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

Sponsor

Vascular Biogenics Ltd. operating as VBL Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT01260506

Collaborator

(none)

Enrollment

Locations

Arm

96.6

Duration (Months)

18.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma Multiforme	Drug: VB-111 Drug: Bevacizumab	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Jul 23, 2015

Actual Study Completion Date :

Dec 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VB-111 Antiangiogenic and vascular disruptive agent	Drug: VB-111 Drug: Bevacizumab Upon progression, subjects will receive a combination therapy of VB-111 and standard of care bevacizumab

Arm

Intervention/Treatment

Experimental: VB-111

Antiangiogenic and vascular disruptive agent

Drug: VB-111

Drug: Bevacizumab

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Progression Free Survival [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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%

Exclusion Criteria:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dana Farber Cancer Institute	Boston	Massachusetts	United States
2	Duke University Medical Center	Durham	North Carolina	United States
3	Uthsc- Ctrc	San Antonio	Texas	United States
4	Tel Aviv Sourasky Medical Center	Tel Aviv		Israel	64239

Sponsors and Collaborators

Vascular Biogenics Ltd. operating as VBL Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vascular Biogenics Ltd. operating as VBL Therapeutics

ClinicalTrials.gov Identifier:

NCT01260506

Other Study ID Numbers:

VB-111-122

First Posted:

Dec 15, 2010

Last Update Posted:

Apr 24, 2020

Last Verified:

Apr 1, 2020

Keywords provided by Vascular Biogenics Ltd. operating as VBL Therapeutics

Relapsed Glioblastoma Multiforme, GBM

Additional relevant MeSH terms:

Glioblastoma

Bevacizumab

Study Results

No Results Posted as of Apr 24, 2020