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

April 23, 2020 updated by: Vascular Biogenics Ltd. operating as VBL Therapeutics
The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in patients with Relapsed Glioblastoma Multiforme.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States
        • Dana Farber Cancer Institute
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University Medical Center
    • Texas
      • San Antonio, Texas, United States
        • Uthsc- Ctrc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vascular Biogenics Ltd. operating as VBL Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

July 23, 2015

Study Completion (Actual)

December 20, 2018

Study Registration Dates

First Submitted

December 13, 2010

First Submitted That Met QC Criteria

December 14, 2010

First Posted (Estimate)

December 15, 2010

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VB-111-122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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