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

Phase 1

Completed

• Conditions: Glioblastoma Multiforme
• Interventions: Drug: VB-111; Drug: Bevacizumab

• Registration Number: NCT01260506
• Lead Sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-14
• Study First Posted: 2010-12-15
• Primary Completion: 2015-07-23
• Study Completion: 2018-12-20
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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%

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VB-111	VB-111	Antiangiogenic and vascular disruptive agent
VB-111	Bevacizumab	Antiangiogenic and vascular disruptive agent

Primary Outcome Measures

Name	Time	Method
Overall Survival	From date of study entry until the date of death from any cause (up to 10 years)

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	6 months

Trial Locations

Locations (4)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Uthsc- Ctrc; 🇺🇸 San Antonio, Texas, United States

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States