Babiker HM, et al. - In view of the demonstrated efficacy of single agent RX-3117 in phase III single agent clinical study of RX-3117 in met-PC and bladder cancer, researchers evaluated RX-3117 in combination with nab-pac as first line treatment of met-PC cancer. This multicenter, open-label phase I/II study included subjects (aged ≥ 18 years) having histologically or radiologically proven met-PC with no prior therapies for metastatic disease, ECOG PS 0-1, and normal lab values. The MTD dose was investigated in phase I; further evaluation of the MTD was done in phase II: RX-3117 (700 mg administered orally once-daily for 5 consecutive days with 2 days off per week) and nab-pac (125 mg/m² administered once weekly) for 3 weeks with 1 week off per 4-week cycle. Outcomes suggest RX-3117 in combination with nab-pac as safe and well tolerable in subjects with met-PC. Twelve subjects displayed antitumor activity per RECIST. Currently, phase II of the clinical study is ongoing.