Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

Phase 1 Completed 15 enrolled Kyowa Kirin, Inc.

NaSingle-groupOpen-labelTreatment

Summary

The primary objective of the open-label, dose-escalation study is to investigate the safety of single-dose monotherapy and repeated-dose of KHK2375 combined with exemestane in female subjects with advanced or recurrent breast cancer. The secondary objective is to investigate the pharmacokinetics and efficacy.

Timeline

Start: 2015-11
Primary completion: 2020-10
Completion: 2020-10

Publications

Masuda N, Tamura K, Yasojima H, Shimomura A, Sawaki M, Lee MJ, Yuno A, Trepel J, Kimura R, Nishimura Y, Saji S, Iwata H. Phase 1 trial of entinostat as monotherapy and combined with exemestane in Japanese patients with hormone receptor-positive advanced breast cancer. BMC Cancer. 2021 Nov 24;21(1):1269. doi: 10.1186/s12885-021-08973-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Entinostat	Small molecule	3 mg	Oral
Subject	Entinostat	Small molecule	5 mg	Oral
Subject	Entinostat	Small molecule	10 mg	Oral
Background	Exemestane	Small molecule	25 mg	Oral

Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

Summary

Timeline

Publications

Drugs

Indications