Phase I Study Of Mtorc1/2 Inhibitor Bi 860585 As Single Agent Or With Exemestane Or Paclitaxel In Patients With Advanced Solid Tumors.

2545Background: BI 860585 is a potent, selective ATP-competitive mTOR serine/threonine kinase inhibitor which has shown preclinical activity against various cancer types. This Phase I trial (NCT01938846) aims to determine the maximum tolerated dose (MTD) of BI 860585 as a single agent or combined with exemestane or paclitaxel in patients (pts) with advanced solid tumors. Methods: This study used a 3+3 design in 3 treatment arms (all in 28-day cycles): single-agent BI 860585 (5–300 mg/day; Arm A), BI 860585 (40–220 mg/day) combined with fixed-dose exemestane (25 mg/day; Arm B), and BI 860585 (80–160 mg/day) combined with paclitaxel (60 or 80 mg/m2/week; Arm C). MTD is defined as the highest dose at which ≤ 1 out of 6 pts experience a dose-limiting toxicity (DLT) during cycle 1. Results: To date, 41 pts have been treated in Arm A, 24 in Arm B and 17 in Arm C. DLTs have been observed in (n DLTs/n evaluable): 4/36 pts, and 4/20 pts in Arm A and B, respectively. No DLT has occurred in 12 pts in Arm C. DLTs (al...