Safety and tolerability of AZD5363 in Japanese patients with advanced solid tumors.

ABSTRACT:

Purpose

Investigate the safety and tolerability of AZD5363 and define a recommended dose for evaluation in Japanese patients with advanced solid malignancies.

Methods

AZD5363 was administered orally as a single dose, and then the dose was escalated to twice daily (bid) in separate continuous (every day) and intermittent (4 days on, 3 days off [4/3] or 2 days on, 5 days off [2/5]) dosing schedules to reach recommended doses defined by dose-limiting toxicity (DLT). Doses for continuous, 4/3, and 2/5 intermittent dosing schedules were 80-400, 360-480, and 640 mg, respectively, and were informed by results from an equivalent study in Caucasian patients.

Results

Forty-one patients received AZD5363. DLTs were only experienced with continuous dosing. 97.6 % of patients repor

SUBMITTER: Tamura K 

PROVIDER: S-EPMC4819940 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature