Conditions: Melanoma and Metastatic Colorectal Cancer
Keywords: BRAF mutant, BRAF mutated, melanoma, metastatic, advanced, RAF kinase inhibitor BRAF V600 mutation
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 107
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

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

Protocol document: