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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics Identifier:
First received: December 13, 2010
Last updated: October 14, 2015
Last verified: October 2015
The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in patients with Relapsed Glioblastoma Multiforme.

Condition Intervention Phase
Glioblastoma Multiforme
Drug: VB-111
Drug: Bevacizumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Vascular Biogenics Ltd. operating as VBL Therapeutics:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: From date of study entry until the date of death from any cause (up to 10 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: December 2010
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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;
  Contacts and Locations
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Please refer to this study by its identifier: NCT01260506

United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States
United States, Texas
Uthsc- Ctrc
San Antonio, Texas, United States
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Vascular Biogenics Ltd. operating as VBL Therapeutics
  More Information

No publications provided

Responsible Party: Vascular Biogenics Ltd. operating as VBL Therapeutics Identifier: NCT01260506     History of Changes
Other Study ID Numbers: VB-111-122
Study First Received: December 13, 2010
Last Updated: October 14, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Vascular Biogenics Ltd. operating as VBL Therapeutics:
Relapsed Glioblastoma Multiforme, GBM

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors processed this record on November 27, 2015