Overview

This trial is active, not recruiting.

Condition glioblastoma multiforme
Treatments vb-111, bevacizumab
Phase phase 1/phase 2
Target VEGF
Sponsor Vascular Biogenics Ltd. operating as VBL Therapeutics
Start date December 2010
End date December 2015
Trial size 75 participants
Trial identifier NCT01260506, VB-111-122

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Antiangiogenic and vascular disruptive agent
vb-111
bevacizumab
Upon progression, subjects will receive a combination therapy of VB-111 and standard of care bevacizumab

Primary Outcomes

Measure
Overall Survival
time frame: From date of study entry until the date of death from any cause (up to 10 years)

Secondary Outcomes

Measure
Progression Free Survival
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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 information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Vascular Biogenics Ltd. operating as VBL Therapeutics.
Location data was received from the National Cancer Institute and was last updated in July 2016.