Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
vandetanib · 2 trials · 5 indications
PFS based on the Kaplan-Meier method is defined as the time between randomization and documented disease progression (PD) per RECIST 1.0 criteria or death, or is censored at time of last disease assessment. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
| Arm | Type | Description |
|---|---|---|
| vandetanib & Docetaxel | EXPERIMENTAL | vandetanib orally and Docetaxel intravenously |
| Placebo and Docetaxel | ACTIVE_COMPARATOR | Placebo orally and docetaxel intravenously |
| Name | Type | Description |
|---|---|---|
| Docetaxel | DRUG | Given intravenously on Day 1 of each 21-day cycle |
| vandetanib | DRUG | taken orally once a day, every day |
| Placebo | DRUG | Taken orally once a day every day |
| Capecitabine | DRUG | Dosage: 1000mg/m2 By mouth twice a day for 14 days or reduced dose of 800mg/m2 PO BID days1-14. |
| Oxaliplatin | DRUG | dosage: 130mg/m2. IV Day 1 of a 21 day cycle or reduced dose of 100mg/m2 IV Day 1. |
| Bevacizumab | DRUG | Dosage: 7.5mg/kg or 10mg/kg. IV Day 1 (21 day cycle) |
Inclusion Criteria: * Histologically or cytologically confirmed TCC. Mixed histologies are allowed as long as the predominant histology is TCC. * Must have received chemotherapy treatment for TCC and have stage IV TCC at the time of study entry. 1-3 prior systemic chemotherapeutic or investigationa...
Vandetanib is an investigational small molecule being studied in oncology for transitional cell carcinoma, gliosarcoma, and anal, colon, and rectal cancers. It is in Phase 1 clinical development for these indications, with completed trials in metastatic colorectal cancer, malignant gliomas, and metastatic transitional cell carcinoma.
Vandetanib is a kinase inhibitor that targets multiple receptors, including EPHA2, EPHB2, EPHA5, EPHA4, EPHA8, EPHA6, EPHA7, EPHB3, EPHA3, EPHB1, EPHB4, EPHA1, EPHA10, PTK6, RET, FLT1, FLT4, KDR, ERBB2, EGFR, ERBB4, ERBB3, SRC, and TEK. It inhibits these targets as part of its mechanism of action.
Vandetanib is being developed by AstraZeneca PLC, a company listed on the stock exchange under the ticker AZN. AstraZeneca is the developer of this investigational oncology drug.
Vandetanib is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Its clinical trials include completed Phase 1 and Phase 2 studies, but the current development stage is Phase 1.
Vandetanib has been studied in three clinical trials: NCT00532909, a Phase 1 study combining vandetanib with capecitabine, oxaliplatin, and bevacizumab for metastatic colorectal cancer; NCT00613223, a Phase 1 dose escalation trial with etoposide for malignant gliomas; and NCT00880334, a randomized Phase 2 study of docetaxel with or without vandetanib in metastatic transitional cell carcinoma.
Vandetanib is also known by the ChEMBL identifier CHEMBL24828. This identifier is used in chemical and biological databases to reference the compound, which is a small molecule kinase inhibitor.