A Phase 3, Randomized, Controlled, Double-Arm, Open-Label, Multi-center Study of VB-111 Combined With Bevacizumab vs. Bevacizumab Monotherapy in Patients With Recurrent Glioblastoma

Status: Completed
Location: See all (57) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• First or second progression of Glioblastoma;

• Measurable disease by RANO criteria at progression;

• Patients ≥18 years of age;

• Patient may have been operated for recurrence. If operated: residual and measurable disease after surgery is required;

• Surgery completed at least 28 days before randomization;

• An interval of at least 12 weeks between prior radiotherapy or at least 23 days from prior chemotherapy, 42 days from nitrosoureas and enrollment in this study;

• Adequate performance, i.e.Karnofsky Performance Score of at least 70%;

• Adequate renal, liver, and bone marrow function according to the following criteria:

• Absolute neutrophil count ≥1500 cells/ml,

• Platelets ≥ 100,000 cells/ml,

• Total bilirubin within upper limit of normal (ULN),

• Aspartate aminotransferase (AST) ≤ 2.0 X ULN,

• Serum creatinine level ≤ ULN or creatinine clearance ≥ 50 ml/min for patients with creatinine levels above normal limits (creatinine clearance calculated by the Cockcroft-Gault formula, see Appendix II),

• PT, PTT (in seconds) not to be prolonged beyond >20% of the upper limits of normal.

Locations
United States
Alabama
University of Alabama
Birmingham
Arizona
Highlands Oncology Group
Rogers
California
University of California Irvine Medical Center
Irvine
University of California Los Angeles
Los Angeles
The Center for Cancer Prevention and Treatment
Orangevale
Kaiser Permanente - Redwood City Medical Center
Redwood City
University of California
San Diego
University of California San Francisco
San Francisco
Stanford University
Stanford
Colorado
Colorado Neurological Institute
Denver
Washington, D.c.
The George Washington University Medical Faculty Associates
Washington
Florida
University of Florida Preston A. Wells, Jr. Center for Brain Tumor Therapy
Gainesville
Orlando Health
Orlando
Georgia
Piedmont Physicians Neuro-Oncology
Atlanta
Illinois
Northwestern University
Chicago
The University of Chicago
Chicago
Kansas
University of Kansas Medical Center
Kansas City
Kentucky
University of Kentucky
Lexington
University of Louisville
Louisville
Louisiana
Louisiana State University Health Science Center
Shreveport
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Dana Farber Cancer Institute
Boston
Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor
Henry Ford Health System
Detroit
Minnesota
Metro-MN Community Oncology Research Consortium
Minneapolis
Missouri
Washington University School of Medicine
Saint Louis
North Carolina
University of North Carolina at Chapel Hill
Chapel Hill
Wake Forest Baptist Medical Center
Winston-salem
New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon
New York
Dent Neurosciences Research Center
Amherst
North Shore University Hospital
Lake Success
Columbia University Medical Center
New York
Derald H. Ruttenberg Treatment Center
New York
University of Rochester Medical Center
Rochester
Stony Brook University, Neurology Associates of Stony Brook
Stony Brook
SUNY Upstate Medical University
Syracuse
Pennsylvania
Penn State Milton S Hershey Medical Center
Hershey
University of Pittsburgh Medical Center
Pittsburgh
Texas
Texas Oncology-Austin Midtown
Austin
Baylor Health Neuro-Oncology Associates
Dallas
University of Texas Southwestern Medical Center
Dallas
: University of Texas, HSC
Houston
MD Anderson
Houston
UTHSCSA
San Antonio
Utah
Huntsman Cancer Institute at The University of Utah
Salt Lake City
Virginia
University of Virginia
Charlottesville
Washington
Swedish Medical Center
Seattle
Wisconsin
University of Wisconsin
Madison
Other Locations
Canada
Tom Baker Cancer Centre
Calgary
London Health Sciences Centre
London
Ottawa Hospital
Ottawa
Sunnybrook Health Science Centre
Toronto
Israel
Rambam Medical Center
Haifa
Hadassah Medical Center
Jerusalem
Rabin Medical Center
Petach Tikvah
Chaim Sheba Medical Center
Ramat Gan
Tel Aviv Sourasky Medical Center
Tel Aviv
Time Frame
Start Date: August 2015
Completion Date: September 30, 2018
Participants
Target number of participants: 252
Treatments
Experimental: Arm 1
VB-111 + Bevacizumab
Active Comparator: Arm 2
Bevacizumab
Sponsors
Leads: Vascular Biogenics Ltd. operating as VBL Therapeutics

This content was sourced from clinicaltrials.gov

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