Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety and Efficacy of VB-111 in Subjects With Advanced Differentiated Thyroid Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Vascular Biogenics Ltd. operating as VBL Therapeutics
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics Identifier:
First received: October 26, 2010
Last updated: January 6, 2014
Last verified: January 2014

The purpose of this study is to examine the safety and evaluate the response of VB-111 on DTC.

Condition Intervention Phase
Differential Thyroid Cancer
Drug: VB-111
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Vascular Biogenics Ltd. operating as VBL Therapeutics:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Objective response [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2010
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VB-111
antiangiogenic and vascular disruptive agent
Drug: VB-111


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically or cytologically confirmed advanced DTC (papillary, follicular, Hurthle cell);
  2. Absence of sensitivity to therapeutic radioiodine;
  3. Measurable disease, defined as at least one non-bony lesion that can be accurately measured in at least one dimension as confirmed with spiral CT scan
  4. Life expectancy >3 months; ECOG performance status (PS) 0, 1, or 2; Karnofsky performance status of ≥60%;
  5. Subjects with a normal/acceptable hematological profile
  6. Subjects with adequate renal function

Exclusion Criteria:

  1. Presence of any of the following:

    • Radiotherapy or chemotherapy <4 weeks prior to baseline visit; (Concurrent and/or prior therapy with octreotide will be allowed, provided tumor progression on this therapy has been demonstrated; Concurrent and/or prior therapy with biphosphonates will be allowed)
    • Radiotherapy to ≥25% of bone marrow;
  2. Major surgery <4 weeks prior to baseline visit;
  3. Any other ongoing investigational agents within 4 weeks before dosing;
  4. Subjects who suffered from an acute cardiac event within the last 12 months, including myocardial infarction, cardiac arrythmia, admission for unstable angina, cardiac angioplasty, or stenting;
  5. QTc prolongation (defined as QTc interval ≥500 msecs) or other significant ECG abnormalities (e.g. frequent ventricular ectopy, evidence of ongoing myocardial ischemia);
  6. Subjects with active vascular disease, either myocardial or peripheral;
  7. Subjects with proliferative and/or vascular retinopathy;
  8. Subjects with known active liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune) other than related to tumor metastases;
  9. Subjects with known CNS metastatic disease (Exception: Subjects with treated CNS metastases stable by radiographic examinations >6 months after definitive therapy administered, are eligible);
  10. Subjects testing positive to one of the following viruses: HIV, HBV or HCV;
  11. Any of the following conditions:

    • Serious or non-healing wound, ulcer, or bone fracture;
    • History of abdominal fistula, gastro-intestinal perforation, active diverticulitis, intra-abdominal abscess or gastro-intestinal tract bleeding within 6 months of dosing;
    • Any history of cerebrovascular accident (CVA) within 6 months of dosing;
    • Current use of therapeutic warfarin (Note: Low molecular weight heparin and prophylactic low-dose warfarin [INR<1.2 X ULN] are permitted);
    • History of bleeding disorder, including subjects with hemophilia, disseminated intravascular coagulation (DIC), or any other abnormality of coagulation potentially predisposing subjects to bleeding;
    • Poorly controlled depression or anxiety disorder, or recent (within the previous 6 months) suicidal ideation;
  12. Subjects with an ongoing requirement for 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 dosing;
  13. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, 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 identifier: NCT01229865

Contact: Yael Cohen, MD +972-3-634-6450

United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Robert Smallridge, MD    904-953-6824   
Principal Investigator: Robert Smallridge, MD         
Sub-Investigator: Michael Menefee, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
Contact: Lori Wirth, MD    617-724-4000   
Contact: Norka Snyder   
Principal Investigator: Lori Wirth, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States
Contact: Keith Bible, MD    507-284-8440   
Principal Investigator: Keith Bible, MD         
Sponsors and Collaborators
Vascular Biogenics Ltd. operating as VBL Therapeutics
  More Information

No publications provided

Responsible Party: Vascular Biogenics Ltd. operating as VBL Therapeutics Identifier: NCT01229865     History of Changes
Other Study ID Numbers: VB-111-103
Study First Received: October 26, 2010
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms by Site
Thyroid Diseases processed this record on March 03, 2015