drugset / Trial / NCT01632228

A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab Compared to Bevacizumab Alone or Onartuzumab Monotherapy in Participants With Recurrent Glioblastoma

NCT01632228

Phase 2 Completed 135 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

This randomized, double-blind, placebo-controlled, multicenter phase II study will evaluate the safety and efficacy of onartuzumab in combination with bevacizumab as compared to bevacizumab alone in participants with recurrent glioblastoma. Participants will be randomized 1:1 to receive either placebo plus bevacizumab every 3 weeks, or onartuzumab plus bevacizumab. Study treatment will continue until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.

Timeline

Start
2012-06-29
Primary completion
2016-01-21
Completion
2016-01-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Onartuzumab Monoclonal antibody 15 mg/kg Intravenous
Background Bevacizumab Monoclonal antibody 15 mg/kg Intravenous

Indications