Phase 2
N=69
Cabozantinib for Advanced Urothelial Cancer
Urothelial Carcinoma · Urethral Neoplasms · Urinary Bladder Neoplasms · Kidney Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01688999 ↗Enrolled (actual)
69
Serious AEs
97.1%
Results posted
Oct 2020
Primary outcome: Primary: Percentage of Participants With Overall Response — 19.1; NA; NA percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cabozantinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Overall Response |
19.1; NA; NA | — |
| SECONDARY Overall Survival |
8.1; 9.3; 5.8 | — |
| SECONDARY Progression Free Survival |
3.7; 5.3; 2.9 | — |
| SECONDARY Number of Participants With Grade 4 Toxicity Hypomagnesium Related to Cabozantinib |
2 | — |
| SECONDARY Number of Participants With Serious and Non-serious Adverse Events Regardless of Attribution |
67 | — |
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.
Eligibility Criteria
- INCLUSION CRITERIA:
Cohort 1 only (urothelial progressive disease)
- Patients must have a histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis. Confirmation may be obtained from any Clinical Laboratory Improvement Amendments (CLIA) certified lab.
- Patients must have progressive metastatic disease. Progressive disease will be defined as new or progressive lesions on cross-sectional imaging.
- Patients must have at least one measurable site of disease
Cohort 2 only (Bone-only)
- Patients must have a histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis. Confirmation may be obtained from any CLIA certified lab.
- Patients must not have measurable progressive disease
- Patient must have appearance of at least one new bone lesion.
Cohort 3 (Rare histologies)
- Patient must have a histologically confirmed diagnosis of non-transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis including but not limited to squamous cell, neuroendocrine, adenocarcinoma including urachal and sarcomatoid. Confirmation may be obtained from any CLIA certified lab.
- Patients must have progressive metastatic disease. Progressive disease will be defined as new or progressive lesions on cross-sectional imaging.
- Patients must have at least one measurable site of disease
All cohorts
- Patients must have been previously treated, as defined by treatment with at least one prior cytotoxic regimen or agent.
- Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of cabozantinib in patients 500 ms within 28 days before treatment initiation.
- The subject has a previously identified allergy or hypersensitivity to components of the study treatment formulation.
- The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
- The subject has had within 2 years before the start of study treatment evidence of another malignancy which required systemic treatment
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with the study agents. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Data sourced from ClinicalTrials.gov (NCT01688999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.