|MDACC Study No:||2012-0238 (clinicaltrials.gov NCT No: NCT01543698)|
|Title:||A Phase Ib/II, multicenter, open-label, dose escalation study of LGX818 in combination with MEK162 in adult patients with BRAF V600 - dependent advanced solid tumors|
|Principal Investigator:||Sapna P. Patel|
|Treatment Agent:||LGX818; MEK162|
|Study Description:||The goal of Phase 1B of this clinical research study is to find the highest |
tolerable combination dose of the targeted therapy drugs called LGX818 and
MEK162 that can be given to patients with advanced colorectal cancer or
melanoma that has a mutation (genetic change) called BRAF. Only melanoma
patients with the BRAF mutation will be enrolled at MD Anderson.
The goal of Phase 2 of this clinical research study is to learn if the highest
tolerable dose combination of LGX818 and MEK162 can help to control advanced
colorectal cancer and/or melanoma with BRAF mutations. The safety of the study
drug combination will also be studied.
LGX818 is designed to block chemical reactions in cancer cells that are needed
for tumor cells to grow, survive, and form the blood vessels needed for tumor
growth. This may cause the cancer cells to die.
MEK162 is designed to block certain proteins that cause cancer cells to grow
and multiply. This may cause the cancer cells to die.