drugset / Trial / NCT00500058

A Phase I, Dose-Escalation Study to Assess the Safety and Biological Activity of Recombinant Human Interleukin-18

NCT00500058

Phase 1 Completed 24 enrolled GlaxoSmithKline
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose is to identify a dose of SB-485232 which is safe, tolerable and effective when used in combination with Rituximab in patients with non-Hodgkin's lymphoma (NHL). This study will use a standard treatment regimen of Rituximab in combination with rising doses of SB-485232. The dose selected from this study will be used in a future studies.

Timeline

Start
2007-07-31
Primary completion
2010-03-04
Completion
2010-03-04

Drugs

EvaluationDrugModalityDoseRoute
Subject IBOCTADEKIN Protein / enzyme biologic 1 ug/kg Intravenous
Subject IBOCTADEKIN Protein / enzyme biologic 100 ug/kg Intravenous
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications