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Completed

NCT Number: NCT04416646

Cabozantinib in the Elderly With Metastatic Renal Cell Carcinoma

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

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Oncologico Veneto

Padova, Italy, 35100

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cabozantinib

Drug

The regimen will be a single oral dose administered daily on a continuous schedule, taken with or without food. The standard dose is 60 mg per day, which can be reduced to 40 or 20 mg according to the latest version of the Summary of Product Characteristics-SPC available. The treating oncologist will evaluate the opportunity to prudentially start treatment at 40 mg/daily in patients screening positively at G8 screening tool, and then escalate to 60 mg/daily only in case of absence of toxicity ³grade 2 at subsequent cycles. Temporary suspensions of treatment are allowed according to the local practice and will be registered if ³ 7 days.

Primary outcomes

  1. 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]

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Istituto Oncologico Veneto IRCCS

Other

Registry information

Official study title

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

Acronym: ZEBRA

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 4, 2020
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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