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 — DRUGVB-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 — DRUGBevacizumab 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 1VB-111 + Bevacizumab
- Active Comparator: Arm 2Bevacizumab
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)
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University of Alabama· Birmingham, ALHighlands Oncology Group· Rogers, AZUniversity of California Irvine Medical Center· Irvine, CAUniversity of California Los Angeles· Los Angeles, CAThe Center for Cancer Prevention and Treatment· Orangevale, CAKaiser Permanente - Redwood City Medical Center· Redwood City, CA
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