CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or metastatic melanoma harboring the BRAF V600 mutation (during dose escalation phase and expansion phase) and patients with metastatic colorectal cancer harboring the BRAF V600 mutation (during the expansion phase) will be enrolled. The study consists of a dose escalation part were cohorts of patients will receive escalating oral doses of LGX818, followed by a safety dose expansion part were patients will be treated with oral dose of LGX818 given at the MTD or RP2D.
Description: LGX818 Plasma concentrationMeasure: Pharmacokinetic profile of LGX818 Time: Approximately 2 years
Description: This includes duration of response, time to response, progression free survival and overall survival.Measure: Tumor response per RECIST Time: Approximately 3 years
Description: Baseline molecular status (mutation/ amplification/ expression) in tumor tissue of potential predictive markersMeasure: Baseline molecular status Time: Approximately 3 years
Single Group Assignment
There is one SNP
2. Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation. --- V600E ---