A pilot, open label, single-arm, phase 0, window of opportunity study of vandetanib-eluting radiopaque embolic beads (BTG-002814) in patients with resectable liver malignancies
Description
Design:
VEROnA is a pilot, open label, single arm, Phase 0 window of opportunity study of vandetanib eluting radiopaque embolic beads.
Treatment:
Single treatment arm. Patients will received one treatment of BTG-002814 (1mL BTG-002814 containing 100mg vandetanib).
Key inclusion/exclusion criteria:
Patients must have resectable HCC or resectable liver metastases from CRC and a candidate for liver surgery with a low risk for surgical morbidity and mortality from liver surgery. Patients must have adequate haematological, liver and renal function.Patients can’t have had any systemic chemotherapy within 3 months prior to screening or previous treatment with transarterial embolization of the liver, radiotherapy or ablation therapy to the liver or prior yttrium-90 microsphere therapy.
Duration of recruitment:
This study aims to treat 12 patients over the duration of 18 months. The study duration per patient is up to 9 weeks.
Aim
The primary aims of VEROnA are to assess the safety and tolerability of treatment with BTG-002814 and to measure the plasma and resected liver tissue concentrations of vandetanib and N-desmethyl vandetanib following treatment with BTG-002814.
The secondary aims of VEROnA are to evaluate the anatomical distribution of BTG-002814 on non-contrast enhanced imaging using 4D CT. Evaluate histopathological features in the surgical specimen following treatment with BTG-002814. Assess changes in blood flow on dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) following treatment with BTG-002814.