The purpose of this study is to evaluate the safety and tolerability of XL147 in subjects with solid tumors or lymphoma. Both a capsule and a tablet formulation will be evaluated. XL147 is a new chemical entity that inhibits PI3 Kinase. Inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
118
Gelatin capsules supplied in 25-mg and 100-mg dosage strengths
Tablets supplied as 100-mg, 150-mg, and 200-mg dosage strengths
Investigational Site Number 1241
Augusta, Georgia, United States
Investigational Site Number 1503
Boston, Massachusetts, United States
Investigational Site Number 1401
Dallas, Texas, United States
Investigational Site Number 3412
Barcelona, Spain
Safety, tolerability, and maximum tolerated dose of oral administration of two formulations of XL147 in two treatment schedules
Time frame: Assessed at each visit/periodic visits
Safety and tolerability of oral dosing with XL147 capsules in subjects with lymphoma, and of XL147 capsules and tablets in subjects with solid tumors
Time frame: Assessed at periodic study visits
Plasma pharmacokinetics of daily oral administration of XL147 in two treatment schedules
Time frame: Assessed during periodic visits
Pharmacodynamic effects of XL147 on tumor tissue when administered at the maximum tolerated dose in two treatment schedules
Time frame: Assessed during periodic visits after MTD is determined
Plasma pharmacokinetics of XL147 capsule and tablet formulations
Time frame: Assessed during periodic visits after the preliminary MTD for the continuous daily dosing schedule is determined
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