Sequential Treatment of Cabozantinib for Advanced Kidney Cancer

This study is looking at how a higher dose of cabozantinib works in people with advanced renal cell carcinoma (RCC), which is a type of kidney cancer. You might be able to join if your kidney cancer has gotten worse after you've already been treated with cabozantinib alone for at least six months. The main goal is to see how long people live without their cancer getting worse (this is called progression-free survival). Researchers will follow participants for up to 24 months to see how well the treatment works.

Study design
This is a single-group study where all 18 participants will receive the same treatment. It is an open-label study, meaning both you and your doctors will know what treatment you are receiving.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed from the start of treatment until your disease gets worse, you have serious side effects, you pass away, or you stop the study treatment for any other reason, for up to 24 months.

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NCT05931393

Sequential Treatment of Cabozantinib for Advanced Renal Cell Carcinoma (RCC)

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Texas Southwestern Medical Center
~18 participants
Updated 2025-10-10 on ClinicalTrials.gov
What's tested:Cabozantinib 80 MG

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival of cabozantinib
Measured over From time of enrollment/treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
RCC
Renal Cell Carcinoma
1 sites across 1 states
Texas1
  • Tian Zhang, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

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Eligibility criteria

Inclusion

Males: (140 - age) x weight (kg)/(serum creatinine \[mg/dL\] × 72)
Females: \[(140 - age) x weight (kg)/(serum creatinine \[mg/dL\] × 72)\] × 0.85 10. Urine protein/creatinine ratio (UPCR) ≤1 mg/mg (≤113.2 mg/mmol), or 24h urine protein ≤1 g 12. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of cabozantinib
documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), or
documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other biological or physiological causes. 2. In addition, females \< 55 years-of-age must have a serum follicle stimulating hormone (FSH) level \> 40 mIU/mL to confirm menopause.
  • Progression free survival of cabozantinibFrom time of enrollment/treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months

    Progression free survival (PFS) will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST v 1.1)