Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Phase I Study to Assess the Safety and Distribution of GT-111 in Patients With Advanced Metastatic Cancer
This study is currently recruiting participants.
Verified by Vascular Biogenics, Ltd, October 2007
Sponsored by: Vascular Biogenics, Ltd
Information provided by: Vascular Biogenics, Ltd
ClinicalTrials.gov Identifier: NCT00559117
  Purpose

Aim of the study is to evaluate the safety and find the maximal tolerated dose of GT-111 in Patients with Advanced Metastatic Cancer


Condition Intervention Phase
Advanced and/or Metastatic Solid Organ Cancer
Drug: GT-111
Phase I

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: A Phase I, Open-Label, Dose Ranging Study to Assess the Safety and Distribution of GT-111 in Patients With Advanced Metastatic Cancer

Further study details as provided by Vascular Biogenics, Ltd:

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 ]

Estimated Enrollment: 48
Study Start Date: November 2007
Estimated Study Completion Date: September 2008
Arms Assigned Interventions
Cohort: Experimental Drug: GT-111
A single intravenously infusion of approximately 5 ml of diluted GT-111 should be administered 1 ml/minute

  Eligibility

Ages Eligible for Study:   18 Years and older
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
  • 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559117

Contacts
Contact: David Snyder, Dr. 972-3-634-6450 david.snyder@vbl.co.il

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44129
Contact: Pierre Triozzi, MD            
Principal Investigator: Pierre Triozzi, Dr.            
United States, Texas
CTRC and Institute for Drug Development Recruiting
San Antonio, Texas, United States, 78229
Contact: Frank Giles, MD            
Principal Investigator: Frank Giles, MD            
Sponsors and Collaborators
Vascular Biogenics, Ltd
Investigators
Principal Investigator: Pierre Triozzi, Dr. Cleveland Clinic
Principal Investigator: Frank Giles, MD CTRC and Institute for Drug Development
  More Information

Study ID Numbers: GT-111001
Study First Received: November 15, 2007
Last Updated: January 21, 2008
ClinicalTrials.gov Identifier: NCT00559117  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Neoplasm Metastasis

Additional relevant MeSH terms:
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009