Date: 2011-01-24
Type of information:
phase: 3
Announcement: initiation
Company: GSK (UK)
Product: GSK’436
Action mechanism: BRAF inhibitor
Disease: advanced or metastatic melanoma with a BRAF V600 mutation
Therapeutic area: Cancer Oncology
Country: Russia, Australia and several countries within North America and Europe
Trial details: BRF113683 is a Phase III, randomised, open-label study comparing the efficacy, safety, and tolerability of GSK’436 to DTIC in patients with advanced (Stage III) or metastatic (Stage IV) melanoma who harbour a BRAF V600 mutation. The primary endpoint of the study will be progression free survival. Patients who progress on DTIC will be allowed to crossover to an optional extension arm of the study to receive GSK’436. The study will be conducted in Russia, Australia and several countries within North America and Europe.
Latest
news: GSK has announced the start of two global Phase III studies in advanced or metastatic melanoma patients with a BRAF V600 mutation. The studies will separately assess the efficacy and safety of two investigational agents, GSK2118436 and GSK1120212, to determine their individual ability to stop or slow the progression of skin cancer in patients whose tumours contain a BRAF V600 mutation, which occurs in 50 to 60 percent of melanoma patients.Commencement of these studies confirms previously announced plans to progress these assets into Phase III.
The BRF113683 Phase III study compares GSK’436, a BRAF inhibitor, to dacarbazine (DTIC) in previously untreated patients with BRAF V600 mutated advanced or metastatic melanoma.
The BRR113683 study has centres open and is actively screening and recruiting patients, but has not yet begun dosing.
