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

NCT01229865 | Completed Phase 2 DMC

• 1 other identifier: VB-111-103
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Differential Thyroid Cancer

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival

  6 months

• Objective response

  6 months

Study Arms (1)

VB-111

EXPERIMENTAL

antiangiogenic and vascular disruptive agent

Drug: VB-111

Interventions

VB-111 DRUG

VB-111

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed advanced DTC (papillary, follicular, Hurthle cell);
• Absence of sensitivity to therapeutic radioiodine;
• 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
• Life expectancy \>3 months; ECOG performance status (PS) 0, 1, or 2; Karnofsky performance status of ≥60%;
• Subjects with a normal/acceptable hematological profile
• Subjects with adequate renal function

You may not qualify if:

• 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;
• Major surgery \<4 weeks prior to baseline visit;
• Any other ongoing investigational agents within 4 weeks before dosing;
• 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;
• QTc prolongation (defined as QTc interval ≥500 msecs) or other significant ECG abnormalities (e.g. frequent ventricular ectopy, evidence of ongoing myocardial ischemia);
• Subjects with active vascular disease, either myocardial or peripheral;
• Subjects with proliferative and/or vascular retinopathy;
• Subjects with known active liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune) other than related to tumor metastases;
• Subjects with known CNS metastatic disease (Exception: Subjects with treated CNS metastases stable by radiographic examinations \>6 months after definitive therapy administered, are eligible);
• Subjects testing positive to one of the following viruses: HIV, HBV or HCV;
• 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;

Sponsors & Collaborators

• Vascular Biogenics Ltd. operating as VBL Therapeutics: lead

Study Sites (3)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, United States

Location

Mayo Clinic

Rochester, Minnesota, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: October 28, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: June 1, 2016
• Last Updated: October 23, 2018

Record last verified: 2015-03

Locations

US (3)