Ignite Creation Date:
2024-05-06 @ 10:28 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03271554
Status:
COMPLETED
Last Update Posted:
2022-11-18
First Post:
2017-09-01
Brief Title:
Treatment Registry of Alectinib in Anaplastic Lymphoma Kinase ALK-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Korea
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
Treatment Registry of Alecensa in Korean Patients With Anaplastic Lymphoma Kinase ALK-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2022-11
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:
Alectinib was approved by the Ministry of Food and Drug Safety MFDS in Korea in Oct 2016 The purpose of this registry is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and effectiveness of the new drug so that the regulatory authority can manage the marketing approval properly
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None