Ximotini (simotinib) / Simcere, Advenchen - LARVOL DELTA

Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of Simotinib Hydrochloride in Patients With Advanced NSCLC (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Clinical • New P1 trial

Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of Simotinib Hydrochloride in Patients With Advanced NSCLC (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.; Trial primary completion date: Oct 2014 ➔ Dec 2015

Clinical • Trial primary completion date • EGFR

Safety, tolerability, and pharmacokinetics of simotinib, a novel specific EGFR tyrosine kinase inhibitor, in patients with advanced non-small cell lung cancer: results of a phase Ib trial. (PubMed, Cancer Manag Res) - P1; " Simotinib was well tolerated, with manageable AEs at doses of up to 650 mg and MTD was not reached. Further studies to explore higher doses are ongoing."

Clinical • Journal • P1 data • PK/PD data