIB (Drug)
TAMOXIFEN
Test
干预措施: TAMOXIFEN (Drug)
结局指标
主要结局
Frequency and severity of AEs/SAEs
Frequency and severity of AEs/SAEs
Proportion of participants with clinical benefit as assessed by the Investigator
Proportion of participants with clinical benefit as assessed by the Investigator
次要结局
未报告次要终点
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (7)
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