>

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 J Jordi , 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.