Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme

VBL Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Glioblastoma Multiforme

Treatments: Drug: Bevacizumab; Drug: VB-111

Study type: Interventional

Funder types: Industry

Identifiers

NCT01260506

VB-111-122

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in patients with Relapsed Glioblastoma Multiforme.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

VB-111

Experimental group

Description:

Antiangiogenic and vascular disruptive agent

Treatment:

Drug: VB-111

Drug: Bevacizumab