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

This study is currently recruiting participants.
Verified January 2014 by Vascular Biogenics Ltd. operating as VBL Therapeutics
Sponsor:
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier:
NCT01229865
First received: October 26, 2010
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229865

Contacts
Contact: Yael Cohen, MD +972-3-634-6450 yaelc@vblrx.com

Locations
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Robert Smallridge, MD    904-953-6824    smallridge.robert@mayo.edu   
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    LWirth@partners.org   
Contact: Norka Snyder       NSnyder@partners.org   
Principal Investigator: Lori Wirth, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States
Contact: Keith Bible, MD    507-284-8440    Bible.Keith@mayo.edu   
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
ClinicalTrials.gov 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
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 22, 2014