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

November 15, 2007
January 6, 2014
November 2007
September 2014   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00559117 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Phase I Study to Assess the Safety and Distribution of VB-111 in Patients With Advanced Metastatic Cancer
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

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

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced and/or Metastatic Solid Organ Cancer
Drug: VB-111
A single intravenously infusion of diluted VB-111 should be administered 1 ml/minute
Experimental: Cohort
Intervention: Drug: VB-111
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
48
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00559117
GT-111001 (VB-111)
Yes
Vascular Biogenics Ltd. operating as VBL Therapeutics
Vascular Biogenics Ltd. operating as VBL Therapeutics
Not Provided
Principal Investigator: Pierre Triozzi, Dr. The Cleveland Clinic
Principal Investigator: Andrew Brenner, MD UTHSC- CTRC and Institute for Drug Development
Vascular Biogenics Ltd. operating as VBL Therapeutics
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP