Glioblastoma Multiforme
Conditions
Keywords
Relapsed Glioblastoma Multiforme, GBM
Brief summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in patients with Relapsed Glioblastoma Multiforme.
Interventions
DRUGVB-111
DRUGBevacizumab
Upon progression, subjects will receive a combination therapy of VB-111 and standard of care bevacizumab
Sponsors
Vascular Biogenics Ltd. operating as VBL Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must have a histologically confirmed diagnosis of glioblastoma multiforme or gliosarcoma; 2. Measurable disease by RANO criteria; 3. Disease progression or recurrence following standard of care treatment with temozolomide and radiation; 4. An interval of at least 4 weeks between prior surgical resection and study enrollment; 5. An interval of at least 12 weeks between prior radiotherapy or at least 4 weeks from prior chemotherapy, and enrollment in this protocol; 6. Recovered to Grade 1 or less from the toxic effects of any earlier intervention; 7. Karnofsky performance status \> 60%
Exclusion criteria
1. Prior anti-angiogenic therapy including VEGF sequestering agents (ie bevacizumab, aflibercept, etc) or VEGFR inhibitors (cediranib, pazopanib, sunitinib, sorafenib, etc); 2. Prior stereotactic radiotherapy; 3. Active infection; 4. Evidence of CNS haemorrhage CTCAE grade 2 or above on baseline MRI; 5. Subjects who suffered from an acute cardiac event within the last 12 months; 6. Subjects with active vascular disease, either myocardial or peripheral; 7. Subjects with proliferative and/or vascular retinopathy; 8. Subjects with known active second malignancy;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | From date of study entry until the date of death from any cause (up to 10 years) |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival | 6 months |
Countries
Israel, United States
Outcome results
None listed