Renal Cell Carcinoma
Conditions
Keywords
Cabozantinib
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.
Interventions
DRUGCabozantinib
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.
Sponsors
Istituto Oncologico Veneto IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical tolerability of Cabozantinib | Average of 1 year | the main purpose is to register the Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of response rate of patients treated with Cabozantinib. | 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 |
Countries
Italy
Outcome results
None listed