Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT04544202
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2024-11-12
First Post:
2020-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Compassionate Use Program BRAF Mutation-positive Patients in the Adjuvant Treatment of Melanoma After Surgical Resection
Sponsor:
Novartis Pharmaceuticals
Organization:
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:
NO_LONGER_AVAILABLE
Status Verified Date:
2024-11
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:
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 patient's 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 patient(s) or
* Alternative treatment options are available and/or
* 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 patient(s) or
* Alternative treatment options are available and/or
* In case of changes in the safety profile or a lack of overall efficacy of the product.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: