A phase I, multicenter, open-label, first-in-human, dose-escalation study of the oral smoothened inhibitor Sonidegib (LDE225) in patients with advanced solid tumors.
AUTHORS
Rodon
JJordi ,
Tawbi
HA Hussein A ,
Thomas
AL Anne L ,
Stoller
RG Ronald G ,
Turtschi
CP Christian P ,
Baselga
J Jose ,
Sarantopoulos
J John ,
Mahalingam
D Devalingam ,
Shou
Y Yaping ,
Moles
MA Melissa A ,
Yang
L Lin ,
Granvil
C Camille ,
Hurh
E Eunju ,
Rose
KL Kristine L ,
Amakye
DD Dereck D ,
Dummer
R Reinhard ,
Mita
AC Alain C .
Clinical cancer research : an official journal of the American Association for Cancer Research. 2014 4 1; 20(7).
1900-9
ABSTRACT
This phase I trial was undertaken to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLT), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of the novel smoothened inhibitor sonidegib (LDE225), a potent inhibitor of hedgehog signaling, in patients with advanced solid tumors.
This phase I trial was undertaken to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLT), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of the novel smoothened inhibitor sonidegib (LDE225), a potent inhibitor of hedgehog signaling, in patients with advanced solid tumors.