A Pharmacokinetic Study of Trabectedin in Patients With Advanced Malignancies and Hepatic Dysfunction

Phase 1 Completed 15 enrolled Janssen Research & Development, LLC PharmaMar · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to characterize the pharmacokinetics (blood levels) of trabectedin after administration to patients with advanced malignancies and hepatic (liver) dysfunction.

Timeline

Start: 2010-12
Primary completion: 2014-04
Completion: 2014-04

Publications

Calvo E, Azaro A, Rodon J, Dirix L, Huizing M, Senecal FM, LoRusso P, Yee L, Poggesi I, de Jong J, Triantos S, Park YC, Knoblauch RE, Parekh TV, Demetri GD, von Mehren M. Hepatic safety analysis of trabectedin: results of a pharmacokinetic study with trabectedin in patients with hepatic impairment and experience from a phase 3 clinical trial. Invest New Drugs. 2018 Jun;36(3):476-486. doi: 10.1007/s10637-017-0546-9. Epub 2017 Nov 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trabectedin	Small molecule	0.58 mg/m2	Intravenous
Subject	Trabectedin	Small molecule	1.3 mg/m2	Intravenous
Background	Dexamethasone	Small molecule	20 mg/m2	Intravenous

A Pharmacokinetic Study of Trabectedin in Patients With Advanced Malignancies and Hepatic Dysfunction

Summary

Timeline

Publications

Drugs

Indications