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

NCT00559117 | Unknown Phase 1 DMC

• 1 other identifier: GT-111001 (VB-111)
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

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

Conditions

Advanced and/or Metastatic Solid Organ Cancer

Outcome Measures

Primary Outcomes (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)

  2 months

Study Arms (1)

Cohort

EXPERIMENTAL

Drug: VB-111

Interventions

VB-111 DRUG

A single intravenously infusion of diluted VB-111 should be administered 1 ml/minute

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vascular Biogenics Ltd. operating as VBL Therapeutics: lead

Study Sites (3)

Dana Farber/Brigham and Women's Cancer Center

Boston, Massachusetts, 02215, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44129, United States

Location

UTHSC- CTRC and Institute for Drug Development

San Antonio, Texas, 78229, United States

Location

Study Officials

• Pierre Triozzi, Dr.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Andrew Brenner, MD

  UTHSC- CTRC and Institute for Drug Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: November 1, 2007
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 27, 2015

Record last verified: 2015-03

Locations

US (3)