Ignite Creation Date:
2024-05-06 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05100134
Status:
AVAILABLE
Last Update Posted:
2024-02-08
First Post:
2021-10-19
Brief Title:
Managed Access Programs for LDK378 Ceritinib
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Managed Access Programs for LDK378 Ceritinib
Status:
AVAILABLE
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 - Available - Managed Access Program MAP Cohort Treatment Plan CLDK378A2003M to provide access to LDK378 ceritinib for ALK-Positive Tumor Pediatric Patients
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None