Status:
COMPLETED
Vandetanib-eluting Radiopaque Embolic Beads in Patients With Resectable Liver Malignancies
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
Biocompatibles UK Ltd
Conditions:
Carcinoma, Hepatocellular
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This is a pilot, open label single arm phase 0 window of opportunity study of vandetanib-eluting radiopaque beads in patients with resectable liver malignancies.
Detailed Description
A pilot open-label single arm multicenter phase 0 window of opportunity study of BTG-002814 given up to 3 weeks prior to surgery in up to 12 patients with resectable Hepatocellular carcinoma (HCC) or ...
Eligibility Criteria
Inclusion
- Male or female adults (≥ 18 years old)
- Patient with resectable HCC (Child Pugh A, International Normalized Ratio (INR) ≤1.5) or resectable liver metastases from CRC and a candidate for liver surgery
- Patients with low risk for surgical morbidity and mortality from liver surgery according to the investigators judgement
- World Health Organization (WHO) performance status 0, 1 or 2
- Adequate haematological function with Hb \>90 g/L, absolute neutrophil count \>1.5 x 10\^9/L, Plt \>100 x 10\^9/L
- Adequate liver function with serum bilirubin \<1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) (or aspartate aminotransferase (AST) if ALT not available) ≤5 x ULN, alkaline phosphatase (ALP) \<5 x ULN
- Adequate renal function with serum creatinine ≤1.5 x ULN and calculated creatinine clearance (GFR) ≥50 mL/min estimated using a validated creatinine clearance calculation (e.g., Cockcroft-Gault or Wright formula).
- Patient is willing to provide blood samples, and tissue samples at surgical resection, for research purposes
- Patient is willing and able to provide written informed consent
Exclusion
- Any systemic chemotherapy within 3 months of the screening visit or any plan to administer systemic chemotherapy prior to surgery
- Previous treatment with transarterial embolisation (with or without chemotherapy) of the liver, prior radiotherapy or ablation therapy to the liver or prior yttrium-90 microsphere therapy
- Any contraindication to vandetanib according to its local label including:
- Hypersensitivity to the active substance
- Congenital long corrected QT interval (QTc) syndrome
- Patients known to have a QTc interval over 480 milliseconds
- Concomitant use of medicinal products known to also prolong the QTc interval and/or induce Torsades de pointes
- Any contraindication to hepatic artery catheterisation or hepatic embolisation procedures (e.g. portal venous thrombosis, severely reduced portal venous flow or hepatofugal blood flow, untreated varices at high risk of bleeding)
- Women of childbearing potential not using effective contraception or women who are breast feeding
- Confirmed allergy to iodine-based intravenous contrast media
- Patients who cannot have CT, MRI or dynamic contrast-enhanced (DCE) MRI Imaging (according to site policy)
- Active uncontrolled cardiovascular disease
- Any co-morbid disease or condition or event that, in the investigator's judgment, would place the patient at undue risk and would preclude the safe use of BTG-002814
- Levels of potassium, calcium, magnesium or thyroid stimulating hormone (TSH) outside the normal ranges, and that in the investigator's judgement are clinically significant, or other laboratory findings that in the view of the investigator makes it undesirable for the patient to participate in the study
- Patients who have participated in another clinical trial with an investigational product within 4 weeks prior to the screening visit
Key Trial Info
Start Date :
May 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03291379
Start Date
May 17 2017
End Date
August 3 2019
Last Update
July 19 2021
Active Locations (1)
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1
University College London Hospital
Bloomsbury, London, United Kingdom, NW1 2BU