Managed Access Programs for LDK378, Ceritinib
Sponsor: Novartis Pharmaceuticals
ClinicalTrials ID:NCT05100134
The Managed Access Programs for ceritinib include CLDK378A2401 and CLDK378A2402, which are no longer available, and CLDK378A2003M, available for pediatric ALK-positive tumors. Eligibility requires a physician's request, serious condition, no trial options, and potential benefit-risk balance. Ceritinib is provided under these conditions without affecting ongoing trials.
Patient Parameters
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Program Overview
The purpose of this registration is to list Managed Access Programs (MAPs) related to LDK378, Ceritinib.
Description
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.
Eligibility Criteria
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.
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