A Phase II Study of Regorafenib With a Lower Starting Dose in Patients With Metastatic Colorectal Cancer: Exposure–Toxicity Analysis of Unbound Regorafenib and Its Active Metabolites (RESET Trial)

Takeshi Suzuki, Yasutaka Sukawa, Chiyo Imamura, Toshiki Masuishi, Hironaga Satake, Yosuke Kumekawa, Shinsuke Funakoshi, Masahito Kotaka, Yoshiki Horie, Sadayuki Kawai, Hiroyuki Okuda, Tetsuji Terazawa, Chihiro Kondoh, Ken Kato, Kenichi Yoshimura, Hideki Ishikawa, Yasuo Hamamoto, Narikazu Boku, Hiromasa Takaishi, Takanori Kanai

Research output: Contribution to journalArticle

Abstract

To improve the tolerability and maintain sufficient efficacy of regorafenib, we conducted a phase II study of regorafenib with a lower starting dose of 120 mg/day for patients with refractory metastatic colorectal cancer. Using this dose-escalation strategy, the disease control rate for the 68 evaluable patients was lower than that in our statistical hypothesis, and a relationship of unbound exposure with toxicity was observed.

Original languageEnglish
Pages (from-to)13-21.e3
JournalClinical Colorectal Cancer
Volume19
Issue number1
DOIs
Publication statusPublished - 2020 Mar

Keywords

  • Advanced colorectal cancer
  • Dose escalation
  • Multikinase inhibitor
  • Pharmacokinetics
  • Protein binding

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology

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    Suzuki, T., Sukawa, Y., Imamura, C., Masuishi, T., Satake, H., Kumekawa, Y., Funakoshi, S., Kotaka, M., Horie, Y., Kawai, S., Okuda, H., Terazawa, T., Kondoh, C., Kato, K., Yoshimura, K., Ishikawa, H., Hamamoto, Y., Boku, N., Takaishi, H., & Kanai, T. (2020). A Phase II Study of Regorafenib With a Lower Starting Dose in Patients With Metastatic Colorectal Cancer: Exposure–Toxicity Analysis of Unbound Regorafenib and Its Active Metabolites (RESET Trial). Clinical Colorectal Cancer, 19(1), 13-21.e3. https://doi.org/10.1016/j.clcc.2019.10.004