Trial Information

A Single-Blind, Multicenter, Placebo-Controlled, Sequential Design Study Evaluating the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram

This is a single-blind, placebo-controlled study to evaluate the potential effects of a
single-dose of tracbetedin on the heart's electrical cycle as measured by electrocardiograms
(ECGs) in patients with advanced cancer. Participation in the study will include a 21-day
screening period, plus two days of single-blinded treatment followed by an optional
open-label extension phase. During the single-blind treatment period (1 cycle) patients will
sequentially receive trabectedin for 1 day and placebo for 1 day and be monitored for safety
for up to 30 days. Only the investigator (physician conducting the study) and study staff
will know which treatment the patient receives during the single-blind phase. The open-label
phase is optional. The duration of the open-label extension will vary by patient. In this
phase, patients will receive trabectedin for as long as the investigator determines that the
patient is receiving benefit from the treatment, or until trabectedin becomes commercially
available for use, whichever is earlier. There are 2 treatment phases: Single-blind and
Open-Label. In the single-blind phase patients will receive one 3-hour intravenous (i.v.)
infusion of trabectedin (1.3 mg/m2) on one day and one 3-hour i.v. infusion of trabectedin
placebo on another day (treatments will be administered on 2 consecutive days). In the
Open-label extension phase, the dose and schedule of trabectedin may modified at the
discretion of the Investigator as appropriate depending on the type of malignancy diagnosed.