Millennium Pharmaceuticals has announced the initiation of multicenter Phase I study of MLN8054, a novel and highly selective Aurora kinase inhibitor, in patients with advanced malignancies. MLN8054, an orally administered small molecule, was discovered and is being developed by Millennium scientists. This first clinical study will assess safety, determine the maximum tolerated dose, and evaluate preliminary activity across a variety of cancers.
The study is expected to enroll approximately 30 patients with advanced solid tumors, including lymphomas. MLN8054 will be given orally and the dose will be escalated in cohorts of patients as tolerability is demonstrated at the given dose level. The primary endpoint is to determine dose-limiting toxicities and maximum tolerated dose. Secondary endpoints of the study will include pharmacokinetics, pharmacodynamics, and preliminary assessment of antitumor activity. Exploratory analysis will also include the evaluation of specific molecular biomarkers.