A Study to Assess the Potential Effects of Ketoconazole on the Pharmacokinetics of Trabectedin in Patients With Advanced Malignancies

Phase 1/2 Completed 12 enrolled Janssen Research & Development, LLC PharmaMar · collab

RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to evaluate the potential effects of ketoconazole on blood levels of trabectedin after administration to patients with advanced malignancies.

Timeline

Start: 2011-02
Primary completion: 2012-11
Completion: 2012-11

Publications

Machiels JP, Staddon A, Herremans C, Keung C, Bernard A, Phelps C, Khokhar NZ, Knoblauch R, Parekh TV, Dirix L, Sharma S. Impact of cytochrome P450 3A4 inducer and inhibitor on the pharmacokinetics of trabectedin in patients with advanced malignancies: open-label, multicenter studies. Cancer Chemother Pharmacol. 2014 Oct;74(4):729-37. doi: 10.1007/s00280-014-2554-1. Epub 2014 Aug 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketoconazole	Small molecule	200 mg	Oral
Subject	Trabectedin	Small molecule	0.2 mg/m2	Intravenous
Subject	Trabectedin	Small molecule	1.3 mg/m2	Intravenous
Background	Dexamethasone	Small molecule	20 mg	Intravenous

A Study to Assess the Potential Effects of Ketoconazole on the Pharmacokinetics of Trabectedin in Patients With Advanced Malignancies

Summary

Timeline

Publications

Drugs

Indications