Phase II Study of MetMAb in Patients with Recurrent Glioblastoma

• Research type

  Research Study

• Full title

  A RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER PHASE II STUDY EVALUATING THE EFFICACY AND SAFETY OF ONARTUZUMAB IN COMBINATION WITH BEVACIZUMAB OR ONARTUZUMAB MONOTHERAPY IN PATIENTS WITH RECURRENT GLIOBLASTOMA

• IRAS ID

  101236

• Contact name

  Michael Brada

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2011-005912-27

• Research summary

  This is a phase II, randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of Onartuzumab in combination with bevacizumab or onartuzumab monotherapy in patients at first recurrence of glioblastoma. The study is funded by F. Hoffmann-La Roche Ltd. Onartuzumab is an experimental agent produced by Roche. Onartuzumab is a monoclonal antibody which attaches to the Met receptor and thereby blocks signals from the environment to the tumor cells. Onartuzumab has been shown to prevent or slow the growth of several different types of human cancer cells grown in animals, and has also shown to shrink some types of cancer in early human testing. Bevacizumab is also a monoclonal antibody and has been approved by the FDA for the treatment of glioblastoma whose disease progressed following an initial therapy. In this study eligible participants will be randomly assigned (1:1:1) to one of three study drug treatment arms: ?½ Arm A: Bevacizumab placebo ?½ Arm B: Onartuzumab bevacizumab ?½ Arm C: Onartuzumab placebo The study consists of a screening period, a study treatment period, and a follow up period. During the treatment period patients will receive treatment by IV infusion every 3 weeks until disease progression, unacceptable toxicity or patient or physician decision to discontinue. After study treatment patients will be contacted every 6 weeks during the follow up period. Approximately 180 patients will be enrolled in the study in Europe, the US and Canada. Approximately 20 patients will be enrolled in the UK. The total study duration, from the first patient recruited to the time of the primary analysis, is approximately 21 months: approximately 12 months of recruitment and approximately 9 months of follow-up for the last patient recruited. The study involves procedures including physical exam, vital signs, electrocardiograms, blood tests, urine tests, MRI scans and patient questionnaires.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  12/LO/0582

• Date of REC Opinion

  23 Apr 2012

• REC opinion

  Favourable Opinion