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

Differential Thyroid Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229865
• Other study ID #: VB-111-103
• Status: Completed
• Phase: Phase 2
• Start date: December 2010
• Est. completion date: June 2016

Study information

• Verified date: March 2015
• Source: Vascular Biogenics Ltd. operating as VBL Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2016
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Differential Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• VB-111

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Biogenics Ltd. operating as VBL Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		6 months
Primary	Objective response		6 months