ZEBRA: Cabozantinib in the Elderly With Metastatic Renal Cell Carcinoma

• Sponsor: Istituto Oncologico Veneto IRCCS (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04416646
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 46.1
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Drug: Cabozantinib

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Cabozantinib in the Elderly With Metastatic Renal Cell Carcinoma: Observational Study
• Actual Study Start Date: Feb 27, 2019
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

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"]

   according to RECIST criteria, only patients with measurable disease will be evaluated for response

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Oncologico Veneto	Padova		Italy	35100

Sponsors and Collaborators

• Istituto Oncologico Veneto IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Umberto basso, Doctor of Medicine I level, Istituto Oncologico Veneto IRCCS
• ClinicalTrials.gov Identifier: NCT04416646
• Other Study ID Numbers: ZEBRA
• First Posted: Jun 4, 2020
• Last Update Posted: Feb 8, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Umberto basso, Doctor of Medicine I level, Istituto Oncologico Veneto IRCCS: Cabozantinib
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Renal Cell

Study Results

No Results Posted as of Feb 8, 2022