Managed Access Programs for LEE011, Ribociclib
试验速览
- 阶段
- 不适用
- 状态
- Available
研究概览
简要总结
The purpose of this registration is to list Managed Access Programs (MAPs) related to LEE011, Ribociclib
详细描述
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
CLEE011X2001I - Available - Managed Access Program (MAP) Individual patient request to provide access to Ribociclib (in US for liquid formulation only)
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供