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A Phase I Study to Assess the Safety and Distribution of VB-111 in Patients With Advanced Metastatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Advanced and/or Metastatic Solid Organ Cancer Drug: VB-111 Phase 1

Detailed Description:
Nine Cohorts of dose escalating VB-111 were completed with a total of 56 subjects enrolled.
Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort Drug: VB-111
A single intravenously infusion of diluted VB-111 should be administered 1 ml/minute


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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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
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Principal Investigator: Pierre Triozzi, Dr. The Cleveland Clinic
Principal Investigator: Andrew Brenner, MD UTHSC- CTRC and Institute for Drug Development
More Information
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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
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes