High-Dose PEG-Intron Pharmacokinetic Study in Patients With Melanoma (Study P04831 AM2)

Summary

The purpose of this study is to establish the pharmacokinetics of PEG-Intron, administered at a dose of 6 μg/kg/week for 8 weeks (induction treatment), followed by a dose of 3 μg/kg/week for up to 252 weeks (maintenance treatment), in patients with high risk melanoma.

Timeline

Start

2007-02-20

Primary completion

2008-05-27

Completion

2012-07-11

Publications

• Results Daud AI, Xu C, Hwu WJ, Urbas P, Andrews S, Papadopoulos NE, Floren LC, Yver A, Deconti RC, Sondak VK. Pharmacokinetic/pharmacodynamic analysis of adjuvant pegylated interferon alpha-2b in patients with resected high-risk melanoma. Cancer Chemother Pharmacol. 2011 Mar;67(3):657-66. doi: 10.1007/s00280-010-1326-9. Epub 2010 May 28.

Drugs

Indications