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

Location:

Rochester, MN., Jacksonville, FL.

Trial status:

Open for Enrollment

Why is this study being done?

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

Who is eligible to participate?

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.

Last updated:

12/17/2012

NCT ID:

NCT01229865

IRB Number:

10-001281