Advanced and/or Metastatic Solid Organ CancerPhase 1NCT00559117
A Phase I Study to Assess the Safety and Distribution of VB-111 in Patients With Advanced Metastatic Cancer
A Phase 1 study testing VB-111 in people with Advanced and/or Metastatic Solid Organ Cancer, run by Vascular Biogenics Ltd. operating as VBL Therapeutics at 3 sites in United States.
Trial summary
Aim of the study is to evaluate the safety and find the maximal tolerated dose of VB-111 in Patients with Advanced Metastatic Cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced and/or Metastatic Solid Organ Cancer
- What is being tested?
- VB-111
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2007to Jun 2015
- Phase
- Phase 1
- 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
- Patients ≥18 years of age
- Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. For Cohort 8, malignancy will include only NET or RCC.
- Karnofsky performance status of ≥70%
- Patients with an adequate hematological profile
- Patients with an adequate renal function
- Males and Females of childbearing potential must utilize a standard contraception method
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Pregnant or breastfeeding patients
- Patients, who suffered from an acute cardiac event within the last 12 months
- Patients with active vascular disease, either myocardial or peripheral
- Patients with proliferative and/or vascular retinopathy
- Patients with known liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune)
- Patients with known CNS metastatic disease
Show all 13Show fewer
- Patients testing positive to one of the following viruses: HIV, HBV or HCV
- Patients receiving chemotherapy or radiotherapy within the last 4 weeks before enrolment
- Patients that have undergone major surgery within the last 4 weeks before enrolment
- Patients may not have received anti-angiogenic therapy within the previous 8 weeks before enrolment.
- Patients may not have received any other investigational agent within 4 weeks before enrolment.
- Patients with an ongoing requirement for an immunosuppressive treatment, including the use of glucocorticoids or cyclosporin, or with a history of chronic use of any such medication within the last 4 weeks before enrolment
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dana Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, 02215
Cleveland Clinic
Cleveland, Ohio, 44129
UTHSC- CTRC and Institute for Drug Development
San Antonio, Texas, 78229
About this study
Official title: A Phase I, Open-Label, Dose Ranging Study to Assess the Safety and Distribution of Single or Multiple Doses of VB-111 in Patients With Advanced Metastatic Cancer
Aim of the study is to evaluate the safety and find the maximal tolerated dose of VB-111 in Patients with Advanced Metastatic Cancer
Read the detailed description
Nine Cohorts of dose escalating VB-111 were completed with a total of 56 subjects enrolled.
- Being tested
- VB-111
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VB-111Drug
A single intravenously infusion of diluted VB-111 should be administered 1 ml/minute
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Experimental | Not described Receives: Drug: VB-111 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced and/or Metastatic Solid Organ CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vascular Biogenics Ltd. operating as VBL Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre Triozzi, Dr., Principal investigator, The Cleveland ClinicAndrew Brenner, MD, Principal investigator, UTHSC- CTRC and Institute for Drug Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559117
- Sponsor's protocol ID
- GT-111001 (VB-111)
- Status last verified
- Mar 2015
- First submitted
- 15 Nov 2007
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose Ranging Study to Assess the Safety and Distribution of Single or Multiple Doses of VB-111 in Patients With Advanced Metastatic Cancer
- ClinicalTrials.gov ID
- NCT00559117
- Acronym / sponsor ID
- GT-111001 (VB-111)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Vascular Biogenics Ltd. operating as VBL TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 16 Nov 2007 (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.
Aim of the study is to evaluate the safety and find the maximal tolerated dose of VB-111 in Patients with Advanced Metastatic Cancer
Detailed description
Nine Cohorts of dose escalating VB-111 were completed with a total of 56 subjects enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Experimental | Drug: VB-111 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients ≥18 years of age
- Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. For Cohort 8, malignancy will include only NET or RCC.
- Karnofsky performance status of ≥70%
- Patients with an adequate hematological profile
- Patients with an adequate renal function
Key exclusion criteria (13 listed)
- Pregnant or breastfeeding patients
- Patients, who suffered from an acute cardiac event within the last 12 months
- Patients with active vascular disease, either myocardial or peripheral
- Patients with proliferative and/or vascular retinopathy
- Patients with known liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune)
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-111A single intravenously infusion of diluted VB-111 should be administered 1 ml/minute | Drug | Cohort |
Primary outcome
Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
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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.
Pierre Triozzi, Dr. principal investigator
The Cleveland Clinic
Andrew Brenner, MD principal investigator
UTHSC- CTRC and Institute for Drug Development
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VB-111 in people with Advanced and/or Metastatic Solid Organ Cancer, run by Vascular Biogenics Ltd. operating as VBL Therapeutics at 3 sites in United States.
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 13 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: status not confirmed, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: 2 months). 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 27 Mar 2015.