safety and efficacy of vb-111 in subjects with advanced differentiated thyroid cancer

Conditions: Differential Thyroid Cancer

Summary: the purpose of this study is to examine the safety and evaluate the response of vb-111 on dtc.


Eligibility 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.