A Phase I/II, open-label, dose escalation trial to evaluate the safety, pharmacokinetics, and pharmacodynamics of RAF265 (CHIR-265) administered orally to patients with locally advanced or metastatic melanoma

Woman and Man

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Extract

The primary objectives of this study are to determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RPTD), dose limiting toxicities (DLTs), and the safety profile of RAF265 when administered orally to patients with locally advanced or metastatic melanoma; to determine the plasma pharmacokinetics (PK) of orally administered RAF265; and to evaluate potential pharmacodynamic effects of RAF265 using tumor/nevus biopsies, peripheral blood samples, and imaging. The primary objective of Arm 4 is to confirm the safety and tolerability of the tablet formulation of RAF265 when dosed daily at its MTD, and to confirm that exposure with the tablet is comparable to that of the liquid formulation under steady-state conditions.

Inclusion criteria

local advanced or metastatic melanoma

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A Phase I/II, open-label, dose escalation trial to evaluate the safety, pharmacokinetics, and pharmacodynamics of RAF265 (CHIR-265) administered orally to patients with locally advanced or metastatic ...