Phase I Study of LY2606368, a Checkpoint Kinase 1 Inhibitor, in Patients With Advanced Cancer.

ABSTRACT:

Purpose

The primary objective was to determine safety, toxicity, and a recommended phase II dose regimen of LY2606368, an inhibitor of checkpoint kinase 1, as monotherapy.

Patients and methods

This phase I, nonrandomized, open-label, dose-escalation trial used a 3 + 3 dose-escalation scheme and included patients with advanced solid tumors. Intravenous LY2606368 was dose escalated from 10 to 50 mg/m(2) on schedule 1 (days 1 to 3 every 14 days) or from 40 to 130 mg/m(2) on schedule 2 (day 1 every 14 days). Safety measures and pharmacokinetics were assessed, and pharmacodynamics were measured in blood, hair follicles, and circulating tumor cells.

Results

Forty-five patients were treated; seven experienced dose-limiting toxicities (all hematologic). The maximum-tolerated

SUBMITTER: Hong D 

PROVIDER: S-EPMC5321045 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature