Ignite Creation Date:
2024-05-05 @ 11:08 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01266967
Status:
COMPLETED
Last Update Posted:
2014-05-08
First Post:
2010-12-02
Brief Title:
A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma to the Brain
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
BRF113929 An Open-Label Two-Cohort Multicentre Study of GSK2118436 as a Single Agent in Treatment Naïve and Previously Treated Subjects With BRAF Mutation-Positive Metastatic Melanoma to the Brain
Status:
COMPLETED
Status Verified Date:
2014-03
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:
Break MB
Brief Summary:
This study is designed to assess the efficacy pharmacokinetics safety and tolerability of an oral twice daily dose of 150 mg GSK2118436 administered to subjects with BRAF V600E or V600K mutation-positive metastatic melanoma to the brain Subjects in Cohort A will not have received any local brain therapy and subjects in Cohort B will have received prior local therapy for brain metastases Subjects will continue on treatment until disease progression death or unacceptable adverse event
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