Glioblastoma MultiformePhase 1/2NCT01260506
Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme
A Phase 1/2 study testing VB-111 and Bevacizumab in people with Glioblastoma Multiforme, run by Vascular Biogenics Ltd. operating as VBL Therapeutics at 4 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in patients with Relapsed Glioblastoma Multiforme. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- VB-111 and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Dec 2010to 20 Dec 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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;
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Dana Farber Cancer Institute
Boston, Massachusetts
Duke University Medical Center
Durham, North Carolina
Uthsc- Ctrc
San Antonio, Texas
About this study
The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in patients with Relapsed Glioblastoma Multiforme.
- Conditions
- Glioblastoma Multiforme
- Being tested
- VB-111, Bevacizumab
- Keywords
- Relapsed Glioblastoma Multiforme, GBM
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VB-111Drug
BevacizumabDrug
Upon progression, subjects will receive a combination therapy of VB-111 and standard of care bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| VB-111 | Experimental | Antiangiogenic and vascular disruptive agent Receives: Drug: VB-111; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: From date of study entry until the date of death from any cause (up to 10 years)
Secondary outcomes (1)
Progression Free Survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startDec 2010
- Primary completion23 Jul 2015
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vascular Biogenics Ltd. operating as VBL Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260506
- Sponsor's protocol ID
- VB-111-122
- Status last verified
- Apr 2020
- First submitted
- 13 Dec 2010
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT01260506
- Acronym / sponsor ID
- VB-111-122
- Conditions
- Glioblastoma Multiforme
- Keywords
- Relapsed Glioblastoma Multiforme, GBM
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Vascular Biogenics Ltd. operating as VBL TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- 23 Jul 2015 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in patients with Relapsed Glioblastoma Multiforme.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VB-111 | Experimental | Drug: VB-111, Drug: BevacizumabAntiangiogenic and vascular disruptive agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VB-111 | Drug | VB-111 |
| BevacizumabUpon progression, subjects will receive a combination therapy of VB-111 and standard of care bevacizumab | Drug | VB-111 |
Primary outcome
Overall Survival
Time frame: From date of study entry until the date of death from any cause (up to 10 years)
1 secondary outcome
Progression Free Survival
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
Related trials for Glioblastoma Multiforme
RecruitingPhase 1
A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM
Glioblastoma Multiforme, Recurrent Glioblastoma
RecruitingPhase 1
A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)
Adult Glioblastoma, High Grade Glioma
Not yet recruitingPhase 1
IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Newly Diagnosed and Recurrent Pediatric High-grade Glioma (pHGG) and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (ndDIPG)
High-grade Glioma, Diffuse Intrinsic Pontine Glioma
Not yet recruitingPhase 1
Immune Modulatory DC Vaccine Against Brain Tumor
Diffuse Intrinsic Pontine Glioma or Glioblastoma
Recruiting
Tear Fluid for the Detection of Tumor-associated Extracellular Vesicles in Glioblastoma Patients
Glioblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VB-111 and Bevacizumab in people with Glioblastoma Multiforme, run by Vascular Biogenics Ltd. operating as VBL Therapeutics at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From date of study entry until the date of death from any cause (up to 10 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.