FDAnews
www.fdanews.com/articles/69074-human-genome-sciences-completes-patient-enrollment-in-hgs-etr1-trial

Human Genome Sciences Completes Patient Enrollment in HGS-ETR1 Trial

February 23, 2005

Human Genome Sciences has completed the enrollment and initial dosing of patients in a Phase II clinical trial of HGS-ETR1 in patients with advanced colorectal cancer.

The Phase II clinical trial is an open-label study to evaluate the efficacy, safety and tolerability of HGS-ETR1 (mapatumumab) in patients with relapsed or refractory colorectal cancer. The Phase II study is being conducted in Germany. Patients enrolled in the trial are receiving up to six cycles of treatment in the absence of disease progression, with HGS-ETR1 administered as an intravenous infusion once every 14 days.

The primary objective of the study is to evaluate tumor response. The secondary objectives are to evaluate the safety and tolerability of HGS-ETR1, to determine plasma concentrations of HGS-ETR1 for use in a population pharmacokinetic analysis, and to evaluate other indicators of disease activity, including time to response, duration of response, and progression-free survival.