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

VBL Therapeutics

Status and phase: Completed; Phase 2

Conditions: Differential Thyroid Cancer

Treatments: Drug: VB-111

Study type: Interventional

Funder types: Industry

Identifiers

NCT01229865

VB-111-103

Details and patient eligibility

About

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

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

VB-111

Experimental group

Description:

antiangiogenic and vascular disruptive agent

Treatment:

Drug: VB-111