Cabozantinib in the Elderly With Metastatic Renal Cell Carcinoma (ZEBRA)

Istituto Oncologico Veneto IRCCS

Status: Active, not recruiting

Conditions: Renal Cell Carcinoma

Treatments: Drug: Cabozantinib

Study type: Observational

Funder types: Other

Identifiers

NCT04416646

ZEBRA

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of Cabozantinib in the treatment of patients with renal cell carcinoma.

Enrollment: 100 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 70 years
• Histological diagnosis of Renal Cell Carcinoma (any histology, with the exclusion of urothelial carcinomas)
• Locally advanced disease or metastatic disease (any site, measurable or non- measurable lesions), progressing after at least one line of VEGFR-targeted therapy (as per official registration of the drug at AIFA, in case of extension to first-line treatment, TKI-naïve patients will also be eligible), with or without previous exposure to check-point inhibitors.
• Life expectancy of at least 3 months
• Adequate hepatic, renal and bone marrow function as judged by the treating oncologist.
• Written informed consent

Exclusion criteria

• Inability to swallow cabozantinib tablets
• Serious comorbidities or cognitive impairment, which may interfere with cabozantinib administration and/or patient's follow up, as judged by the treating physician
• Absence of a reliable caregiver, as judged by the treating physician