Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults With Solid Tumors
Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the safety and tolerability of XL765 in combination
with erlotinib (Tarceva®) in subjects with solid tumors. XL765 is a new chemical entity that
inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been
shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas
inactivation of mTOR has been shown to inhibit the growth of tumor cells. Erlotinib is an
orally administered inhibitor of EGFR (also known as HER1) tyrosine kinase. It was approved
by the FDA as a single agent for the treatment of patients with locally advanced or
metastatic non-small-cell lung cancer (NSCLC) after failure of at least one prior
chemotherapy regimen and in combination with gemcitabine for first line treatment of patients
with locally advanced, unresectable or metastatic pancreatic cancer.