Overview
Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2021-12-01
2021-12-01
Target enrollment:
0
0
Participant gender:
Female
Female
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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Kyowa Hakko Kirin Company, Limited
Kyowa Kirin Co., Ltd.Treatments:
Entinostat
Exemestane
Criteria
Inclusion Criteria:- Postmenopausal women aged ≥ 20 and < 75 years at the time of consent;
- Estrogen receptor positive and/or progesterone receptors positive;
- HER2-negative
- Nonresectable advanced or recurrent breast cancer previously treated with nonsteroidal
aromatase inhibitor (AI), and planning to be treated with exemestane
Exclusion Criteria:
- Radiation therapy or immuno therapy within 14 days before the first dose of
investigational product;
- Chemotherapy, biological medicines, other pharmacotherapy or major surgery within 21
days before the first dose of the investigational product;
- Prior chemotherapies of ≥ 3 regimens for advanced or recurrent breast cancer;
- Ongoing treatment with other investigational product