Vandetanib-eluting Radiopaque Embolic Beads in Patients With Resectable Liver Malignancies (VEROnA)

Boston Scientific

Status and phase: Completed; Early Phase 1

Conditions: Carcinoma, Hepatocellular; Metastatic Colorectal Cancer

Treatments: Drug: BTG-002814

Study type: Interventional

Funder types: Industry

Identifiers

NCT03291379

BTG-002814-01

Details and patient eligibility

About

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.

Full 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 Colorectal cancer (CRC) with liver metastases.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female adults (≥ 18 years old)
2. 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
3. Patients with low risk for surgical morbidity and mortality from liver surgery according to the investigators judgement
4. World Health Organization (WHO) performance status 0, 1 or 2
5. Adequate haematological function with Hb >90 g/L, absolute neutrophil count >1.5 x 10^9/L, Plt >100 x 10^9/L
6. 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
7. 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).
8. Patient is willing to provide blood samples, and tissue samples at surgical resection, for research purposes
9. Patient is willing and able to provide written informed consent

Exclusion criteria

1. Any systemic chemotherapy within 3 months of the screening visit or any plan to administer systemic chemotherapy prior to surgery

2. 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

3. 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

4. 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)

5. Women of childbearing potential not using effective contraception or women who are breast feeding

6. Confirmed allergy to iodine-based intravenous contrast media

7. Patients who cannot have CT, MRI or dynamic contrast-enhanced (DCE) MRI Imaging (according to site policy)

8. Active uncontrolled cardiovascular disease

9. 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

10. 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

11. Patients who have participated in another clinical trial with an investigational product within 4 weeks prior to the screening visit

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

BTG-002814

Experimental group

Description:

Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)

Treatment:

Drug: BTG-002814