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

Primary Purpose

Advanced and/or Metastatic Solid Organ Cancer

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

VB-111

About this trial

This is an interventional treatment trial for Advanced and/or Metastatic Solid Organ Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dana Farber/Brigham and Women's Cancer Center
Cleveland Clinic
UTHSC- CTRC and Institute for Drug Development

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort

Arm Description

Outcomes

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT00559117

First Posted

November 15, 2007

Last Updated

March 26, 2015

Sponsor

Vascular Biogenics Ltd. operating as VBL Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT00559117

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Unknown status

Study Start Date

November 2007 (undefined)

Primary Completion Date

June 2015 (Anticipated)

Study Completion Date

June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vascular Biogenics Ltd. operating as VBL Therapeutics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced and/or Metastatic Solid Organ Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

VB-111

Intervention Description

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

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre Triozzi, Dr.

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Andrew Brenner, MD

Organizational Affiliation

UTHSC- CTRC and Institute for Drug Development

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana Farber/Brigham and Women's Cancer Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44129

Country

United States

Facility Name

UTHSC- CTRC and Institute for Drug Development

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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