Managed Access Programs for LDK378, Ceritinib

NCT05100134 | Unknown

• 1 other identifier: CLDK378A2401
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

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

Interventions

ceritinib DRUG

Patients receive ceritinib

Also known as: LDK378

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lymphoma, Large-Cell, Anaplastic; Granuloma, Plasma Cell

Interventions

ceritinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Granuloma; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: October 29, 2021
• Last Updated: April 1, 2026

Record last verified: 2026-03