Trial · NCT03291379
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | To Assess the Safety and Tolerability of Treatment With BTG-002814 | Continuously throughout the study totalling 9 weeks | Safety population - all participants treated with BTG-002814 | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Maximum Concentration (Cmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814 | 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) | all participants treated with BTG-002814 | ng/mL | MEAN |
| PRIMARY | Concentration of Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814 | Following surgical resection of tumour | 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. | ng/mL | NUMBER |
| PRIMARY | Time Taken to Reach the Maximum Concentration (Tmax) of Vandetanib and N-desmethyl Vandetanib in Plasma Following Treatment With BTG-002814 | 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) | all participants treated with BTG-002814 | hours | MEAN |
| PRIMARY | Concentration of Vandetanib and N-desmethyl Vandetanib in Plasma Over Time Until End of Study Following Treatment With BTG-002814 | 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) | all participants treated with BTG-002814 | ng*h/mL | MEAN |
| PRIMARY | Concentration of N-desmethyl Vandetanib in Resected Liver Tissue Following Treatment With BTG-002814 | Following surgical resection of tumour | 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. | ng/mL | NUMBER |
| SECONDARY | Evaluate the Anatomical Distribution of BTG-002814 on Non-contrast Enhanced Imaging Using 4D CT | 1 day after treatment | 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. | µL | NUMBER |
| SECONDARY | Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Analysing Percentage of Tumour Necrosis and Viability | Post-surgery (tumour resection) | all participants treated with BTG-002814 | percentage of surgical specimen | MEDIAN |
| SECONDARY | Evaluation of Histopathological Features in the Surgical Specimen (Malignant and Non-malignant Liver Tissue) by Assessing Number of Participants With Any Vascular Changes. | Post-surgery (tumour resection) | Count of Participants | NUMBER | |
| 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. | Baseline, pre-treatment, up to 3 days prior to surgical resection of tumour | |||
| OTHER_PRE_SPECIFIED | Study Blood Biomarkers With the Potential to Identify Patients Likely to Respond to Treatment With BTG-002814 | Baseline, pre-treatment, 1 day after treatment, Up to 3 days prior to surgical resection, end of study (28-32 days post-surgery). | |||
| OTHER_PRE_SPECIFIED | Study Tissue Biomarkers to Explore Key Immune, Inflammatory and Drug Related Mechanisms | Baseline, pre-treatment, Up to 3 days prior to surgical resection. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03291379/outcomes