Status:
COMPLETED
Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme
Lead Sponsor:
Vascular Biogenics Ltd. operating as VBL Therapeutics
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in patients with Relapsed Glioblastoma Multiforme.
Eligibility Criteria
Inclusion
- Subjects must have a histologically confirmed diagnosis of glioblastoma multiforme or gliosarcoma;
- Measurable disease by RANO criteria;
- Disease progression or recurrence following standard of care treatment with temozolomide and radiation;
- An interval of at least 4 weeks between prior surgical resection and study enrollment;
- An interval of at least 12 weeks between prior radiotherapy or at least 4 weeks from prior chemotherapy, and enrollment in this protocol;
- Recovered to Grade 1 or less from the toxic effects of any earlier intervention;
- Karnofsky performance status \> 60%
Exclusion
- Prior anti-angiogenic therapy including VEGF sequestering agents (ie bevacizumab, aflibercept, etc) or VEGFR inhibitors (cediranib, pazopanib, sunitinib, sorafenib, etc);
- Prior stereotactic radiotherapy;
- Active infection;
- Evidence of CNS haemorrhage CTCAE grade 2 or above on baseline MRI;
- Subjects who suffered from an acute cardiac event within the last 12 months;
- Subjects with active vascular disease, either myocardial or peripheral;
- Subjects with proliferative and/or vascular retinopathy;
- Subjects with known active second malignancy;
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2018
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01260506
Start Date
December 1 2010
End Date
December 20 2018
Last Update
April 24 2020
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States
2
Duke University Medical Center
Durham, North Carolina, United States
3
Uthsc- Ctrc
San Antonio, Texas, United States
4
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239