The purpose of this study is to determine the safety and tolerability of XL765. 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
83
Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths administered orally
Investigational Site Number 1302
Detroit, Michigan, United States
Investigational Site Number 1435
Omaha, Nebraska, United States
Investigational Site Number 1402
San Antonio, Texas, United States
Investigational Site Number 3411
Barcelona, Spain
Safety, tolerability, and maximum tolerated dose (MTD) of daily oral administration of XL765 in two treatment schedules
Time frame: Assessed at each visit/periodic visits
Plasma pharmacokinetics of daily oral administration of XL765 in two treatment schedules
Time frame: Assessed at periodic visits
Pharmacodynamic effects of XL765 on tumor tissue when administered at the MTD in two treatment schedules
Time frame: Assessed during periodic vixits after MTD is determined
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