Cabozantinib in advanced renal cell carcinoma: A phase II, open-label, single-arm study of Japanese patients.

ABSTRACT:

Objectives

To evaluate the efficacy and safety of cabozantinib, through a bridging study to METEOR, in Japanese patients with advanced renal cell carcinoma who had progressed after prior tyrosine kinase inhibitor therapy.

Methods

This phase II, open-label, single-arm study (ClinicalTrials.gov registration number: NCT03339219) included adult Japanese patients with advanced renal cell carcinoma and measurable disease who had received one or more tyrosine kinase inhibitors. Patients received cabozantinib 60 mg orally once daily while there was clinical benefit, or until unacceptable toxicity or disease progression. The primary end-point was objective response rate per Response Evaluation Criteria in Solid Tumors Version 1.1. Secondary end-points included clinical benefit rate (

SUBMITTER: Tomita Y 

PROVIDER: S-EPMC7689847 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature