A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma
Status:
Active, not recruiting
Trial end date:
2022-07-31
Target enrollment:
Participant gender:
Summary
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.