Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04489433
Status:
AVAILABLE
Last Update Posted:
2024-02-08
First Post:
2020-07-23
Brief Title:
Compassionate Use Program to Access Trametinib and Dabrafenib for Patients With BRAF Mutation-positive Metastatic Melanoma
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Managed Access Program MAP Cohort Treatment Plan CDRB436B2005CM to Provide Access to Trametinib and Dabrafenib for Patients With BRAF Mutation-positive Metastatic Melanoma
Status:
AVAILABLE
Status Verified Date:
2024-02
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 Cohort Treatment Plan is to allow access to trametinib monotherapy or in combination and dabrafenib monotherapy or in combination for eligible patients diagnosed with metastatic melanoma BRAF mutation-positive
Detailed Description:
The patients Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations
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
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
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