Conditions: Melanoma
Keywords: LGX818 BRAF Inhibitor Stage IV melanoma unresectable stage III melanoma BRAFV600 mutation 13-053
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 7
Healthy volunteers: no

Brief summary:
The purpose of this phase II study is to find out if an investigational drug called LGX818 can stop the melanoma from growing.

Detailed description:

Arms:
arm 1: LGX818 capsules will be administered orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.

Interventions: intervention 1: LGX818
Intervention descriptions: intervention 1: None

Protocol document: