A phase I dose-escalation study of BI 811283, an Aurora B inhibitor, administered every three weeks in patients with advanced solid tumors.
2010
3011 Background: The serine/threonine kinase Aurora B regulates several mitotic processes and is an attractive target for therapeutic intervention. BI 811283 has demonstrated potent antitumor activity in cancer models at well-tolerated doses, with hallmarks of Aurora B inhibition. Methods: Patients with advanced, nonresectable and/or metastatic solid tumors were randomized to two treatment schedules (q2w and q3w) in a bicentric phase I dose-escalation study. The primary outcome measure was to determine the MTD of each treatment schedule—results for the q2w schedule are reported separately. In the 3-week treatment schedule (q3w), patients received BI 811283 as a 24 h i.v. infusion on day 1 of each 21-day treatment cycle. To determine the MTD, a modified 3+3 trial design with de-escalation when DLT was reached was conducted. After determination of the MTD, up to nine additional patients could be treated. PK and determinations of the phosphorylation of histone H3 in skin biopsies as PD assessments were perfo...
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