Effect of trabectedin on the QT interval in patients with advanced solid tumor malignancies.

ABSTRACT:

Purpose

The primary objective of this study was to access the potential effects of trabectedin on the QT/QTc interval in patients with locally advanced or metastatic solid tumors.

Methods

Patients (n = 75) who had received ≤3 previous lines of chemotherapy and had either relapsed or had progressive disease were enrolled. Patients were administered 3-h intravenous infusions of placebo (saline) on day 1 and trabectedin (1.3 mg/m(2)) on day 2. Time-matched serial triplicate ECG recordings and pharmacokinetic blood samples were collected over 24 h on both days. Heart rate corrected mean QT intervals and changes from predose baseline in QTc (ΔQTc) were assessed. The difference in ΔQTc between trabectedin and placebo was calculated at each time point (ΔΔQTc).

Results

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SUBMITTER: Thertulien R 

PROVIDER: S-EPMC3265736 | biostudies-literature | 2012 Feb

REPOSITORIES: biostudies-literature