A single supratherapeutic dose of ridaforolimus does not prolong the QTc interval in patients with advanced cancer.

ABSTRACT:

Purpose

This dedicated QTc study was designed to evaluate the effect of the mammalian target of rapamycin inhibitor, ridaforolimus, on the QTc interval in patients with advanced malignancies.

Methods

We conducted a fixed-sequence, single-blind, placebo-controlled study. Patients (n = 23) received placebo on day 1 and a single 100-mg oral dose of ridaforolimus on day 2 in the fasted state. Holter electrocardiogram (ECG) monitoring was performed for 24 h after each treatment, and blood ridaforolimus concentrations were measured for 24 h after dosing. The ECGs were interpreted in a blinded fashion, and the QT interval was corrected using Fridericia's formula (QTcF). After a washout of at least 5 days, 22 patients went on to receive a therapeutic regimen of ridaforolimus (40 mg

SUBMITTER: Lush RM 

PROVIDER: S-EPMC3456920 | biostudies-literature | 2012 Oct

REPOSITORIES: biostudies-literature