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

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ClinicalTrials.gov Identifier: NCT02511405
Recruitment Status : Completed
First Posted : July 30, 2015
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: VB-111 + bevacizumab Drug: Bevacizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2015
Actual Primary Completion Date : November 3, 2017
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
VB-111 + Bevacizumab
 Drug: VB-111 + bevacizumab

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
Active Comparator: Arm 2
Bevacizumab
 Drug: Bevacizumab
Bevacizumab will be administered intravenously at a dose of 10mg/kg every 2 weeks


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

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: To be assessed from date of randomization until the date of disease progression, assessed up to 10 years. ]
  2. Tumor response as measured by RANO Criteria [ Time Frame: To be assessed from date of randomization until the date of disease progression, assessed up to 10 years. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02511405


Locations
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Sponsors and Collaborators
Vascular Biogenics Ltd. operating as VBL Therapeutics
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier: NCT02511405    
Other Study ID Numbers: VB-111-215
First Posted: July 30, 2015    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: January 2017
Keywords provided by Vascular Biogenics Ltd. operating as VBL Therapeutics:
rGBM
Recurrent Glioblastoma
Recurrent GBM
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms, Nerve Tissue
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors