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Managed Access Programs for LDK378, Ceritinib

NCT05100134

No Longer AvailableN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Anaplastic Lymphoma Kinase (ALK)- Positive Tumors, Non-small Cell Lung Cancer (NSCLC)

Interventions: ceritinib

The purpose of this registration is to list Managed Access Programs (MAPs) related to LDK378, Ceritinib.

Eligibility overview

Sex: ALL

Age: 1 Year to —

Healthy volunteers: No

Study type: EXPANDED_ACCESS

Eligibility criteria

Inclusion Criteria:

1. An independent request was received from a licensed physician.
2. 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.
3. The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial.
4. 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.
5. 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).
6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
7. Managed Access provision is allowed per local laws/regulations.