drugset / Trial / NCT03520231

Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases

NCT03520231

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

EvaluationDrugModalityDoseRoute
Subject Denosumab Monoclonal antibody 120 mg Subcutaneous
Background Carboplatin Small molecule Intravenous
Background Cisplatin Other / unclassified Intravenous
Background Gemcitabine Small molecule Intravenous