A phase I study of single-agent BEZ235 special delivery system sachet in Japanese patients with advanced solid tumors.

ABSTRACT:

Purpose

BEZ235 is a dual kinase inhibitor of phosphatidylinositol 3-kinase (PI3K) and mammalian target of rapamycin, which are key components of the PI3K pathway. This was an open-label, multicenter, dose-escalation, phase I study of single-agent BEZ235 in Japanese oncology patients to determine the maximum tolerated dose (MTD) of BEZ235 based on dose-limiting toxicities (DLTs).

Methods

Dose escalation was guided by a standard 3 + 3 method and was based on DLTs observed in Cycle 1 and other safety, pharmacokinetic, and pharmacodynamic information. A total of 35 adult Japanese patients with advanced solid tumors received BEZ235 according to once daily (qd; n = 27) or twice daily (bid; n = 8) dosing schedules.

Results

Two DLTs, namely, allergic reaction and thrombocytop

SUBMITTER: Toyoda M 

PROVIDER: S-EPMC6394493 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature