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Clinical trial

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

ID
Name
ZEBRA
Description
The purpose of this study is to evaluate the safety and efficacy of Cabozantinib in the treatment of patients with renal cell carcinoma.
Trial arms
Trial start
2019-02-27
Estimated PCD
2023-06-26
Trial end
2024-03-01
Status
Active (not recruiting)
Treatment
Cabozantinib
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.
Size
100
Primary endpoint
Clinical tolerability of Cabozantinib
Average of 1 year
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2024-02-21

1 organization

1 product

1 indication

Organization
Istituto Oncologico Veneto IRCCS
Product
Cabozantinib
Indication
Renal Cell Carcinoma