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

• ClinicalTrials.gov Identifier: NCT03291379
• Recruitment Status: Completed
• First Posted: September 25, 2017
• Results First Posted: February 3, 2021
• Last Update Posted: February 3, 2021
• Sponsor: Biocompatibles UK Ltd
• Information provided by (Responsible Party): Biocompatibles UK Ltd

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Carcinoma, Hepatocellular; Metastatic Colorectal Cancer
• Intervention: Drug: BTG-002814
• Enrollment: 8

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	BTG-002814
Arm/Group Description	Single arm: BTG-002814 (vandetanib-eluting radiopaque beads) BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
Period Title: Overall Study
Started	8
Completed	8
Not Completed	0

Baseline Characteristics

Arm/Group Title		BTG-002814
Arm/Group Description		Single arm: BTG-002814 (vandetanib-eluting radiopaque beads) BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
Overall Number of Baseline Participants		8
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	8 participants
		62.5; (50 to 69)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	8 participants
	Female	1 12.5%
	Male	7 87.5%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	8 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	7 87.5%
	More than one race	0 0.0%
	Unknown or Not Reported	1 12.5%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United Kingdom	Number Analyzed	8 participants
		8
World Health Organisation (WHO) Performance Status; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	8 participants
Grade 0 (asymptomatic)		8 100.0%
Grade 1 (Symptomatic, but ambulatory)		0 0.0%
Grade 2 (Symptomatic, <50% in bed)		0 0.0%
Tumour type [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	8 participants
Hepatocellular carcinoma (HCC)		2 25.0%
Metastatic colorectal cancer (mCRC)		6 75.0%
		[1] Measure Description: Participants must have resectable Hepatocellular carcinoma (HCC) (Child Pugh A, international normalized ratio (INR) ≤1.5) or resectable liver metastases from colorectal cancer (CRC) and be a candidate for liver surgery
Number of liver lesions; Mean (Standard Deviation); Unit of measure: Count
	Number Analyzed	8 participants
		1.6 (1.4)

Outcome Measures

1. Primary Outcome

Title	To Assess the Safety and Tolerability of Treatment With BTG-002814
Description	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

Outcome Measure Data

Analysis Population Description

Safety population - all participants treated with BTG-002814

Arm/Group Title	BTG-002814
Arm/Group Description:	Single arm: BTG-002814 (vandetanib-eluting radiopaque beads) BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
Overall Number of Participants Analyzed	8
Measure Type: Count of Participants; Unit of Measure: Participants
participants with treatment emergent Adverse Events (AEs)	8 100.0%
participants with treatment emergent Serious Adverse Events (SAEs)	4 50.0%

2. Primary Outcome

Title	Maximum Concentration (Cmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814
Description	Pharmacokinetic (PK) analysis of participants plasma samples by liquid chromatography with tandem mass spectrometry at the following timepoints: pre-treatment, post treatment (2 hours, 4 hours, 24 hours), prior to surgery, and end of study to derive Cmax.
Time Frame	pre-treatment, 2 hours post-treatment, 4 hours post treatment, 24 hours post treatment, prior to surgery, and end of study (28-32 days post-surgery)

Outcome Measure Data

Analysis Population Description

all participants treated with BTG-002814

Arm/Group Title	BTG-002814
Arm/Group Description:	Single arm: BTG-002814 (vandetanib-eluting radiopaque beads) BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
Overall Number of Participants Analyzed	8
Mean (Standard Deviation); Unit of Measure: ng/mL
Vandetanib Plasma Cmax	24.3 (13.94)
N-desmethyl Plasma Cmax	0.6 (0.82)

3. Primary Outcome

Title	Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Description	PK analysis of participants resected liver tissue samples by liquid chromatography with tandem mass spectrometry to determine vandetanib concentrations at the centre, middle, and edge of the tumour, as well as in the normal tissue surrounding the tumour (1cm away).
Time Frame	Following surgical resection of tumour

Outcome Measure Data

Analysis Population Description

Results were not available for 2 patients where sample was incorrectly prepared, or no sample was received. For patients with multiple tumours, only the treated tumours were sampled and analysed. The results for this outcome measure are reported by individual subject (where data was available) by each sample location (centre, middle, edge of the tumour or 1cm away from tumour) per row.

Arm/Group Title		BTG-002814
Arm/Group Description:		Single arm: BTG-002814 (vandetanib-eluting radiopaque beads) BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
Overall Number of Participants Analyzed		6
Measure Type: Number; Unit of Measure: ng/mL
Subject 01: Vandetanib concentration centre of tumour	Number Analyzed	1 participants
		404000
Subject 01: Vandetanib concentration middle of tumour	Number Analyzed	1 participants
		394000
Subject 01: Vandetanib concentration edge of tumour	Number Analyzed	1 participants
		327000
Subject 01: Vandetanib concentration 1cm away from tumour	Number Analyzed	1 participants
		10800
Subject 03: Vandetanib concentration centre of tumour	Number Analyzed	1 participants
		8510
Subject 03: Vandetanib concentration middle of tumour	Number Analyzed	1 participants
		11000
Subject 03: Vandetanib concentration edge of tumour	Number Analyzed	1 participants
		18800
Subject 03: Vandetanib concentration 1cm away from tumour	Number Analyzed	1 participants
		9120
Subject 05: Vandetanib concentration centre of tumour	Number Analyzed	1 participants
		7340
Subject 05: Vandetanib concentration middle of tumour	Number Analyzed	1 participants
		7550
Subject 05: Vandetanib concentration edge of tumour	Number Analyzed	1 participants
		12500
Subject 05: Vandetanib concentration 1cm away from tumour	Number Analyzed	1 participants
		7090
Subject 06: Vandetanib concentration centre of tumour	Number Analyzed	1 participants
		160000
Subject 06: Vandetanib concentration middle of tumour	Number Analyzed	1 participants
		151000
Subject 06: Vandetanib concentration edge of tumour	Number Analyzed	1 participants
		11100
Subject 06: Vandetanib concentration 1cm away from tumour	Number Analyzed	1 participants
		1480
Subject 07: Vandetanib concentration centre of tumour	Number Analyzed	1 participants
		4570
Subject 07: Vandetanib concentration middle of tumour	Number Analyzed	1 participants
		531
Subject 07: Vandetanib concentration edge of tumour	Number Analyzed	1 participants
		441
Subject 07: Vandetanib concentration 1cm away from tumour	Number Analyzed	1 participants
		2760
Subject 08: Vandetanib concentration centre of tumour	Number Analyzed	1 participants
		1140
Subject 08 (1cm lesion): whole tumour Vandetanib concentration	Number Analyzed	1 participants
		93500
Subject 08 (inferior lesion): Vandetanib concentration centre of tumour	Number Analyzed	1 participants
		6180
Subject 08: Vandetanib concentration middle of tumour	Number Analyzed	1 participants
		1240
Subject 08 (inferior lesion): Vandetanib concentration middle of tumour	Number Analyzed	1 participants
		1440
Subject 08: Vandetanib concentration edge of tumour	Number Analyzed	1 participants
		2840
Subject 08 (inferior lesion): Vandetanib concentration edge of tumour	Number Analyzed	1 participants
		2710
Subject 08: Vandetanib concentration 1cm away from tumour	Number Analyzed	1 participants
		29100
Subject 08 (1 cm lesion): Vandetanib concentration 1cm away from tumour	Number Analyzed	1 participants
		5350
Subject 08 (inferior lesion): Vandetanib concentration 1cm away from tumour	Number Analyzed	1 participants
		6010

4. Primary Outcome

Title	Time Taken to Reach the Maximum Concentration (Tmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814
Description	PK analysis of participants plasma samples by liquid chromatography with tandem mass spectrometry at the following timepoints: pre-treatment, post treatment (2 hours, 4 hours, 24 hours), prior to surgery, and end of study to derive Tmax
Time Frame	pre-treatment, 2 hours post-treatment, 4 hours post treatment, 24 hours post treatment, prior to surgery, and end of study (28-32 days post-surgery)

Outcome Measure Data

Analysis Population Description

all participants treated with BTG-002814

Arm/Group Title	BTG-002814
Arm/Group Description:	Single arm: BTG-002814 (vandetanib-eluting radiopaque beads) BTG-002814: BTG-002814 containing 100 mg vandetanib
Overall Number of Participants Analyzed	8
Mean (Standard Deviation); Unit of Measure: hours
Vandetanib Plasma Tmax	26.0 (67.08)
N-desmethyl Plasma Tmax	0.8 (1.04)

5. Primary Outcome

Title	Concentration of Vandetanib and N-desmethyl Vandetanib in Plasma Over Time Until End of Study Following Treatment With BTG-002814
Description	PK analysis of participants plasma samples by liquid chromatography with tandem mass spectrometry at the following timepoints: pre-treatment, post treatment (2 hours, 4 hours, 24 hours), prior to surgery, and end of study to derive AUCEoS (area under the curve at end of study).
Time Frame	pre-treatment, 2 hours post-treatment, 4 hours post treatment, 24 hours post treatment, prior to surgery, and end of study (28-32 days post-surgery)

Outcome Measure Data

Analysis Population Description

all participants treated with BTG-002814

Arm/Group Title	BTG-002814
Arm/Group Description:	Single arm: BTG-002814 (vandetanib-eluting radiopaque beads) BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
Overall Number of Participants Analyzed	8
Mean (Standard Deviation); Unit of Measure: ng*h/mL
Vandetanib Plasma AUCEoS	6979.3 (3188.21)
N-desmethyl Plasma AUCEoS	81.1 (169.40)

6. Primary Outcome

Title	Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
Description	PK analysis of participants resected liver tissue samples by liquid chromatography with tandem mass spectrometry to determine N-desmethyl vandetanib concentrations at the centre, middle, and edge of the tumour, as well as in the normal tissue surrounding the tumour (1cm away).
Time Frame	Following surgical resection of tumour

Outcome Measure Data

Analysis Population Description

Results were not available for 2 patients where sample was incorrectly prepared, or no sample was received. For patients with multiple tumours, only the treated tumours were sampled and analysed. The results for this outcome measure are reported by individual subject (where data was available), by each sample location (centre, middle, edge of the tumour, 1cm away from tumour) per row.

Arm/Group Title		BTG-002814
Arm/Group Description:		Single arm: BTG-002814 (vandetanib-eluting radiopaque beads) BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
Overall Number of Participants Analyzed		6
Measure Type: Number; Unit of Measure: ng/mL
Subject 01: N-desmethyl Vandetanib concentration centre of tumour	Number Analyzed	1 participants
		4620
Subject 01: N-desmethyl Vandetanib concentration middle of tumour	Number Analyzed	1 participants
		4740
Subject 01: N-desmethyl Vandetanib concentration edge of tumour	Number Analyzed	1 participants
		3680
Subject 01: N-desmethyl Vandetanib concentration 1cm away from tumour	Number Analyzed	1 participants
		280
Subject 03: N-desmethyl concentration centre of tumour	Number Analyzed	1 participants
		69.6
Subject 03: N-desmethyl Vandetanib concentration middle of tumour	Number Analyzed	1 participants
		59.8
Subject 03: N-desmethyl Vandetanib concentration edge of tumour	Number Analyzed	1 participants
		69.2
Subject 03: N-desmethyl Vandetanib concentration 1cm away from tumour	Number Analyzed	1 participants
		831
Subject 05: N-desmethyl concentration centre of tumour	Number Analyzed	1 participants
		421
Subject 05: N-desmethyl Vandetanib concentration middle of tumour	Number Analyzed	1 participants
		418
Subject 05: N-desmethyl Vandetanib concentration edge of tumour	Number Analyzed	1 participants
		469
Subject 05: N-desmethyl Vandetanib concentration 1cm away from tumour	Number Analyzed	1 participants
		544
Subject 06: N-desmethyl concentration centre of tumour	Number Analyzed	1 participants
		113
Subject 06: N-desmethyl Vandetanib concentration middle of tumour	Number Analyzed	1 participants
		93.9
Subject 06: N-desmethyl Vandetanib concentration edge of tumour	Number Analyzed	1 participants
		11.4
Subject 06: N-desmethyl Vandetanib concentration 1cm away from tumour	Number Analyzed	1 participants
		55.6
Subject 07: N-desmethyl concentration centre of tumour	Number Analyzed	1 participants
		21
Subject 07: N-desmethyl Vandetanib concentration middle of tumour	Number Analyzed	1 participants
		15.7
Subject 07: N-desmethyl Vandetanib concentration edge of tumour	Number Analyzed	1 participants
		28.7
Subject 07: N-desmethyl Vandetanib concentration 1cm away from tumour	Number Analyzed	1 participants
		84
Subject 08: N-desmethyl concentration centre of tumour	Number Analyzed	1 participants
		39.3
Subject 08 (1cm lesion): whole tumour N-desmethyl concentration	Number Analyzed	1 participants
		208
Subject 08 (inferior lesion): N-desmethyl concentration centre of tumour	Number Analyzed	1 participants
		80.2
Subject 08: N-desmethyl Vandetanib concentration middle of tumour	Number Analyzed	1 participants
		57.1
Subject 08 (inferior lesion): N-desmethyl Vandetanib concentration middle of tumour	Number Analyzed	1 participants
		101
Subject 08: N-desmethyl Vandetanib concentration edge of tumour	Number Analyzed	1 participants
		145
Subject 08 (inferior lesion): N-desmethyl Vandetanib concentration edge of tumour	Number Analyzed	1 participants
		171
Subject 08: N-desmethyl Vandetanib concentration 1cm away from tumour	Number Analyzed	1 participants
		389
Subject 08 (1 cm lesion): N-desmethyl Vandetanib concentration 1cm away from tumour	Number Analyzed	1 participants
		342
Subject 08 (inferior lesion): N-desmethyl Vandetanib concentration 1cm away from tumour	Number Analyzed	1 participants
		405

7. Secondary Outcome

Title	Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
Description	An automated thresholding and filtering algorithm was designed to allow the volume of delivered beads to be quantitatively determined for regions of interest (liver, registered sample, tumour, tumour dilated 1cm, tumour dilated 2cm) from the pre-surgical non-contrast CT scan and the PET/CT of the explanted liver samples following surgery.
Time Frame	1 day after treatment

Outcome Measure Data

Analysis Population Description

All 8 subjects treated with BTG-002814 were analysed, however, not all subjects have sampling of all regions (liver, registered sample, tumour, tumour dilated 1cm, tumour dilated 2cm) due to some samples not being able to be accurately processed and registered. The data for this outcome measure is reported by individual subject, for each sample region (where data is available) per row.

Arm/Group Title		BTG-002814
Arm/Group Description:		Single arm: BTG-002814 (vandetanib-eluting radiopaque beads) BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
Overall Number of Participants Analyzed		8
Measure Type: Number; Unit of Measure: µL
Subject 01: Liver	Number Analyzed	1 participants
		928.83
Subject 01: Registered sample	Number Analyzed	1 participants
		399.27
Subject 01: Tumour	Number Analyzed	1 participants
		361.14
Subject 01: tumour dilated 1cm	Number Analyzed	1 participants
		393.79
Subject 01: Tumour dilated 2cm	Number Analyzed	1 participants
		479.28
Subject 02: Liver	Number Analyzed	1 participants
		764.69
Subject 02: Tumour	Number Analyzed	1 participants
		596.78
Subject 02: Tumour dilated 1cm	Number Analyzed	1 participants
		617.72
Subject 02: Tumour dilated 2cm	Number Analyzed	1 participants
		649.97
Subject 03: Liver	Number Analyzed	1 participants
		594.79
Subject 03: Registered sample	Number Analyzed	1 participants
		116.54
Subject 03: Tumour	Number Analyzed	1 participants
		0.32
Subject 03: Tumour dilated 1cm	Number Analyzed	1 participants
		36.26
Subject 03: Tumour dilated 2cm	Number Analyzed	1 participants
		108.85
Subject 04: Liver	Number Analyzed	1 participants
		852.03
Subject 05: Liver	Number Analyzed	1 participants
		849.29
Subject 05: Registered sample	Number Analyzed	1 participants
		751.62
Subject 05: Tumour	Number Analyzed	1 participants
		0
Subject 5: Tumour dilated 1cm	Number Analyzed	1 participants
		15.26
Subject 05: Tumour dilated 2cm	Number Analyzed	1 participants
		86.28
Subject 06: Liver	Number Analyzed	1 participants
		202.56
Subject 06: Registered sample	Number Analyzed	1 participants
		148.09
Subject 06: Tumour	Number Analyzed	1 participants
		51.14
ubject 06: Tumour dilated 1cm	Number Analyzed	1 participants
		115.39
Subject 06: Tumour dilated 2cm	Number Analyzed	1 participants
		166.80
Subject 07: Liver	Number Analyzed	1 participants
		720.78
Subject 07: Registered sample	Number Analyzed	1 participants
		103.82
Subject 07: Tumour	Number Analyzed	1 participants
		4.32
Subject 07: Tumour dilated 1cm	Number Analyzed	1 participants
		75.43
Subject 07: Tumour dilated 2cm	Number Analyzed	1 participants
		133.26
Subject 08: Liver	Number Analyzed	1 participants
		693.73
Subject 08: Registered sample	Number Analyzed	1 participants
		422.37
Subject 08: Tumour	Number Analyzed	1 participants
		21.87
Subject 08: Tumour dilated 1cm	Number Analyzed	1 participants
		264.90
Subject 08: Tumour dilated 2cm	Number Analyzed	1 participants
		378.15

8. Secondary Outcome

Title	Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Analysing Percentage of Tumour Necrosis and Viability
Description	An evaluation of histopathological features in both malignant and non-malignant liver tissue from the surgical specimen was performed by microscopic examination. Sections of resected liver tissue was paraffin-embedded and Hematoxylin and Eosin (H&E) slides were produced. The H&E slides were scanned to produce 3D pathology models of tumour volume and compared to the 3D models generated from clinical imaging. This allowed the extent of tumour necrosis and viable tumour to be determined.
Time Frame	Post-surgery (tumour resection)

Outcome Measure Data

Analysis Population Description

all participants treated with BTG-002814

Arm/Group Title	BTG-002814
Arm/Group Description:	Single arm: BTG-002814 (vandetanib-eluting radiopaque beads) BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
Overall Number of Participants Analyzed	8
Median (Full Range); Unit of Measure: percentage of surgical specimen
Tumour necrosis	92.5; (5 to 100)
Viable tumour	7.5; (0 to 95)

9. Secondary Outcome

Title	Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Assessing Number of Participants With Any Vascular Changes.
Description	An evaluation of histopathological features in both malignant and non-malignant liver tissue from the surgical specimen was performed by microscopic examination. Sections of resected liver tissue was paraffin-embedded and Hematoxylin and Eosin (H&E) slides were produced. The H&E slides were scanned to produce 3D pathology models of tumour volume and compared to the 3D models generated from clinical imaging. This allowed any vascular changes to be determined.
Time Frame	Post-surgery (tumour resection)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BTG-002814
Arm/Group Description:	Single arm: BTG-002814 (vandetanib-eluting radiopaque beads) BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
Overall Number of Participants Analyzed	8
Measure Type: Number; Unit of Measure: Count of Participants
Vascular changes absent	8
Vascular changes present	0

10. Secondary Outcome

Title	Assessment of Changes in Blood Flow on Dynamic Contrast-Enhanced (DCE) MRI Following Treatment With BTG-002814. The Following Parameters Will be Derived From DCE-MRI Images: Ktrans, Kep and Ve.
Description	After acquisition of DCE-MRI liver sequences, tumour signal intensity curves were used to calculate tissue parameters describing tumour perfusion, blood flow and vascularity, before and following treatment with BTG 002814. Bland Altman analysis showed the variability between baseline and pre-treatment readings to be too high, so an interpretation of the changes in blood flow prior to surgery is unreliable.
Time Frame	Baseline, pre-treatment, up to 3 days prior to surgical resection of tumour

Outcome Measure Data Not Reported

11. Other Pre-specified Outcome

Title	Study Blood Biomarkers With the Potential to Identify Patients Likely to Respond to Treatment With BTG-002814
Description	The following serum biomarkers were measured at Baseline, pre-treatment, 1 day after treatment, Up to 3 days prior to surgical resection, end of study ; cytokines, chemokines and growth factors relevant to cancer and inflammation.
Time Frame	Baseline, pre-treatment, 1 day after treatment, Up to 3 days prior to surgical resection, end of study (28-32 days post-surgery).

Outcome Measure Data Not Reported

12. Other Pre-specified Outcome

Title	Study Tissue Biomarkers to Explore Key Immune, Inflammatory and Drug Related Mechanisms
Description	The following tissue biomarkers were measured at Baseline, pre-treatment, Up to 3 days prior to surgical resection; Levels of serum alpha-fetoprotein (AFP) in patients with HCC. Levels of serum Carcinoembryonic Antigen (CEA), Cancer Antigen (CA)19-9 and CA-125 in patients with metastatic colorectal cancer (mCRC).
Time Frame	Baseline, pre-treatment, Up to 3 days prior to surgical resection.

Outcome Measure Data Not Reported

Adverse Events

Time Frame	From date participant signed Informed Consent until the patient's last visit (up to 9 weeks) (or after this date if the site Investigator feels the event is related to study treatment)
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	BTG-002814
Arm/Group Description	Single arm: BTG-002814 (vandetanib-eluting radiopaque beads) BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib
All-Cause Mortality
	BTG-002814
	Affected / at Risk (%)
Total	1/8 (12.50%)
Serious Adverse Events
	BTG-002814
	Affected / at Risk (%)	# Events
Total	4/8 (50.00%)
Gastrointestinal disorders
Ileus * 1	1/8 (12.50%)	1
Upper gastrointestinal hemorrhage * 1	1/8 (12.50%)	1
Hepatobiliary disorders
Ascites * 1	1/8 (12.50%)	1
Post procedural bile leak * 1	1/8 (12.50%)	1
Infections and infestations
Lung infection * 1	1/8 (12.50%)	1
Postoperative wound infection * 1	2/8 (25.00%)	2
Sepsis * 1	1/8 (12.50%)	1
Injury, poisoning and procedural complications
Abdominal wound dehiscence * 1	1/8 (12.50%)	1
Renal and urinary disorders
Renal failure acute * 1	1/8 (12.50%)	1
1 Term from vocabulary, MedDRA (21.0); * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	BTG-002814
	Affected / at Risk (%)	# Events
Total	8/8 (100.00%)
Cardiac disorders
Bradycardia * 1	3/8 (37.50%)	5
Cardiac signs and symptoms NEC * 1	1/8 (12.50%)	1
Sinus bradycardia * 1	2/8 (25.00%)	2
Ear and labyrinth disorders
Tinnitus * 1	2/8 (25.00%)	2
Gastrointestinal disorders
Abdominal distension * 1	1/8 (12.50%)	2
Abdominal pain * 1	8/8 (100.00%)	19
Constipation † 1	5/8 (62.50%)	6
Diarrhoea * 1	1/8 (12.50%)	1
Dry mouth * 1	1/8 (12.50%)	1
Dyspepsia * 1	5/8 (62.50%)	8
Gastritis * 1	2/8 (25.00%)	2
Gastrooesophageal reflux disease * 1	2/8 (25.00%)	2
Nausea * 1	5/8 (62.50%)	8
Vomiting * 1	2/8 (25.00%)	2
General disorders
Fatigue * 1	7/8 (87.50%)	23
Influenza like illness * 1	1/8 (12.50%)	1
Non-cardiac chest pain * 1	1/8 (12.50%)	1
Pain * 1	2/8 (25.00%)	2
Pyrexia * 1	2/8 (25.00%)	2
Infections and infestations
Lung infection * 1	1/8 (12.50%)	1
Postoperative wound infection * 1	2/8 (25.00%)	3
Investigations
Alanine aminotransferase * 1	5/8 (62.50%)	8
Aspartate aminotransferase * 1	5/8 (62.50%)	7
Blood albumin * 1	3/8 (37.50%)	25
Blood alkaline phosphatase * 1	5/8 (62.50%)	5
Blood bilirubin * 1	1/8 (12.50%)	1
Blood calcium * 1	2/8 (25.00%)	2
Blood creatinine * 1	2/8 (25.00%)	7
Blood glucose * 1	5/8 (62.50%)	8
Blood lactic acid * 1	1/8 (12.50%)	1
Blood magnesium * 1	1/8 (12.50%)	1
Blood sodium * 1	1/8 (12.50%)	1
Blood thyroid stimulating hormone * 1	2/8 (25.00%)	2
Blood urea * 1	2/8 (25.00%)	2
Blood uric acid * 1	4/8 (50.00%)	6
C-reactive protein * 1	1/8 (12.50%)	14
Electrocardiogram QT prolonged * 1	2/8 (25.00%)	4
Gamma-glutamyl transferase * 1	5/8 (62.50%)	8
Glomerular filtration rate * 1	1/8 (12.50%)	1
Haemoglobin * 1	8/8 (100.00%)	15
International normalized ratio † 1	1/8 (12.50%)	1
Neutrophil count * 1	1/8 (12.50%)	11
Neutrophil count decreased * 1	4/8 (50.00%)	6
Platelet count * 1	2/8 (25.00%)	2
Weight decreased * 1	3/8 (37.50%)	3
White blood cell count * 1	2/8 (25.00%)	14
Metabolism and nutrition disorders
Decreased appetite * 1	5/8 (62.50%)	7
Dehydration * 1	1/8 (12.50%)	1
Musculoskeletal and connective tissue disorders
Arthralgia * 1	2/8 (25.00%)	2
Back pain * 1	2/8 (25.00%)	2
Groin pain * 1	1/8 (12.50%)	2
Myalgia * 1	1/8 (12.50%)	1
Nervous system disorders
Paraesthesia * 1	2/8 (25.00%)	2
Psychiatric disorders
Delirium * 1	1/8 (12.50%)	1
Insomnia * 1	1/8 (12.50%)	1
Respiratory, thoracic and mediastinal disorders
Cough * 1	2/8 (25.00%)	2
Dysphonia * 1	1/8 (12.50%)	1
Dyspnoea * 1	2/8 (25.00%)	2
Hiccups * 1	2/8 (25.00%)	2
Laryngeal inflammation * 1	1/8 (12.50%)	1
Oropharyngeal pain * 1	1/8 (12.50%)	1
Skin and subcutaneous tissue disorders
Dermatitis acneiform * 1	1/8 (12.50%)	1
Pruritus * 1	1/8 (12.50%)	1
Rash * 1	1/8 (12.50%)	1
Vascular disorders
Haematoma * 1	1/8 (12.50%)	2
Hypertension * 1	7/8 (87.50%)	12
Hypotension * 1	3/8 (37.50%)	4
1 Term from vocabulary, MedDRA (21.0); * Indicates events were collected by non-systematic assessment; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Sarah Cooper
• Organization: Biocompatibles UK Ltd
• Phone: 07805354224
• EMail: Sarah-Jane.Cooper@bsci.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Beaton L, Tregidgo HFJ, Znati SA, Forsyth S, Clarkson MJ, Bandula S, Chouhan M, Lowe HL, Zaw Thin M, Hague J, Sharma D, Pollok JM, Davidson BR, Raja J, Munneke G, Stuckey DJ, Bascal ZA, Wilde PE, Cooper S, Ryan S, Czuczman P, Boucher E, Hartley JA, Lewis AL, Jansen M, Meyer T, Sharma RA. VEROnA Protocol: 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. JMIR Res Protoc. 2019 Oct 2;8(10):e13696. doi: 10.2196/13696.

• Responsible Party: Biocompatibles UK Ltd
• ClinicalTrials.gov Identifier: NCT03291379
• Other Study ID Numbers: BTG-002814-01
• First Submitted: May 17, 2017
• First Posted: September 25, 2017
• Results First Submitted: October 5, 2020
• Results First Posted: February 3, 2021
• Last Update Posted: February 3, 2021