A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study Evaluating the Efficacy and Safety of Onartuzumab (MetMAb) in Combination With Bevacizumab or Onartuzumab Monotherapy in Patients With Recurrent Glioblastoma
This randomized, double-blind, placebo-controlled, multicenter phase II study will evaluate the safety and efficacy of onartuzumab (MetMAb) in combination with bevacizumab as compared to bevacizumab alone and of onartuzumab as monotherapy in patients with recurrent glioblastoma. Patients will be randomized 1:1:1 to receive either placebo plus bevacizumab every 3 weeks, or onartuzumab plus bevacizumab, or onartuzumab plus placebo. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : onartuzumab
- drug : bevacizumab placebo
- drug : onartuzumab placebo
- drug : bevacizumab
Phase: Phase 2
Ages Eligible For Study:
- Adult patients, >/= 18 years of age - Histologically confirmed glioblastoma at first recurrence after concurrent or adjuvant chemoradiotherapy - Imaging confirmation of first tumor progression or regrowth as defined by RANO criteria - Prior treatment with temozolomide - No more than one prior chemotherapy - No prior treatment with bevacizumab or other VEGF- or VEGF-receptor-targeted agent - No prior exposure to experimental treatment targeting either HGF or Met pathway - No prior treatment with prolifeprospan 20 with carmustine wafer - No prior intracerebral agent - Recovery from the toxic effects of prior therapy - No evidence of recent haemorrhage on baseline MRI of the brain - No need for urgent palliative intervention for primary disease (e.g. impending herniation) - Karnofsky performance status >/= 70% - Stable or decreasing dose of corticosteroids within 5 days prior to randomization - Prior therapy with gamma knife or other focal high-dose radiotherapy is allowed, but the patient must have subsequent histologic documentation of recurrence, unless the recurrence is a new lesion outside the irradiated field - Patients who have undergone recent surgery for recurrent or progressive tumor are eligible provided that: surgery must have confirmed the recurrence, a minimum of 28 days must have elapsed from the day of surgery to randomization and for core or needle biopsy, a minimum of 7 days must have elapsed prior to randomization, and craniotomy or intracranial biopsy site must be adequately healed and free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of randomization - Availability of formalin fixed paraffin embedded tumor tissue representative of glioblastoma