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



Status:Completed
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/25/2018
Start Date:August 2015
End Date:September 30, 2018

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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

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.


Inclusion Criteria:

1. First or second progression of Glioblastoma;

2. Measurable disease by RANO criteria at progression;

3. Patients ≥18 years of age;

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

5. Surgery completed at least 28 days before randomization;

6. 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;

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

8. 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.

Exclusion Criteria:

1. Prior anti-angiogenic therapy including VEGF sequestering agents (i.e. bevacizumab,
aflibercept, etc.) or VEGFR inhibitors (cedirinib, pazopanib, sunitinib, sorafenib,
etc.);

2. Prior stereotactic radiotherapy;

3. Pregnant or breastfeeding patients;

4. Concomitant medication that may interfere with study results; e.g. immunosuppressive
agents other than corticosteroids;

5. Active infection;

6. Evidence of significant CNS haemorrhage i.e. CTCAE grade 2 or above;

7. Expected to have surgery during study period;

8. Patients with active vascular disease, either myocardial or peripheral (i.e. acute
coronary syndrome, cerebral stroke, transient ischemic attack or arterial thrombosis
or symptomatic peripheral vascular disease within the past 3 months);

9. Patients with known proliferative and/or vascular retinopathy;

10. Patients with known liver disease (alcoholic, drug/toxin induced, genetic, or
autoimmune);

11. Patients with known active second malignancy other than non-melanoma skin cancers,
non-metastatic prostate cancer, in situ cervical cancer, and ductal or lobular
carcinoma in situ of the breast. Patients are not considered to have a currently
active malignancy if they have completed anticancer therapy and have been disease free
for greater than 2 years prior to screening;

12. Patients testing positive to one of the following viruses: HIV, HBV and HCV within the
last 6 months;

13. Patients that have undergone major surgery within the last 4 weeks before enrollment;

14. Patients who have received treatment with any other investigational agent within 4
weeks before enrollment.
We found this trial at
49
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Patrick Wen, MD
Phone: 617-667-1832
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Frances Collichio, MD
Phone: 919-966-4432
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Rimas Lukas, MD
Phone: 773-702-7716
University of Chicago One of the world's premier academic and research institutions, the University of...
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Timothy Cloughesy, MD
Phone: 310-794-3521
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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24 Sturtevant St
Orlando, Florida 32806
Principal Investigator: Nicholas G Avgeropoulos, MD
Phone: 321-843-2546
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Nimish Mohile, MD
Phone: 585-276-3971
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Amherst, New York
Principal Investigator: Laszlo Mechtler, MD
Phone: 716-558-5670
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: Aaron Mammoser, MD
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Atlanta, Georgia
Principal Investigator: Erin Dunbar, MD
Phone: 404-425-7927
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Austin, Texas 78705
Principal Investigator: Morris D Groves, MD
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Birmingham, Alabama 35294
Principal Investigator: X. Stan Han, MD
Phone: 205-934-1432
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Patrick Wen, MD
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Calgary, Alberta
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: David Schiff, MD
Phone: 434-924-5859
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Priya Kumthekar, MD
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Dallas, Texas
Principal Investigator: Karen Fink, MD
Phone: 214-818-8382
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Edward Pan, MD
Phone: 214-648-5874
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Denver, Colorado
Principal Investigator: Michael Pearlman, MD
Phone: 303-806-7423
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Detroit, Michigan 48202
Principal Investigator: Tobias Walbert, MD
Phone: 313-916-3731
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Principal Investigator: Michael Glantz, MD
Phone: 717-531-0003
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Houston, Texas 77030
Principal Investigator: John de Groot, MD
Phone: 713-745-5769
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Houston, Texas 77030
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Irvine, California 92697
Principal Investigator: Jose Carrillo, MD
Phone: 714-456-8442
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Michael Salacz, MD
Phone: 913-945-7552
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Lake Success, New York 11042
Principal Investigator: Michael Schulder, MD
Phone: 516-470-6901
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Lara Ronan, MD
Phone: 603-653-0590
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lexington, Kentucky
859) 257-9000
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Eric Burton, MD
Phone: 502-562-3429
University of Louisville The University of Louisville is a state supported research university located in...
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: H Ian Robins, MD
Phone: 1-800-622-8922
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Minneapolis, Minnesota 55416
Principal Investigator: Richard Peterson, MD
Phone: 952-993-1555
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Teri Kreisl, MD
Phone: 212-342-0571
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, New York
Principal Investigator: Adilia Hormigo, MD
Phone: 212-241-9843
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Orangevale, California
Principal Investigator: Lars Anker, MD
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Jan Drappatz, MD
Phone: 412-647-8569
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Redwood City, California 94063
Principal Investigator: Scott Peak, MD
Phone: 650-299-2290
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Rogers, Arizona
Principal Investigator: Joseph Beck, MD
Phone: 479-878-7024
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Principal Investigator: Randy Jensen, MD
Phone: 801-587-4024
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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San Antonio, Texas 78229
Principal Investigator: Andrew Brenner, MD
Phone: 210-450-5798
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San Diego, California 92103
Principal Investigator: David Piccioni, MD
Phone: 858-822-5377
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San Francisco, California 94143
Principal Investigator: Nicholas Butowski, MD
Phone: 415-514-5521
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Tara Benkers, MD
Phone: 206-386-3878
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Shreveport, Louisiana 71130
Principal Investigator: Gary Burton, MD
Phone: 318-813-1403
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Seema Nagpal, MD
Phone: 650-723-6095
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Stony Brook, New York
Principal Investigator: Agnieszka Kowalska, mD
Phone: 631-444-2599
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750 East Adams Street
Syracuse, New York 13210
Principal Investigator: Mijung Lee, MD
Phone: 315-464-5476
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Washington, District of Columbia 20037
Principal Investigator: Jonathan Sherman, MD
Phone: 202-741-2602
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Winston-Salem, North Carolina 27157
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