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

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ClinicalTrials.gov Identifier: NCT03291379
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Biocompatibles UK Ltd

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Metastatic Colorectal Cancer Drug: BTG-002814 (vandetanib-eluting radiopaque beads) Early Phase 1

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 HCC or CRC with liver metastases.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 1 mL BTG-002814 containing 100 mg vandetanib
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VEROnA: A Window of Opportunity Study of Vandetanib-eluting Radiopaque Embolic Beads (BTG-002814) in Patients With Resectable Liver Malignancies
Actual Study Start Date : May 17, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Vandetanib
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BTG-002814
Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)
Drug: BTG-002814 (vandetanib-eluting radiopaque beads)
BTG-002814 containing 100 mg vandetanib



Primary Outcome Measures :
  1. Adverse events (AEs) related to treatment with BTG-002814 using the National Cancer Institute- Common Terminology Criteria for Adverse Events- Version 4.0 (NCI-CTCAE v4.0) [ Time Frame: Continuously throughout the study totalling 9 weeks ]
    To assess the safety and tolerability of treatment with BTG-002814

  2. Concentration of vandetanib and N-desmethyl vandetanib in plasma following treatment with BTG-002814 [ Time Frame: 0, 2, 4, 24, 36 hours post treatment and, 1 day prior to and 30-32 days after liver resection surgery ]
    Measure the plasma concentrations of vandetanib and the N-desmethyl metabolite following treatment with BTG-002814

  3. Concentration of vandetanib and N-desmethyl vandetanib in resected liver tissue following treatment with BTG-002814 [ Time Frame: 7-21 days following treatment ]
    Measure the concentrations of vandetanib and the N-desmethyl metabolite in the resected liver tissue samples following treatment with BTG-002814


Secondary Outcome Measures :
  1. BTG-002814 distribution [ Time Frame: 1 day after treatment ]
    Distribution of BTG-002814 on non-contrast enhanced imaging of tumor vasculature and regions of interest using 4D CT

  2. Evaluation of histopathological features [ Time Frame: 7 to 21 days after treatment ]
    Evaluation of histopathological features in the surgical specimen (malignant and non-malignant liver tissue): tumor necrosis, viable tumor, vascular changes

  3. Assessment of changes in blood flow [ Time Frame: Baseline, day 1, 6 to 20 days after treatment] ]
    Assessment of changes in blood flow on DCE-MRI following treatment. The following parameters will be derived from DCE-MRI images: Ktrans, Kep and Ve


Other Outcome Measures:
  1. Blood biomarkers [ Time Frame: Throughout study involvement totaling 9 weeks ]
    Study blood biomarkers with the potential to identify patients likely to respond to treatment with BTG-002814

  2. Distribution of BTG-002814 [ Time Frame: 7 to 21 days after treatment ]
    Correlate the distribution of BTG-002814 on imaging with pathology by 3D modeling



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female adults (≥ 18 years old)
  2. Patient with resectable HCC (Child Pugh A, 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. 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 ULN, ALT (or AST if ALT not available) ≤5 x ULN, 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., Cockroft-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 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291379


Contacts
Contact: Dr. Nermeen Varawalla +44 1276 902 205 Nermeen.varawalla@btgplc.com

Locations
United Kingdom
University College London Hospital Recruiting
Bloomsbury, London, United Kingdom, NW1 2BU
Contact: Professor Ricky Sharma         
Sponsors and Collaborators
Biocompatibles UK Ltd
Investigators
Principal Investigator: Professor Ricky Sharma University College, London

Responsible Party: Biocompatibles UK Ltd
ClinicalTrials.gov Identifier: NCT03291379     History of Changes
Other Study ID Numbers: BTG-002814-01
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biocompatibles UK Ltd:
mCRC, HCC, radiopaque beads, vandetanib

Additional relevant MeSH terms:
Colorectal Neoplasms
Carcinoma, Hepatocellular
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Liver Diseases