A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab Compared to Bevacizumab Alone or Onartuzumab Monotherapy in Participants With Recurrent Glioblastoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT01632228
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Participants will receive bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion every 3 weeks until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.
  • Onartuzumab — DRUG
    Participants will receive onartuzumab 15 mg/kg IV infusion every 3 weeks until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.
  • Placebo — DRUG
    Participants will receive placebo matched with onartuzumab until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.

Study Details

This randomized, double-blind, placebo-controlled, multicenter phase II study will evaluate the safety and efficacy of onartuzumab in combination with bevacizumab as compared to bevacizumab alone in participants with recurrent glioblastoma. Participants will be randomized 1:1 to receive either placebo plus bevacizumab every 3 weeks, or onartuzumab plus bevacizumab. Study treatment will continue until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.

Key Dates

First listed
Jul 2, 2012
Start date
Jun 29, 2012
Status verified
Feb 2018
Primary completion
Jan 21, 2016
Completion
Jan 21, 2016

Study Design

Enrollment
135 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Onartuzumab + Bevacizumab
    All participants will receive onartuzumab intravenous (IV) infusion followed by bevacizumab IV infusion every 3 weeks.
  • Active Comparator: Placebo + Bevacizumab
    All participants will receive placebo matched with onartuzumab followed by bevacizumab IV infusion every 3 weeks.

Primary Outcome Measure

Progression-free survival (PFS) as Assessed by Investigator According to Response Assessment in Neuro-Oncology (RANO) Criteria [ Time Frame: Baseline until disease progression, intolerable toxicity, participant or physician decision, or death, whichever occurs first (assessed every 6 weeks up to 18 months) ]

Locations (19)

FacilityCityStateZIPSite coordinators
University of Alabama At Birmingham; Neuro-OncologyBirminghamAlabama35294-
Cedars Sinai Medical Center; NeurosurgeryLos AngelesCalifornia90048-
UCLALos AngelesCalifornia90095-
USCF - NeurosurgerySan FranciscoCalifornia94143-
Stanford Comprehensive Cancer CenterStanfordCalifornia94305-
University of ColoradoAuroraColorado80045-
Florida Cancer Specialists - EnglewoodEnglewoodFlorida34223-
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)St. PetersburgFlorida33705-
Moffitt Cancer CenterTampaFlorida33647-
North Western Univ; NeurologyChicagoIllinois60611-
Northshore University Health System; CardiologyEvanstonIllinois60201-
Henry Ford Health SystemDetroitMichigan48202-
Duke University Medical CenterDurhamNorth Carolina27710-
Hatton Research InstitutesCincinnatiOhio45220-
Sarah Cannon Cancer Center - Tennessee Oncology, PllcNashvilleTennessee37203-
Baylor Research Inst.DallasTexas75246-
University of VirginaCharlottesvilleVirginia22908-
Virginia Cancer InstituteRichmondVirginia23226-
Seattle Cancer Care Alliance; Investigational Drug ServiceSeattleWashington98101-

Find similar trials in Birmingham, AL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Alabama At Birmingham; Neuro-Oncology· Birmingham, ALCedars Sinai Medical Center; Neurosurgery· Los Angeles, CAUCLA· Los Angeles, CAUSCF - Neurosurgery· San Francisco, CAStanford Comprehensive Cancer Center· Stanford, CAUniversity of Colorado· Aurora, CO

Related Studies