Open AccessA Phase I study of pevonedistat plus capecitabine plus oxaliplatin in patients with advanced gastric cancer refractory to platinum (NCCH-1811)
Author(s) -
Hirokazu Shoji,
Daisuke Takahari,
Hiroki Hara,
Kengo Nagashima,
Jun Adachi,
Narikazu Boku
Publication year - 2021
Publication title -
future science oa
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.825
H-Index - 23
ISSN - 2056-5623
DOI - 10.2144/fsoa-2021-0023
Subject(s) - oxaliplatin , capecitabine , tolerability , paclitaxel , medicine , cisplatin , oncology , refractory (planetary science) , pharmacology , phases of clinical research , cancer , clinical trial , adverse effect , chemotherapy , colorectal cancer , biology , astrobiology
Based on synergistic anti-tumor effects between blockades of NEDD8 activating enzyme and a platinum in preclinical studies, this Phase I study is designed to investigate the safety and tolerability of pevonedistat in combination with capecitabine plus oxaliplatin as third-line or later treatment in patients with unresectable advanced/recurrent gastric cancer who were previously treated with fluoropyrimidines and platinum (cisplatin or oxaliplatin) as the first-line treatment and paclitaxel (including nab-paclitaxel) as the second-line treatment. The aim of this trial is to determine the recommended dose of pevonedistat and to see its pharmacokinetics in combination with capecitabine plus oxaliplatin in the dose-finding part and explore its efficacy and safety in the expansion part. Trial registration number: jRCT2031190020 (jRCTs: the Japan Registry of Clinical Trials).