Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337617
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2024-03-22
Brief Title:
A Multi-center Retrospective Study With Secondary Use of Data of Tafinlar Dabrafenib Plus Mekinist Trametinib in Chinese Patients With BRAF V600 Mutation Positive Melanoma
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Multi-center Retrospective Study With Secondary Use of Data of Tafinlar Dabrafenib Plus Mekinist Trametinib in Chinese Patients With BRAF V600 Mutation Positive Melanoma
Status:
COMPLETED
Status Verified Date:
2024-03
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:
This was a multi-center observational retrospective cohort study to evaluate the effectiveness and safety of dabrafenib in combination with trametinib in Chinese patients with unresectable or metastatic BRAF V600 mutation positive melanoma for mucosal melanoma patients Cohort A and non-mucosal melanoma patients Cohort B cutaneous and acral melanoma separately Study population was identified as patients initiating dabrafenib plus trametinib from 01 May 2020 to 31 July 2022 who fulfilled the inclusionexclusion criteria The follow-up period ended at the earliest of the following end of study observation period ie 31 December 2022 death upon withdrawal of consent or the last available record
Detailed Description:
None
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