Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BTG-002814 · 1 trial · 2 indications
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)
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.
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).
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
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).
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).
| Arm | Type | Description |
|---|---|---|
| BTG-002814 | EXPERIMENTAL | Single arm: BTG-002814 (vandetanib-eluting radiopaque beads) |
| Name | Type | Description |
|---|---|---|
| BTG-002814 | DRUG | BTG-002814 containing 100 mg vandetanib |
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 ...
BTG-002814 is a small molecule being developed by Boston Scientific Corporation for the treatment of hepatocellular carcinoma, a type of liver cancer. It is administered as vandetanib-eluting radiopaque embolic beads, which are placed directly into the liver to deliver the drug locally. The drug is currently in early-stage clinical development.
BTG-002814 is a small molecule that is delivered via embolic beads, which block blood flow to tumors while releasing the drug vandetanib locally. Vandetanib is a kinase inhibitor that targets pathways involved in tumor growth and angiogenesis. This approach aims to concentrate the drug at the tumor site while reducing systemic exposure.
BTG-002814 is being developed by Boston Scientific Corporation, a medical device and pharmaceutical company traded on the New York Stock Exchange under the ticker BSX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with liver malignancies.
BTG-002814 is in Phase 1 clinical development. A completed early-phase trial (NCT03291379) evaluated the drug in patients with resectable liver malignancies, including hepatocellular carcinoma and metastatic colorectal cancer. The drug is investigational and has not been approved by regulatory authorities.
BTG-002814 has been studied in one completed clinical trial, NCT03291379, titled "Vandetanib-eluting Radiopaque Embolic Beads in Patients With Resectable Liver Malignancies." This early-phase study enrolled 8 participants in the United Kingdom and included patients with hepatocellular carcinoma and metastatic colorectal cancer.
BTG-002814 is a formulation of vandetanib, a kinase inhibitor, delivered via radiopaque embolic beads. While vandetanib is the active pharmaceutical ingredient, BTG-002814 refers to the specific drug-eluting bead product developed by Boston Scientific for local delivery to liver tumors.