A Phase I Study to Assess the Safety and Distribution of VB-111 in Patients With Advanced Metastatic Cancer
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ClinicalTrials.gov Identifier: NCT00559117 |
Recruitment Status : Unknown
Verified March 2015 by Vascular Biogenics Ltd. operating as VBL Therapeutics.
Recruitment status was: Active, not recruiting
First Posted : November 16, 2007
Last Update Posted : March 27, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced and/or Metastatic Solid Organ Cancer | Drug: VB-111 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 48 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | November 2007 |
Estimated Primary Completion Date : | June 2015 |
Estimated Study Completion Date : | June 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: Cohort |
Drug: VB-111
A single intravenously infusion of diluted VB-111 should be administered 1 ml/minute |
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559117
United States, Massachusetts | |
Dana Farber/Brigham and Women's Cancer Center | |
Boston, Massachusetts, United States, 02215 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44129 | |
United States, Texas | |
UTHSC- CTRC and Institute for Drug Development | |
San Antonio, Texas, United States, 78229 |
Principal Investigator: | Pierre Triozzi, Dr. | The Cleveland Clinic | |
Principal Investigator: | Andrew Brenner, MD | UTHSC- CTRC and Institute for Drug Development |
Responsible Party: | Vascular Biogenics Ltd. operating as VBL Therapeutics |
ClinicalTrials.gov Identifier: | NCT00559117 |
Other Study ID Numbers: |
GT-111001 (VB-111) |
First Posted: | November 16, 2007 Key Record Dates |
Last Update Posted: | March 27, 2015 |
Last Verified: | March 2015 |
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