Cabozantinib in the Elderly With Metastatic Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

— ZEBRA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04416646
• Other study ID #: ZEBRA
• Status: Active, not recruiting
• Start date: February 27, 2019
• Est. completion date: March 1, 2024

Study information

• Verified date: February 2024
• Source: Istituto Oncologico Veneto IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: March 1, 2024
• Est. primary completion date: June 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Italy	Istituto Oncologico Veneto	Padova

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Oncologico Veneto IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Description of response rate of patients treated with Cabozantinib.	according to RECIST criteria, only patients with measurable disease will be evaluated for response	From date of randomization until the date of last documented, assessed up to 18 months"