Clinical Trial Details
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NCT01632228 : A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab Compared to Bevacizumab Alone or Onartuzumab Monotherapy in Patients With Recurrent Glioblastoma
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- 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

- 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

- 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

- Availability of formalin fixed paraffin embedded tumor tissue representative of

Exclusion Criteria:

- Pregnant or lactating women

- Inadequate hematologic, renal or liver function

- History or presence of serious cardio-vascular disease

- New York Heart Association Grade II or greater congestive heart failure

- History of another malignancy in the previous 3 years, except for in situ cancer or
basal or squamous cell skin cancer

- Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg
and/or diastolic blood pressure >100 mmHg while on antihypertensive medication)

- Prior history of hypertensive crisis or hypertensive encephalopathy

- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or
recent peripheral arterial thrombosis) within 6 months prior to randomization

- Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic

- Known hypersensitivity to any excipients of onartuzumab or bevacizumab
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