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

NCT01260506 | Completed Phase 1 DMC

• 1 other identifier: VB-111-122
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Glioblastoma Multiforme

Keywords

Relapsed Glioblastoma Multiforme, GBM

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  From date of study entry until the date of death from any cause (up to 10 years)

Secondary Outcomes (1)

• Progression Free Survival

  6 months

Study Arms (1)

VB-111

EXPERIMENTAL

Antiangiogenic and vascular disruptive agent

Drug: VB-111; Drug: Bevacizumab

Interventions

VB-111 DRUG

VB-111

Bevacizumab DRUG

Upon progression, subjects will receive a combination therapy of VB-111 and standard of care bevacizumab

VB-111

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• Vascular Biogenics Ltd. operating as VBL Therapeutics: lead

Study Sites (4)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Location

Duke University Medical Center

Durham, North Carolina, United States

Location

Uthsc- Ctrc

San Antonio, Texas, United States

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 15, 2010
• Study Start: December 1, 2010
• Primary Completion: July 23, 2015
• Study Completion: December 20, 2018
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

US (3); IL (1)