drugset / Trial / NCT00363636
A Study of Galiximab + Rituximab Versus Rituximab + Placebo in Follicular Non-Hodgkin's Lymphoma (NHL)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | galiximab | Monoclonal antibody | 500 mg/m2 | Intravenous |