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

This study is currently recruiting participants.
Verified January 2014 by Vascular Biogenics Ltd. operating as VBL Therapeutics
Sponsor:
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier:
NCT01260506
First received: December 13, 2010
Last updated: January 6, 2014
Last verified: January 2014

December 13, 2010
January 6, 2014
December 2010
January 2015   (final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01260506 on ClinicalTrials.gov Archive Site
Overall Survival [ Time Frame: Lifetime ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme
Not Provided

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

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glioblastoma Multiforme
  • Drug: VB-111
  • Drug: Bevacizumab
    Upon progression, subjects will receive a combination therapy of VB-111 every 2 months and standard of care bevacizumab
Experimental: VB-111
Antiangiogenic and vascular disruptive agent
Interventions:
  • Drug: VB-111
  • Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
Not Provided
January 2015   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
No
Contact: Yael Cohen, MD +972-3-634-6450 yaelc@vblrx.com
United States,   Israel
 
NCT01260506
VB-111-122
Yes
Vascular Biogenics Ltd. operating as VBL Therapeutics
Vascular Biogenics Ltd. operating as VBL Therapeutics
Not Provided
Not Provided
Vascular Biogenics Ltd. operating as VBL Therapeutics
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP