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

April 9, 2026 updated by: Umberto basso, Istituto Oncologico Veneto IRCCS

Cabozantinib in the Elderly With Metastatic Renal Cell Carcinoma: Observational Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italy
      • Padova, Italy, Italy, 35100
        • Istituto Oncologico Veneto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be enrolled from Italian oncology Centers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical tolerability of Cabozantinib
Time Frame: Average of 1 year
the main purpose is to register the Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of response rate of patients treated with Cabozantinib.
Time Frame: From date of randomization until the date of last documented, assessed up to 18 months"
according to RECIST criteria, only patients with measurable disease will be evaluated for response
From date of randomization until the date of last documented, assessed up to 18 months"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Oncologico Veneto IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2019

Primary Completion (Actual)

June 26, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZEBRA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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