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| Name | Class |
|---|---|
| Biocompatibles UK Ltd | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTG-002814 | Experimental | Single arm: BTG-002814 (vandetanib-eluting radiopaque beads) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTG-002814 | Drug | BTG-002814 containing 100 mg vandetanib |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Continuously throughout the study totalling 9 weeks |
| 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. | 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) |
| 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). | Following surgical resection of tumour |
| 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 | 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) |
| Concentration of Vandetanib and N-desmethyl Vandetanib in Plasma Over Time Until End of Study Following Treatment With BTG-002814 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, pre-treatment, 1 day after treatment, Up to 3 days prior to surgical resection, end of study (28-32 days post-surgery). |
Inclusion Criteria:
Exclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Professor Ricky Sharma | University College, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London Hospital | Bloomsbury | London | NW1 2BU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31579027 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | BTG-002814 | Single arm: BTG-002814 (vandetanib-eluting radiopaque beads) BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BTG-002814 | Single arm: BTG-002814 (vandetanib-eluting radiopaque beads) BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Safety population - all participants treated with BTG-002814 | Posted | Count of Participants | Participants | Continuously throughout the study totalling 9 weeks |
|
|
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)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BTG-002814 | Single arm: BTG-002814 (vandetanib-eluting radiopaque beads) BTG-002814 (vandetanib-eluting radiopaque beads): BTG-002814 containing 100 mg vandetanib |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA (21.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Cooper | Biocompatibles UK Ltd | 07805354224 | Sarah-Jane.Cooper@bsci.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 3, 2018 | Aug 20, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2019 | Aug 19, 2020 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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1 mL BTG-002814 containing 100 mg vandetanib
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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). |
| 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) |
| 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). | Following surgical resection of tumour |
| 1 day after treatment |
| 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. | Post-surgery (tumour resection) |
| 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. | Post-surgery (tumour resection) |
| 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. | Baseline, pre-treatment, up to 3 days prior to surgical resection of tumour |
| 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). | Baseline, pre-treatment, Up to 3 days prior to surgical resection. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| World Health Organisation (WHO) Performance Status | Count of Participants | Participants |
|
| Tumour type | 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 | Count of Participants | Participants |
|
| Number of liver lesions | Mean | Standard Deviation | Count |
|
| Participants |
|
|
| Primary | 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. | all participants treated with BTG-002814 | Posted | Mean | Standard Deviation | ng/mL | 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) |
|
|
|
| Primary | 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). | 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. | Posted | Number | ng/mL | Following surgical resection of tumour |
|
|
|
| Primary | 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 | all participants treated with BTG-002814 | Posted | Mean | Standard Deviation | hours | 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) |
|
|
|
| Primary | 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). | all participants treated with BTG-002814 | Posted | Mean | Standard Deviation | ng*h/mL | 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) |
|
|
|
| Primary | 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). | 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. | Posted | Number | ng/mL | Following surgical resection of tumour |
|
|
|
| Secondary | 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. | 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. | Posted | Number | µL | 1 day after treatment |
|
|
|
| Secondary | 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. | all participants treated with BTG-002814 | Posted | Median | Full Range | percentage of surgical specimen | Post-surgery (tumour resection) |
|
|
|
| Secondary | 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. | Posted | Number | Count of Participants | Post-surgery (tumour resection) |
|
|
|
| Secondary | 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. | Not Posted | Baseline, pre-treatment, up to 3 days prior to surgical resection of tumour | Participants |
| Other Pre-specified | 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. | Not Posted | Baseline, pre-treatment, 1 day after treatment, Up to 3 days prior to surgical resection, end of study (28-32 days post-surgery). | Participants |
| Other Pre-specified | 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). | Not Posted | Baseline, pre-treatment, Up to 3 days prior to surgical resection. | Participants |
| 1 |
| 8 |
| 4 |
| 8 |
| 8 |
| 8 |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Ascites | Hepatobiliary disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Post procedural bile leak | Hepatobiliary disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA (21.0) | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Cardiac signs and symptoms NEC | Cardiac disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Alanine aminotransferase | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Aspartate aminotransferase | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Blood albumin | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Blood alkaline phosphatase | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Blood bilirubin | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Blood calcium | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Blood creatinine | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Blood glucose | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Blood lactic acid | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Blood magnesium | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Blood sodium | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Blood thyroid stimulating hormone | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Blood urea | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Blood uric acid | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| C-reactive protein | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Gamma-glutamyl transferase | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Glomerular filtration rate | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Haemoglobin | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| International normalized ratio | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Neutrophil count | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Platelet count | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| White blood cell count | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (21.0) | Non-systematic Assessment |
|
Not provided
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
|
| Subject 01: Vandetanib concentration edge of tumour |
|
|
| Subject 01: Vandetanib concentration 1cm away from tumour |
|
|
| Subject 03: Vandetanib concentration centre of tumour |
|
|
| Subject 03: Vandetanib concentration middle of tumour |
|
|
| Subject 03: Vandetanib concentration edge of tumour |
|
|
| Subject 03: Vandetanib concentration 1cm away from tumour |
|
|
| Subject 05: Vandetanib concentration centre of tumour |
|
|
| Subject 05: Vandetanib concentration middle of tumour |
|
|
| Subject 05: Vandetanib concentration edge of tumour |
|
|
| Subject 05: Vandetanib concentration 1cm away from tumour |
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|
| Subject 06: Vandetanib concentration centre of tumour |
|
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| Subject 06: Vandetanib concentration middle of tumour |
|
|
| Subject 06: Vandetanib concentration edge of tumour |
|
|
| Subject 06: Vandetanib concentration 1cm away from tumour |
|
|
| Subject 07: Vandetanib concentration centre of tumour |
|
|
| Subject 07: Vandetanib concentration middle of tumour |
|
|
| Subject 07: Vandetanib concentration edge of tumour |
|
|
| Subject 07: Vandetanib concentration 1cm away from tumour |
|
|
| Subject 08: Vandetanib concentration centre of tumour |
|
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| Subject 08 (1cm lesion): whole tumour Vandetanib concentration |
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| Subject 08 (inferior lesion): Vandetanib concentration centre of tumour |
|
|
| Subject 08: Vandetanib concentration middle of tumour |
|
|
| Subject 08 (inferior lesion): Vandetanib concentration middle of tumour |
|
|
| Subject 08: Vandetanib concentration edge of tumour |
|
|
| Subject 08 (inferior lesion): Vandetanib concentration edge of tumour |
|
|
| Subject 08: Vandetanib concentration 1cm away from tumour |
|
|
| Subject 08 (1 cm lesion): Vandetanib concentration 1cm away from tumour |
|
|
| Subject 08 (inferior lesion): Vandetanib concentration 1cm away from tumour |
|
|
|
| Subject 01: N-desmethyl Vandetanib concentration edge of tumour |
|
|
| Subject 01: N-desmethyl Vandetanib concentration 1cm away from tumour |
|
|
| Subject 03: N-desmethyl concentration centre of tumour |
|
|
| Subject 03: N-desmethyl Vandetanib concentration middle of tumour |
|
|
| Subject 03: N-desmethyl Vandetanib concentration edge of tumour |
|
|
| Subject 03: N-desmethyl Vandetanib concentration 1cm away from tumour |
|
|
| Subject 05: N-desmethyl concentration centre of tumour |
|
|
| Subject 05: N-desmethyl Vandetanib concentration middle of tumour |
|
|
| Subject 05: N-desmethyl Vandetanib concentration edge of tumour |
|
|
| Subject 05: N-desmethyl Vandetanib concentration 1cm away from tumour |
|
|
| Subject 06: N-desmethyl concentration centre of tumour |
|
|
| Subject 06: N-desmethyl Vandetanib concentration middle of tumour |
|
|
| Subject 06: N-desmethyl Vandetanib concentration edge of tumour |
|
|
| Subject 06: N-desmethyl Vandetanib concentration 1cm away from tumour |
|
|
| Subject 07: N-desmethyl concentration centre of tumour |
|
|
| Subject 07: N-desmethyl Vandetanib concentration middle of tumour |
|
|
| Subject 07: N-desmethyl Vandetanib concentration edge of tumour |
|
|
| Subject 07: N-desmethyl Vandetanib concentration 1cm away from tumour |
|
|
| Subject 08: N-desmethyl concentration centre of tumour |
|
|
| Subject 08 (1cm lesion): whole tumour N-desmethyl concentration |
|
|
| Subject 08 (inferior lesion): N-desmethyl concentration centre of tumour |
|
|
| Subject 08: N-desmethyl Vandetanib concentration middle of tumour |
|
|
| Subject 08 (inferior lesion): N-desmethyl Vandetanib concentration middle of tumour |
|
|
| Subject 08: N-desmethyl Vandetanib concentration edge of tumour |
|
|
| Subject 08 (inferior lesion): N-desmethyl Vandetanib concentration edge of tumour |
|
|
| Subject 08: N-desmethyl Vandetanib concentration 1cm away from tumour |
|
|
| Subject 08 (1 cm lesion): N-desmethyl Vandetanib concentration 1cm away from tumour |
|
|
| Subject 08 (inferior lesion): N-desmethyl Vandetanib concentration 1cm away from tumour |
|
|
|
| Subject 01: Tumour |
|
|
| Subject 01: tumour dilated 1cm |
|
|
| Subject 01: Tumour dilated 2cm |
|
|
| Subject 02: Liver |
|
|
| Subject 02: Tumour |
|
|
| Subject 02: Tumour dilated 1cm |
|
|
| Subject 02: Tumour dilated 2cm |
|
|
| Subject 03: Liver |
|
|
| Subject 03: Registered sample |
|
|
| Subject 03: Tumour |
|
|
| Subject 03: Tumour dilated 1cm |
|
|
| Subject 03: Tumour dilated 2cm |
|
|
| Subject 04: Liver |
|
|
| Subject 05: Liver |
|
|
| Subject 05: Registered sample |
|
|
| Subject 05: Tumour |
|
|
| Subject 5: Tumour dilated 1cm |
|
|
| Subject 05: Tumour dilated 2cm |
|
|
| Subject 06: Liver |
|
|
| Subject 06: Registered sample |
|
|
| Subject 06: Tumour |
|
|
| ubject 06: Tumour dilated 1cm |
|
|
| Subject 06: Tumour dilated 2cm |
|
|
| Subject 07: Liver |
|
|
| Subject 07: Registered sample |
|
|
| Subject 07: Tumour |
|
|
| Subject 07: Tumour dilated 1cm |
|
|
| Subject 07: Tumour dilated 2cm |
|
|
| Subject 08: Liver |
|
|
| Subject 08: Registered sample |
|
|
| Subject 08: Tumour |
|
|
| Subject 08: Tumour dilated 1cm |
|
|
| Subject 08: Tumour dilated 2cm |
|
|