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

NCT03520231 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-11-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Denosumab

RANK Ligand Inhibitor

OTHER

Denosumab Placebo

Placebo

DRUG

Gemcitabine

Antineoplastic Agent

DRUG

Carboplatin

Antineoplastic Agent

DRUG

Cisplatin

Antineoplastic Agent

DIETARY_SUPPLEMENT

Calcium

Calcium Supplement

DIETARY_SUPPLEMENT

Vitamin D

Vitamin D Supplement

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Srikala Sridhar, M.D. · Princess Margaret Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-04
Primary Completion
2020-12-01
Completion
2020-12-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03520231 on ClinicalTrials.gov