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
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
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: 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 Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014