Actively Recruiting
Sequential Treatment of Cabozantinib for Advanced Renal Cell Carcinoma (RCC)
Led by University of Texas Southwestern Medical Center · Updated on 2025-10-10
18
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn about the effects of a higher dose of ncabozantinib in patients with advanced renal cell carcinoma who have progressed on or after receiving cabozantinib treatment.
CONDITIONS
Official Title
Sequential Treatment of Cabozantinib for Advanced Renal Cell Carcinoma (RCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with advanced renal cell carcinoma (locally advanced unresectable or metastatic) of any histology who progressed on or after cabozantinib monotherapy
- Prior cabozantinib treatment for at least 6 months showing sensitivity
- Ability to tolerate prior cabozantinib at 60 mg daily with manageable side effects
- Prior PD-1 or PD-L1 inhibitor treatment allowed
- Measurable disease according to RECIST 1.1 criteria
- For up to 5 patients: archival tissue available within 30 days of consent and willingness to undergo biopsy at 12 weeks, or willingness to undergo baseline and 12-week biopsies
- Age 18 years or older at time of consent
- ECOG performance status of 0 to 2
- Ability to understand and follow study requirements and provide informed consent
- No washout period required for cabozantinib; 4 weeks or 4 half-lives washout for other anticancer therapies
- Recovery to baseline or grade 1 or less for prior treatment toxicities, unless clinically nonsignificant or stable on supportive therapy
- Adequate organ and marrow function based on specific laboratory criteria within 14 days before first dose
- Agreement to use accepted contraception methods during the study and for 4 months after last dose if sexually active and fertile
- Female participants of childbearing potential must meet specific sterilization or menopausal status criteria
You will not qualify if you...
- Radiation therapy for bone metastasis within 2 weeks or other radiation therapy within 4 weeks before first dose
- Systemic radionuclide treatment within 6 weeks before first dose
- Known brain metastases or cranial epidural disease unless treated and stable as specified
- Use of certain anticoagulants not allowed; some anticoagulant therapies permitted under conditions
- Uncontrolled or significant recent illnesses including severe heart conditions, uncontrolled hypertension, recent stroke or thromboembolic events within 6 months
- Gastrointestinal disorders with high risk of perforation or fistula, or recent abdominal complications within 6 months
- Significant bleeding events within 6 weeks before first dose
- Cavitating pulmonary lesions symptomatic or known endotracheal/endobronchial disease
- Lesions invading or encasing major blood vessels
- Serious non-healing wounds, moderate to severe liver impairment, or recent acute COVID-19 infection without recovery
- Major surgery within 2 weeks or minor surgery within 10 days before first dose without complete healing
- Corrected QT interval over 500 ms or additional risk factors for torsades de pointes
- Pregnant or breastfeeding women
- Inability to swallow tablets
- Allergy or severe reactions to study drug components
- Another active malignancy within 2 years requiring treatment, except certain locally curable cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
A
Amy Rowell, MBA,CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here