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

Glioblastoma Multiforme Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260506
• Other study ID #: VB-111-122
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2010
• Est. completion date: December 20, 2018

Study information

• Verified date: April 2020
• Source: Vascular Biogenics Ltd. operating as VBL Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 20, 2018
• Est. primary completion date: July 23, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• VB-111

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

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Duke University Medical Center	Durham	North Carolina
United States	Uthsc- Ctrc	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Biogenics Ltd. operating as VBL Therapeutics

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		From date of study entry until the date of death from any cause (up to 10 years)
Secondary	Progression Free Survival		6 months