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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths; daily dosing
Tablets supplied in 25-mg, 100-mg, and 150-mg strengths; daily dosing
Investigational Site Number 168983
Philadelphia, Pennsylvania, United States
Safety, tolerability, and maximum tolerated dose of XL765 administered in combination with erlotinib
Time frame: Assessed during periodic visits
To evaluate plasma pharmacokinetics of XL765 and erlotinib when administered in combination
Time frame: Assessed during periodic visits
To evaluate preliminary efficacy of XL765 in combination with erlotinib in subjects with non-small-cell lung cancer (NSCLC) and other solid tumors
Time frame: Assessed during periodic visits
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