A randomized, double-blinded, placebo-controlled, multicenter phase II study to evaluate the efficacy and safety of onartuzumab in combination with bevacizumab relative to placebo + bevacizumab in patients with glioblastoma at first recurrence.
Brain & Nervous System
Onartuzumab is a monovalent antibody that targets the Met receptor. Hepatocyte growth factor (HGF) and its receptor Met can stimulate growth, invasion, and survival in tumor cells. Inhibiting Met receptor and HGF may impact tumor cell proliferation, motility, invasion, and survival and promote tumor regression.
IRB Protocol #
Monica Robischon at 720-848-0661 or firstname.lastname@example.org
Eligibility and Other Participant Information
1.GBM at first recurrence after concurrent or adjuvant chemoradiotherapy
2.Patients with initial diagnosis of a lower-grade glioma are eligible if a subsequent biopsy was determined to be glioblastoma
3.No prior bevacizumab or other VEGF- or VEGF-receptor-targeted agent
4.No prior Gliadel wafers
5.Prior gamma knife or other focal high-dose radiotherapy is allowed if histologic documentation of recurrence or if new lesion is outside the irradiated field
6.KPS > 70