Falchook G, et al. - In this open-label phase 1 trial of 191 patients and randomized phase 2 clinical trial of 142 patients with recurrent ovarian cancer or advanced breast cancer, researchers assessed the activity of alisertib in combination with weekly paclitaxel in patients with breast (phase 1) and ovarian cancer (phase 1 and phase 2). At 33 sites (US, France, and Poland), investigators conducted an open-label phase 1 and randomized phase 2 clinical trial, from April 16, 2010 for phase 1 and March 28, 2012 to August 12, 2013 for phase 2. According to findings, alisertib plus paclitaxel had more favorable progression-free survival (PFS) outcomes vs paclitaxel alone. Neutropenia, stomatitis and anemia were noted adverse events in this analysis, all of which were more prevalent with the combination regimen.