Publication
Title
Effect of trabectedin on the QT interval in patients with advanced solid tumor malignancies
Author
Abstract
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. Patients (n = 75) who had received a parts per thousand currency sign3 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 (Delta QTc) were assessed. The difference in Delta QTc between trabectedin and placebo was calculated at each time point (Delta Delta QTc). The upper limits of the 90% confidence interval for Delta Delta QTcF and Delta Delta QTcB at all time points were less than the prespecified noninferiority margin of 10 ms (a parts per thousand currency sign6.65 ms). No patient had a QTc > 500 ms or a time-matched increase from baseline in QTc > 60 ms at any time point. Regression analyses indicated Delta Delta QTc was poorly correlated with trabectedin concentration. No adverse events suggestive of proarrhythmic potential were reported. Trabectedin did not prolong the QTc interval. Safety and pharmacokinetic profiles of trabectedin were similar to that observed in other ovarian and breast cancer studies.
Language
English
Source (journal)
Cancer chemotherapy and pharmacology. - Berlin
Publication
Berlin : 2012
ISSN
0344-5704
Volume/pages
69:2(2012), p. 341-350
ISI
000299516700006
Full text (Publisher's DOI)
Full text (publisher's version - intranet only)
UAntwerpen
Faculty/Department
Research group
Publication type
Subject
Affiliation
Publications with a UAntwerp address
External links
Web of Science
Record
Identification
Creation 05.03.2012
Last edited 16.07.2017
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