管理访问计划提供对 Ribociclib 的访问,用于局部晚期或转移性癌症对可用治疗方案耐药或难治以及使用 CDK 抑制剂治疗的候选者
管理访问计划 (MAP) 队列治疗计划 CLEE011A2408 以提供对 Ribociclib(LEE011,Kisqali®)的访问,用于局部晚期或转移性癌症对现有治疗方案耐药或难治,以及使用 CDK 抑制剂治疗的候选者(包括使用 D-cyclin 的肿瘤) -CDK4/6-INK4a-Rb 通路异常)
The purpose of this registration is to list Managed Access Programs (MAPs) related to LEE011, Ribociclib
研究概览
详细说明
CLEE011A2408 - No longer available - Managed Access Program (MAP) Cohort to provide access to ribociclib (LEE011, Kisqali®), for locally advanced or metastatic cancer resistant or refractory to available treatment options and candidate for therapy with a CDK inhibitor (including tumors with D-cyclin-CDK4/6-INK4a-Rb pathway abnormalities)
CLEE011A2006M - Available - Managed Access Program (MAP) Cohort to provide access to Ribociclib for patients diagnosed with early-stage HR+HER2 (stages II and III) - breast cancer requiring adjuvant treatment with an ET based regimen
研究类型
扩展访问类型
- 中型人口
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- An independent request was received from a licensed physician.
- The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
- The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial.
- There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
- The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
- Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
- Managed Access provision is allowed per local laws/regulations.
学习计划
研究是如何设计的?
合作者和调查者
研究记录日期
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.