MGI initiates Phase I irofulven/Gemzar trial

MGI Pharma has announced the initiation of a dose-escalating Phase Iclinical trial of its novel anticancer compound irofulven in combination with Eli Lilly's Gemzar (gemcitabine hydrochloride) for the treatment of advanced cancers.

The trial, which is designed to evaluate the maximum tolerated dose, safety, antitumor activity and pharmacokinetics of a combination of the two drugs, will utilize two-weekly dosing schedule for irofulven, which has demonstrated greatly improved tolerability and comparable or greater dose intensity, compared to other regimens.

Preclinical studies demonstrated that irofulven caused a synergistic effect against tumor cells when combined with certain approved drugs, including Gemzar, and is currently in a Phase I trial in combination with Aventis' Camptosar (CPT-11) in non-small cell lung cancer. Irofulven has also demonstrated antitumor activity as a single agent in pancreatic, ovarian and prostate cancers, and is now in a Phase III trial for the treatment of advanced-stage, gemcitabine-refractory cancer. Side effects of the drug when administered as a single agent are comparable to other chemotherapies, and include bone marrow suppression, nausea, vomiting and fatigue.