Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04887519
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2021-05-13
Brief Title:
A Study of Brigatinib to Treat Adults With Anaplastic Lymphoma Kinase ALK Positive Metastatic Non Small Cell Lung Cancer NSCLC
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
Post Authorization Study to Monitor Efficacy Effectiveness and Safety of Brigatinib Alunbrig in Anaplastic Lymphoma Kinase ALK Positive Metastatic Non Small Cell Lung Cancer NSCLC in Argentina
Status:
COMPLETED
Status Verified Date:
2023-04
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 aims of the study are to assess the safety profile of brigatinib and the clinical response rates in adults with Anaplastic Lymphoma Kinase ALK-Positive Metastatic Non Small Cell Lung Cancer NSCLC Treatment with brigatinib and follow-up will be according to routine clinical practice
Study doctors will review the participants medical records at the start of the study then at 12 and 24 weeks after treatment starts
Study doctors will review the participants medical records at the start of the study then at 12 and 24 weeks after treatment starts
Detailed Description:
This is a prospective observational post-marketing surveillance study of brigatinib in participants with advanced or metastatic NSCLC This study will assess the safety efficacy and effectiveness of brigatinib for its approved indications in a routine clinical practice setting under real world use
The study will enroll approximately 37 participants The data will be collected both prospectively andor retrospectively at the specialized centers and outpatient oncology clinics and will be recorded by the investigator in the electronic Case Report Form eCRF based on the routine medical care data that is collected in the medical records All the participants will be assigned to a single observational cohort
All Participants
This multi-center study will be conducted in Argentina The overall duration of the study will be approximately 52 weeks Data collection will be based on routine visit after every 12 weeks from the start of treatment up to 24 weeks of follow up or death or cancer progression or treatment discontinuation whichever occurs first
The study will enroll approximately 37 participants The data will be collected both prospectively andor retrospectively at the specialized centers and outpatient oncology clinics and will be recorded by the investigator in the electronic Case Report Form eCRF based on the routine medical care data that is collected in the medical records All the participants will be assigned to a single observational cohort
All Participants
This multi-center study will be conducted in Argentina The overall duration of the study will be approximately 52 weeks Data collection will be based on routine visit after every 12 weeks from the start of treatment up to 24 weeks of follow up or death or cancer progression or treatment discontinuation whichever occurs first
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