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Managed Access Programs for LDK378, Ceritinib

Managed Access Programs for LDK378, Ceritinib

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT05100134
Enrollment
Unknown
Registered
2021-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

MAP, Manage access program, ceritinib, ALK positive tumors, Non-small cell lung cancer (NSCLC), Anaplastic large cell lymphoma (ALCL), Inflammatory myofibroblastic tumour (IMT),, LDK378

Brief summary

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

Detailed 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 - No longer available- Managed Access Program (MAP) Cohort Treatment Plan CLDK378A2003M to provide access to LDK378 (ceritinib), for ALK-Positive Tumor Pediatric Patients.

Interventions

DRUGceritinib

Patients receive ceritinib

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026