Abstract
3104 Background: BMS-754807 is a potent reversible inhibitor of IGF-1R and IR family kinases (IGF-1R, IR; Ki <2nM). Methods: CA191002 is an ascending dose study of once daily BMS-754807 in subjects with solid tumors. Study objectives include determination of maximum tolerated dose, assessment of safety, effects on metabolic parameters, pharmacokinetics, and pharmacodynamics. Antitumor activity is assessed by radiological responses and FDG- and FLT-PET imaging. Results: To date 19 subjects (12 M, 7 F, median age 59 yr) have been treated at daily doses of 4, 10, 20, 30, 50 or 70 mg. Dosing duration was 17 - 233 d. Fatigue (G1, n=3) and hyperglycemia (≤ G3, n=3) were the most frequent related adverse events (AEs). One related AE (reversible asymptomatic postprandial hyperglycemia) was G3; all other related AEs were ≤ G2. Metabolic AEs were managed by diet and/or comedication. No dose limiting toxicities have been observed and further dose escalation continues. BMS- 754807 exposure increased in relation to do...
Published Version
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call