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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma

Thank you

Trial Information

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


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
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

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
anticoagulation)

- Known hypersensitivity to any excipients of onartuzumab or bevacizumab

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (investigator-assessed): onartuzumab + bevacizumab versus placebo + bevacizumab

Outcome Time Frame:

21 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

GO27819

NCT ID:

NCT01632228

Start Date:

June 2012

Completion Date:

November 2013

Related Keywords:

  • Glioblastoma
  • Glioblastoma

Name

Location

Hinsdale, Illinois  60521
Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
McLean, Virginia  22101
Denver, Colorado  
Charlotte, North Carolina