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

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Study is closed to enrollment

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Keith Bible, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Robert Smallridge, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20116769

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