CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 69 enrolled
Drug / intervention
Cabozantinibdrug
Likely dose
Cabozantinib 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01688999
NCT01688999Phase 2Completed

A Phase II Study of Cabozantinib (XL184) in Patients With Advanced/Metastatic Urothelial Carcinoma

National Cancer Institute (NCI)·interventional·Posted Sep 20, 2012·Updated Oct 18, 2022

In Brief

A Phase 2 clinical trial evaluating Cabozantinib for Urothelial Carcinoma and 3 related conditions. Completed, enrolled 69 participants across 1 site.

Detailed Summary

Background: \- Cabozantinib is a drug that slows the growth of blood vessels that feed tumors. It is approved for medullary thyroid cancer. However, studies have shown that prostate and ovarian tumors respond to it. Researchers want see if cabozantinib can be a safe and effective treatment for urothelial cancer. Objectives: \- To test the safety and effectiveness of cabozantinib for advanced urothelial cancer. Eligibility: \- Individuals at least 18 years of age who have advanced urothelial cancer that has not responded to standard treatments. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tumor tissue samples will also be collected. Imaging studies will also be performed. * Participants will take cabozantinib by mouth once per day on each day of a 28-day cycle. * Treatment will be monitored with frequent blood tests and imaging studies. * Participants will continue to take the study drug for as long as their cancer does not worsen and side effects are not too severe.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 20, 2012
Enrollment StartSep 11, 2012
Primary CompletionDec 11, 2017
Study CompletionSep 14, 2020
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 13.8 years ago

Interventions

Cabozantinibdrug

60 mg by mouth (PO) daily each 28 day cycle. Treatment continues until toxicity or disease progression.