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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01229865
Recruitment Status : Unknown
Verified March 2015 by Vascular Biogenics Ltd. operating as VBL Therapeutics.
Recruitment status was:  Active, not recruiting
First Posted : October 28, 2010
Last Update Posted : March 27, 2015
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics

October 26, 2010
October 28, 2010
March 27, 2015
December 2010
October 2014   (Final data collection date for primary outcome measure)
  • Progression Free Survival [ Time Frame: 6 months ]
  • Objective response [ Time Frame: 6 months ]
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Complete list of historical versions of study NCT01229865 on Archive Site
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Safety and Efficacy of VB-111 in Subjects With Advanced Differentiated Thyroid Cancer
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The purpose of this study is to examine the safety and evaluate the response of VB-111 on DTC.
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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Differential Thyroid Cancer
Drug: VB-111
Experimental: VB-111
antiangiogenic and vascular disruptive agent
Intervention: Drug: VB-111
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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June 2016
October 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Vascular Biogenics Ltd. operating as VBL Therapeutics
Vascular Biogenics Ltd. operating as VBL Therapeutics
Not Provided
Not Provided
Vascular Biogenics Ltd. operating as VBL Therapeutics
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP