A Phase I Study of Pevonedistat Plus Capecitabine Plus Oxaliplatin in Patients With Advanced Gastric Cancer Refractory to Platinum (NCCH-1811) | Zendy

Hirokazu Shoji | Zendy; Daisuke Takahari | Zendy; Hiroki Hara | Zendy; Kengo Nagashima | Zendy; Jun Adachi | Zendy; Narikazu Boku | Zendy

Open Access

A 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 , medicine , paclitaxel , cisplatin , oncology , refractory (planetary science) , phases of clinical research , pharmacology , cancer , adverse effect , clinical trial , 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).

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