Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme
Completed · Phase 1/Phase 2
Conditions studied: Glioblastoma Multiforme
In brief
The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in patients with Relapsed Glioblastoma Multiforme.
Key facts
- Study ID
- NCT01260506
- Run by
- Vascular Biogenics Ltd. operating as VBL Therapeutics
- People needed
- 75
- Starts
- 2010-12-01
- Expected to finish
- 2018-12-20
- Last updated by the study team
- 2020-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%
You may not qualify if…
- 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;
Where it is running
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Uthsc- Ctrc — San Antonio, Texas, United States
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
Full record on ClinicalTrials.gov
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