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CompletedNCT03291379VEROnAUpdated Jul 19, 2021Results posted

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

An Early Phase 1 interventional study of BTG-002814 in Carcinoma, Hepatocellular and Metastatic Colorectal Cancer, sponsored by Boston Scientific Corporation. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-19.

Sponsored by Boston Scientific Corporation · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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 Colorectal cancer (CRC) with liver metastases.

02

Conditions studied

  • Carcinoma, Hepatocellular
  • Metastatic Colorectal Cancer

Keywords

  • mCRC, HCC, radiopaque beads, vandetanib
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    BTG-002814

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

    Drug: BTG-002814

Interventions

  • DrugBTG-002814

    BTG-002814 containing 100 mg vandetanib

    Also known as: vandetanib-eluting radiopaque beads

05

What researchers measure

Primary outcomes

  1. To Assess the Safety and Tolerability of Treatment With BTG-002814

    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

  2. Maximum Concentration (Cmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814

    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)

  3. Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814

    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

  4. Time Taken to Reach the Maximum Concentration (Tmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814

    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)

  5. Concentration of Vandetanib and N-desmethyl Vandetanib in Plasma Over Time Until End of Study Following Treatment With BTG-002814

    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)

  6. Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814

    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

Secondary outcomes

  1. Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT

    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

  2. Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Analysing Percentage of Tumour Necrosis and Viability

    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)

  3. Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Assessing Number of Participants With Any Vascular Changes.

    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)

  4. 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.

    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

Other outcomes

  1. Study Blood Biomarkers With the Potential to Identify Patients Likely to Respond to Treatment With BTG-002814

    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).

  2. Study Tissue Biomarkers to Explore Key Immune, Inflammatory and Drug Related Mechanisms

    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.

06

Results

Posted Feb 3, 2021

Participant flow

Participant flow — Overall Study
MilestoneBTG-002814
Started8
Completed8
Not completed0

Outcome measures

PrimaryTo Assess the Safety and Tolerability of Treatment With BTG-002814

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
Reported as:
Count of participants · Participants
To Assess the Safety and Tolerability of Treatment With BTG-002814
ParticipantsBTG-002814
participants with treatment emergent Adverse Events (AEs)8
participants with treatment emergent Serious Adverse Events (SAEs)4
PrimaryMaximum Concentration (Cmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814

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)
Reported as:
Mean · ng/mL
Maximum Concentration (Cmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814
ng/mLBTG-002814
Vandetanib Plasma Cmax24.3 ± 13.94
N-desmethyl Plasma Cmax0.6 ± 0.82
PrimaryConcentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814

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
Reported as:
Number · ng/mL
Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
ng/mLBTG-002814
Subject 01: Vandetanib concentration centre of tumour404000
Subject 01: Vandetanib concentration middle of tumour394000
Subject 01: Vandetanib concentration edge of tumour327000
Subject 01: Vandetanib concentration 1cm away from tumour10800
Subject 03: Vandetanib concentration centre of tumour8510
Subject 03: Vandetanib concentration middle of tumour11000
Subject 03: Vandetanib concentration edge of tumour18800
Subject 03: Vandetanib concentration 1cm away from tumour9120
Subject 05: Vandetanib concentration centre of tumour7340
Subject 05: Vandetanib concentration middle of tumour7550
Subject 05: Vandetanib concentration edge of tumour12500
Subject 05: Vandetanib concentration 1cm away from tumour7090
Subject 06: Vandetanib concentration centre of tumour160000
Subject 06: Vandetanib concentration middle of tumour151000
Subject 06: Vandetanib concentration edge of tumour11100
Subject 06: Vandetanib concentration 1cm away from tumour1480
Subject 07: Vandetanib concentration centre of tumour4570
Subject 07: Vandetanib concentration middle of tumour531
Subject 07: Vandetanib concentration edge of tumour441
Subject 07: Vandetanib concentration 1cm away from tumour2760
Subject 08: Vandetanib concentration centre of tumour1140
Subject 08 (1cm lesion): whole tumour Vandetanib concentration93500
Subject 08 (inferior lesion): Vandetanib concentration centre of tumour6180
Subject 08: Vandetanib concentration middle of tumour1240
Subject 08 (inferior lesion): Vandetanib concentration middle of tumour1440
Subject 08: Vandetanib concentration edge of tumour2840
Subject 08 (inferior lesion): Vandetanib concentration edge of tumour2710
Subject 08: Vandetanib concentration 1cm away from tumour29100
Subject 08 (1 cm lesion): Vandetanib concentration 1cm away from tumour5350
Subject 08 (inferior lesion): Vandetanib concentration 1cm away from tumour6010
PrimaryTime Taken to Reach the Maximum Concentration (Tmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814

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)
Reported as:
Mean · hours
Time Taken to Reach the Maximum Concentration (Tmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814
hoursBTG-002814
Vandetanib Plasma Tmax26.0 ± 67.08
N-desmethyl Plasma Tmax0.8 ± 1.04
PrimaryConcentration of Vandetanib and N-desmethyl Vandetanib in Plasma Over Time Until End of Study Following Treatment With BTG-002814

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)
Reported as:
Mean · ng*h/mL
Concentration of Vandetanib and N-desmethyl Vandetanib in Plasma Over Time Until End of Study Following Treatment With BTG-002814
ng*h/mLBTG-002814
Vandetanib Plasma AUCEoS6979.3 ± 3188.21
N-desmethyl Plasma AUCEoS81.1 ± 169.40
PrimaryConcentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814

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
Reported as:
Number · ng/mL
Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814
ng/mLBTG-002814
Subject 01: N-desmethyl Vandetanib concentration centre of tumour4620
Subject 01: N-desmethyl Vandetanib concentration middle of tumour4740
Subject 01: N-desmethyl Vandetanib concentration edge of tumour3680
Subject 01: N-desmethyl Vandetanib concentration 1cm away from tumour280
Subject 03: N-desmethyl concentration centre of tumour69.6
Subject 03: N-desmethyl Vandetanib concentration middle of tumour59.8
Subject 03: N-desmethyl Vandetanib concentration edge of tumour69.2
Subject 03: N-desmethyl Vandetanib concentration 1cm away from tumour831
Subject 05: N-desmethyl concentration centre of tumour421
Subject 05: N-desmethyl Vandetanib concentration middle of tumour418
Subject 05: N-desmethyl Vandetanib concentration edge of tumour469
Subject 05: N-desmethyl Vandetanib concentration 1cm away from tumour544
Subject 06: N-desmethyl concentration centre of tumour113
Subject 06: N-desmethyl Vandetanib concentration middle of tumour93.9
Subject 06: N-desmethyl Vandetanib concentration edge of tumour11.4
Subject 06: N-desmethyl Vandetanib concentration 1cm away from tumour55.6
Subject 07: N-desmethyl concentration centre of tumour21
Subject 07: N-desmethyl Vandetanib concentration middle of tumour15.7
Subject 07: N-desmethyl Vandetanib concentration edge of tumour28.7
Subject 07: N-desmethyl Vandetanib concentration 1cm away from tumour84
Subject 08: N-desmethyl concentration centre of tumour39.3
Subject 08 (1cm lesion): whole tumour N-desmethyl concentration208
Subject 08 (inferior lesion): N-desmethyl concentration centre of tumour80.2
Subject 08: N-desmethyl Vandetanib concentration middle of tumour57.1
Subject 08 (inferior lesion): N-desmethyl Vandetanib concentration middle of tumour101
Subject 08: N-desmethyl Vandetanib concentration edge of tumour145
Subject 08 (inferior lesion): N-desmethyl Vandetanib concentration edge of tumour171
Subject 08: N-desmethyl Vandetanib concentration 1cm away from tumour389
Subject 08 (1 cm lesion): N-desmethyl Vandetanib concentration 1cm away from tumour342
Subject 08 (inferior lesion): N-desmethyl Vandetanib concentration 1cm away from tumour405
SecondaryEvaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT

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
Reported as:
Number · µL
Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT
µLBTG-002814
Subject 01: Liver928.83
Subject 01: Registered sample399.27
Subject 01: Tumour361.14
Subject 01: tumour dilated 1cm393.79
Subject 01: Tumour dilated 2cm479.28
Subject 02: Liver764.69
Subject 02: Tumour596.78
Subject 02: Tumour dilated 1cm617.72
Subject 02: Tumour dilated 2cm649.97
Subject 03: Liver594.79
Subject 03: Registered sample116.54
Subject 03: Tumour0.32
Subject 03: Tumour dilated 1cm36.26
Subject 03: Tumour dilated 2cm108.85
Subject 04: Liver852.03
Subject 05: Liver849.29
Subject 05: Registered sample751.62
Subject 05: Tumour0
Subject 5: Tumour dilated 1cm15.26
Subject 05: Tumour dilated 2cm86.28
Subject 06: Liver202.56
Subject 06: Registered sample148.09
Subject 06: Tumour51.14
ubject 06: Tumour dilated 1cm115.39
Subject 06: Tumour dilated 2cm166.80
Subject 07: Liver720.78
Subject 07: Registered sample103.82
Subject 07: Tumour4.32
Subject 07: Tumour dilated 1cm75.43
Subject 07: Tumour dilated 2cm133.26
Subject 08: Liver693.73
Subject 08: Registered sample422.37
Subject 08: Tumour21.87
Subject 08: Tumour dilated 1cm264.90
Subject 08: Tumour dilated 2cm378.15
SecondaryEvaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Analysing Percentage of Tumour Necrosis and Viability

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)
Reported as:
Median · percentage of surgical specimen
Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Analysing Percentage of Tumour Necrosis and Viability
percentage of surgical specimenBTG-002814
Tumour necrosis92.5 (5 to 100)
Viable tumour7.5 (0 to 95)
SecondaryEvaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Assessing Number of Participants With Any Vascular Changes.

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)
Reported as:
Number · Count of Participants
Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Assessing Number of Participants With Any Vascular Changes.
Count of ParticipantsBTG-002814
Vascular changes absent8
Vascular changes present0
SecondaryAssessment 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.

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

Results for this outcome have not been posted.

Other pre-specifiedStudy Blood Biomarkers With the Potential to Identify Patients Likely to Respond to Treatment With BTG-002814

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).

Results for this outcome have not been posted.

Other pre-specifiedStudy Tissue Biomarkers to Explore Key Immune, Inflammatory and Drug Related Mechanisms

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.

Results for this outcome have not been posted.

Adverse events

Collected over 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). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BTG-0028141/8 (12.5%)4/8 (50%)8/8 (100%)
Most frequent serious events
Most frequent serious events
EventBTG-002814
Postoperative wound infectionInfections and infestations2/8
IleusGastrointestinal disorders1/8
Upper gastrointestinal hemorrhageGastrointestinal disorders1/8
AscitesHepatobiliary disorders1/8
Post procedural bile leakHepatobiliary disorders1/8
Lung infectionInfections and infestations1/8
SepsisInfections and infestations1/8
Abdominal wound dehiscenceInjury, poisoning and procedural complications1/8
Renal failure acuteRenal and urinary disorders1/8
Most frequent other events
Showing 10 of 67
Most frequent other events
EventBTG-002814
Abdominal painGastrointestinal disorders8/8
HaemoglobinInvestigations8/8
FatigueGeneral disorders7/8
HypertensionVascular disorders7/8
ConstipationGastrointestinal disorders5/8
DyspepsiaGastrointestinal disorders5/8
NauseaGastrointestinal disorders5/8
Alanine aminotransferaseInvestigations5/8
Aspartate aminotransferaseInvestigations5/8
Blood alkaline phosphataseInvestigations5/8

Baseline characteristics

Age, Continuous
Age, Continuous(years)BTG-002814
Median62.5 (50 to 69)
Sex: Female, Male
Sex: Female, Male(Participants)BTG-002814
Female1
Male7
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BTG-002814
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White7
More than one race0
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)BTG-002814
United Kingdom8
World Health Organisation (WHO) Performance Status
World Health Organisation (WHO) Performance Status(Participants)BTG-002814
Grade 0 (asymptomatic)8
Grade 1 (Symptomatic, but ambulatory)0
Grade 2 (Symptomatic, <50% in bed)0
Tumour type
Tumour type(Participants)BTG-002814
Hepatocellular carcinoma (HCC)2
Metastatic colorectal cancer (mCRC)6
Number of liver lesions
Number of liver lesions(Count)BTG-002814
Mean1.6 ± 1.4
07

Study locations

1 site
  • University College London Hospital
    Bloomsbury, London NW1 2BU, United Kingdom
08

References and documents

Publications

  • 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. PubMed 31579027 ↗

Study documents

  • Study protocol · Dec 3, 2018
  • Statistical analysis plan · May 16, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Registry details

Key details

Study ID
NCT03291379
Lead sponsor
Boston Scientific Corporation
Collaborators
Biocompatibles UK Ltd
Responsible party
Sponsor
First posted
Sep 25, 2017
Start date
May 17, 2017
Primary completion
Aug 3, 2019
Completion
Aug 3, 2019
Results posted
Feb 3, 2021
Last update
Jul 19, 2021

Study contacts

Professor Ricky Sharma
principal investigator · University College, London

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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