Phase I trial of enzalutamide, gemcitabine, and nab-paclitaxel as a first-line treatment for advanced pancreatic cancer.

e15250 Background: Sex steroid hormones may play an important role in the growth and progression of pancreatic cancer. In the Phase Ia portion of this trial, we evaluated the safety and tolerability of the combination of enzalutamide, a novel androgen receptor (AR) antagonist with gemcitabine and nab-paclitaxel in pts with metastatic pancreatic cancer as a first-line treatment. Methods: Standard 3+3 dose escalation design was used to evaluate 2 dose levels of enzalutamide: 80 mg and 160 mg daily. Gemcitabine (1000 mg/m2) and nab-paclitaxel (125 mg/m2) was administered IV on days 1, 8 and 15 of a 28-day cycle. The dose limiting toxicity (DLT) period was 28-days or until the beginning of the second cycle. A full PK profile was evaluated for nab-paclitaxel after the initial dose through 48 hours post dose while enzalutamide was tested on day 1 at 1 and 2 hours post dose along with levels every 7 days to follow achievement of steady state by day 29 (C2D1). Results: Twelve patients with stage IV pancreatic can...