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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified March 2015 by Vascular Biogenics Ltd. operating as VBL Therapeutics.
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by (Responsible Party):

Vascular Biogenics Ltd. operating as VBL Therapeutics

ClinicalTrials.gov Identifier:

NCT00559117

First received: November 15, 2007

Last updated: March 26, 2015

Last verified: March 2015

History of Changes

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:	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

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 ]


Estimated Enrollment:	48
Study Start Date:	November 2007
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	June 2015 (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:

Nine Cohorts of dose escalating VB-111 were completed with a total of 56 subjects enrolled.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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


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:	March 26, 2015

Additional relevant MeSH terms:


Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes

ClinicalTrials.gov processed this record on June 22, 2017

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