The purpose of this study is to determine the safest dose of the multiple Raf kinase inhibitor (including c-Raf, B-Raf, and the activated mutant B-RafV600E) XL281, how often it should be taken, and how well subjects with cancer tolerate XL281. This study will also determine how the body reacts to XL281 when it is taken with and without food, and with and without Pepcid (famotidine), a drug that inhibits stomach acid production.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Gelatin capsules supplied as 5-, 25-, and 100-mg strengths
single dose, supplied as 20-mg or 40-mg tablets
Premiere Oncology of Arizona
Scottsdale, Arizona, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Safety, tolerability, and maximum tolerated dose (MTD) of once daily or twice daily oral administration of XL281
Time frame: Assessed at periodic visits
To assess the pharmacokinetic/pharmacodynamic/preliminary clinical activity relationship following XL281 administration in different tumor types from subjects treated at the MTD
Time frame: Assessed at periodic visits
To determine the bioavailability of XL281 under fed and fasted conditions, and with or without the concomitant use of a single dose of famotidine in subjects with solid tumors
Time frame: Assessed during the second, third, and fourth week of the first cycle of dosing
Plasma pharmacokinetics of once daily or twice daily oral administration of XL281
Time frame: Assessed at periodic visits
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Sarah Cannon Research Institute
Nashville, Tennessee, United States
Mary Crowley Cancer Research Center
Dallas, Texas, United States