The purpose of this registration is to list Managed Access Programs (MAPs) related to LDK378, Ceritinib.
Who can participate
Age range1 Year
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.