Exploratory Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon Cancer

Phase 2 Completed 79 enrolled Asahi Kasei Therapeutics Corporation

RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to evaluate the efficacy and safety of ART-123 for the prevention of cancer treatment related symptoms in patients with postoperative stage II / III colon cancer.

Timeline

Start: 2016-07
Primary completion: 2018-02
Completion: 2018-02

Publications

Kotaka M, Saito Y, Kato T, Satake H, Makiyama A, Tsuji Y, Shinozaki K, Fujiwara T, Mizushima T, Harihara Y, Nagata N, Kurihara N, Ando M, Kusakawa G, Sakai T, Uchida Y, Takamoto M, Kimoto S, Hyodo I. A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy. Cancer Chemother Pharmacol. 2020 Nov;86(5):607-618. doi: 10.1007/s00280-020-04135-8. Epub 2020 Sep 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	thrombomodulin alfa	Protein / enzyme biologic	380 iu/kg	Intravenous

Indications

No indication recorded.