Rovithi M, et al. - In order to achieve dose and schedule optimization of treatment with tyrosine kinase inhibitors, researchers conducted a phase I clinical trial of once weekly or once every 2 weeks administration of high-dose sunitinib in patients with refractory solid malignancies. Eligible patients were those with advanced cancer refractory to standard treatment. The patients received escalating doses of sunitinib, in 100 mg increments, starting at 200 mg once weekly with use of a standard 3 + 3 phase I design. Findings support the feasibility of sunitinib administered once weekly at 300 mg or once every 2 weeks at 700 mg, with comparable tolerability as daily administration. The most optimal schedule could be that which involved administration of 700 mg once every 2 weeks because it leads to the achievement of the highest maximum plasma concentration.