Phase I Dose-Finding Study of OPB-111077, a Novel STAT3 Inhibitor, in Patients with Advanced Hepatocellular Carcinoma.

ABSTRACT:

Purpose

The signal transducer and activator of transcription 3 (STAT3) signaling pathway might be a promising therapeutic target for hepatocellular carcinoma (HCC).

Materials and methods

This study was a multicenter, open-label, non-comparative, dose escalating phase I study of OPB-111077, an oral STAT3 inhibitor, in patients with advanced HCC who failed on sorafenib. Continuous dosing (daily administration, 50 to 400 mg) and intermittent dosing (4-days on/3-days off administration: 300 to 900 mg) regimens were evaluated and the dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended dose (RD) were the primary endpoints.

Results

A total of 33 patients (19 for continuous dosing and 14 for intermittent dosing) were enrolled. One patient experience

SUBMITTER: Yoo C 

PROVIDER: S-EPMC6473286 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature