Cabozantinib in the Elderly With Metastatic Renal Cell Carcinoma
NCT ID: NCT04416646
Last Updated: 2024-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
100 participants
OBSERVATIONAL
2019-02-27
2024-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
70 Years
ALL
No
Sponsors
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Istituto Oncologico Veneto IRCCS
OTHER
Responsible Party
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Umberto basso
Doctor of Medicine I level
Locations
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Istituto Oncologico Veneto
Padua, , Italy
Countries
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Other Identifiers
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ZEBRA
Identifier Type: -
Identifier Source: org_study_id
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