Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

NCT ID: NCT02623751

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2020-10-31

Brief 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KHK2375 PO and Exemestane PO

KHK2375 and Exemestane

Group Type: EXPERIMENTAL

KHK2375

Intervention Type: DRUG

KHK2375 will be orally administered once weekly. KHK2375 in combination with exemestane will be repeatedly administered in a 28-day cycle.

Exemestane will be orally administered once daily.

Exemestane

Intervention Type: DRUG

KHK2375 will be orally administered once weekly. KHK2375 in combination with exemestane will be repeatedly administered in a 28-day cycle.

Exemestane will be orally administered once daily.

Interventions

KHK2375

KHK2375 will be orally administered once weekly. KHK2375 in combination with exemestane will be repeatedly administered in a 28-day cycle.

Exemestane will be orally administered once daily.

Intervention Type: DRUG

Exemestane

KHK2375 will be orally administered once weekly. KHK2375 in combination with exemestane will be repeatedly administered in a 28-day cycle.

Exemestane will be orally administered once daily.

Intervention Type: DRUG

Other Intervention Names

Entinostat; MS-275; SDNX-275

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chikusa-ku, Aichi-ken, Japan

Chuo-ku, Osaka, Japan

Chuo-ku, Tokyo, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 34819039 (View on PubMed)

Other Identifiers

2375-001

Identifier Type: -

Identifier Source: org_study_id