Trial Information

An Open-Label, Multicenter, Pharmacokinetic Study of Trabectedin in Subjects With Advanced Malignancies and Hepatic Dysfunction

This is an open-label (patients will know the names of study drugs they receive),
single-dose, study that will examine the pharmacokinetics (blood levels) and assess survival
and safety of trabectedin in patients with advanced malignancies who either have hepatic
(liver) dysfunction or do not have hepatic dsyfunction (patients enrolled without hepatic
dysfunction will be referred to as the control group). Trabectedin is a drug being developed
to treat patients with cancer that will be administered intravenously (i.v.) through a
catheter (tube) into a central vein. In addition, dexamethasone, a drug used to prevent
nausea and vomiting in chemotherapy patients that may have protective effects on the liver,
will be administered to patients before the administration of trabectedin. Patients who
complete the treatment phase of the study who in the opinion of the investigator would
derive an overall clinical benefit from further treatment with trabectedin will have the
opportunity to continue treatment with trabectedin in the optional extension phase. The dose
and schedule of trabectedin may be modified by the treating physician in the optional
extension phase to be more appropriate for the type of malignancy being treated. A single
dose of trabectedin (1.3 mg/m2 in patients in the control group and 0.58 mg/m2 in patients
with hepatic dysfunction) will be administered by i.v.infusion over a 3-hour period. The
dose of trabectedin may be adjusted if necessary for patients with hepatic dysfunction
subsequently enrolled in the study. All patients will be administered dexamethasone 20 mg
i.v. (or equivalent) approximately 30 minutes before the administration of trabectedin.