A Phase I Study to Assess the Safety and Distribution of VB-111 in Patients With Advanced Metastatic Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Vascular Biogenics Ltd. operating as VBL Therapeutics
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier:
NCT00559117
First received: November 15, 2007
Last updated: March 26, 2015
Last verified: March 2015
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Purpose
Aim of the study is to evaluate the safety and find the maximal tolerated dose of VB-111 in Patients with Advanced Metastatic Cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced and/or Metastatic Solid Organ Cancer |
Drug: VB-111 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Vascular Biogenics Ltd. operating as VBL Therapeutics:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cohort |
Drug: VB-111
A single intravenously infusion of diluted VB-111 should be administered 1 ml/minute
|
Detailed Description:
Nine Cohorts of dose escalating VB-111 were completed with a total of 56 subjects enrolled.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559117
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559117
Locations
| 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 | |
Sponsors and Collaborators
Vascular Biogenics Ltd. operating as VBL Therapeutics
Investigators
| Principal Investigator: | Pierre Triozzi, Dr. | The Cleveland Clinic |
| Principal Investigator: | Andrew Brenner, MD | UTHSC- CTRC and Institute for Drug Development |
More Information
| Responsible Party: | Vascular Biogenics Ltd. operating as VBL Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00559117 History of Changes |
| Other Study ID Numbers: | GT-111001 (VB-111) |
| Study First Received: | November 15, 2007 |
| Last Updated: | March 26, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes |
ClinicalTrials.gov processed this record on September 23, 2016