A Phase 2 Study of Cabozantinib in Japanese Participants With Advanced Renal Cell Carcinoma

Summary

The purpose of this study is to evaluate the efficacy of cabozantinib measured by Independent Radiology Committee (IRC)-assessed objective response rate (ORR) in Japanese participants with advanced renal cell carcinoma (RCC) that has progressed after prior vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) therapy.

Timeline

Start

2017-12-13

Primary completion

2020-08-25

Completion

2020-08-25

Publications

• Nakaigawa N, Tomita Y, Tamada S, Tatsugami K, Osawa T, Oya M, Kanayama H, Miura Y, Sassa N, Nishimura K, Nozawa M, Masumori N, Miyoshi Y, Kuroda S, Kimura A. Final efficacy and safety results and biomarker analysis of a phase 2 study of cabozantinib in Japanese patients with advanced renal cell carcinoma. Int J Clin Oncol. 2023 Mar;28(3):416-426. doi: 10.1007/s10147-022-02283-w. Epub 2023 Jan 3.
• Tomita Y, Tatsugami K, Nakaigawa N, Osawa T, Oya M, Kanayama H, Nakayama Kondoh C, Sassa N, Nishimura K, Nozawa M, Masumori N, Miyoshi Y, Kuroda S, Tanaka S, Kimura A, Tamada S. Cabozantinib in advanced renal cell carcinoma: A phase II, open-label, single-arm study of Japanese patients. Int J Urol. 2020 Nov;27(11):952-959. doi: 10.1111/iju.14329. Epub 2020 Aug 12.

Drugs

Indications