drugset / Trial / NCT03520231
Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a phase 2 study of the drug denosumab for the management bone metastases from urothelial cancer. The purpose of this study is to find out how effective denosumab is in the management of bone metastases from urothelial cancer. This will be done by comparing denosumab with standard treatment, compared to placebo and standard treatment. Denosumab is a monoclonal antibody that binds to a protein called Receptor Activator of Nuclear Factor κB (RANK). RANK works by telling certain cells called osteoclasts to break down bone tissue. The binding of denosumab to RANK stops it from telling osteoclasts to break down bone tissue which may help with symptoms related bone metastases from urothelial cancer.
Timeline
- Start
- 2018-09-04
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denosumab | Monoclonal antibody | 120 mg | Subcutaneous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Cisplatin | Other / unclassified | — | Intravenous |
| Background | Gemcitabine | Small molecule | — | Intravenous |