A single-blind, placebo-controlled, sequential design study evaluating the potential effects of trabectedin on the QT intervals.

e13096 Background: Trabectedin (Tr) is a new class of antitumor agents with a unique mechanism of action, involving the transcription- dependent nucleotide excision repair system. Methods: Enrolled patients (n=75; pts) had locally advanced or metastatic solid tumors who received ≤3 prior lines of chemotherapy and who had relapsed or progressive disease following standard of care treatment with chemotherapy or were intolerant to such therapy. Pts were administered placebo (saline solution, PBO) and Tr (1.3 mg/m2) as 3-h IV infusions on Days (D) 1 and 2, respectively. The primary objective was to assess the potential effects of Tr on the QT/QTc interval. Serial triplicate ECG recordings and time- matched pharmacokinetic (PK) blood samples were collected over 24 hours on D 1 and 2. The QT/QTc was assessed by comparing mean QTc intervals and changes from baseline (ΔQTc), by Fredericia's and Bazett's methods. The difference in ΔQTc between Tr and PBO was calculated at each time point (ΔΔQTc). Noninferiority wa...