Cabozantinib for Advanced Urothelial Cancer

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01688999
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 11, 2012
Status verified
Sep 2022
Primary completion
Dec 11, 2017
Completion
Sep 14, 2020

Study Design

Enrollment
69 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib
    Administered orally at a dose of 60 mg once daily on each day of a 28-day cycle.

Primary Outcome Measure

Percentage of Participants With Overall Response [ Time Frame: Median follow-up was 61.2 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMaryland20892-

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