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
- Kidney Neoplasms
- Urethral Neoplasms
- Urinary Bladder Neoplasms
- Urothelial Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- Cabozantinib — DRUG60 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: CabozantinibAdministered 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | - |
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