Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06262919
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-02-08
Brief Title:
Special Drug Use-results Surveillance of TafinlarMekinist
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Observational Study to Assess Safety and Effectiveness of Dabrafenib and Trametinib in Patients With BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor
Status:
RECRUITING
Status Verified Date:
2024-07
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 is a prospective multicenter single-arm non-interventional and observational J-PMS conducted by the central registration system and operated in Electronic data capture
Detailed Description:
In the Post-Marketing Surveillance PMS dabrafenib and trametinib are used as the marketed drugs Registration of the corresponding patients is to be conducted by the central registered system under current medical practice
Target number of adult patient is 65 as the number of patients in the effectiveness analysis set
Target number of pediatric patient is not determined Estimated number of enrolled patients is approximately 20 as the number of patients in the enrolled set
The observation period for pediatric patients will last after the start of treatment until 8 years planned November 2031 after the approval of additional indications regardless of discontinuation of the product in order to collect long-term information from as many patients as possible during the reexamination period The duration of observation for adult patients will be 1 year after the start of treatment with the product
Target number of adult patient is 65 as the number of patients in the effectiveness analysis set
Target number of pediatric patient is not determined Estimated number of enrolled patients is approximately 20 as the number of patients in the enrolled set
The observation period for pediatric patients will last after the start of treatment until 8 years planned November 2031 after the approval of additional indications regardless of discontinuation of the product in order to collect long-term information from as many patients as possible during the reexamination period The duration of observation for adult patients will be 1 year after the start of treatment with the product
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