Ignite Creation Date:
2024-05-05 @ 10:57 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01227889
Status:
COMPLETED
Last Update Posted:
2017-10-04
First Post:
2010-10-21
Brief Title:
A Study Comparing GSK2118436 to Dacarbazine DTIC in Previously Untreated Subjects With BRAF Mutation Positive Advanced Stage III or Metastatic Stage IV Melanoma
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase III Randomized Open-label Study Comparing GSK2118436 to Dacarbazine DTIC in Previously Untreated Subjects With BRAF Mutation Positive Advanced Stage III or Metastatic Stage IV Melanoma
Status:
COMPLETED
Status Verified Date:
2017-08
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:
BRF113683 is a Phase III randomized open-label study comparing the efficacy safety and tolerability of GSK2118436 to dacarbazine DTIC in subjects with BRAF mutant advanced Stage III or metastatic Stage IV melanoma Subjects will be randomized to receive 150 mg of GSK2118436 twice daily or 1000 mgm2 DTIC every 3 weeks and continue on treatment until disease progression death or unacceptable adverse event Subjects who progress on DTIC will be allowed to crossover to an optional extension arm of the study to receive GSK2118436
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None