drugset / Trial / NCT00363636

A Study of Galiximab + Rituximab Versus Rituximab + Placebo in Follicular Non-Hodgkin's Lymphoma (NHL)

NCT00363636 ↗

Phase 3 Terminated 340 enrolled Biogen
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a Phase III, multicenter, global, clinical study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with follicular NHL. The purpose of the study is to compare the clinical benefit of galiximab when given in combination with rituximab as compared with rituximab alone (given with placebo) in subjects with follicular NHL. Safety and pharmacokinetics (PK) of galiximab and rituximab will also be evaluated.

Timeline

Start
2006-09
Primary completion
2010-01
Completion
2010-04

Outcome

Outcome not reported

Stopped (Enrollment): “Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject galiximab Monoclonal antibody 500 mg/m2 Intravenous

Indications