NCT05100134Available不适用
Managed Access Programs for LDK378, Ceritinib
适应症
相关药物
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 LDK378, Ceritinib.
详细描述
CLDK378A2401 - No longer available - Managed Access Program (MAP) to provide access to Ceritinib, for ALK Positive Tumors.
CLDK378A2402 - No longer available - An open-label, multi-center, Expanded Treatment Protocol (ETP) of oral LDK378 in adult patients with non-small cell lung cancer (NSCLC) characterized by ALK positivity.
CLDK378A2003M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLDK378A2003M to provide access to LDK378 (ceritinib), for ALK-Positive Tumor Pediatric Patients.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 12 Years 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
研究者
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