Phase I Study of OPB-31121, an Oral STAT3 Inhibitor, in Patients with Advanced Solid Tumors.

ABSTRACT:

Purpose

OPB-31121 is an oral STAT3 inhibitor with a good preclinical antitumor activity. This phase I dose-escalation study of OPB-31121 was conducted to determine maximum-tolerated dose (MTD), safety, pharmacokinetics, and preliminary antitumor efficacy in patients with advanced solid tumors.

Materials and methods

Patients received OPB-31121 once daily for 28 days of each cycle followed by 2 weeks rest. A standard 3+3 design was used for dose-escalation. Safety and response were evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) ver. 3.0 and Response Evaluation Criteria in Solid Tumor (RECIST) ver. 1.0, respectively.

Results

Twenty-five patients were treated with OPB-31121 at five dose levels: 100 mg (n=4), 200 mg (n

SUBMITTER: Oh DY 

PROVIDER: S-EPMC4614199 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature