Cabozantinib in the Elderly With Metastatic Renal Cell Carcinoma

NCT04416646 | Completed

• 1 other identifier: ZEBRA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Cell Carcinoma

Keywords

Cabozantinib

Outcome Measures

Primary Outcomes (1)

• Clinical tolerability of Cabozantinib

  the main purpose is to register the Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]

  Average of 1 year

Secondary Outcomes (1)

• Description of response rate of patients treated with Cabozantinib.

  From date of randomization until the date of last documented, assessed up to 18 months"

Interventions

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.

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be enrolled from Italian oncology Centers

You may qualify if:

• Age 70 years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Oncologico Veneto IRCCS: lead

Study Sites (1)

Istituto Oncologico Veneto

Padova, Italy, 35100, Italy

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

cabozantinib

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine I level

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: June 4, 2020
• Study Start: February 27, 2019
• Primary Completion: June 26, 2023
• Study Completion: December 31, 2023
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

IT (1)