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:
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier:
NCT00559117
First received: November 15, 2007
Last updated: January 6, 2014
Last verified: January 2014
  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: September 2014
Estimated Primary Completion Date: September 2014 (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:

Seven Cohorts of dose escalating VB-111 were completed with a total of 33 subjects enrolled.

An additional cohort (Cohort 8) has been added to include multiple doses of VB-111 within disease specific subgroups (Neuroendocrine Tumor, Renal Cell Carcinoma). Subjects will receive a single infusion of VB-111 every 2 months until progression. 18-36 subjects are expected to be enrolled at 3 centers.

  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. 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

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

No publications provided

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: January 6, 2014
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 July 20, 2014