A Phase 3, Pivotal Trial of VB-111 Plus Bevacizumab vs. Bevacizumab in Patients With rGBM (GLOBE)
This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2015 by Vascular Biogenics Ltd. operating as VBL Therapeutics
Sponsor:
Vascular Biogenics Ltd. operating as VBL Therapeutics
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier:
NCT02511405
First received: July 29, 2015
Last updated: NA
Last verified: July 2015
History: No changes posted
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Purpose
The purpose of this pivotal, phase 3, randomized, multicenter study is to compare VB-111 plus bevacizumab to bevacizumab in adult patients with recurrent GBM.
Condition Intervention Phase
Recurrent Glioblastoma
Drug: VB-111 + bevacizumab
Drug: Bevacizumab
Phase 3
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Resource links provided by NLM:
Drug Information available for: Bevacizumab
Genetic and Rare Diseases Information Center resources: Anaplastic Astrocytoma Glioblastoma Glioma Gliosarcoma Neuroepithelioma
U.S. FDA Resources
Further study details as provided by Vascular Biogenics Ltd. operating as VBL Therapeutics:
Primary Outcome Measures:
Overall survival [ Time Frame: From date of study entry until the date of death from any cause (up to 10 years) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Progression Free Survival [ Time Frame: To be assessed every 2 months ] [ Designated as safety issue: No ]
Tumor response as measured by RANO Criteria [ Time Frame: To be assessed every 2 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 252
Study Start Date: August 2015
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Prior anti-angiogenic therapy including VEGF sequestering agents (i.e. bevacizumab, aflibercept, etc.) or VEGFR inhibitors (cedirinib, pazopanib, sunitinib, sorafenib, etc.);
Prior stereotactic radiotherapy;
Pregnant or breastfeeding patients;
Concomitant medication that may interfere with study results; e.g. immunosuppressive agents other than corticosteroids;
Active infection;
Evidence of significant CNS haemorrhage i.e. CTCAE grade 2 or above;
Expected to have surgery during study period;
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);
Patients with known proliferative and/or vascular retinopathy;
Patients with known liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune);
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;
Patients testing positive to one of the following viruses: HIV, HBV and HCV within the last 6 months;
Patients that have undergone major surgery within the last 4 weeks before enrollment;
Patients who have received treatment with any other investigational agent within 4 weeks before enrollment.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
No Contacts or Locations Provided
More Information
Additional Information:
GLOBE Study Website This link exits the ClinicalTrials.gov site
VBL Therapeutics Company Website This link exits the ClinicalTrials.gov site
No publications provided
Responsible Party: Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier: NCT02511405 History of Changes
Other Study ID Numbers: VB-111-215
Study First Received: July 29, 2015
Last Updated: July 29, 2015
Health Authority: United States: Food and Drug Administration
Keywords provided by Vascular Biogenics Ltd. operating as VBL Therapeutics:
rGBM
Recurrent GBM
Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
