Clinical trial NCT01229865: Safety and Efficacy of VB-111 in Subjects With Advanced Differentiated Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Differential Thyroid Cancer
Lead sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-10-28
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 6 months
measure: Objective response
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References: