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.

Objective

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.

 

Brief Eligibility:

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

IRB Protocol Number

12-1297

All Other Trials

• Brain & Nervous System

Cancer Trials

• Brain and Nervous System Tumors
• All Cancers

Contact

MONICA ROBISCHON at 720-848-0661
or MONICA.ROBISCHON@ucdenver.edu

Eligibility and Other Participant Information

Brief Eligibility:

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