Date: 2011-01-24
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: GSK (UK)
Product: GSK’212
Action
mechanism: MEK inhibitor
Disease: advanced/metastatic melanoma focuses on patients with BRAF V600 mutation who have had no more than one prior regimen of chemotherapy and no prior BRAF inhibitor treatment
Therapeutic area: Cancer Oncology
Country: Australia, Argentina, Russia and several countries within North America and Europe.
Trial
details: The METRIC Phase III study of GSK’212, a MEK inhibitor, in patients with advanced/metastatic melanoma focuses on patients with BRAF V600 mutation who have had no more than one prior regimen of chemotherapy and no prior BRAF inhibitor treatment. The primary endpoint of the study is progression free survival. Patients in the chemotherapy cohort will be allowed to crossover to receive GSK’212 therapy after their disease progresses. The study will be conducted in Australia, Argentina, Russia 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 METRIC study compares GSK’212, a MEK inhibitor, to chemotherapy (DTIC or paclitaxel) in advanced or metastatic melanoma patients with a BRAF V600 mutation. The METRIC study has begun dosing patients.
