Access Programs for LDK378, Ceritinib
Sponsor: Novartis Pharmaceuticals
ClinicalTrials ID:NCT05100134
This information is about special programs that allow patients to access the drug Ceritinib (LDK378) for treating certain types of cancer, especially when other treatments are not available.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
These programs are designed to provide access to Ceritinib, a medication used for treating ALK-positive tumors, including in adults with non-small cell lung cancer (NSCLC) and in children with ALK-positive tumors. Some programs are no longer available, while others are still open for eligible patients.
Description
There are different Managed Access Programs (MAPs) for Ceritinib:
-
CLDK378A2401: This program is no longer available. It was a Managed Access Program to provide Ceritinib for patients with ALK-positive tumors.
-
CLDK378A2402: This program is also no longer available. It was an open-label, multi-center program for adults with ALK-positive non-small cell lung cancer (NSCLC).
-
CLDK378A2003M: This program is currently available. It is a Managed Access Program for children with ALK-positive tumors, allowing them to access Ceritinib.
Eligibility Criteria
Inclusion Criteria
- A licensed doctor must request access on behalf of the patient.
- The patient has a serious or life-threatening condition with no other satisfactory treatment options.
- The patient cannot join or continue in a clinical trial.
- The potential benefits of the treatment must outweigh the risks, and the risks should be reasonable given the patient's condition.
- The patient must meet any additional medical criteria set by experts or health authorities.
- Providing the drug must not interfere with any ongoing or planned clinical trials by Novartis.
- The program must comply with local laws and regulations.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.