Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04544202
Status:
AVAILABLE
Last Update Posted:
2023-10-18
First Post:
2020-09-03
Brief Title:
Compassionate Use Program BRAF Mutation-positive Patients in the Adjuvant Treatment of Melanoma After Surgical Resection
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Managed Access Program MAP Cohort Treatment Plan CDRB436F2001CM to Provide Access to Trametinib and Dabrafenib Combination Therapy in the Adjuvant Treatment of High-risk BRAF 600 Mutation-positive Melanoma After Surgical Resection
Status:
AVAILABLE
Status Verified Date:
2023-10
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 Treatment Plan is to allow access to trametinib and dabrafenib for eligible high-risk BRAF mutation-positive patients in the adjuvant treatment of melanoma after surgical resection The patients Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations
Detailed Description:
The requesting Treating Physician submitted a request for access to drug often referred to as Compassionate Use to Novartis which was reviewed and approved by the medical team experienced with the drug and indication
This program will provide access to patients until
All participating countries have received marketing authorization and product is commercially available and accessible to all participating patients or
Alternative treatment options are available andor
In case of changes in the safety profile or a lack of overall efficacy of the product
This program will provide access to patients until
All participating countries have received marketing authorization and product is commercially available and accessible to all participating patients or
Alternative treatment options are available andor
In case of changes in the safety profile or a lack of overall efficacy of 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