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NCT05100134 Clinical Trial

Managed Access Programs for LDK378, Ceritinib

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:
Managed Access Programs for LDK378, Ceritinib

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT05100134
Other study ID # CLDK378A2401
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date February 2024
Source Novartis
Contact MAP requests are initiated by a licensed physician.https:// www.
Phone 1-888-669-6682
Email novartis.email@novartis.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ceritinib
Patients receive ceritinib

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals
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