TY - JOUR
T1 - A Phase II Study of Regorafenib With a Lower Starting Dose in Patients With Metastatic Colorectal Cancer
T2 - Exposure–Toxicity Analysis of Unbound Regorafenib and Its Active Metabolites (RESET Trial)
AU - Suzuki, Takeshi
AU - Sukawa, Yasutaka
AU - Imamura, Chiyo K.
AU - Masuishi, Toshiki
AU - Satake, Hironaga
AU - Kumekawa, Yosuke
AU - Funakoshi, Shinsuke
AU - Kotaka, Masahito
AU - Horie, Yoshiki
AU - Kawai, Sadayuki
AU - Okuda, Hiroyuki
AU - Terazawa, Tetsuji
AU - Kondoh, Chihiro
AU - Kato, Ken
AU - Yoshimura, Kenichi
AU - Ishikawa, Hideki
AU - Hamamoto, Yasuo
AU - Boku, Narikazu
AU - Takaishi, Hiromasa
AU - Kanai, Takanori
N1 - Funding Information:
The present study was supported by Keio Gijuku Academic Development Funds and the Japan Society for the Promotion of Science Grants-in-Aid for Scientific Research (grant JP17K08961). We thank all the patients who participated in the present study and their families. We also thank Ms Minae Nishiguchi for data management.
Funding Information:
The present study was supported by Keio Gijuku Academic Development Funds and the Japan Society for the Promotion of Science Grants-in-Aid for Scientific Research (grant JP17K08961 ). We thank all the patients who participated in the present study and their families. We also thank Ms Minae Nishiguchi for data management.
Publisher Copyright:
© 2019 Elsevier Inc.
PY - 2020/3
Y1 - 2020/3
N2 - 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.
AB - 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.
KW - Advanced colorectal cancer
KW - Dose escalation
KW - Multikinase inhibitor
KW - Pharmacokinetics
KW - Protein binding
UR - http://www.scopus.com/inward/record.url?scp=85075332951&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85075332951&partnerID=8YFLogxK
U2 - 10.1016/j.clcc.2019.10.004
DO - 10.1016/j.clcc.2019.10.004
M3 - Article
C2 - 31732439
AN - SCOPUS:85075332951
SN - 1533-0028
VL - 19
SP - 13-21.e3
JO - Clinical Colorectal Cancer
JF - Clinical Colorectal Cancer
IS - 1
ER -
