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 anal, colon, and rectal cancers, gliosarcoma, and transitional cell carcinoma. It is a kinase inhibitor in Phase 1 clinical development. Vandetanib is not approved and remains under investigation for these indications.
Vandetanib is a kinase inhibitor, belonging to the -nib class of drugs that block specific enzymes involved in cancer cell growth. It is being studied for its effects on tumors in anal, colon, and rectal cancers, gliosarcoma, and transitional cell carcinoma, though its precise molecular targets are not specified.
Vandetanib is being developed by AstraZeneca PLC, a company traded under the ticker AZN. The drug is an investigational small molecule in Phase 1 clinical development for multiple oncology indications, including anal, colon, and rectal cancers, gliosarcoma, and transitional cell carcinoma.
Vandetanib is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed for its studied indications, including a Phase 1 trial for metastatic colorectal cancer and a Phase 2 trial for transitional cell carcinoma.
Vandetanib has been studied in clinical trials including NCT00532909, a Phase 1 trial combining Vandetanib with capecitabine, oxaliplatin, and bevacizumab for metastatic colorectal cancer, and NCT00613223, a Phase 1 dose escalation trial with etoposide for malignant gliomas. NCT00880334 was a Phase 2 randomized study of docetaxel with or without Vandetanib in metastatic transitional cell carcinoma.
Vandetanib is a distinct investigational kinase inhibitor developed by AstraZeneca. It is not known to be the same as any other drug. Its development focuses on anal, colon, and rectal cancers, gliosarcoma, and transitional cell carcinoma, with completed trials showing it is still in early clinical phases.