A Phase 3, Pivotal Trial of VB-111 Plus Bevacizumab vs. Bevacizumab in Patients With Recurrent Glioblastoma (GLOBE)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Vascular Biogenics Ltd. operating as VBL Therapeutics
Study ID
NCT02511405
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • VB-111 + bevacizumab — DRUG
    VB-111 will be administered intravenously at a dose of 1x10e13 VPs every 2 months Bevacizumab will be administered intravenously at a dose of 10mg/kg every 2 weeks
  • Bevacizumab — DRUG
    Bevacizumab will be administered intravenously at a dose of 10mg/kg every 2 weeks

Study Details

The purpose of this pivotal, phase 3, randomized, multicenter study is to compare VB-111 plus bevacizumab to bevacizumab in adult patients with recurrent Glioblastoma.

Key Dates

First listed
Jul 30, 2015
Start date
Aug 31, 2015
Status verified
Jan 2017
Primary completion
Nov 3, 2017
Completion
Sep 30, 2018

Study Design

Enrollment
252 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    VB-111 + Bevacizumab
  • Active Comparator: Arm 2
    Bevacizumab

Primary Outcome Measure

Overall survival [ Time Frame: From date of study entry until the date of death from any cause (up to 10 years) ]

Locations (48)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama--
Highlands Oncology GroupRogersArizona--
University of California Irvine Medical CenterIrvineCalifornia--
University of California Los AngelesLos AngelesCalifornia--
The Center for Cancer Prevention and TreatmentOrangevaleCalifornia--
Kaiser Permanente - Redwood City Medical CenterRedwood CityCalifornia--
University of CaliforniaSan DiegoCalifornia--
University of California San FranciscoSan FranciscoCalifornia--
Stanford UniversityStanfordCalifornia--
Colorado Neurological InstituteDenverColorado--
The George Washington University Medical Faculty AssociatesWashington D.C.District of Columbia--
University of Florida Preston A. Wells, Jr. Center for Brain Tumor TherapyGainesvilleFlorida--
Orlando HealthOrlandoFlorida--
Piedmont Physicians Neuro-OncologyAtlantaGeorgia--
Northwestern UniversityChicagoIllinois--
The University of ChicagoChicagoIllinois--
University of Kansas Medical CenterKansas CityKansas--
University of KentuckyLexingtonKentucky--
University of LouisvilleLouisvilleKentucky40202-
Louisiana State University Health Science CenterShreveportLouisiana--
Beth Israel Deaconess Medical CenterBostonMassachusetts--
Dana Farber Cancer InstituteBostonMassachusetts--
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan--
Henry Ford Health SystemDetroitMichigan--
Metro-MN Community Oncology Research ConsortiumMinneapolisMinnesota55416-
Washington University School of MedicineSt LouisMissouri63110-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire--
Dent Neurosciences Research CenterAmherstNew York--
North Shore University HospitalLake SuccessNew York--
Columbia University Medical CenterNew YorkNew York--
Derald H. Ruttenberg Treatment CenterNew YorkNew York--
University of Rochester Medical CenterRochesterNew York--
Stony Brook University, Neurology Associates of Stony BrookStony BrookNew York--
SUNY Upstate Medical UniversitySyracuseNew York--
University of North Carolina at Chapel HillChapel HillNorth Carolina--
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina--
Penn State Milton S Hershey Medical CenterHersheyPennsylvania--
University of Pittsburgh Medical CenterPittsburghPennsylvania--
Texas Oncology-Austin MidtownAustinTexas78705-
Baylor Health Neuro-Oncology AssociatesDallasTexas--
University of Texas Southwestern Medical CenterDallasTexas--
: University of Texas, HSCHoustonTexas--
MD AndersonHoustonTexas--
UTHSCSASan AntonioTexas--
Huntsman Cancer Institute at The University of UtahSalt Lake CityUtah--
University of VirginiaCharlottesvilleVirginia--
Swedish Medical CenterSeattleWashington--
University of WisconsinMadisonWisconsin--

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